title: Collection d'échantillons Biologiques Humains de Sujets Sains et Malades Pour la Mise au Point et la Validation de Nouvelles méthodes de Diagnostic et Pour la réalisation d'Expertises Dans le Domaine Des Maladies Infectieuses et Tropicales

acronym: Diagmicoll

summary: Direct constitution of collections from various samples taken on a prospective cohort of healthy volunteers, to prepare human biological samples of known characteristics (biochemical and serological in particular) and quality controlled.

ReferenceCitation: Pajot A, Michel ML, Mancini-Bourgine M, Ungeheuer MN, Ojcius DM, Deng Q, Lemonnier FA, Lone YC. Identification of novel HLA-DR1-restricted epitopes from the hepatitis B virus envelope protein in mice expressing HLA-DR1 and vaccinated human subjects. Microbes Infect. 2006 Oct;8(12-13):2783-90. Epub 2006 Sep 12.

ReferenceCitation: Buffet PA, Milon G, Brousse V, Correas JM, Dousset B, Couvelard A, Kianmanesh R, Farges O, Sauvanet A, Paye F, Ungeheuer MN, Ottone C, Khun H, Fiette L, Guigon G, Huerre M, Mercereau-Puijalon O, David PH. Ex vivo perfusion of human spleens maintains clearing and processing functions. Blood. 2006 May 1;107(9):3745-52. Epub 2005 Dec 29.

ReferenceCitation: Launay O, Toneatti C, Bernède C, Njamkepo E, Petitprez K, Leblond A, Larnaudie S, Goujon C, Ungeheuer MN, Ajana F, Raccurt C, Beytout J, Chidiac C, Bouhour D, Guillemot D, Guiso N. Antibodies to tetanus, diphtheria and pertussis among healthy adults vaccinated according to the French vaccination recommendations. Hum Vaccin. 2009 May;5(5):341-6. Epub 2009 May 9.

ReferenceCitation: Taneja N, Nato F, Dartevelle S, Sire JM, Garin B, Thi Phuong LN, Diep TT, Shako JC, Bimet F, Filliol I, Muyembe JJ, Ungeheuer MN, Ottone C, Sansonetti P, Germani Y. Dipstick test for rapid diagnosis of Shigella dysenteriae 1 in bacterial cultures and its potential use on stool samples. PLoS One. 2011;6(10):e24830. doi: 10.1371/journal.pone.0024830. Epub 2011 Oct 3.

ReferenceCitation: Azimi-Nezhad M, Lambert D, Ottone C, Perrin C, Chapel C, Gaillard G, Pfister M, Masson C, Tabone E, Betsou F, Meyronet D, Ungeheuer MN, Siest SV. Influence of pre-analytical variables on VEGF gene expression and circulating protein concentrations. Biopreserv Biobank. 2012 Oct;10(5):454-61. doi: 10.1089/bio.2012.0016.

ReferenceCitation: Berthet N, Paulous S, Coffey LL, Frenkiel MP, Moltini I, Tran C, Matheus S, Ottone C, Ungeheuer MN, Renaudat C, Caro V, Dussart P, Gessain A, Desprès P. Resequencing microarray method for molecular diagnosis of human arboviral diseases. J Clin Virol. 2013 Mar;56(3):238-43. doi: 10.1016/j.jcv.2012.10.022. Epub 2012 Dec 7.

ReferenceCitation: Duran C, Nato F, Dartevelle S, Thi Phuong LN, Taneja N, Ungeheuer MN, Soza G, Anderson L, Benadof D, Zamorano A, Diep TT, Nguyen TQ, Nguyen VH, Ottone C, Bégaud E, Pahil S, Prado V, Sansonetti P, Germani Y. Rapid diagnosis of diarrhea caused by Shigella sonnei using dipsticks; comparison of rectal swabs, direct stool and stool culture. PLoS One. 2013 Nov 22;8(11):e80267. doi: 10.1371/journal.pone.0080267. eCollection 2013.

ReferenceCitation: Frémond ML, Pérot P, Muth E, Cros G, Dumarest M, Mahlaoui N, Seilhean D, Desguerre I, Hébert C, Corre-Catelin N, Neven B, Lecuit M, Blanche S, Picard C, Eloit M. Next-Generation Sequencing for Diagnosis and Tailored Therapy: A Case Report of Astrovirus-Associated Progressive Encephalitis. J Pediatric Infect Dis Soc. 2015 Sep;4(3):e53-7. doi: 10.1093/jpids/piv040. Epub 2015 Jul 12.

ReferenceCitation: Vayssier-Taussat M, Cosson JF, Degeilh B, Eloit M, Fontanet A, Moutailler S, Raoult D, Sellal E, Ungeheuer MN, Zylbermann P. How a multidisciplinary 'One Health' approach can combat the tick-borne pathogen threat in Europe. Future Microbiol. 2015;10(5):809-18. doi: 10.2217/fmb.15.15. Review.

ReferenceCitation: Neven B, Pérot P, Bruneau J, Pasquet M, Ramirez M, Diana JS, Luzi S, Corre-Catelin N, Chardot C, Moshous D, Leclerc Mercier S, Mahlaoui N, Aladjidi N, Le Bail B, Lecuit M, Bodemer C, Molina TJ, Blanche S, Eloit M. Cutaneous and Visceral Chronic Granulomatous Disease Triggered by a Rubella Virus Vaccine Strain in Children With Primary Immunodeficiencies. Clin Infect Dis. 2017 Jan 1;64(1):83-86. Epub 2016 Oct 6. Erratum in: Clin Infect Dis. 2017 May 1;64(9):1297.

ReferenceCitation: Guet-Revillet H, Jais JP, Ungeheuer MN, Coignard-Biehler H, Duchatelet S, Delage M, Lam T, Hovnanian A, Lortholary O, Nassif X, Nassif A, Join-Lambert O. The Microbiological Landscape of Anaerobic Infections in Hidradenitis Suppurativa: A Prospective Metagenomic Study. Clin Infect Dis. 2017 Jul 15;65(2):282-291. doi: 10.1093/cid/cix285.

ReferenceCitation: Charlier C, Perrodeau É, Leclercq A, Cazenave B, Pilmis B, Henry B, Lopes A, Maury MM, Moura A, Goffinet F, Dieye HB, Thouvenot P, Ungeheuer MN, Tourdjman M, Goulet V, de Valk H, Lortholary O, Ravaud P, Lecuit M; MONALISA study group. Clinical features and prognostic factors of listeriosis: the MONALISA national prospective cohort study. Lancet Infect Dis. 2017 May;17(5):510-519. doi: 10.1016/S1473-3099(16)30521-7. Epub 2017 Jan 28. Erratum in: Lancet Infect Dis. 2017 Sep;17(9):897.

ReferenceCitation: Belizna C, Stojanovich L, Cohen-Tervaert JW, Fassot C, Henrion D, Loufrani L, Nagy G, Muchardt C, Hasan M, Ungeheuer MN, Arnaud L, Alijotas-Reig J, Esteve-Valverde E, Nicoletti F, Saulnier P, Godon A, Reynier P, Chrétien JM, Damian L, Omarjee L, Mahé G, Pistorius MA, Meroni PL, Devreese K. Primary antiphospholipid syndrome and antiphospholipid syndrome associated to systemic lupus: Are they different entities? Autoimmun Rev. 2018 Aug;17(8):739-745. doi: 10.1016/j.autrev.2018.01.027. Epub 2018 Jun 6. Review.

ReferenceCitation: Belizna C, Pregnolato F, Abad S, Alijotas-Reig J, Amital H, Amoura Z, Andreoli L, Andres E, Aouba A, Apras Bilgen S, Arnaud L, Bienvenu B, Bitsadze V, Blanco P, Blank M, Borghi MO, Caligaro A, Candrea E, Canti V, Chiche L, Chretien JM, Cohen Tervaert JW, Damian L, Delross T, Dernis E, Devreese K, Djokovic A, Esteve-Valverde E, Favaro M, Fassot C, Ferrer-Oliveras R, Godon A, Hamidou M, Hasan M, Henrion D, Imbert B, Jeandel PY, Jeannin P, Jego P, Jourde-Chiche N, Khizroeva J, Lambotte O, Landron C, Latino JO, Lazaro E, de Leeuw K, Le Gallou T, Kiliç L, Limper M, Loufrani L, Lubin R, Magy-Bertrand N, Mahe G, Makatsariya A, Martin T, Muchardt C, Nagy G, Omarjee L, Van Paasen P, Pernod G, Perrinet F, Pïres Rosa G, Pistorius MA, Ruffatti A, Said F, Saulnier P, Sene D, Sentilhes L, Shovman O, Sibilia J, Sinescu C, Stanisavljevic N, Stojanovich L, Tam LS, Tincani A, Tollis F, Udry S, Ungeheuer MN, Versini M, Cervera R, Meroni PL. HIBISCUS: Hydroxychloroquine for the secondary prevention of thrombotic and obstetrical events in primary antiphospholipid syndrome. Autoimmun Rev. 2018 Dec;17(12):1153-1168. doi: 10.1016/j.autrev.2018.05.012. Epub 2018 Oct 12. Review.

location_facility:
Institut Pasteur
Centre d'infectiologie, hopitale Necker


type: Registry Identifier

title: Clinical Application of New Pheochromocytoma Markers: INSERM Pilot Study of the Specificity of Elevated Plasma EM66 Concentrations in Patients With Pheochromocytoma or Paraganglioma Compared to Patients With Essential Hypertension

acronym: PHEO

summary: Pheochromocytoma or paraganglioma are tumors generating hypertension as a symptom. Different biological tests are currently available to diagnose these tumors. However, they all lack specificity since they do not distinguish cases of hypertension without pheochromocytoma or paraganglioma. To improve the diagnostic specificity of these tumors, the investigators are testing a new marker called EM66.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: University Hospital, Rouen

location_facility: Inserm U982/EA 4310; Rouen University (DC2N)

location_facility: Endocrinology Department, Gustave-Roussy Institute

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


title: Study of the Predictive Markers and the Pathophysiological Mechanisms of Alzheimer's Disease: Transverse and Longitudinal Approach in Anatomical and Functional Multimodal Imaging

acronym: IMAP+

summary: Alzheimer's disease (AD) is a major public health problem due to its socio-economic weight. An early diagnosis of AD is urgently needed as it would constitute a determinant breakthrough from a social, financial and research standpoints. Therefore, the investigators need predictive markers of AD, and neuroimaging is a particularly promising tool, especially when using complementary neuroimaging techniques and a longitudinal design, allowing to assess the relationships between the different biomarkers of the disease, their dynamic and their chronology.

status: Unknown status

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Diagnostic

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Kuhn E, Moulinet I, Perrotin A, La Joie R, Landeau B, Tomadesso C, Bejanin A, Sherif S, De La Sayette V, Desgranges B, Vivien D, Poisnel G, Chételat G. Cross-sectional and longitudinal characterization of SCD patients recruited from the community versus from a memory clinic: subjective cognitive decline, psychoaffective factors, cognitive performances, and atrophy progression over time. Alzheimers Res Ther. 2019 Jul 8;11(1):61. doi: 10.1186/s13195-019-0514-z.

ReferenceCitation: Gonneaud J, Arenaza-Urquijo EM, Fouquet M, Perrotin A, Fradin S, de La Sayette V, Eustache F, Chételat G. Relative effect of APOE ε4 on neuroimaging biomarker changes across the lifespan. Neurology. 2016 Oct 18;87(16):1696-1703. Epub 2016 Sep 28.

lead_sponsor: University Hospital, Caen

location_facility: Inserm - EPHE - University of Caen U1077

intervention_type: Biological

status_simplified: Unknown


type: Other Identifier

title: Randomized Controlled Study Assessing the Feasibility and the Medico-economic Impact of Nutritional Intervention in Women With Breast Cancer Under Adjuvant Chemotherapy

acronym: PASAPAS

summary:
Breast cancer is the most common cancer in women. Weight gain in adulthood, overweight or obesity, physical inactivity and alcohol consumption are risk factors commonly associated with risk of breast cancer (mainly for post-menopausal for overweight and obesity). Reduced physical activity is one factor likely to weight gain in women after adjuvant chemotherapy for localized breast cancer. Furthermore, physical activity appropriately could improve many prognostic factors and survival of women after breast cancer. Adapted Physical Activity (APA) could improve fitness, quality of life, body image, treatment compliance and reduce fatigue.

After diagnosis of breast cancer, there is many possible risk factors of mortality or morbidity related to nutritional factors available to management. These risks prevention through management of these patients appears indispensable through an APA program.

