summary: Dietary protein differing by their amino acid composition could modulate undesirable metabolic and functional responses to a meal rich in saturated fat and sugars. This study aims at examining the specific effects of dairy protein with different cysteine contents on the postprandial undesirables effects elicited by the ingestion of a high fat meal in overweight subjects.

ReferenceCitation: Pujos-Guillot E, Brandolini-Bunlon M, Fouillet H, Joly C, Martin JF, Huneau JF, Dardevet D, Mariotti F. Metabolomics Reveals that the Type of Protein in a High-Fat Meal Modulates Postprandial Mitochondrial Overload and Incomplete Substrate Oxidation in Healthy Overweight Men. J Nutr. 2018 Jun 1;148(6):876-884. doi: 10.1093/jn/nxy049.

ReferenceCitation: Mariotti F, Valette M, Lopez C, Fouillet H, Famelart MH, Mathe V, Airinei G, Benamouzig R, Gaudichon C, Tome D, Tsikas D, Huneau JF. Casein Compared with Whey Proteins Affects the Organization of Dietary Fat during Digestion and Attenuates the Postprandial Triglyceride Response to a Mixed High-Fat Meal in Healthy, Overweight Men. J Nutr. 2015 Dec;145(12):2657-64. doi: 10.3945/jn.115.216812. Epub 2015 Oct 21.

sponsor_collaborators: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement


summary: Dietary protein is the more satiating nutrient, however it is not clear whether satiety may be influenced by the nature of the protein. This study was designed to assess potential differences between protein sources on satiety and their relationship with digestive and metabolic kinetics.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Basic Science

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Marsset-Baglieri A, Fromentin G, Airinei G, Pedersen C, Leonil J, Piedcoq J, Remond D, Benamouzig R, Tome D, Gaudichon C. Milk protein fractions moderately extend the duration of satiety compared with carbohydrates independently of their digestive kinetics in overweight subjects. Br J Nutr. 2014 Aug 28;112(4):557-64. doi: 10.1017/S0007114514001470. Epub 2014 Jun 26.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

evidence: oa repository (via OAI-PMH doi match)

host_type: repository

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CHU de Clermont-Ferrand

repository_normalized: HAL

version: submittedVersion

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Institut | Nicod

repositories_concat: HAL

unpaywall_oa_status: bronze

publisher_dissemination: Cambridge University Press

ReferenceCitation: Boutrou R, Gaudichon C, Dupont D, Jardin J, Airinei G, Marsset-Baglieri A, Benamouzig R, Tome D, Leonil J. Sequential release of milk protein-derived bioactive peptides in the jejunum in healthy humans. Am J Clin Nutr. 2013 Jun;97(6):1314-23. doi: 10.3945/ajcn.112.055202. Epub 2013 Apr 10.

oa_colors: green hybrid

evidence: open (via crossref license)

license: publisher-specific-oa

license_normalized: publisher-specific

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - memSIC

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

lead_sponsor: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

intervention_type: Dietary Supplement

lead_sponsor_type: academique

status_simplified: Completed


title: PASCA-MM Study. Impact of the PASCA (PArcours de Santé au Cours du CAncer) Program on Complications Associated With Multiple Myeloma and/or Its Treatments in the Context of a First Hematopoietic Stem Cell Autograft, in Adults Aged 18 to 70.

acronym: PASCA -MM

summary:
This is a prospective, multicentre, phase III, randomised, controlled intervention study.

Two groups of patients with equal numbers will be studied and each patient will be allocated to one of the two groups described below by randomisation (ratio 1:1).

Each patient will be allocated to one of the two groups described below by randomisation (ratio 1:1).

- PASCA interventional group

For both the 7 complications of interest (primary objective) and the 13 secondary complications (secondary objective), a specific and proactive referral will be made systematically after each screening assessment, depending on the level of risk, estimated according to decision trees (management guide) and through the dedicated PASCA network of healthcare professionals, in order to initiate early treatment and follow-up if necessary.

- Control group

For the 7 complications of interest (primary objective) as well as for the 13 complications (secondary objective): all the data from each identification check-up will be sent to the onco-haematological transmitted to the referring onco-haematologists, so that they can initiate their own management.

=> For all patients, regardless of group

All patients will receive four screening assessments covering the 7 complications of interest and 13 secondary complications:

Visit No.1 (T1), 1-2 months after the autologous haematopoietic stem cell transplantation (aHSCT), corresponding to the patient's visit to his or her Multiple Myeloma (MM) monitoring consultation and/or the start of his or her consolidation treatment.
Visit No.2 (T2), 4 months after aHSCT, corresponding to a patient's visit for the end of consolidation treatment;
Visit No.3 (T3), 14 months after the last aHSCT, corresponding to a visit by the patient during his or her maintenance treatment;
Visit No.4 (T4), 24 months after the last aHSCT, corresponding to a visit by the patient for a MM monitoring consultation.

study_start_date_type: Anticipated

status: Not yet recruiting

study_completion_date_type: Anticipated

primary_purpose: Prevention

enrollment_type: Anticipated

lead_sponsor: Centre Leon Berard

sponsor_collaborators:
Centre Leon Berard
National Cancer Institute, France

intervention_type: Behavioral

status_simplified: Ongoing


type: Other Identifier

title: Positioning of Molecular Markers in Clinical Routine for the Management of Patients With Adrenal Cancers/Tumors (COMETE-CARE)

acronym: COMETE-CARE

summary:
The adrenal cancer research network "COMETE" is federating French research on rare adrenal cancers. COMETE achieved major breakthroughs in the molecular characterization of adrenocortical carcinomas (ACC) and malignant pheochromocytomas/paragangliomas (MPP). Recently, COMETE successfully derived potential biomarkers for prognosis, theranostic and follow-up. Those biomarkers have been retrospectively validated. However the benefit for patients in real life conditions is not yet established.