Thus, the investigators propose to test the feasibility of implementing a program of dietary intervention and APA to prevent the risk of weight gain (which affects more than half of patients) and maintain and/or increase their level of physical activity during and after adjuvant chemotherapy.

design_allocation: Randomized

ReferenceType: result

ReferenceCitation: Majed B, Moreau T, Senouci K, Salmon RJ, Fourquet A, Asselain B. Is obesity an independent prognosis factor in woman breast cancer? Breast Cancer Res Treat. 2008 Sep;111(2):329-42. Epub 2007 Oct 16.

ReferenceCitation: Trédan O, Bajard A, Meunier A, Roux P, Fiorletta I, Gargi T, Bachelot T, Guastalla JP, Lallemand Y, Faure C, Pérol D, Bachmann P. Body weight change in women receiving adjuvant chemotherapy for breast cancer: a French prospective study. Clin Nutr. 2010 Apr;29(2):187-91. doi: 10.1016/j.clnu.2009.08.003. Epub 2009 Aug 26.

ReferenceCitation: Holmes MD, Chen WY, Feskanich D, Kroenke CH, Colditz GA. Physical activity and survival after breast cancer diagnosis. JAMA. 2005 May 25;293(20):2479-86.

ReferenceCitation: Newton RU, Galvão DA. Exercise in prevention and management of cancer. Curr Treat Options Oncol. 2008 Jun;9(2-3):135-46. doi: 10.1007/s11864-008-0065-1. Epub 2008 Aug 13. Review.

ReferenceCitation: Pierce JP, Stefanick ML, Flatt SW, Natarajan L, Sternfeld B, Madlensky L, Al-Delaimy WK, Thomson CA, Kealey S, Hajek R, Parker BA, Newman VA, Caan B, Rock CL. Greater survival after breast cancer in physically active women with high vegetable-fruit intake regardless of obesity. J Clin Oncol. 2007 Jun 10;25(17):2345-51.

ReferenceCitation: Febvey-Combes O, Jobard E, Rossary A, Pialoux V, Foucaut AM, Morelle M, Delrieu L, Martin A, Caldefie-Chézet F, Touillaud M, Berthouze SE, Boumaza H, Elena-Herrmann B, Bachmann P, Trédan O, Vasson MP, Fervers B. Effects of an Exercise and Nutritional Intervention on Circulating Biomarkers and Metabolomic Profiling During Adjuvant Treatment for Localized Breast Cancer: Results From the PASAPAS Feasibility Randomized Controlled Trial. Integr Cancer Ther. 2021 Jan-Dec;20:1534735420977666. doi: 10.1177/1534735420977666.

ReferenceCitation: Perrier L, Foucaut AM, Morelle M, Touillaud M, Kempf-Lépine AS, Heinz D, Gomez F, Meyrand R, Baudinet C, Berthouze S, Reynes E, Carretier J, Guillemaut S, Pérol D, Trédan O, Philip T, Bachmann P, Fervers B. Cost-effectiveness of an exercise and nutritional intervention versus usual nutritional care during adjuvant treatment for localized breast cancer: the PASAPAS randomized controlled trial. Support Care Cancer. 2020 Jun;28(6):2829-2842. doi: 10.1007/s00520-019-05078-4. Epub 2019 Nov 15.

ReferenceCitation: Foucaut AM, Morelle M, Kempf-Lépine AS, Baudinet C, Meyrand R, Guillemaut S, Metzger S, Bourne-Branchu V, Grinand E, Chabaud S, Pérol D, Carretier J, Berthouze SE, Reynes E, Perrier L, Rebattu P, Heudel PE, Bachelot T, Bachmann P, Fervers B, Trédan O, Touillaud M. Feasibility of an exercise and nutritional intervention for weight management during adjuvant treatment for localized breast cancer: the PASAPAS randomized controlled trial. Support Care Cancer. 2019 Sep;27(9):3449-3461. doi: 10.1007/s00520-019-4658-y. Epub 2019 Jan 24.

lead_sponsor: Centre Leon Berard


status: Active, not recruiting

primary_purpose: Treatment

intervention_type: Radiation

acronym: PNET 5 MB

title: AN INTERNATIONAL PROSPECTIVE TRIAL ON MEDULLOBLASTOMA (MB) IN CHILDREN OLDER THAN 3 TO 5 YEARS WITH WNT BIOLOGICAL PROFILE (PNET 5 MB - LR and PNET 5 MB - WNT-HR), AVERAGE-RISK BIOLOGICAL PROFILE (PNET 5 MB -SR), OR TP53 MUTATION, AND REGISTRY FOR MB OCCURRING IN THE CONTEXT OF GENETIC PREDISPOSITION

study_completion_date_type: Anticipated

lead_sponsor: Universitätsklinikum Hamburg-Eppendorf

type: EudraCT Number

source: euctr

location_country:
Denmark
Poland
Portugal
Spain
Ireland
Austria
Italy
Netherlands
United Kingdom
Switzerland
Sweden
France
Belgium
Norway
Germany
Czechia

location_facility: University Medical Center Hamburg-Eppendorf

location_facility: Fondazione IRCCS Istituto Nazionale Tumori

location_facility: Barncancercentrum Drottning Silvias Barnochungdomssjukhus

location_facility: The Children's Memorial Health Institute

location_facility: Klinikum Schwabing, Pediatric Hospital of Technical University

location_facility: Prinses Máxima Center for Pediatric Oncology

location_facility: University Hospital München, Dr. von Haunersches Kinderspital

location_facility: Vestische Kinder- und Jugendklinik, University Witten/Herdecke

summary:
The study PNET 5 MB has been designed for children with medulloblastoma of standard risk (according to the risk-group definitions which have been used so far; e.g. in PNET 4). With the advent of biological parameters for stratification into clinical medulloblastoma trials, the ß-catenin status will be the only criterion according to which study patients will be assigned to either treatment arm PNET 5 MB - LR or to PNET 5 MB - SR, respectively. The initial diagnostic assessments (imaging, staging, histology, and tumor biology) required for study entry are the same for both treatment arms. With the amendment for version 12 of the protocol, patients who have a WNT-activated medulloblastoma with clinically high-risk features can be included in the PNET 5 MB WNT-HR study, and patients with a high-risk SHH medulloblastoma with TP53 mutation (both somatic or germline including mosaicism) can be included in the PNET5 MB SHH-TP53 study.

Data on patients with pathogenic germline alteration or cancer predisposition syndrome, who cannot be included in any prospective trial due to unavailability or due to physician or family decision, can be documented within the observational PNET 5 MB registry.

status_simplified: Ongoing


title: Multicentre Validation of a Fetal Urine Peptidome-based Classifier to Predict Post-natal Renal Function in Posterior Urethral Valves

acronym: Antenatal

summary: Validate the use of fetal urine peptidome-analysis and explore amniotic fluid markers for the stratification of fetuses with Posterior Urethral Valve for post-natal renal function.

study_start_date_type: Actual

status: Recruiting

ReferenceType: background

ReferenceCitation: Hogan J, Dourthe ME, Blondiaux E, Jouannic JM, Garel C, Ulinski T. Renal outcome in children with antenatal diagnosis of severe CAKUT. Pediatr Nephrol. 2012 Mar;27(3):497-502. doi: 10.1007/s00467-011-2068-6. Epub 2011 Dec 14.

ReferenceCitation: Seeds JW. Diagnostic mid trimester amniocentesis: how safe? Am J Obstet Gynecol. 2004 Aug;191(2):607-15. Review.

ReferenceCitation: Clark TJ, Martin WL, Divakaran TG, Whittle MJ, Kilby MD, Khan KS. Prenatal bladder drainage in the management of fetal lower urinary tract obstruction: a systematic review and meta-analysis. Obstet Gynecol. 2003 Aug;102(2):367-82. Review.

ReferenceCitation: Morris RK, Malin GL, Quinlan-Jones E, Middleton LJ, Hemming K, Burke D, Daniels JP, Khan KS, Deeks J, Kilby MD; Percutaneous vesicoamniotic shunting in Lower Urinary Tract Obstruction (PLUTO) Collaborative Group. Percutaneous vesicoamniotic shunting versus conservative management for fetal lower urinary tract obstruction (PLUTO): a randomised trial. Lancet. 2013 Nov 2;382(9903):1496-506. doi: 10.1016/S0140-6736(13)60992-7. Epub 2013 Aug 14.

ReferenceCitation: Schmoor C, Sauerbrei W, Schumacher M. Sample size considerations for the evaluation of prognostic factors in survival analysis. Stat Med. 2000 Feb 29;19(4):441-52.

ReferenceCitation: Lijmer JG, Mol BW, Heisterkamp S, Bonsel GJ, Prins MH, van der Meulen JH, Bossuyt PM. Empirical evidence of design-related bias in studies of diagnostic tests. JAMA. 1999 Sep 15;282(11):1061-6. Erratum in: JAMA 2000 Apr 19;283(15):1963.

ReferenceCitation: Rutjes AW, Reitsma JB, Di Nisio M, Smidt N, van Rijn JC, Bossuyt PM. Evidence of bias and variation in diagnostic accuracy studies. CMAJ. 2006 Feb 14;174(4):469-76.

ReferenceCitation: Donders AR, van der Heijden GJ, Stijnen T, Moons KG. Review: a gentle introduction to imputation of missing values. J Clin Epidemiol. 2006 Oct;59(10):1087-91. Epub 2006 Jul 11. Review.

ReferenceCitation: Klein J, Lacroix C, Caubet C, Siwy J, Zürbig P, Dakna M, Muller F, Breuil B, Stalmach A, Mullen W, Mischak H, Bandin F, Monsarrat B, Bascands JL, Decramer S, Schanstra JP. Fetal urinary peptides to predict postnatal outcome of renal disease in fetuses with posterior urethral valves (PUV). Sci Transl Med. 2013 Aug 14;5(198):198ra106. doi: 10.1126/scitranslmed.3005807.

ipd_sharing: No

lead_sponsor: University Hospital, Toulouse

location_country:
Poland
Spain
Italy
United Kingdom
Netherlands
Switzerland
France
Belgium
Germany

location_facility: Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico

location_facility: Centre Olympe de Gouges du CHRU de Tours

location_facility: Polish Mothers Memorial Hospital Research Institute

location_facility: Centre hospitalier universitaire Chu Amiens Salouël Hôpital sud

location_facility: CHU de Grenoble - Hôpital Couple-Enfant - Département de la Génétique

location_facility: Leiden University Medical Center Dept of prenatal diagnosis and therapy

location_facility: FetalMedicine Centre Birmingham Women's Hospital

location_facility: Hôpital Paule de Viguier-Hôpital des enfants- Site Purpan

location_facility: Hôpital des Enfants Hôpitaux universitaire Genève (HUG)

location_facility: Hôpital Bagatelle (Talence) - CHU Pellegrin (Bordeaux)

location_facility: Centre Hospitalier Universitaire de Montpellier


title: Prospective Monocentric Study Evaluating Patients' Satisfaction and Efficacy of Compression Using Surgical Gloves in Peripheral Neuropathies Induced by Taxane or Platinum-based Chemotherapies

acronym: ELEGANT

summary: Evaluation of Satisfaction & Efficacy of Compression Using Surgical Gloves in Peripheral Neuropathies Due to Chemotherapy

location_facility:
Centre Léon Bérard
Infirmerie Protestante

intervention_type: Device


title: Pilot Study for the Development of a Non-invasive Diagnostic Score to Differentiate Between Essential Thrombocythemia, Premyelofibrosis and Myelofibrosis

acronym: BioScoreSMP

summary: Prospective study for the development of a non-invasive score for differentiating prefibrotic myelofibrosis from essential thrombocytosis and overt myelofibrosis.

ipd_sharing: Yes

ipd_sharing_description: Data of study protocol, Statiscal analysis plan and the infromed consent form will be made available after the study completion

lead_sponsor: University Hospital, Angers

location_facility:
CHRU de Brest - Hôpital Morvan
Chu Angers

intervention_type: Diagnostic Test


acronym: OBILUP

intervention_type: Drug

title: Induction Therapy for Lupus Nephritis With no Added Oral Steroids: An Open Label Randomised Multicentre Controlled Trial Comparing Oral Corticosteroids Plus Mycophenolate Mofetil (MMF) Versus Obinutuzumab and MMF

lead_sponsor: Assistance Publique - Hôpitaux de Paris

ReferenceCitation: Tunnicliffe DJ, Palmer SC, Henderson L, Masson P, Craig JC, Tong A, Singh-Grewal D, Flanc RS, Roberts MA, Webster AC, Strippoli GF. Immunosuppressive treatment for proliferative lupus nephritis. Cochrane Database Syst Rev. 2018 Jun 29;6:CD002922. doi: 10.1002/14651858.CD002922.pub4. Review.

ReferenceCitation: Wofsy D, Hillson JL, Diamond B. Abatacept for lupus nephritis: alternative definitions of complete response support conflicting conclusions. Arthritis Rheum. 2012 Nov;64(11):3660-5. doi: 10.1002/art.34624.

ReferenceCitation: Dall'Era M, Cisternas MG, Smilek DE, Straub L, Houssiau FA, Cervera R, Rovin BH, Mackay M. Predictors of long-term renal outcome in lupus nephritis trials: lessons learned from the Euro-Lupus Nephritis cohort. Arthritis Rheumatol. 2015 May;67(5):1305-13. doi: 10.1002/art.39026.

ReferenceCitation: Costedoat-Chalumeau N, Houssiau F, Izmirly P, Le Guern V, Navarra S, Jolly M, Ruiz-Irastorza G, Baron G, Hachulla E, Agmon-Levin N, Shoenfeld Y, Dall'Ara F, Buyon J, Deligny C, Cervera R, Lazaro E, Bezanahary H, Leroux G, Morel N, Viallard JF, Pineau C, Galicier L, Van Vollenhoven R, Tincani A, Nguyen H, Gondran G, Zahr N, Pouchot J, Piette JC, Petri M, Isenberg D. A Prospective International Study on Adherence to Treatment in 305 Patients With Flaring SLE: Assessment by Drug Levels and Self-Administered Questionnaires. Clin Pharmacol Ther. 2018 Jun;103(6):1074-1082. doi: 10.1002/cpt.885. Epub 2017 Nov 9. Corrected and republished in: Clin Pharmacol Ther. 2019 Aug;106(2):374-382.

ReferenceCitation: Costedoat-Chalumeau N, Galicier L, Aumaître O, Francès C, Le Guern V, Lioté F, Smail A, Limal N, Perard L, Desmurs-Clavel H, Boutin du LT, Asli B, Kahn JE, Pourrat J, Sailler L, Ackermann F, Papo T, Sacré K, Fain O, Stirnemann J, Cacoub P, Jallouli M, Leroux G, Cohen-Bittan J, Tanguy ML, Hulot JS, Lechat P, Musset L, Amoura Z, Piette JC; Group PLUS. Hydroxychloroquine in systemic lupus erythematosus: results of a French multicentre controlled trial (PLUS Study). Ann Rheum Dis. 2013 Nov;72(11):1786-92. doi: 10.1136/annrheumdis-2012-202322. Epub 2012 Nov 10.

ReferenceCitation: Costedoat-Chalumeau N, Amoura Z, Hulot JS, Aymard G, Leroux G, Marra D, Lechat P, Piette JC. Very low blood hydroxychloroquine concentration as an objective marker of poor adherence to treatment of systemic lupus erythematosus. Ann Rheum Dis. 2007 Jun;66(6):821-4. Epub 2007 Feb 26.

ReferenceCitation: Costedoat-Chalumeau N, Pouchot J, Guettrot-Imbert G, Le Guern V, Leroux G, Marra D, Morel N, Piette JC. Adherence to treatment in systemic lupus erythematosus patients. Best Pract Res Clin Rheumatol. 2013 Jun;27(3):329-40. doi: 10.1016/j.berh.2013.07.001. Review.

ReferenceCitation: Jolly M, Galicier L, Aumaître O, Francès C, Le Guern V, Lioté F, Smail A, Limal N, Perard L, Desmurs-Clavel H, Boutin DL, Asli B, Kahn JE, Pourrat J, Sailler L, Ackermann F, Papo T, Sacré K, Fain O, Stirnemann J, Cacoub P, Jallouli M, Leroux G, Cohen-Bittan J, Hulot JS, Arora S, Amoura Z, Piette JC, Costedoat-Chalumeau N; PLUS group. Quality of life in systemic lupus erythematosus: description in a cohort of French patients and association with blood hydroxychloroquine levels. Lupus. 2016 Jun;25(7):735-40. doi: 10.1177/0961203315627200. Epub 2016 Feb 13.

ReferenceCitation: Dossier C, Hogan J. Response to Majeranowski. Pediatr Nephrol. 2021 Jun;36(6):1653. doi: 10.1007/s00467-021-04982-4. Epub 2021 Mar 10.

location_facility: Internal medicine, Cochin hospital, APHP

summary:
This is a randomised, open label, controlled non-inferiority phase III multicentre trial.

As primary objective, the study aims to demonstrate that a regimen free of additional oral corticosteroids but with obinutuzumab (and MMF) is non-inferior to a regimen based on oral corticosteroids and MMF in achieving the primary outcome of complete renal response at week 52 without receiving corticosteroids above a prespecified dose.

As secondary objectives, the study aims:

To compare the efficacy of the treatments in both arms in terms of:

partial plus complete renal response at week 52;
proteinuria < 0.8g/g at week 52;
extrarenal flares;
response as defined by a >4 points reduction in SELENA-SLEDAI score at week 52.

To compare the safety of the treatments in both arms in terms of occurrence of:

toxicity of corticosteroids;
serious Adverse Events;
serious Infectious Episodes;
new damage.
To compare the number of patients with non-adherence to treatment in both arms.
To estimate the efficiency of obinutuzumab in this indication.

The ancillary studies will allow:

To implement a biobank (serum, plasma, DNA, cells and urine) and a bank of renal biopsies for studies that will be part of separate research funding bids (patients will be informed that their samples and data may be used for subsequent studies and offered to consent or not).
To identify which target therapeutic levels of MMF best predicts response with least toxicity (ancillary study).
To have long term data on renal function and damage.


title: A Multicenter Phase 2 Single-arm Proof-of-concept Trial to Assess the Efficacy and Safety of Ustekinumab in Association With Prednisone for the Treatment of Non-infectious Severe Uveitis (NISU)

acronym: USTEKINISU

summary:
Uveitis is characterized by inflammation of the uvea, which is the middle portion of the eye. The greatest challenge for the treatment of uveitis is patients who have inflammation involving the posterior segment, either primarily in the vitreous (intermediate uveitis), the choroid or retina (posterior uveitis), or involving the entire eye (panuveitis). The term "uveitis" denotes a heterogeneous collection of diseases including infections, systemic immune-mediated diseases like sarcoidosis, and immune-mediated syndromes confined to the eye like sympathetic ophthalmia. Despite the progress in recent decades, uveitis and the related intraocular inflammation are comparable to diabetes or macular degeneration as a cause of lost quality-adjusted life years due to visual morbidity, and as such are a significant public health problem. The Standardization of Uveitis Nomenclature Working Group Guidelines recommend the use of corticosteroids as the first-line therapy for patients with active uveitis. However, long-term corticosteroid treatment can cause serious systemic and ocular side effects, such as hypertension, diabetes, osteoporosis, cataract, and glaucoma that limit its use in the treatment of uveitis. Alternatively, immunomodulatory therapy (IMT) drugs are given as steroid-sparing agents and have shown good clinical results for both systemic diseases and ocular inflammatory diseases. Given the side effects of chronic corticosteroid therapy and better understanding of the mechanisms of autoimmune-mediated uveitis, the aim of the treatment for patients with noninfectious uveitis is steroid-free remission with IMT. While uveitis is a heterogeneous disease with polygenic and environmental factors, most forms of immune-mediated uveitis are thought to be due to an imbalance between regulatory mechanisms that inhibit the immune system and inflammatory mechanisms, which have evolved to rid the body of infectious organisms, but which can result in immune-mediated, often chronic disease if they are activated outside the context of the immediate infection. The pathophysiology of non-infectious uveitis involves the rupture of peripheral tolerance, resulting in auto-aggressive Th1 or Th17 lymphocytes reaching the eye. L-12 and IL-23 are two key cytokines involved in Th1 and Th17 polarization in uveitis, respectively. Furthermore, these two cytokines share a common subunit (p40). Ustekinumab, a humanized anti-p40 monoclonal antibody, is able to target both IL-12 and IL-23 pathways, thus disrupting Th1 and Th17 immune responses.

Decreasing the dose as well as the duration of treatment with GC is of particular importance in uveitis, and ustekinumab, which selectively inhibits Th1 and Th17 pathways in the inflammatory cascade, could provide a ideal additional therapy for non-infectious severe uveitis (NISU) to reach this objective.

Therefore, in the present study, we propose to evaluate the efficacy and safety of ustekinumab for the treatment of NISU.

lead_sponsor: Centre Hospitalier Universitaire Dijon

location_facility:
CHU Dijon Bourgogne
CH Avignon


title: Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Could Decrease the Incidence of Oxygen Desaturation During Suspension Laryngoscopy: a Randomized Controlled Trial

acronym: optilaryngo

summary:
Suspension laryngoscopy is realised during apnea. In effect, surgeons are in the mouth of the patient and we can't have access at the aiways.

So investigators like to use a Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) to increase time of apnea and decrease the impact of oxygen desaturation.

location_facility:
CaenUH
Centre François Baclesse


title: COLON-IM : Prospective Cohort Study About Colorectal Environment : Microbiota and Immune Infiltrate in Normal, Dysplastic and Neoplastic Colorectal Tissue

summary: The primary objective of COLON-IM is to describe colorectal tissue microenvironment (neutrophils infiltrate) of patients with benign or malignant colorectal lesion (from stage I to III according to Tumor Node Metastasis (TNM)/ Union for International Cancer Control (UICC) classification).

location_facility:
Centre Leon Berard
GARBIT Vincent


title: Pharmaco-metabolomic Effects of Statins: METASTATINE

acronym: METASTATINE

summary: Statins are effective in cardio-vascular prevention by lowering LDL-Cholesterol levels but also through other mechanisms poorly understood. Our hypothesis is that some of these effects are mediated by microbiota alteration, leading to diminution of expression of microbiota derived pro-atherogenic metabolites.

lead_sponsor: French Cardiology Society

location_facility:
CIC HEGP
CIC La Sapétrière

lead_sponsor_type: industriel


title: 18-FDG Tumour Metabolism Changes in PDL1 Superior to 50% Stage III/IV Non Small Cell Lung Cancer During First Line Treatment With Pembrolizumab

summary: The aim of this study is to describe the early dynamics of 18-FDG uptake in non smal cell lung cancer during first line treatment with pembrolizumab, and to evaluate whether or not they differ according to treatment response at 3 months.

primary_purpose: Other

lead_sponsor: Centre Henri Becquerel

location_facility:
CHU
Centre Henri Becquerel


title: Pupillometry : Predictive Indicator in External Ventricular Drain Clamping ?

acronym: CLAMP

summary:
Pupillar diameter variation to predict success or failure of external ventricular derivation clamping.

Pupillometry utilisation as a diagnostic tool in external ventricular clamping test in neurological ICU should improve patients care in several ways :

earlier use of ventriculo-peritoneal or ventriculo-atrial shunts to shorten the external ventricular treatment duration and thus reduce risks of infection and hospital stay duration
limit the medical imagery prescription and radiation exposition
avoid neurological deterioration linked to the external ventricular drain clamping in case of the pupillometric parameters variation would be earlier than clinical signs

lead_sponsor: Association Pro-arte

location_facility:
CHU Clermont Ferrand
Chu Grenoble Alpes


title: Implantation Sur Cinq Centres Médico-Psychologiques Franciliens du Parcours Socio-Sanitaire orienté Vers le Rétablissement (PASSVers2)

summary: Prospective longitudinal uncontrolled multicenter study, with cohort follow-up, focusing on patients, professionals, relatives and structures evolution during the implementation of recovery based intervention.

study_start_date_type: Anticipated

status: Not yet recruiting

primary_purpose: Supportive Care

ReferenceCitation: Bazin, N. Les suivis sociosanitaires des personnes présentant un trouble mental sévère et persistant : expérimentation PASSVers à Versailles. Inf. Psychiatr. 95, 509-513 (2019).

lead_sponsor: Versailles Hospital

location_facility: Centre Hospitalier d'Argenteuil, secteurs 95G05, 95G06, 95G13,

location_facility: Centre Hospitalier de Versailles, secteur 78G17, Centre Bleuler, Versailles

location_facility: Centre Hospitalier de Plaisir, secteur 78G16, CMP de Rambouillet

location_facility: Etablissement de Santé Mentale de Rueil-Malmaison, Groupe MGEN, secteur 92G13, CMP de Rueil-Malmaison

location_facility: Hôpital Sainte Anne - GHU Paris Psychiatrie & Neurosciences, secteur G75015

intervention_type: Behavioral


title: Study of Subcutaneous Interstitial Pressure During Sepsis

acronym: PISEP

summary:
The pathophysiology of sepsis is characterized by the sudden onset of vasodilation and vascular permeability with capillary leakage. This leakage contributes to the development of generalized edema which is not clinically detectable below 4 litres but which becomes visible after a few days. The edema accumulates mainly at the subcutaneous level due to the high compliance of this tissue. Edema, and therefore hydrosodium overload, testifies to the severity of the inflammation. However, it could also be harmful in itself (affecting microcirculation and increasing mortality) as suggested by numerous clinical and experimental studies.