Main objective : to implement COMETE biomarkers as a routine standard of care for adrenal cancer.

The primary end point is double :

Proportion of biomarkers results provided within 3 months after surgery,
The proportion of "informative" biomarkers, corresponding to markers passing quality controls and returning a value that is not in the grey zone of the measure.
Secondary objective : to estimate the impact of COMETE biomarkers on patients management.

Secondary endpoints :

Proportion of patients with discrepant clinical and molecular markers ; for discrepancies, proportion of decisions impacted by biomarkers results
Proportion of high risk patients for whom an actionable molecular target was identified
Predictive value (positive and negative) of biomarkers to detect recurrences
Molecular signatures of "extraordinary responders" to treatments (corresponding to the exceptional RECIST complete response, or to the >80% tumor reduction sutained for >6months)

design_allocation: Non-Randomized

primary_purpose: Diagnostic

ReferenceType: background

ReferenceCitation: Assie G, Jouinot A, Fassnacht M, Libe R, Garinet S, Jacob L, Hamzaoui N, Neou M, Sakat J, de La Villeon B, Perlemoine K, Ragazzon B, Sibony M, Tissier F, Gaujoux S, Dousset B, Sbiera S, Ronchi CL, Kroiss M, Korpershoek E, De Krijger R, Waldmann J, Quinkler M, Haissaguerre M, Tabarin A, Chabre O, Luconi M, Mannelli M, Groussin L, Bertagna X, Baudin E, Amar L, Coste J, Beuschlein F, Bertherat J. Value of Molecular Classification for Prognostic Assessment of Adrenocortical Carcinoma. JAMA Oncol. 2019 Oct 1;5(10):1440-1447. doi: 10.1001/jamaoncol.2019.1558.

ReferenceCitation: Lenders JWM, Kerstens MN, Amar L, Prejbisz A, Robledo M, Taieb D, Pacak K, Crona J, Zelinka T, Mannelli M, Deutschbein T, Timmers HJLM, Castinetti F, Dralle H, Widimsky J, Gimenez-Roqueplo AP, Eisenhofer G. Genetics, diagnosis, management and future directions of research of phaeochromocytoma and paraganglioma: a position statement and consensus of the Working Group on Endocrine Hypertension of the European Society of Hypertension. J Hypertens. 2020 Aug;38(8):1443-1456. doi: 10.1097/HJH.0000000000002438.

ReferenceCitation: Jouinot A, Lippert J, Sibony M, Violon F, Jeanpierre L, De Murat D, Armignacco R, Septier A, Perlemoine K, Letourneur F, Izac B, Ragazzon B, Leroy K, Pasmant E, North MO, Gaujoux S, Dousset B, Groussin L, Libe R, Terris B, Fassnacht M, Ronchi CL, Bertherat J, Assie G. Transcriptome in paraffin samples for the diagnosis and prognosis of adrenocortical carcinoma. Eur J Endocrinol. 2022 Apr 21;186(6):607-617. doi: 10.1530/EJE-21-1228.

ReferenceCitation: Chabre O, Libe R, Assie G, Barreau O, Bertherat J, Bertagna X, Feige JJ, Cherradi N. Serum miR-483-5p and miR-195 are predictive of recurrence risk in adrenocortical cancer patients. Endocr Relat Cancer. 2013 Jul 5;20(4):579-94. doi: 10.1530/ERC-13-0051. Print 2013 Aug.

ReferenceCitation: Bancos I, Taylor AE, Chortis V, Sitch AJ, Jenkinson C, Davidge-Pitts CJ, Lang K, Tsagarakis S, Macech M, Riester A, Deutschbein T, Pupovac ID, Kienitz T, Prete A, Papathomas TG, Gilligan LC, Bancos C, Reimondo G, Haissaguerre M, Marina L, Grytaas MA, Sajwani A, Langton K, Ivison HE, Shackleton CHL, Erickson D, Asia M, Palimeri S, Kondracka A, Spyroglou A, Ronchi CL, Simunov B, Delivanis DA, Sutcliffe RP, Tsirou I, Bednarczuk T, Reincke M, Burger-Stritt S, Feelders RA, Canu L, Haak HR, Eisenhofer G, Dennedy MC, Ueland GA, Ivovic M, Tabarin A, Terzolo M, Quinkler M, Kastelan D, Fassnacht M, Beuschlein F, Ambroziak U, Vassiliadi DA, O'Reilly MW, Young WF Jr, Biehl M, Deeks JJ, Arlt W; ENSAT EURINE-ACT Investigators. Urine steroid metabolomics for the differential diagnosis of adrenal incidentalomas in the EURINE-ACT study: a prospective test validation study. Lancet Diabetes Endocrinol. 2020 Sep;8(9):773-781. doi: 10.1016/S2213-8587(20)30218-7. Epub 2020 Jul 23.