The transfer of fluids between vascular and interstitial compartments during sepsis therefore has a central role in the pathophysiology of the disease and associated mortality. These transfers are mainly controlled at the microvascular level (with constant permeability) by the difference between capillary (CP) and interstitial (IP) pressures. In healthy subjects, subcutaneous IP is discreetly negative (-1 mmHg) and varies very little. On the other hand, a sometimes drastic decrease in IP has been described in various localized and systemic inflammatory situations. These pressure variations may be explained by the collagen structure of the interstitial tissue and a change in the three-dimensional conformation of these macromolecules induced by inflammation mediators. In an animal model of sepsis, a study showed significantly lower pressure in a group of animals in endotoxic shock. IP has never been measured in humans during sepsis. The objective of this study is to analyze subcutaneous IP (SCIP) in patients with septic shock compared with controls in order to evaluate the direct role of interstitial tissue in the onset of edema during sepsis.

primary_purpose: Basic Science

location_facility:
CHU de DIJON
HCL - Hôpital Edouard Herriot

intervention_type: Procedure


title: Involvement of SK3 Calcium Channel in Taxane Neuropathy

acronym: NEUROTAX

summary: Taxane neuropathy is a common and long-term side effect of long-term morbidity in patients surviving cancer. No preventive or symptomatic treatment has been shown to be effective. Its pathophysiology is poorly known and probably multifactorial. A possible mechanism would be mediated by the activation of the SK3 calcium channel: a retrospective study carried out at the University Hospital of Tours (Carina RUA) found a significant association between the number of CAG triplets in the KCNN3 gene coding for the SK3 channel and the appearance of a taxane neuropathy.

lead_sponsor: University Hospital, Tours

location_facility: Department of Medical Oncology, University Hospital, Tours

location_facility: Department of Oncology, Hospital, Chinon


title: Early Determinants of Multidimensional Outcome at School Age After Neonatal Arterial Ischemic Stroke (AVCnn7 Years Study)

summary:
While perinatal ischemic stroke is the most frequent form of childhood stroke, early determinants of outcome remain poorly understood. Two main structural biases limit the accuracy of most studies: heterogeneity of the population and short follow-up.

Perinatal ischemic stroke includes several conditions that differ in pathophysiology and timing of occurrence. Yet, it is not surprising that risk factors and outcome depend primarily on the type of stroke. Age at evaluation also plays a major role after a neonatal insult. Even though the original lesion is static and focal in perinatal stroke, its consequences grow over time within the maturing brain and affect all fields of neurodevelopment.

The objective of the AVCnn study was to delineate the determinants, clinical and imaging presentation, mechanism, and long term outcome of a category of perinatal stroke (neonatal arterial ischemic stroke: NAIS). This led to the AVCnn cohort, which now gives us the opportunity to regularly monitor a large cohort of children having suffered an NAIS.

ReferenceCitation: Thébault G, Martin S, Brouillet D, Brunel L, Dinomais M, Presles É, Fluss J, Chabrier S; AVCnn Study Group. Manual dexterity, but not cerebral palsy, predicts cognitive functioning after neonatal stroke. Dev Med Child Neurol. 2018 Oct;60(10):1045-1051. doi: 10.1111/dmcn.13752. Epub 2018 Apr 6.

ReferenceCitation: Dinomais M, Thébault G, Hertz-Pannier L, Gautheron V, Nguyen The Tich S, Fluss J, Chabrier S; AVCnn Study Group. Is there an excess of left-handedness after neonatal stroke? Cortex. 2017 Nov;96:161-164. doi: 10.1016/j.cortex.2017.08.007. Epub 2017 Aug 16.

ReferenceCitation: Groeschel S, Hertz-Pannier L, Delion M, Loustau S, Husson B, Kossorotoff M, Renaud C, Nguyen The Tich S, Chabrier S, Dinomais M; AVCnn study group. Association of transcallosal motor fibres with function of both hands after unilateral neonatal arterial ischemic stroke. Dev Med Child Neurol. 2017 Oct;59(10):1042-1048. doi: 10.1111/dmcn.13517. Epub 2017 Aug 17.

ReferenceCitation: Dinomais M, Hertz-Pannier L, Groeschel S, Delion M, Husson B, Kossorotoff M, Renaud C, Chabrier S, The Tich SN; AVCnn Study Group. Does Contralesional Hand Function After Neonatal Stroke Only Depend on Lesion Characteristics? Stroke. 2016 Jun;47(6):1647-50. doi: 10.1161/STROKEAHA.116.013545. Epub 2016 May 10.

ReferenceCitation: Chabrier S, Peyric E, Drutel L, Deron J, Kossorotoff M, Dinomais M, Lazaro L, Lefranc J, Thébault G, Dray G, Fluss J, Renaud C, Nguyen The Tich S; Accident Vasculaire Cérébral du nouveau-né (AVCnn; [Neonatal Stroke]) Study Group. Multimodal Outcome at 7 Years of Age after Neonatal Arterial Ischemic Stroke. J Pediatr. 2016 May;172:156-161.e3. doi: 10.1016/j.jpeds.2016.01.069. Epub 2016 Mar 9.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
Centre Hospitalier de La Cote Basque
Chu de Saint Etienne
Chu de Brest
Chu D'Angers
Hopital Necker


title: Functional Implication of Corpus Callosum in Voluntary Strength in COPD Patients

summary: Patients with COPD have lower capability of activating their muscles. At the cortical level, force production is not only controlled by contralateral primary motor cortex but also by ipsilateral motor cortex. The aim of this study is to determine whether ipsilateral areas are functionally impaired in COPD.

lead_sponsor: 5 Santé


title: MYeloma Resistance And Clonal Evolution

acronym: MYRACLE

summary: Multiple Myeloma (MM) is often associated with progression, temporary response to therapy and a high relapse rate over time resulting in a poor long-term prognosis. Because MM is classified as an incurable disease, therapeutic resistance is of great interest. However, knowledge about the biological mechanisms underlying resistance associated with MM therapies and about associated predictors remains poor. The MYRACLE cohort, a multicenter prospective cohort of patients with MM, is set up to address this limitation.

ipd_sharing: Undecided

lead_sponsor: Nantes University Hospital

location_facility:
La Roche sur Yon Hospital Departmental
Nantes University Hospital


title: Immune Damage and Vaccination in COPD Patients

acronym: ALTIBPCO

summary: Better understanding of the specificities of the vaccine response in patients with COPD

status: Suspended

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility:
CHI Créteil
CHU Henri-Mondor


title: SEMI-CLOSED LOOP "FOR THE CONTROL OF BLOOD GLUCOSE IN DIABETIC SUBJECTS DIABELOOP First CLINICAL PROJECT: Under Project 3 (UP3), CREATING A DATABASE

summary: The aim this study is the acquisition and management of a data base for the development of the glycaemic regulation algorithms. This database will integrate the measures of blood glucose and the glycaemia level of the Dexcom sensor on a regular time, the injections of insulin delivered by Debiotech JewelPUMP and the level of insulin in the blood. This database will also contain the bolus of insulin injected at meals and the content of meals, the reduction insulin level during physical activity and the quantification of this physical activity. A study will also be conducted to compare the pharmacokinetics of a bolus of insulin identical with the JewelPUMP either the usual pump of the patient.

lead_sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

location_facility:
CHU de Caen
Centre Hospitalier Sud Francilien
CHU Jean Minjoz
CHU Toulouse
Chu Montpellier
University Hospital Grenoble
CHU de Nancy


acronym: MALIBU

title: MALIBU Trial - Phase II Study of Combination Ibrutinib and Rituximab in Untreated Marginal Zone Lymphomas

lead_sponsor: International Extranodal Lymphoma Study Group (IELSG)

location_country: Portugal Italy Switzerland France Belgium

location_facility: Istituto Oncologico della Svizzera Italiana (IOSI)

location_facility: A.O.U. Città della Salute e della Scienza di Torino Ospedale Molinette

location_facility: Fondazione IRCCS - Istituto Nazionale dei Tumori

location_facility: Azienda Ospedaliera Arcispedale Santa Maria Nuova IRCCS

location_facility: Ospedale di Circolo e Fondazione Macchi di Varese

location_facility: IRCCS Centro di Riferimento Oncologico di Aviano

location_facility: Azienda Ospedaliera Universitaria Ospedali Riuniti - Università Politecnica delle Marche

location_facility: Università degli Studi di Roma La Sapienza

location_facility: Fondazione IRCCS - Policlinico San Matteo

location_facility: Fondazione IRCCS - Cà Granda - Ospedale Maggiore Policlinico

location_facility: AAST Grande Ospedale Metropolitano Niguarda

location_facility: Giovanni Paolo II/I.R.C.C.S. Istituto Tumori

location_facility: Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI)

location_facility: Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.

location_facility: CHU de Grenoble - Hôpital Albert MICHALLON

location_facility: CHU Dijon Bourgogne - Hôpital François Mitterand

summary:
Single-arm, phase II clinical trial of patients with Extranodal Marginal Zone Lymphoma (EMZL). It is planned to recruit 130 patients.

Additional patients with Splenic Marginal Zone Lymphoma (SMZL), up to 30, and Nodal Marginal Zone Lymphoma (NMZL), up to 15, will be included in the trial in order to preliminary explore the clinical activity and safety of the combination treatment proposed.

The study primary endpoints will be analysed on the EMZL population. Outcome of patients with SMZL and NMZL will be analysed and reported separately


title: Controlled Trial Testing the Effectiveness of Motivational Support on Physical Activity and Fatigue of Patients With Multiple Sclerosis

acronym: apsep

summary: The purpose of this study is to evaluate the effectiveness of an 8-week intervention based on implementation intention (motivation) in patients with multiple sclerosis on objectively measured physical activity.

lead_sponsor: University of Paris 5 - Rene Descartes

location_facility:
CHU Poissy Saint germain
Hôpital Raymond-Poincaré


title: An Open Prospective Randomised Long-Term Effectiveness Study, Comparing Best Medical Practice With or Without Adjunctive VNS Therapy in Patients 16 Years and Older With Pharmaco-resistant Partial Epilepsy

summary: This is a post-market medical device study. This study will compare best medical practice with or without adjunctive VNS Therapy in patients who are 16 years and older with pharmacoresistant partial epilepsy.

status: Terminated

ReferenceCitation: Gilliam F. Optimizing health outcomes in active epilepsy. Neurology. 2002 Apr 23;58(8 Suppl 5):S9-20. Review.

ReferenceCitation: Kwan P, Brodie MJ. Early identification of refractory epilepsy. N Engl J Med. 2000 Feb 3;342(5):314-9.

ReferenceCitation: Sillanpää M, Jalava M, Kaleva O, Shinnar S. Long-term prognosis of seizures with onset in childhood. N Engl J Med. 1998 Jun 11;338(24):1715-22.

ReferenceCitation: Mattson RH, Cramer JA, Collins JF, Smith DB, Delgado-Escueta AV, Browne TR, Williamson PD, Treiman DM, McNamara JO, McCutchen CB, et al. Comparison of carbamazepine, phenobarbital, phenytoin, and primidone in partial and secondarily generalized tonic-clonic seizures. N Engl J Med. 1985 Jul 18;313(3):145-51.

ReferenceCitation: Mattson RH, Cramer JA, Collins JF. A comparison of valproate with carbamazepine for the treatment of complex partial seizures and secondarily generalized tonic-clonic seizures in adults. The Department of Veterans Affairs Epilepsy Cooperative Study No. 264 Group. N Engl J Med. 1992 Sep 10;327(11):765-71.

ReferenceCitation: Mattson RH, Cramer JA, Collins JF. Prognosis for total control of complex partial and secondarily generalized tonic clonic seizures. Department of Veterans Affairs Epilepsy Cooperative Studies No. 118 and No. 264 Group. Neurology. 1996 Jul;47(1):68-76.

ReferenceCitation: Schmidt D. The clinical impact of new antiepileptic drugs after a decade of use in epilepsy. Epilepsy Res. 2002 Jun;50(1-2):21-32. Review.

ReferenceCitation: Lhatoo SD, Wong IC, Polizzi G, Sander JW. Long-term retention rates of lamotrigine, gabapentin, and topiramate in chronic epilepsy. Epilepsia. 2000 Dec;41(12):1592-6.

ReferenceCitation: Morris GL 3rd, Mueller WM. Long-term treatment with vagus nerve stimulation in patients with refractory epilepsy. The Vagus Nerve Stimulation Study Group E01-E05. Neurology. 1999 Nov 10;53(8):1731-5. Erratum in: Neurology 2000 Apr 25;54(8):1712.

ReferenceCitation: Malow BA, Edwards J, Marzec M, Sagher O, Ross D, Fromes G. Vagus nerve stimulation reduces daytime sleepiness in epilepsy patients. Neurology. 2001 Sep 11;57(5):879-84.

ReferenceCitation: Harden CL, Pulver MC, Ravdin LD, Nikolov B, Halper JP, Labar DR. A Pilot Study of Mood in Epilepsy Patients Treated with Vagus Nerve Stimulation. Epilepsy Behav. 2000 Apr;1(2):93-99.

ReferenceCitation: Elger G, Hoppe C, Falkai P, Rush AJ, Elger CE. Vagus nerve stimulation is associated with mood improvements in epilepsy patients. Epilepsy Res. 2000 Dec;42(2-3):203-10.

ReferenceCitation: Clark KB, Naritoku DK, Smith DC, Browning RA, Jensen RA. Enhanced recognition memory following vagus nerve stimulation in human subjects. Nat Neurosci. 1999 Jan;2(1):94-8.

ReferenceCitation: McLachlan RS, Sadler M, Pillay N, Guberman A, Jones M, Wiebe S, Schneiderman J. Quality of life after vagus nerve stimulation for intractable epilepsy: is seizure control the only contributing factor? Eur Neurol. 2003;50(1):16-9.

ReferenceCitation: Cramer JA, Ben Menachem E, French J. Review of treatment options for refractory epilepsy: new medications and vagal nerve stimulation. Epilepsy Res. 2001 Nov;47(1-2):17-25. Review.

ReferenceCitation: Gilliam FG, Fessler AJ, Baker G, Vahle V, Carter J, Attarian H. Systematic screening allows reduction of adverse antiepileptic drug effects: a randomized trial. Neurology. 2004 Jan 13;62(1):23-7.

ReferenceCitation: Ryvlin P, Gilliam FG, Nguyen DK, Colicchio G, Iudice A, Tinuper P, Zamponi N, Aguglia U, Wagner L, Minotti L, Stefan H, Boon P, Sadler M, Benna P, Raman P, Perucca E. The long-term effect of vagus nerve stimulation on quality of life in patients with pharmacoresistant focal epilepsy: the PuLsE (Open Prospective Randomized Long-term Effectiveness) trial. Epilepsia. 2014 Jun;55(6):893-900. doi: 10.1111/epi.12611. Epub 2014 Apr 22. Erratum in: Epilepsia. 2014 Sep;55(9):1476. Epilepsia. 2015 Jun;56(6):983.

lead_sponsor: Cyberonics, Inc.

location_country:
Spain
Italy
United Kingdom
Netherlands
Canada
Sweden
France
Belgium
Norway
Germany

location_facility: Hospital Ruber Internacional, Servicio de neurología

location_facility: Hôpital Neurologique, Untité d'épileptologie

location_facility: Sächsisches Epilepsiezentrum Radeberg, Epilepsiezentrum Kleinwachau

location_facility: Hôpital Gui De Chauliac, Service Explorations Neurologiques et Epileptologie

location_facility: Universitetssjukhuset i Lund, Neurologiska kliniken

location_facility: Universitätskliniken Bonn, Klinik für Epileptologie

location_facility: Medisch Spectrum Twente, Dienst Neurologie

location_facility: Walton Centre, Dept of Neurosciences, Clinical Sciences Centre

location_facility: Institute of Neuroscience and Physiology, Clinical Neuroscience and Rehabilitation

location_facility: Azienda Ospendaliero-Universitaria, Caressi Dep Neuroscience

location_facility: Foothills Hospital, Neurology Department

location_facility: Medisch Centrum Rijnmond-Zuid, locatie Clara, Dienst Neurologie

location_facility: Klinikum der Philips-Universität Marburg, Fachbereich, 20 - Medizin / Klinik Neurologie / Epilepsie Zentrum

location_facility: Azienda Ospedaliero Universitaria - Ospedali Riuniti Umberto I - Lancisi - Salesi, NeuroPsichiatria Infantile

location_facility: Hopital Roger Salengro, Service de Neurologie

location_facility: Addenbrookes Hospital, Dept of Neurosurgery

location_facility: Hospital General de Valencia, Neurology/Neurophisiology

location_facility: Spesialsykehuset for Epilepsi, Dep of Neurodiagnostics

location_facility: Hôpital Sainte-Anne, Service de Neurochirurgie

location_facility: Hospital Clínico Universitario, Servicio de neurología

location_facility: Universitätsklinik Erlangen, Zentrum für Epilepsie ZEE

location_facility: Kings College Hospital, Dept of Neurosurgery

location_facility: ULB-Hôpital Erasme, Centre de référence pour le traitement de l'épilepsie réfractaire - Neurologie

location_facility: Universita di Bologna, Clinica Neurologica

location_facility: Stichting Epilepsie Instituut Nederland, Dienst Neurologie

location_facility: Montreal Neurological Institute, Clinical Research

location_facility: Klinik der Ernst-Moritz-Arndt-Universität, Neurologische Klinik

location_facility: Università Cattolica Del Sacro Cuore, Istituto di NeuroChirurgia

location_facility: Centro Epilessia, Dipartimento di Neuroscienze

location_facility: Universita degli Studi di Cagliari - Policlinico Monserrato, Clinica Neurologica

location_facility: National Hospital for Neurology and Neurosurgery

location_facility: Hospital General Basico De La Defensa de Valencia, Servicio de neurología

location_facility: Azienda Ospedaliera "Bianchi Melacrino Morelli", Centro Regionale Epilessie

location_facility: UZ Gent, Department of Neurology, 1K12/A


title: A Randomized Double-blind Phase II Study Evaluating the Role of Maintenance Therapy With Cabozantinib in High Grade Uterine Sarcoma (HGUtS) After Stabilization or Response to Doxorubicin +/- Ifosfamide Following Surgery or in Metastatic First Line Treatment

summary:
This study aims to investigate a drug called Cabozantinib which belongs to a family of drugs that have effects on tumour growth, blood supply, invasion and spread.

Therefore, we want to find out whether taking cabozantinib after treatment with surgery and chemotherapy is effective and safe for patients who responded or had stable disease after their chemotherapy.

All participants will receive 4-6 cycles of standard chemotherapy. Those with stabilization or response to the standard chemotherapy will be split into 2 groups (cabozantinib or placebo).

ReferenceCitation: Hanvic B, Ray-Coquard I. Gynecological sarcomas: literature review of 2020. Curr Opin Oncol. 2021 Jul 1;33(4):345-350. doi: 10.1097/CCO.0000000000000753. Review.

ReferenceCitation: Ray-Coquard I, Hatcher H, Bompas E, Casado A, Westermann A, Isambert N, Casali PG, Pratap S, Stark D, Valverde C, Anand A, Huizing M, Floquet A, Lindner L, Hermes B, Seddon B, Coens C, Jones R, Reed N. A randomized double-blind phase II study evaluating the role of maintenance therapy with cabozantinib in high-grade uterine sarcoma after stabilization or response to doxorubicin ± ifosfamide following surgery or in metastatic first line treatment (EORTC62113). Int J Gynecol Cancer. 2020 Oct;30(10):1633-1637. doi: 10.1136/ijgc-2020-001519. Epub 2020 Jun 15.

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country:
United Kingdom
Spain
Italy
France
Netherlands

location_facility: NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital

location_facility: Nottingham University Hospitals NHS Trust - City Hospital

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: University College London Hospitals NHS Foundation Trust - University College Hospital

location_facility: Oxford University Hospitals NHS Trust - Churchill Hospital

location_facility: Academisch Medisch Centrum at University of Amsterdam

location_facility: Leeds Teaching Hospitals NHS Trust - St. James's University Hospital

location_facility: Institut de Cancerologie de l'Ouest (ICO) - Centre Rene Gauducheau

location_facility: Cambridge University Hospital NHS - Addenbrookes Hospital


title: REACTION: A Phase II Study of Etoposide and Cis/Carboplatin With or Without Pembrolizumab in Untreated Extensive Small Cell Lung Cancer

acronym: REACTION

summary: This is a multicenter, open-label, two armed, controlled, and randomized phase II trial investigating the activity of pembrolizumab in combination with standard chemotherapy in Extensive Disease (ED)-SCLC.

location_country:
France
United Kingdom
Italy

location_facility: Assistance Publique - Hopitaux de Marseille - Hopital Nord

location_facility: Ospedale S. Luigi Gonzaga - Universita Di Torino

location_facility: Azienda Ospedaliero-Universitaria "Santa Maria della Misericordia" di Udine

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital

location_facility: Assistance Publique - Hopitaux de Paris - Hopital Avicenne

location_facility: Centre Hospitalier d'Avignon - Hopital Duffaut

location_facility: Centre Hopitalier Intercommunal De Creteil


title: Biological and Functional Determinants of the Endothelial and Vascular Response to Exercise Training in COPD Patients

acronym: cDysEndoBPCO

summary:
Vascular comorbidities constitute a major burden in COPD patients. The atherosclerosis process is preceded by the onset of an endothelial dysfunction (assessed by the flow-mediated dilatation (FMD)), which is a risk factor for later ischemic vascular complications and death. In COPD, this endothelial dysfunction could be explained by intrinsic endothelial cell properties, or the effect of a pathogenic endothelial cell microenvironment (inflammation and/or oxidative stress). Exercise training constitue a powerful stimulus for the endothelial function, and could be mediated by the mobiliaztion and function of endothelial progenitors. While exercise training is an efficient intervention in COPD patients, its vascular effect appear blunted. The endothelial function response to training has appeared heterogeneous in COPD patients, and possibly linked to the endothelial cel lesion. Thus, endothelial function (assessed by the FMD) response to exercise training would be lower in COPD patients with a baseline impairment of the their FMD. In addition, of biological and functional factors could explained the magnitude of the FMD response in COPD patients.The aim of the study are thus :

To compare the FMD change in COPD patients with FMD above (FMD+) and under the median FMD (FMD-) after 4 weeks of exercise training in the whole study population.

To compare between COPD patients FMD+, COPD patients FMD- and healthy "control" subjects, the endothelial inflammation and senescence at baseline and the endothelial progenitor mobilization and function change induced by exercise (maximal exercise test and training).

To compare between COPD patients FMD+, COPD patients FMD- and healthy "control" subjects the effect of the endothelial microenvironment on the cellular pathways regulating the endothelial function in vitro at baseline and changes after exercise training.

To test in COPD patients the association between the magnitude of the FMD changes after training and biological, functional and clinical factors (inflammation oxidative stress markers, endothelial biomarkers, pulmonary impairment and phenotype, cardiovascular risks factors, vascular function, metabolic markers, physical activity level, …)

lead_sponsor: University Hospital, Montpellier

location_facility:
CHU Montpellier and CHU Nimes
University Hospital, Paris


acronym: PEACE 6 - Unfit

title: A Double-blind Randomised Phase III Trial Evaluating the Efficacy of ADT +/- Darolutamide in de Novo Metastatic Prostate Cancer Patients With Vulnerable Functional Ability and Not Elected for Docetaxel or Androgen Receptor Targeted Agents

lead_sponsor: UNICANCER

ipd_sharing_description: IPD can be shared upon request to the sponsor

location_facility: Institut de cancérologie Strasbourg Europe

location_facility: Centre Groupe Hospitalier Diaconesses Croix Saint-Simon

location_facility: CHU de Poitiers - Pôle Régional de Cancérologie

location_facility: Centre Hospitalier Intercommunal de Toulon-La Seyne - Hôpital Ste Musse

location_facility: Clinique Sainte Anne - Strasbourg Oncologie Libérale

summary: This is a Phase III, international, multicentre, randomised, double-blinded placebo controlled trial, evaluating the efficacy and safety of ADT +/- darolutamide in castration-naïve de novo metastatic prostate cancer patients with vulnerable functional ability who have not elected for docetaxel or other androgen receptor pathway inhibitors.


title: Impact of a Strategy Based on the Unyvero® Testing System on Appropriate Antimicrobial Treatment in Patients With Suspected Aspiration Pneumonia Requiring Mechanical Ventilation : a Randomized Controlled Unblinded Trial

acronym: APAPI

summary:
The two most common consequences resulting from aspiration are chemical pneumonitis and bacterial aspiration pneumonia. Both entities present with comparable clinical signs and symptoms. In the absence of a reliable clinical or biological marker to differentiate between these two conditions, most patients with suspected aspiration are treated empirically with antibiotics. De-escalation of initial antibiotic treatment is encouraged based on the results of microbiological results, usually performed before starting antimicrobial treatment. However, in most hospitals, 48-72h are required to obtain the results of microbiological cultures, and to de-escalate empirical large spectrum antibiotic treatment.