ipd_sharing: No

lead_sponsor: Assistance Publique - Hôpitaux de Paris

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
National Cancer Institute, France

location_facility: GH Paris Centre, Assistance Publique - Hôpitaux de Paris

intervention_type: Other


title: Pilot Study in Cancer Patients Scheduled for Surgery Evaluating Different Smoking Cessation Protocols : Nicotine Replacement, Motivational Interviewing (MI), Cognitive Behavioural Therapy (CBT) or Hypnotherapy

acronym: RESPIRE

summary: This trial offers support and assistance to patients wishing to quit smoking in order to increase the success rate of smoking cessation and all the benefits associated with it. Patients will be monitored by a tobacco specialist and will be able to benefit from one or more therapies complementary to Nicotine Replacement Therapy (NRT): Motivational Interviewing (MI), Cognitive Behavioural Therapy (CBT) or Hypnotherapy.

study_start_date_type: Actual

status: Recruiting

primary_purpose: Treatment

lead_sponsor: Institut Cancerologie de l'Ouest

sponsor_collaborators:
Institut Cancerologie de l'Ouest
National Cancer Institute, France

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

intervention_type: Drug

lead_sponsor_type: industriel


title: Randomized Multicentric Comparative Study Between a Conventional and an Intensive Follow up Strategy After Treatment of a Head and Neck Squamous Cell Carcinoma

acronym: SURVEILL'ORL

summary: Phase III randomized trial to compare the efficacy in terms of overall survival of two follow-up strategies (conventional versus intensive) among smokers and/or alcohol drinkers patients, older than 35 year, in complete remission 2-4 months after treatment of head and neck squamous cell carcinoma Patients will be randomized after the post-treatment check-up (clinical examination and reference imaging including PET-CT for patients ≥ N2) performed 2 to 4 months after the end of treatment. The randomization ratio is 1:1.

status: Active, not recruiting

primary_purpose: Other

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

intervention_type: Procedure


title: Surgical Resection Plus Chemotherapy Versus Chemotherapy Alone in Oligometastatic Stage IV Gastric Cancer - a Multicenter, Prospective, Open-labeled, Two-armed, Randomized, Controlled Phase III Trial

acronym: SURGIGAST

summary: Surgical resection of the primary tumour and treatment of the metastatic site in oligometastatic stage IV metastatic gastric adenocarcinoma enhances survival and improves quality of life with acceptable postoperative morbidity and mortality in a selected group of operable patients with only one metastatic site that does not progress under chemotherapy.

lead_sponsor: University Hospital, Lille

sponsor_collaborators:
University Hospital, Lille
National Cancer Institute, France

appel_a_projets: PHRCK

region: Hauts-de-France

nom_etablissement: CHR LILLE

type_etablissement: CH

acronyme: SURGIGAST

titre: Impact de l'exérèse du primitif sur la survie globale dans l'adénocarcinome gastrique métastatique

discipline_principale: surgery

nom_porteur: MARIETTE

prenom_porteur: Christophe


title: A Phase III Randomized Study of Chemo-radiotherapy Versus Radiotherapy Alone in the Adjuvant Treatment of Salivary Glands and Nasal Tumors (IMRT or Protontherapy)

acronym: SANTAL

summary:
A phase III, multicenter, randomized, open-label, french study comparing:

Arm A : Radiotherapy alone (66 to 70 Gy; 5 fractions/week; 1fraction/day; 2 Gy/fraction) (IMRT or protontherapy)
Arm B: Radiotherapy (66 to 70 Gy; 5 fractions/week; 1fraction/day; 2 Gy/fraction; IMRT or protontherapy) + concomitant cisplatin 100 mg/m2 IV on day 1 - J22 - 43 (3 cycles)

ReferenceCitation: Ferrari M, Orlandi E, Bossi P. Sinonasal cancers treatments: state of the art. Curr Opin Oncol. 2021 May 1;33(3):196-205. doi: 10.1097/CCO.0000000000000726.

oa_host_type: repository

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: green

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Joshi NP, Broughman JR. Postoperative Management of Salivary Gland Tumors. Curr Treat Options Oncol. 2021 Feb 9;22(3):23. doi: 10.1007/s11864-021-00820-9.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Springer-Nature

lead_sponsor: Groupe Oncologie Radiotherapie Tete et Cou


title: Phase I Trial Evaluating the Safety of Durvalumab in Combination With Docetaxel, Cisplatin and 5-FU in Induction for Locally Advanced Head and Neck Squamous Cell Carcinoma

acronym: MEDINDUCTION

summary:
The prognosis of patients with locally advanced SCCHN is poor. Results of recent randomized trials evaluating induction chemotherapy by docetaxel, cisplatin, 5 fluorouracil are conflicting, and benefit on overall survival is uncertain. Improve efficacy of induction chemotherapy is important without increase toxicities. Durvalumab is a promising agent in SSCHN. The safety of combination of docetaxel, cisplatin, 5 fluorouracil with durvalumab is unknown.

The aim of the study is to evaluate the feasibility and the safety of the association of DCF (standard regimen for induction in SSCCHN) and durvalumab. The safety profile of DCF and durvalumab are different, so the expected toxicities should not be additive. The addition of durvalumab to DCF could improve the efficacy of induction chemotherapy and the prognostic of patients with SSCCHN.

Concerning the translational research, the aim will be to explore the relationships between immune capacity, specificity, activation state and clinical outcome to help elucidate the determinants of response to immunotherapy.

status: Unknown status

sponsor_collaborators: Gustave Roussy, Cancer Campus, Grand Paris

status_simplified: Unknown


title: Allogenic Immunotherapy Based on Natural Killer Cell Adoptive Transfer in Metastatic Gastrointestinal Carcinoma Treated With Cetuximab : a Phase I Trial

summary:
Gastrointestinal (GI) cancers account for the most common cancers. Despite recent advances in GI cancer treatments, the 5-year overall survival rate for these patients remain unacceptable, except for patients who are candidates for metastasis surgical resection. Strategies leading to a decrease of metastatic number and size will contribute to improve the probability to undergo a curative surgical procedure.

Haploidentical Natural Killer (NK) cells can persist and expand in vivo following adoptive transfer and may have a role in the treatment of selected malignancies, since the failure to recognize the appropriate KIR ligand on a mismatched tumor cell can trigger NK cell elimination of that target cell. NK also express an activating Fc receptor that mediates antibody-dependent cellular cytotoxicity (ADCC) and production of immune modulatory cytokines in response to antibody-coated targets. Cetuximab, an IgG1 chimeric monoclonal antibody against colorectal cancers that expressed EGFR (epidermal growth factor receptor), improves overall survival and progression-free survival and preserves quality-of-life measures in patients with colorectal cancer in whom other treatments have failed.

In an attempt to improve the outcome in GI cancers, we will conduct a phase I/II clinical trial assessing NK cell based immunotherapy. Patients with liver metastases related to a EGFR+ GI cancer, previously treated by a standard chemotherapy that did not achieve a complete response or a curative resection of residual metastases will be included in this phase I/II trial supported by the French National Institute of Cancer (INCA, PHRC 2005). This phase I/II study will involve 22 patients. The main objective of this study will be to demonstrate the safety of NK hepatic intraarterial infusion in association with cetuximab. Secondary objectives will include the assessment of the clinical efficacity of this strategy.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Financial Incentive for Smoking Cessation in Pregnancy

acronym: FISCP

summary:
Maternal smoking during pregnancy (MSDP) increases the risk of adverse pregnancy and birth outcomes and may have long-lasting effects in the offspring.Financial incentives may increase smoking abstinence rate in pregnancy and therefore reduce MSDP related negative health effects. This is a randomized open label study comparing financial incentives for smoking abstinence with no financial incentives for smoking abstinence.Research objectives

To test the efficacy of financial incentives on smoking abstinence rate among pregnant smokers;
To explore the heterogeneity of efficacy according to individual characteristics: socioeconomic status, social background, smoking characteristics, personality traits, time and risk preferences to determine profiles of women which could benefit best from this kind of intervention;
To provide a cost-benefit analysis based on the cost of newborn and children disease due to maternal smoking during pregnancy.

ReferenceCitation: Berlin I, Berlin N, Malecot M, Breton M, Jusot F, Goldzahl L. Financial incentives for smoking cessation in pregnancy: multicentre randomised controlled trial. BMJ. 2021 Dec 1;375:e065217. doi: 10.1136/bmj-2021-065217. Erratum In: BMJ. 2021 Dec 3;375:n3012. BMJ. 2022 Feb 22;376:o448.

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - IRD - Institut de recherche pour le développement

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot

publisher_dissemination: British Medical Journal

ReferenceCitation: Berlin N, Goldzahl L, Jusot F, Berlin I. Protocol for study of financial incentives for smoking cessation in pregnancy (FISCP): randomised, multicentre study. BMJ Open. 2016 Jul 26;6(7):e011669. doi: 10.1136/bmjopen-2016-011669.

oa_colors: green gold

evidence: oa journal (via doaj)

repository_institution: PubMed Central - Europe PMC

license: cc-by

license_normalized: cc-by

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

repository_institution: University of Edinburgh - Edinburgh Research Explorer

repositories:
HAL
PubMed Central
pure.ed.ac.uk

repositories_concat: HAL;PubMed Central;pure.ed.ac.uk

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

unpaywall_oa_status: gold


title: Prospective National Multicentre Study to Validate a Model of Surgical Deescalation in Atypicals Breast Lesions

summary:
Routine screening mammography has increased the non-palpable suspicious lesion detection rate, requiring histopathological evaluation. The discovery of atypical lesions on the breast biopsy is associated with two interrelated risks:

The risk of underestimating the severity of the lesion biopsied currently leads systematically to achieve a surgical resection for these patients while a breast cancer (BC) will finally identified at surgery in 10 to 25% of cases. Thus, unnecessary surgeries will be performed in 75 to 90% of cases (no cancer).
These breast lesions confer long-term increase in the subsequent risk of breast cancer (cumulative incidence of 15 to 25% at 25 years). Thus, women identified with atypical lesions are then followed using clinical and mammographic annual evaluation.