The use of the Unyvero®, a multiplex PCR-based testing system, for detection of respiratory bacterial pathogens would allow decreasing the percentage of patients with aspiration syndrome who will receive unappropriated antibiotic treatment at Day 3.

lead_sponsor: University Hospital, Lille

location_facility:
Hôpital Roger Salengro, CHU
Chu Amiens Picardie


title: Optimization of VIM Targeting in Essential Tremor Surgery

acronym: Opti-VIM

summary: Deep brain stimulation (DBS) for essential tremor is based on the intermedius ventralis nucleus of the thalamus (VIM) stimulation. This structure is however very difficult to target, as it remains invisible on imaging. The current procedure based on awake surgery with clinical and electrophysiological testings has several limitations that lead us to develop a probabilistic model to locate precisely the target. This study aims to show that asleep DBS surgery based on this new targeting method leads to at least the same clinical results than the classical procedure.

lead_sponsor: University Hospital, Bordeaux

location_facility:
Hospices Civils de Lyon
CHU de Bordeaux


acronym: PREMIER

title: A Multi-center, Randomized, Double-blind, Placebo Controlled Phase III Study to Assess the Efficacy, Safety, and Tolerability of PXT3003 in Charcot-Marie-Tooth Type 1A (CMT1A)

lead_sponsor: Pharnext SA

location_country:
Denmark
Spain
Italy
Canada
United States
France
Israel
Belgium
Germany

location_facility: CIUSS de Saguenay-Lac-Saint-Jean Centre d'etudes Cliniques

location_facility: University of Kansas Medical Center Research Institute

location_facility: University Hospital Muenster UKM Department of Neurology

location_facility: Providence St. Luke's Rehabilitation Medical Center

location_facility: Azienda Ospedaliera Universitaria San Martino Universita Degli Studi di Genova Clinica Neurologica

location_facility: Centre de reference des maladies neuromusculaires AOC Hopital Pellegrin CHU de Bordeaux

location_facility: Friedrich-Baur-Institut, Neurologische Klinik und Poliklinik Ludwig-Maximilians-Universität

location_facility: Centre de Reference des Maladies Neuromusculaires AOC Service de Neurologie, CHU d'Angers

location_facility: UNC Department of Neurology Peripheral Neuropathy Center

location_facility: UHN Toronto General Hospital Krembil Neuroscience Centre

location_facility: Association lnstitut de Myologie Hopital Pitie-Salpetriere Service de Neuro-Myologie

location_facility: University Medical Centre Goettingen, Dept. of Clinical Neurology

location_facility: Universitätsklinikum Tübingen Crona Kliniken Neuromuskuläres Zentrum

location_facility: University Hospital RWTH Aachen, Department of Neurology and Institute for Neuropathology

location_facility: Azienda Ospedaliera Universitaria Policlinico "G. Martino" di Messina

location_facility: Complejo Hospitalario Universitario de Santiago

location_facility: UCLA Department of Psychiatry and Biobehavioral Sciences

location_facility: Hackensack Meridian Health Hackensack University Medical Center

location_facility: Colombia University Department of Neurology

location_facility: CHU de Quebec-Universite Laval- Hopital Enfant-Jesus

location_facility: The Ohio State University Wexner Medical Center

location_facility: UC Davis Health Department of Physical Medicine and Rehabilitation

location_facility: MU Health Care Neurology and Sleep Disorders Clinic

location_facility: Rigshospitalet, University of Copenhagen Copenhagen Neuromuscular Center

location_facility: Ottawa Hospital Research Institute- Neuromuscular Research Centre

location_facility: Hospital Universitario Clinico San Carlos

location_facility: University of Florida Clinical Research Center

location_facility: Hospital Universitario y Politécnico La Fé

location_facility: Centre d'investigation Clinique CHU de Strasbourg Hopital de Hautepierre

location_facility: Neurology Clinic at University of Washington Medical Center

location_facility: Montreal Neurological Institute and Hospital-Clinical Research Unit

location_facility: University Hospital GB Rossi UOC Neurologia B, AOUI Verona Department of Neuroscience, Biomedicine and Movement Sciences

location_facility: Hadassah Ein Kerem University Medical Center Department of Neurology

location_facility: Service de Neurologie et Maladies Neuromusculaires, CHU de Marseille - Hopital La Timone

location_facility: University of Miami Leonard M. Miller School of Medicine

location_facility: Advent Health Medical Group Neurology Orlando

location_facility: Massachusetts General Hospital Neuromuscular Diagnostic Center

summary:
The study will consist of 2 periods: Double-blind Treatment and Open-Label Extension(OLE) Period.

-Double-blind Treatment Period - This will be randomized, double-blind, placebo-controlled part of the study which will be conducted in parallel groups, ie,1 group receiving the active treatment (PXT3003) and the other group receiving placebo.

Primary endpoint of the study will be assessed at Month 15.

-Open-label Extension (OLE) Period - All subjects completing Double-blind Treatment Period will be given an opportunity to enter the OLE Period of the study and receive the active treatment (PXT3003). The duration of the OLE Period will be based on Sponsor discretion, ie, Sponsor intends to keep the study open until the study drug PXT3003 is commercially available.

During this period, the long-term safety and efficacy of PXT3003 will be assessed as an exploratory objective.

Double-blind Treatment Period Objectives:

Primary:

To evaluate the efficacy of treatment with PXT3003 (a fixed-dose combination of [RS]-baclofen, naltrexone hydrochloride [HCl], and D-sorbitol) compared to placebo in subjects with Charcot-Marie-Tooth disease type 1A (CMT1A).

Secondary:

To evaluate the safety and tolerability of PXT3003 treatment in subjects with CMT1A.

Exploratory:

To characterize the relationship between plasma biomarkers and response to PXT3003 treatment.

OLE Period Objective:

Exploratory:

To evaluate the long-term safety and efficacy of PXT3003.


title: A Phase 1/2 Study to Assess the Safety, Pharmacokinetics, and Efficacy of Daily Intravenous of AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia

summary: The primary objective is to define the safety and tolerability of AB8939 in patients with AML by determining the dose-limiting toxicities, the maximum tolerated dose, and the recommended dose for dose expansion study.

ReferenceCitation: Goubard A, Humbert M, Mansfield C, Hermine O, Dubreuil P, et al. In Vivo Assessment of the Next Generation Microtubule-Destabilizing Agent AB8939 in Patient-derived Xenograft Models of Acute Myeloid Leukemia. Blood (2019) 134 (Supplement_1): 5142. doi.org/10.1182/blood-2019-127143

ReferenceCitation: Goubard A, Humbert M, Mansfield C, Hermine O, Dubreuil P, et al. AB8939, a Microtubule-Destabilizing Agent with Potential to Overcome Multidrug Resistance, is Active Across the Range (M0-M7) of Acute Myeloid Leukemia Subtypes. Blood (2019) 134 (Supplement_1): 5154. doi.org/10.1182/blood-2019-127021

ReferenceCitation: Humbert M, Goubard A, Mansfield C, Hermine O, Dubreuil P, et al. Anticancer Activity of a Highly Potent Small Molecule Tubulin Polymerization Inhibitor, AB8939. Blood (2019) 134 (Supplement_1): 2075. doi.org/10.1182/blood-2019-122540

lead_sponsor: AB Science

location_country:
United States
Spain
France

location_facility:
Institut Paoli Calmettes
Clínica Universidad de Navarra
Hospital Universitario Quirónsalud
MD Anderson Cancer Center
Hospital Universitario 12 de Octubre


title: Evaluation of the Valiant Mona LSA Thoracic Stent Graft System in Thoracic Aortic Aneurysms and Chronic Dissections

acronym: MONA-LSA

summary: To ensure adequate seal of currently available stent grafts, a proximal 20 mm of healthy aorta is recommended. Extending the proximal landing zone into the arch by intentional covering of the left subclavian artery (LSA) without revascularization expose to serious neurologic complications. Serious risks are also known to accompany subclavian revascularization. The Valiant Mona LSA Thoracic Stent Graft System (Medtronic,Santa Rosa, Calif) consists of a main stent graft and a branch stent graft designed to maintain LSA patency. The purpose of this study is to characterize the safety and effectiveness of this device for the treatment of Aneurysms and chronic Type B dissections of the arch.

status: Withdrawn

primary_purpose: Device Feasibility

lead_sponsor: University Hospital, Toulouse

location_facility:
CHU Toulouse, Hôpital Rangueil
Hôpital Timone Adultes


title: Phase II Open-label, Multicentre, Randomized Trial of Neoadjuvant Palbociclib in Combination With Hormonal Therapy and HER2 Blockade Versus Paclitaxel in Combination With HER2 Blockade for Postmenopausal Patients With Hormone Receptor Positive/HER2 Positive Early Breast Cancer

acronym: TOUCH

summary: This is a phase II open-label, multicentre, randomized trial. The study assesses the treatment of postmenopausal patients with hormone receptor positive/HER2 positive early breast cancer with neoadjuvant palbociclib in combination with hormonal therapy and HER2 blockade, versus the treatment with paclitaxel in combination with HER2 blockade.

ReferenceCitation: Biganzoli L, Wildiers H, Oakman C, Marotti L, Loibl S, Kunkler I, Reed M, Ciatto S, Voogd AC, Brain E, Cutuli B, Terret C, Gosney M, Aapro M, Audisio R. Management of elderly patients with breast cancer: updated recommendations of the International Society of Geriatric Oncology (SIOG) and European Society of Breast Cancer Specialists (EUSOMA). Lancet Oncol. 2012 Apr;13(4):e148-60. doi: 10.1016/S1470-2045(11)70383-7. Epub 2012 Mar 30. Review.

ReferenceCitation: Biganzoli L, Aapro M, Loibl S, Wildiers H, Brain E. Taxanes in the treatment of breast cancer: Have we better defined their role in older patients? A position paper from a SIOG Task Force. Cancer Treat Rev. 2016 Feb;43:19-26. doi: 10.1016/j.ctrv.2015.11.009. Epub 2015 Dec 15. Review.

ReferenceCitation: Cancer Genome Atlas Network. Comprehensive molecular portraits of human breast tumours. Nature. 2012 Oct 4;490(7418):61-70. doi: 10.1038/nature11412. Epub 2012 Sep 23.

ReferenceCitation: Cristofanilli M, Turner NC, Bondarenko I, Ro J, Im SA, Masuda N, Colleoni M, DeMichele A, Loi S, Verma S, Iwata H, Harbeck N, Zhang K, Theall KP, Jiang Y, Bartlett CH, Koehler M, Slamon D. Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, double-blind, phase 3 randomised controlled trial. Lancet Oncol. 2016 Apr;17(4):425-439. doi: 10.1016/S1470-2045(15)00613-0. Epub 2016 Mar 3. Erratum in: Lancet Oncol. 2016 Apr;17 (4):e136. Lancet Oncol. 2016 Jul;17 (7):e270.

ReferenceCitation: Demidenko E. Sample size and optimal design for logistic regression with binary interaction. Stat Med. 2008 Jan 15;27(1):36-46.

ReferenceCitation: Finn RS, Dering J, Conklin D, Kalous O, Cohen DJ, Desai AJ, Ginther C, Atefi M, Chen I, Fowst C, Los G, Slamon DJ. PD 0332991, a selective cyclin D kinase 4/6 inhibitor, preferentially inhibits proliferation of luminal estrogen receptor-positive human breast cancer cell lines in vitro. Breast Cancer Res. 2009;11(5):R77. doi: 10.1186/bcr2419.

ReferenceCitation: Finn RS, Martin M, Rugo HS, Jones S, Im SA, Gelmon K, Harbeck N, Lipatov ON, Walshe JM, Moulder S, Gauthier E, Lu DR, Randolph S, Diéras V, Slamon DJ. Palbociclib and Letrozole in Advanced Breast Cancer. N Engl J Med. 2016 Nov 17;375(20):1925-1936.

ReferenceCitation: Herschkowitz JI, He X, Fan C, Perou CM. The functional loss of the retinoblastoma tumour suppressor is a common event in basal-like and luminal B breast carcinomas. Breast Cancer Res. 2008;10(5):R75. doi: 10.1186/bcr2142. Epub 2008 Sep 9.

ReferenceCitation: Jenkins EO, Deal AM, Anders CK, Prat A, Perou CM, Carey LA, Muss HB. Age-specific changes in intrinsic breast cancer subtypes: a focus on older women. Oncologist. 2014 Oct;19(10):1076-83. doi: 10.1634/theoncologist.2014-0184. Epub 2014 Aug 20.