The goal would be to get a model to assess the risk and no longer operate those patients at high risk of BC. Several groups have attempted to identify predictors of concurrent or secondary BC associated with the discovery of an unusual lesion at biopsy. However, they are often focused on a subtype of atypia (eg atypical metaplasia, atypical ductal hyperplasia, atypical lobular hyperplasia) and no prediction model has been validated in prospective multicenter. Based on a large retrospective study at Gustave Roussy, a prediction model (Nomat) has been developed, common to all atypical lesions, which can predict the presence of a BC at excision surgery (risk of concurrent BC). This model is based on the age of the patient, the disappearance of radiographic abnormalities (microcalcifications in general) after the biopsy and initial radiological lesion size. This model has good performance with an area under the curve (AUC) of 0.72. In previous series, with a BC high-risk threshold of 20%, negative predictive value was 90%, and this model would have prevented the surgery in 51% of patients (low risk patients by model). It is essential to validate this model by forward-looking and in different centers to ensure its relevance.

This is a multicenter prospective validation of the model on 300 patients operated for atypical lesions in 21 centers. All patients with atypical breast lesions have a routine surgery. The clinical data, imaging and histological data will be collected prospectively. The main objective of this study is to validate the model Nomat.

ReferenceCitation: Uzan C, Mazouni C, Rossoni C, De Korvin B, de Lara CT, Cohen M, Chabbert N, Zilberman S, Boussion V, Vincent Salomon A, Espie M, Coutant C, Marchal F, Salviat F, Boulanger L, Doutriaux-Dumoulin I, Jouve E, Mathelin C, de Saint Hilaire P, Mollard J, Balleyguier C, Joyon N, Triki ML, Delaloge S, Michiels S. Prospective Multicenter Study Validate a Prediction Model for Surgery Uptake Among Women with Atypical Breast Lesions. Ann Surg Oncol. 2021 Apr;28(4):2138-2145. doi: 10.1245/s10434-020-09107-z. Epub 2020 Sep 12.

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - memSIC

location_facility: Gustave Roussy Cancer Campus Grand Paris

region: Île-de-France

nom_etablissement: INSTITUT GUSTAVE ROUSSY

type_etablissement: CLCC

titre: Etude prospective multicentrique nationale visant à valider un nomogramme de désescalade chirurgicale dans les lésions bénignes atypiques du sein

discipline_principale: breast surgery

nom_porteur: UZAN

prenom_porteur: Catherine


title: Modulation of the Expression of Papillomavirus (HPV) Oncoproteins to Major the Radiosensitivity: Phase I Trial Combining an Antiviral Agent VISTIDE and Radiochemotherapy in Cervical Cancers

acronym: HPV-RX

summary: The treatment of cervical tumors depends on the stage of the disease. In advanced forms (nodal and / or local extension to the vagina and / or parameters) , radiotherapy associated with curietherapy , plays a major role. Until recently this association was the standard treatment for advanced stage uterine cancer. With this combination, rates of local failures (evolutionary prosecution and local recurrences) were 20 to 50% in stages IIb and 50-75 % for stage III. More than 50% for patients with a cervical cancer locally advanced (FIGO stages II / IV) . The standard treatment, external radiotherapy followed by curietherapy allows expect survival rates at 5 years for approximately 30-45 %. For ten years, numerous studies have evaluated the addition of concurrent chemotherapy to radiotherapy in cancer of the cervix. More than 19 randomized trials have been published. A meta-analysis of these trials was undertaken to assess the role of radiochemotherapy in cancers of the cervix. The first meta-analysis published by the Cochrane Collaborative Group, taking into account 4580 patient, shows an improvement in survival, both in terms of progression free survival and overall survival for patients treated with radio chemotherapy respectively 16% and 12 % (p < 0.0001). The rate of metastasis is also decreased (p < 0.0001). Survival rates were significantly better when platinum salt was used ( p < 0.0001 ) . However, no clinical benefit of chemoradiotherapy has been demonstrated for tumors stages [1, 2] locally advanced, possibly due to small number of patients. The investigators have previously shown that antiviral agents used in preclinical models, Cidofovir® causes the selective radiosensitization of cells infected by the papillomavirus (HPV). This trial proposes to study a new concept to increase radiochemotherapy efficiency: the modulation of the expression of viral oncoproteins HPV virus by an antiviral agent.


title: Postoperative Hepatic Arterial Chemotherapy in High-risk Patients as Adjuvant Treatment After Resection of Colorectal Liver Metastases - A Randomized Phase II/III Trial

summary:
Currently, no adjuvant study with hepatic arterial infusion in the adjuvant setting is opened. Recently, the results of a phase II study (NCT00268463, NSABP-C-09) assessing the potential benefit of systemic oxaliplatin and capecitabine alternating with HAI of FUDR, after resection of CRLM have been reported.

The primary end point was 2-year survival. Fifty-five of 76 eligible patients were able to initiate protocol-directed therapy and completed median of six cycles (range, one to six). Three postoperative or treatment-related deaths were reported. Overall, 88% of evaluable patients were alive at 2 years. With a median followup of 4.8 years, a total of 30 patients have had disease recurrence, 11 involving the liver. Median disease-free survival was 32.7 months. In conclusion alternating HAI of FUDR and systemic capecitabine and oxaliplatin met the prespecified end point of higher than 85% survival at 2 years and were clinically tolerable.

status: Suspended

ReferenceCitation: Goere D, Pignon JP, Gelli M, Elias D, Benhaim L, Deschamps F, Caramella C, Boige V, Ducreux M, de Baere T, Malka D. Postoperative hepatic arterial chemotherapy in high-risk patients as adjuvant treatment after resection of colorectal liver metastases - a randomized phase II/III trial - PACHA-01 (NCT02494973). BMC Cancer. 2018 Aug 6;18(1):787. doi: 10.1186/s12885-018-4697-7.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inserm

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

titre: Chimiothérapie intra-artérielle hépatique adjuvante chez les patients à risque élevé de récidive hépatique après résection de métastases hépatiques d'origine colorectale

discipline_principale: adjuvant chemotherapy

nom_porteur: GOERE

prenom_porteur: Diane


acronym: CARBONOMIC

summary: The purpose of the study is to follow tumoral proteins metabolism by in vivo no radioactive isotopic tagging (carbon 13 and nitrogen 15).

status: Terminated

lead_sponsor: University Hospital, Grenoble

sponsor_collaborators:
University Hospital, Grenoble
National Cancer Institute, France


title: Quantification, Analysis and Simulation of Facial Mimics Movements

acronym: SIMOVI-IRM

summary:
The SIMOVI project is a collaboration between our Department of Maxillofacial Surgery (CHU Amiens) and the Biomechanical bioengineer Research Department and Roberval Labs (Technological University of Compiègne). The question raised is the extent to which a facial mimic can be evaluated objectively. In today's clinical practice, the investigators use grading systems based on muscular scale or testing, in order to evaluate a facial muscular disorder. This assessment remains subjective because the investigators are deducing from surfacing cutaneous deformations the movement quality of the solicited muscle.

This qualitative approach is therefore an approximate approach and deserves to be better thought to plan a surgical treatment which involves mimic facial muscle (as rehabilitation of facial palsy, cleft palate for example), to monitor the results, and to follow the recovery and progress in physiotherapy care.

The aim of this study is to correlate external soft tissue movement (essentially cutaneous) during facial mimic with internal movement (essentially facial mimic muscle) using qualitative and QUANTITATIVE indicators, and to perform a biomechanical model of selected mimic face's movement using the precedent data.

ReferenceCitation: Autuori B, Bruyere-Garnier K, Morestin F, Brunet M, Verriest JP. Finite element modeling of the head skeleton with a new local quantitative assessment approach. IEEE Trans Biomed Eng. 2006 Jul;53(7):1225-32. doi: 10.1109/TBME.2006.872812.

ReferenceCitation: Barbarino GG, Jabareen M, Trzewik J, Nkengne A, Stamatas G, Mazza E. Development and validation of a three-dimensional finite element model of the face. J Biomech Eng. 2009 Apr;131(4):041006. doi: 10.1115/1.3049857.

ReferenceCitation: Bensamoun SF, Ringleb SI, Littrell L, Chen Q, Brennan M, Ehman RL, An KN. Determination of thigh muscle stiffness using magnetic resonance elastography. J Magn Reson Imaging. 2006 Feb;23(2):242-7. doi: 10.1002/jmri.20487.

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ReferenceCitation: Hartl DM, Kolb F, Bretagne E, Bidault F, Sigal R. Cine-MRI swallowing evaluation after tongue reconstruction. Eur J Radiol. 2010 Jan;73(1):108-13. doi: 10.1016/j.ejrad.2008.10.005. Epub 2008 Dec 16.

ReferenceCitation: Farrugia ME, Robson MD, Clover L, Anslow P, Newsom-Davis J, Kennett R, Hilton-Jones D, Matthews PM, Vincent A. MRI and clinical studies of facial and bulbar muscle involvement in MuSK antibody-associated myasthenia gravis. Brain. 2006 Jun;129(Pt 6):1481-92. doi: 10.1093/brain/awl095. Epub 2006 May 3.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Evaluation of the Diagnostic Performance of MRI±Biopsy to Optimize Resection of Ductal Carcinoma In Situ (DCIS) Breast Cancer

acronym: IRCIS

summary: The purpose of this study is to evaluate the diagnostic performance of MRI±biopsy to optimize resection of Ductal Carcinoma In Situ (DCIS) breast cancer.

ReferenceCitation: Balleyguier C, Dunant A, Ceugnart L, Kandel M, Chauvet MP, Cherel P, Mazouni C, Henrot P, Rauch P, Chopier J, Zilberman S, Doutriaux-Dumoulin I, Jaffre I, Jalaguier A, Houvenaeghel G, Guerin N, Callonnec F, Chapellier C, Raoust I, Mathieu MC, Rimareix F, Bonastre J, Garbay JR. Preoperative Breast Magnetic Resonance Imaging in Women With Local Ductal Carcinoma in Situ to Optimize Surgical Outcomes: Results From the Randomized Phase III Trial IRCIS. J Clin Oncol. 2019 Apr 10;37(11):885-892. doi: 10.1200/JCO.18.00595. Epub 2019 Feb 27.

publisher_dissemination: American Society of Clinical Oncology (ASCO)


title: Validation of a Screening Tool in Geriatric Oncology

acronym: ONCODAGE

summary:
RATIONALE: A screening questionnaire may help doctors plan better treatment for older patients with cancer.