ReferenceCitation: Johnston S, Pippen J Jr, Pivot X, Lichinitser M, Sadeghi S, Dieras V, Gomez HL, Romieu G, Manikhas A, Kennedy MJ, Press MF, Maltzman J, Florance A, O'Rourke L, Oliva C, Stein S, Pegram M. Lapatinib combined with letrozole versus letrozole and placebo as first-line therapy for postmenopausal hormone receptor-positive metastatic breast cancer. J Clin Oncol. 2009 Nov 20;27(33):5538-46. doi: 10.1200/JCO.2009.23.3734. Epub 2009 Sep 28.

ReferenceCitation: Kaufman B, Mackey JR, Clemens MR, Bapsy PP, Vaid A, Wardley A, Tjulandin S, Jahn M, Lehle M, Feyereislova A, Révil C, Jones A. Trastuzumab plus anastrozole versus anastrozole alone for the treatment of postmenopausal women with human epidermal growth factor receptor 2-positive, hormone receptor-positive metastatic breast cancer: results from the randomized phase III TAnDEM study. J Clin Oncol. 2009 Nov 20;27(33):5529-37. doi: 10.1200/JCO.2008.20.6847. Epub 2009 Sep 28.

ReferenceCitation: Malorni L, Piazza S, Ciani Y, Guarducci C, Bonechi M, Biagioni C, Hart CD, Verardo R, Di Leo A, Migliaccio I. A gene expression signature of retinoblastoma loss-of-function is a predictive biomarker of resistance to palbociclib in breast cancer cell lines and is prognostic in patients with ER positive early breast cancer. Oncotarget. 2016 Sep 13;7(42):68012-68022. doi: 10.18632/oncotarget.12010.

ReferenceCitation: Miles D, Baselga J, Amadori D, Sunpaweravong P, Semiglazov V, Knott A, Clark E, Ross G, Swain SM. Treatment of older patients with HER2-positive metastatic breast cancer with pertuzumab, trastuzumab, and docetaxel: subgroup analyses from a randomized, double-blind, placebo-controlled phase III trial (CLEOPATRA). Breast Cancer Res Treat. 2013 Nov;142(1):89-99. doi: 10.1007/s10549-013-2710-z. Epub 2013 Oct 16.

ReferenceCitation: Witkiewicz AK, Ertel A, McFalls J, Valsecchi ME, Schwartz G, Knudsen ES. RB-pathway disruption is associated with improved response to neoadjuvant chemotherapy in breast cancer. Clin Cancer Res. 2012 Sep 15;18(18):5110-22. doi: 10.1158/1078-0432.CCR-12-0903. Epub 2012 Jul 18.

lead_sponsor: ETOP IBCSG Partners Foundation

location_country: France Italy Switzerland Belgium

location_facility: Istituti Clinici Scientifici Maugeri SpA-SB,Via Salvatore Maugeri N° 10

location_facility: E.O. Ospedali Galliera, Mura delle Cappuccine, 14

location_facility: Clinique Saint Elizabeth, Place Louise Godin 15

location_facility: Ospedale Civile di Lecco,Via della Filanda 14

location_facility: Brustzentrum Thurgau / Kantonsspital Frauenfeld, Pfaffenholzstrasse 4

location_facility: University Hospital Zurich, Frauenklinikstrasse 10

location_facility: ASO "SS Antonio e Biagio Cesare Arrigo, Via Venezia 16

location_facility: Centro di Riferimento Oncologico (CRO), Via Franco Gallini 2

location_facility: CHR de la Citadelle, Boulevard du XIIe de Ligne, 1

location_facility: U.O Medicina Oncologica Ospedale di Carpi, Via G. Molinari, 2

location_facility: Hospital of Prato, Via Dolce dei Mazzamuti, 7

location_facility: Kantonsspital St. Gallen, Rorschacher Strasse 95

location_facility: Azienda Ospedaliero-Universitaria di Udine, Piazzale S.M. Misericordia 15

location_facility: Istituto scientifico Romagnolo per lo studio e la cura,Via Piero Maroncelli 40

location_facility: Università del Piemonte Orientale - SCDU Oncologia, Corso Mazzini 18

location_facility: A.O. Universitaria Pisana Ospedale Santa Chiara Pisa, Via Roma 67

location_facility: Comprensorio Sanitario Bolzano, Via Lorenz Bohler, 5

location_facility: UO Oncologia, Rimini Hospital, Via Settembrini 2

location_facility: Ospedale Policlinico San Martino,Largo Rosanna Benzi,10

location_facility: Groupe Hospitalier Diaconesses Croix Saint Simon

location_facility: Institut de Cancérologie de l'Ouest (ICO)

location_facility: AO Universitaria Ospedale Di Circolo e Fondazione,v.le L. Borri, 57

location_facility: Ospedali Riuniti di Bergamo, A.O.Papa Giovanni XXIII, Piazza OMS1

location_facility: Clinica Oncologica-Ospedali Riuniti Ancona, Via Conca n.71,

location_facility: ASST Spedali Civili Brescia, Piazzale Spedali Civili n.1

location_facility: Ospedale S. Orsola-Malpighi, Viale Ercolani 4/2

location_facility: Azienda Ospedaliero-Universitaria di Parma, via Gramsci 14

location_facility: Oncology Institute of Southern Switzerland (IOSI), Ospedale San Giovanni, IOSI

location_facility: Clinique Saint- Joseph, Rue de Hesbaye 75

location_facility: Santa Maria delle Croci Hospital, Viale Randi 5

location_facility: Universitatsspital Basel, Petersgraben 4


title: Impact of Physical Rehabilitation on Sarcopenia Inolder and Chronic Kidney Patients

acronym: IMPREPA

summary: Older patients with chronic renal failure suffer from sarcopenia. Loss of muscle function is associated with increased morbidity and mortality. Currently few treatment are available. The aim of this study is to evaluate the impact of physical rehabilitation in this population on muscle performance and quality of life.

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de Néphrologie, Centre Hospitalier Lyon Sud

location_facility: Service de Médecine du vieillissement, soins de suite et de rééducation, Centre Hospitalier Lyon SUd


title: Pregnancy Loss Between 15 and 22 Weeks SA Within the Network of Perinatal Period of Western Brittany : Case Control Study

acronym: PEGREP

summary: The etiologies and some risk factors for pregnancy loss in the 2nd trimester are described in the literature. However, there are some risk factors that are not studied. The PEGREP study is a retrospective observational case-control study whose main objective is to identify risk factors for pregnancy loss between 15 and 22 weeks. The patients included cases are women who had a pregnancy loss between 15 and 22 SA between 2010 and 2015 and who were listed during the mortality reviews of the perinatal network of Western Brittany. The patient witnesses gave birth at the end of a healthy child in one of the maternity of Western Brittany. Matching 1 case for 1 controls was done on the woman's age, parity and number of fetuses.

time_perspective: Retrospective

lead_sponsor: University Hospital, Brest

location_facility:
SALAUN Anne -Laure
CHRU de Brest


title: Phase III Randomised Trial to Evaluate the Benefit of Adjuvant Hormonal Treatment With Leuprorelin Acetate (Eligard® 45 mg) for 24 Months After Radical Prostatectomy in Patients With High Risk of Recurrence.

summary:
PRINCIPAL OBJECTIVE: Evaluation of effectiveness in terms of survival without metastases to 10 years, of adjuvant hormonal treatment with leuprorelin acetate (Eligard® 45 mg) for 24 months after radical prostatectomy in patients with high risk of recurrence.

SECONDARY OBJECTIVE(S):

PSA evolution
Evaluation of testosterone level
Specific survival
Overall survival
Tolerance
Quality of life (QLQ-C30 questionnaires)

location_facility: Centre Hopsitalier Prive - Polyclinique Du Littoral


title: Endogenous Mechanisms of Inactivation of the Endothelium Tumor

acronym: BreastIls

summary:
The role of immunity in the development of cancers, and the associated escape mechanisms, have attracted renewed interest since the publication of tests testing immunological checkpoint inhibitors. One of the steps in the probably least studied immunological response is the penetration of immunocompetent cells within the tumor across the vascular barrier. This infiltration is suggested as a prognostic and predictive marker of treatment response, particularly in triple negative HER2 (Human Epidermal Growth Factor Receptor-2) overexpressing breast cancers. The methods of evaluating these infiltrates are complex and have been the subject of recommendations.

A better understanding of the mechanisms of infiltration of immunity cells within tumors will certainly help to better understand the impact of cancer treatments and develop new therapeutic strategies.

It is this issue of vascular endothelium that Dr. Soncin's team is developing as part of an INCa (Institut National du cancer) project. The egfl7 / VE-statin (vascular endothelial-statin) gene is thought to be involved in transendothelial passage of immune cells from vascular lumen to tumor. Its expression has already been studied in a series of breast cancers. Other markers of endothelial activation are currently being identified.

The main objective of this project will be to better understand the behavior of the endothelium in a population of breast cancer where the infiltrate in immune cells is precisely likely to play a leading role. This retrospective cohort of 250 to 300 cases treated with adjuvant and neoadjuvant will be immunologically characterized using the recommendations of Salgado et al. that a multicentric team of pathologists will take ownership. This evaluation will be counter-appraised.

Once our cohort is immunologically characterized, our project will focus on better understanding the endothelial mechanisms involved: which cells? immunophenotyping of immunity cells. By which vessels? (measurement of densities in blood and lymphatic vessels, density in HEV). By what mechanisms? Do the actors identified in vitro within the Inca project have an in vivo translation

lead_sponsor: Centre Oscar Lambret

location_facility:
Centre Oscar Lambret
Centre Henri Becquerel


title: Motor REHAbilitation TEChnologies for CHIldren With Disability

summary: The aim of the RehaTech4Child survey led by EACD is to identify the digital technologies (e.g., robotic devices and treadmill systems, virtual reality and gaming systems, telehealth) that are used in clinical practices throughout Europe, and to know more about how rehabilitation professionals use or not use digital technologies in motor rehabilitation practices within the paediatric population. This knowledge would eventually help in designing the future technological developments based on the feedback from rehabilitation professionals.

time_perspective: Cross-Sectional


title: A Prospective Cohort Study of Efficacy, Safety and Characterization of Immune Response to Vaccinations in Hematopoietic Stem Cell Transplant Recipients

acronym: VaccHemInf

summary: Hematopoietic stem cell transplantation (HSCT) is a cellular therapy aiming at curing some hematological diseases. Upon transplantation, recipients experience a phase of profound immune suppression with loss of protective immunity against most infectious agents. Revaccination of HSCT recipients against vaccine-preventable infections is an important post-transplant intervention for reducing morbi-mortality. The VaccHemInf project aims at assessing the efficacy of recommended vaccines in adult recipients of HSCT, through the antibody titers reference method and a panel of immune functional assays.

primary_purpose: Prevention

ReferenceCitation: Conrad A, Boccard M, Valour F, Alcazer V, Tovar Sanchez AT, Chidiac C, Laurent F, Vanhems P, Salles G, Brengel-Pesce K, Meunier B, Trouillet-Assant S, Ader F; Lyon HEMINF Study Group. VaccHemInf project: protocol for a prospective cohort study of efficacy, safety and characterisation of immune functional response to vaccinations in haematopoietic stem cell transplant recipients. BMJ Open. 2019 Feb 15;9(2):e026093. doi: 10.1136/bmjopen-2018-026093.

location_facility:
Centre Hospitalier Lyon Sud
Hôpital de la Croix Rousse


title: Evaluation of Multidisciplinary Collaboration Care Program in Pulmonary Arterial Hypertension

acronym: ETHAP

summary:
Pulmonary arterial hypertension (PAH) is a severe pulmonary vascular affection, which treatment has evolved in the last few years, improving quality of life. However, adherence to treatment has not been assessed in such patients. The investigators developed a collaborative care model involving clinical pharmacists in PAH. The objective of this work is to evaluate the impact of such model of care on medication errors and adverse events, quality of life and clinical criteria.

This randomized multicentre controlled study will include approximately 100 PAH patients (NYHA II to IV). After inclusion, patients will receive either collaborative care including consultations with specialized pharmacist and nurse, or classic follow-up. Each patient will be followed during 18 months from the date of inclusion.

The investigators hope to show the positive impact of a collaborative care model in PAH. More specifically, the investigators aim to show the interest of long-term patient education to improve patient safety related to drugs, but also their quality of life, and have preliminary data about usual clinical criteria.

ReferenceCitation: Roustit M, Chaumais MC, Chapuis C, Gairard-Dory A, Hadjadj C, Chanoine S, Allenet B, Sitbon O, Pison C, Bedouch P; ETHAP Study Group. Evaluation of a collaborative care program for pulmonary hypertension patients: a multicenter randomized trial. Int J Clin Pharm. 2020 Aug;42(4):1128-1138. doi: 10.1007/s11096-020-01047-8. Epub 2020 May 21.

lead_sponsor: University Hospital, Grenoble

location_facility: Clinical Research Center Inserm CIC03 - Grenoble University Hospital


title: Phase-3 Study, Randomized, Controlled, Multi-center, Double Blind, Comparing Palliative Radiotherapy With or Without Carboplatin

acronym: METAXIOM

summary:
The study population has locally advanced or metastatic bronchial or head and neck cancer.

This study assesses the value of concomitant chemo/radiotherapy with carboplatin daily during metastatic radiotherapy versus radiotherapy alone.

The realization of a systemic treatment during the radiotherapy could make it possible to obtain a benefit on the control of the evolution of the metastases and thus of the pains generated, as well as on the quality of life of the patients. In addition, a benefit in overall survival is possible.

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility:
Fabrice Denis
Institut de Cancérologie de l'Ouest

intervention_type: Combination Product


title: A Phase IIb, Prospective, Multicentre, Double-blind, Triple-arm, Randomized Versus Placebo Trial, to Assess the Efficacy of a Single Injection of Either 2 or 10 x 106 Autologous Adipose Derived Mesenchymal Stromal Cells (ASC) in the Treatment of Mild to Moderate Osteoarthritis (OA) of the Knee, Active and Unresponsive to Conservative Therapy for at Least 12 Months

summary:
ASCs will be administered via intra-articular use into the knee joint affected by OA where they are expected to exert their therapeutic effects.

The objective of this clinical trial is to generate efficacy and tolerability profiles of single injections of 2 dosages of autologous ASCs versus standard of care (placebo), when administered locally into a knee joint affected by OA after in vitro cell expansion. The potential of ASC to lead to a disease-modifying therapeutic option for the treatment of this chronic and debilitating disease will be assessed by MRI after 1 and 2 years.

This will be a phase IIb, multi-centre, prospective, randomized, double-blind study, comparing culture-expanded autologous ASC with placebo.


title: The Multitasking Rehabilitation She Enhanced Walking Speed Compared to the Simple Post Stroke Rehabilitation Task (AVC)?

acronym: SYNCOMOT

summary:
Stroke is the leading cause of severe disability in adults. The first cause of alterations in the quality of life and autonomy in these patients are disorders of walking and the balance. They are the leading cause of falls responsible for important medical, surgical and economic complications as well as a reactionary social isolation.

The techniques of rehabilitation of walking to the subacute phase of a stroke are usually based on automatic walking.Off walking is a complex activity usually performed in everyday life in association with multiple tasks. It is therefore interesting to re-educate walking in dual task or even in multitasking.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Prospective Study to Assess Quality of Life and Psychological Vulnerability in Patients With Metastatic Breast Cancer RH+

acronym: EPOCA

summary:
Metastatic breast cancer (MBC) is a dark prognostic disease with survival at 5 years of less than 20% and a median survival of 24 to 30 months after diagnosis of metastasis. Thus, metastatic diagnosis can be expected to have a different impact on the quality of life of patients in early and advanced stages.

However, MBC benefits from therapeutics that improve patients' quality of life and even improve overall survival. The main objectives of this prospective study are :

to evaluate the evolution over time of the quality of life of patients treated for positive hormonal receptors (RH+) metastatic breast cancer, according to the therapeutic class ;
to evaluate the psychological vulnerability of these patients since the announcement of their metastatic diagnosis and during their treatments. Finally, when interviewing oncologists, to know the factors involved in a treatment change decision process for the same patient.

location_facility:
Ico Nantes
Ico Angers


title: Prospective, Multicentric Study Evaluating the Surgical Treatment by Mastectomy With Immediate Prosthetic Breast Reconstruction in Patients With Breast Cancer and Receiving Adjuvant Therapy by TomoTherapy +/-Chemotherapy.

acronym: MARTA

summary:
Prospective, multicentric, non-randomized phase II study evaluating the surgical treatment by mastectomy with immediate prosthetic breast reconstruction in patients with breast cancer and receiving adjuvant therapy by TomoTherapy +/-Chemotherapy.

Patients with non-inflammatory and non-metastatic invasive mammary carcinoma will be included in this study.

The study procedure will be a surgical treatment by mastectomy with immediate prosthetic breast reconstruction followed by an adjuvant therapy: TomoTherapy +/-Chemotherapy (radiation therapy alone or preceded by chemotherapy).

The nature of the chemotherapy treatment will be decided according to the standards of each center.

The patients will be followed for the study up to 36 months after the surgical procedure.

lead_sponsor: Institut Claudius Regaud

location_facility: Institut Universitaire Du Cancer de Toulouse - Oncopole


title: Evaluation of Sphingolipids as Predictive Biomarkers of Immune Checkpoint Inhibitor Response in Melanoma Patients

acronym: IMMUSPHINX

summary:
This trial is a translational proof-of-concept, open-label, prospective cohort study of 60 patients aiming to identify the clinical markers and/or biomarkers associated with therapeutic response to immune checkpoints inhibitors, in patients with advanced melanoma.

The study will be conducted on a population of patients treated with anti-PD-1 alone (nivolumab or pembrolizumab) or in combination (nivolumab + ipilimumab) in the context of routine care.

For each included patient, blood samples will be collected at different time points.

If feasible, an optional tumor biopsy specimen will be collected during baseline visit.

All included patients will be followed-up for tumor response and toxicity until Week 12.

After Week 12, survival data (tumor status and/or survival status) will be collected every 3 months until a maximum duration of 1 year from the first study dose.


title: Urinary Postpartum Handicap Prevention: Pelvic Floor Exercises vs Control. Multicentric Randomized Trial

summary:
Objective: Compare pelvic floor disorders (urinary incontinence, anal incontinence, genital prolapse, perineal pain, sexual troubles) 12 month after a first delivery between a group of women with prenatal pelvic floor exercises and a control group.

Hypothesis: Prenatal pelvic floor exercises reduce postpartum urinary incontinence.

ReferenceCitation: Woodley SJ, Lawrenson P, Boyle R, Cody JD, Mørkved S, Kernohan A, Hay-Smith EJC. Pelvic floor muscle training for preventing and treating urinary and faecal incontinence in antenatal and postnatal women. Cochrane Database Syst Rev. 2020 May 6;5:CD007471. doi: 10.1002/14651858.CD007471.pub4.

ReferenceCitation: Fritel X, de Tayrac R, Bader G, Savary D, Gueye A, Deffieux X, Fernandez H, Richet C, Guilhot J, Fauconnier A. Preventing Urinary Incontinence With Supervised Prenatal Pelvic Floor Exercises: A Randomized Controlled Trial. Obstet Gynecol. 2015 Aug;126(2):370-377. doi: 10.1097/AOG.0000000000000972.

lead_sponsor: Centre Hospitalier Universitaire de la Réunion

location_facility:
CHU Antoine-Béclère
CHU Clermont
CHR Réunion, CH Félix-Guyon
CH Poissy-Saint-Germain
CHU Caremeau


title: Development and Validation of a Language Screening Test in Acute Right Hemispheric Strokes

acronym: R-LAST

summary:
This is a bi-centric study whose main objective is the validation of a rapid screening test for language disorders in the acute phase of right hemisphere stroke.

Primary objective

The main objective is the validation of a rapid language disorder screening tool that will be used in the acute phase of right hemispheric stroke.

Secondary objectives

Secondary objectives are:

Characterize the "atypical crossed aphasia" since the acute phase of stroke with a large cohort of patients , which, to our knowledge, has never been done.
Re-evaluate the number of patients with acute language disorder in right hemisphere stroke.
Validate the use of R-LAST by different categories of carers

lead_sponsor: Versailles Hospital

location_facility:
CH Sud Francilien
CH de Versailles


title: MRI in Multiple Myeloma: Analysis of the Axial Skeleton Versus Whole Body. What is the Required Analysis?

acronym: MYMO

summary: The investigators wish to determine which anatomic regions need to be explored in order to correctly diagnose myeloma: whether axial skeletal MRI alone is sufficient or whether it is necessary to perform a total skeletal MRI.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility:
CHU Montpellier
CHU Nimes


title: Comparison of the Radiological Pattern Between the Cerebral Stroke of Arterial and Venous Origin

acronym: PATTERN

summary: There are few published data on the patterns of parenchymal imaging abnormalities in a context of cerebral venous thrombosis (CVT). The objectives of the present study were to describe the patterns of parenchymal lesions associated with CVT and to determine the lesion sites.

location_facility:
CHU Rouen
CHU Amiens


title: Effect of Different Form of Upper Limb Muscles Training on Dyspnea in COPD

acronym: REHABSUP

summary: Evaluate the effect of upper limbs strength training versus the effect of upper limbs endurance training, on dyspnea, in patients with COPD during a pulmonary rehabilitation program.

ReferenceCitation: Beaumont M, Péran L, Berriet AC, Le Ber C, Le Mevel P, Courtois-Communier E, Couturaud F. Effect of different form of upper limb muscles training on dyspnea in chronic obstructive pulmonary disease: A study protocol. Medicine (Baltimore). 2020 Sep 18;99(38):e22131. doi: 10.1097/MD.0000000000022131.

location_facility:
CH Pays de Morlaix
CHRU de Brest


title: Relieve the Patient's Thirst, Refresh the Mouth First

acronym: ICU-MIC

summary:
Thirst is considered as one of the most distressing symptoms experienced by patients hospitalized in the Intensive Care Unit (ICU). Whereas pain is a permanent concern for all caregivers, thirst is often ignored and its complications are poorly known. Mechanisms involved in thirst regulation are numerous and complex. To date, care of thirst is still non optimal. Critically ill patients are usually rehydrated intravenously or using a naso-gastric tube, thus shunting the mouth as a therapeutic target to relieve the patient's thirst.

Water, cold and mint applied in mouth were studied separately and were shown to decrease thirst significantly on animal models and healthy humans.

Therefore, the hypothesis of this study is that application of small mint ice cubes in mouth of very dehydrated ICU patients should allow decreasing quickly and significantly thirst for these patients, before the correction of their biological parameters, like natremia and osmolarity.

lead_sponsor: Centre Hospitalier Arras

location_facility:
Centre Hospitalier de Lens
Centre Hospitalier d'Arras


acronym: TRIALS study

title: A Double-blind, Placebo-controlled, Exploratory Randomised Clinical Trial to Assess the Safety and Efficacy of IFB-088 Plus Riluzole 100 mg vs Placebo Plus Riluzole 100 mg in Patients With Bulbar-onset Amyotrophic Lateral Sclerosis.

lead_sponsor: InFlectis BioScience

location_country: France Italy

location_facility: Sant'Andrea Hospital Unit of Neuromuscular Disorders

location_facility: CHU de Clermont-Ferrand, Hôpital Gabriel Montpied

location_facility: Clinica Neurologica Amaducci (tertiary motor neuron Centre)

location_facility: CHU de Toulouse - Hôpital Pierre-Paul Riquet

location_facility: AOU Università degli Studi della Campania "Luigi Vanvitelli"

location_facility: Centro Regionale Esperto per la Sclerosi Laterale Amiotrofica (C.R.E.S.L.A.)

location_facility: APHM Hôpital La Timone Adultes SCE Maladies Neuromusculaires / SLA

location_facility: Centro Clinico NeMO per le Malattie Neuromuscolari

summary:
Prospective, international, randomised, double-blind, placebo controlled, multicentre, parallel group study. Patients will be randomised in a 2:1 allocation ratio to receive either IFB-088 + riluzole 100 mg or placebo + riluzole 100 mg. This clinical trial is an exploratory study, designed to show a signal of efficacy of IFB-088 through ALSFRS-R, MITOS and King's College. Respiratory function will be followed through SVC. Biomarkers and quality of life will also be evaluated throughout the study.

Patients will be treated over a 6-month period. After a screening/consent visit, patients will undergo clinic visits at randomisation (V0), at 2 weeks (V1), and at months 1 (V2), 3 (V3) and 6 (V4). One week after V0, the patient will undergo urine analysis (dipstick) and blood sampling for measurement of creatinine. At the V2 visit, in addition to other assessments, patients will undergo blood sampling for PK measurements and urine sampling for crystalluria examination. Blood and urine chemistry, as well as physical examination and vital signs assessment to assess safety will be performed at each visit for safety purpose and crystalluria examination will be repeated at the follow-up visit, performed one month ± one week after V4.