PURPOSE: This clinical trial is studying a questionnaire in screening older patients with cancer.

primary_purpose: Screening

ReferenceCitation: Bellera CA, Artaud F, Rainfray M, Soubeyran PL, Mathoulin-Pelissier S. Modeling individual and relative accuracy of screening tools in geriatric oncology. Ann Oncol. 2017 May 1;28(5):1152-1157. doi: 10.1093/annonc/mdx068.

ReferenceType: result

ReferenceCitation: Soubeyran P, Bellera C, Goyard J, Heitz D, Cure H, Rousselot H, Albrand G, Servent V, Jean OS, van Praagh I, Kurtz JE, Perin S, Verhaeghe JL, Terret C, Desauw C, Girre V, Mertens C, Mathoulin-Pelissier S, Rainfray M. Screening for vulnerability in older cancer patients: the ONCODAGE Prospective Multicenter Cohort Study. PLoS One. 2014 Dec 11;9(12):e115060. doi: 10.1371/journal.pone.0115060. eCollection 2014.

evidence: oa repository (via OAI-PMH title match)

repository_institution: 4 institutions : Université de Strasbourg, Université de Haute Alsace, INSA Strasbourg, Bibliothèque Nationale et Universitaire de Strasbourg - univOAK

repository_normalized: univOAK

evidence: oa repository (semantic scholar lookup)

repositories:
PubMed Central
pdfs.semanticscholar.org
univOAK

publisher_dissemination: Public Library of Science

lead_sponsor: Institut Bergonié

sponsor_collaborators:
Institut Bergonié
National Cancer Institute, France


title: Diffuse Large B Cell Non-Hodgkin's Lymphoma in the Vulnerable/Frail Elderly. A Multicentric Randomized Phase II Trial With Emphasis on Geriatric Assessment and Quality of Life

summary:
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, vincristine sulfate, prednisone, and liposome-encapsulated doxorubicin citrate, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. It is not yet known whether rituximab and combination chemotherapy are more effective when given together with or without liposome-encapsulated doxorubicin citrate in treating older patients with diffuse large B-cell non-Hodgkin lymphoma.

PURPOSE: This randomized phase II trial is studying the side effects of giving rituximab together with cyclophosphamide, vincristine sulfate, and prednisone with or without liposome-encapsulated doxorubicin citrate and to see how well it works in treating older patients with stage II, stage III, or stage IV diffuse large B-cell non-Hodgkin lymphoma.


acronym: HORGEN

summary:
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using anastrozole may fight breast cancer by lowering the amount of estrogen the body makes. Fulvestrant may fight breast cancer by blocking the use of estrogen by the tumor cells. Given the lack of clinical data on fulvestrant in patients with large operable or locally advanced hormone-receptor-positive breast cancer, and the potential to identify differences in the mechanism of resistance using the neoadjuvant model,we decided to perform a multicentre randomised phase II clinical trial of anastrozole and fulvestrant.

PURPOSE: The aim of this study was to assess the efficacy of neoadjuvant anastrozole and fulvestrant treatment of large operable or locally advanced hormone-receptor-positive breast cancer not eligible for initial breast-conserving surgery, and to identify genomic changes occurring after treatment.

ReferenceCitation: Quenel-Tueux N, Debled M, Rudewicz J, MacGrogan G, Pulido M, Mauriac L, Dalenc F, Bachelot T, Lortal B, Breton-Callu C, Madranges N, de Lara CT, Fournier M, Bonnefoi H, Soueidan H, Nikolski M, Gros A, Daly C, Wood H, Rabbitts P, Iggo R. Clinical and genomic analysis of a randomised phase II study evaluating anastrozole and fulvestrant in postmenopausal patients treated for large operable or locally advanced hormone-receptor-positive breast cancer. Br J Cancer. 2015 Aug 11;113(4):585-94. doi: 10.1038/bjc.2015.247. Epub 2015 Jul 14.

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

repositories_concat: PubMed Central;eprints.whiterose.ac.uk

ReferenceCitation: Lerebours F, Pulido M, Fourme E, Debled M, Becette V, Bonnefoi H, Rivera S, MacGrogan G, Mouret-Reynier MA, de Lara CT, Pierga JY, Breton-Callu C, Venat-Bouvet L, Mathoulin-Pelissier S, de la Motte Rouge T, Dalenc F, Sigal B, Bachelot T, Lemonnier J, Quenel-Tueux N. Predictive factors of 5-year relapse-free survival in HR+/HER2- breast cancer patients treated with neoadjuvant endocrine therapy: pooled analysis of two phase 2 trials. Br J Cancer. 2020 Mar;122(6):759-765. doi: 10.1038/s41416-020-0733-x. Epub 2020 Jan 31.

repository_institution: Universite de Bordeaux - Oskar-Bordeaux

repositories_concat: PubMed Central;oskar-bordeaux.fr

repositories_institution:
PubMed Central - Europe PMC
Universite de Bordeaux - Oskar-Bordeaux

title: Response to Neoadjuvant Treatment With Anti-aromatase Anastrozole and Anti-estrogen Fulvestrant: a Randomized Phase II Study in Postmenopausal Patients With Hormone-sensitive Non-metastatic Breast Cancer and an Exploratory Study of Molecular Signatures of Response.

type: EudraCT Number

source: euctr


title: Assessment of [18F]FLT-PET Imaging for Diagnosis and Prognosis of Brain Tumors

acronym: FLT

summary: The primary objective of this study is to assess the efficacy of the radiopharmaceutical 3'-deoxy-3'-[F-18]fluorothymidine, [F-18]FLT, a tracor of cell proliferation, using Positron Emission Tomography (PET) imaging for the tumor diagnosis and prognosis in a group of 50 patients with different type of brain tumors.[F-18]FLT PET imaging will be compared to the current used imaging techniques of MRI, spectroscopy imaging, PET imaging using [11C]MET tracer, immunohistochemical analysis and clinical parameters.

lead_sponsor: University Hospital, Caen

sponsor_collaborators:
University Hospital, Caen
National Cancer Institute, France


title: Impact for Care for Patients With Alcohol Addiction and Treated for ORL Cancer

summary: The aim of the study is to compare the hospitalisation period in ORL surgery for two groups of patients. One of them will be treated for alcohol addiction to weaning them before the surgery ORL. The other group will be treated with usual methods.

lead_sponsor: Department of Clinical Research and Innovation

location_facility: Fédération des maladies de l'appareil digestif - Hôpital ARCHET


title: Economic Evaluation of Image Guided Radiation Therapy For Prostate Cancer

summary: During the 7 to 8 weeks of conformal radiotherapy for prostate carcinoma, the prostate has an intra-pelvic motion which is not detectable by the conventional portal imaging. This prostate motion may lead to a mistargeting, which possibly decreases the local control. On the other hand, the new 3D on board imaging (3D OBI) allows to localize the target but is expensive. The cost/effectiveness ratio is not well established, as well as the frequency of using such imaging during the course of radiation.


title: A Comparison Between Individual and Wastewater SARS-CoV2 RNA Sequencing

acronym: Cagablea

summary: The aim is to compare the percentage of the different SARS-CoV2 lineages that are detected in wastewater samples with matched clinical samples. About 1,400 swab samples from patients living in Nice were tested by Biogroup between Oct 19th and Oct 23rd (Week 43 of 2020). The sequence of 81 PCR positive samples, corresponding to all samples that were unambiguously assigned to one of the wastewater catchment areas and their lineage was determined. These values were compared to values measured in wastewater.

study_type: Observational

time_perspective: Cross-Sectional

ipd_sharing: Undecided

lead_sponsor: Centre Hospitalier Universitaire de Nice

collaborators: Centre National de la Recherche Scientifique, France

location_facility:
Nice Hospital
Ipmc . Cnrs


title: Characterization and Quantification of Motor Speech Disorders in Huntington's Disease: Identification of Acoustic Markers

acronym: TPMH

summary: The study proposes to identify deviant speech dimensions in patients with HD at presymptomatic and declared stages of the disease, compared to healthy subjects, using the computerized MonPaGe speech protocol. This tool is based on a multidimensional and quantified assessment of voice and speech, by a set of targeted acoustic and perceptual criteria.

time_perspective: Prospective

lead_sponsor: University Hospital, Bordeaux

sponsor_collaborators: Centre National de la Recherche Scientifique, France

location_facility: Centre Hospitalier Universitaire de Bordeaux

appel_a_projets: PHRIP

region: Nouvelle-Aquitaine

nom_etablissement: CHU DE BORDEAUX

acronyme: TPMH

titre: Caractérisation et quantification des troubles de la parole dans la Maladie de Huntington: identification de marqueurs acoustiques.

discipline_principale: génétique

nom_porteur: FRAISSE

prenom_porteur: Sonia


title: Cerebral Bases of the Cognitive Learning in the Executive Control In the Adolescence

acronym: APEX-ADO

summary: The purpose of this study is to investigate the cognitive and brain effects of inhibitory control (IC) training at adolescence.

ReferenceCitation: Ahr E, Houde O, Borst G. Inhibition of the mirror generalization process in reading in school-aged children. J Exp Child Psychol. 2016 May;145:157-65. doi: 10.1016/j.jecp.2015.12.009. Epub 2016 Jan 27.

ReferenceCitation: Cachia A, Borst G, Vidal J, Fischer C, Pineau A, Mangin JF, Houde O. The shape of the ACC contributes to cognitive control efficiency in preschoolers. J Cogn Neurosci. 2014 Jan;26(1):96-106. doi: 10.1162/jocn_a_00459. Epub 2013 Aug 5.

ReferenceCitation: Borst G, Cachia A, Vidal J, Simon G, Fischer C, Pineau A, Poirel N, Mangin JF, Houde O. Folding of the anterior cingulate cortex partially explains inhibitory control during childhood: a longitudinal study. Dev Cogn Neurosci. 2014 Jul;9:126-35. doi: 10.1016/j.dcn.2014.02.006. Epub 2014 Feb 27.

lead_sponsor: Centre Hospitalier St Anne

location_facility: Centre de Recherche Clinique (CRC) - CHSA


title: EPIBRAINRAD : Study of Neurological Complication After Radiotherapy for Glioblastoma High Grade

acronym: EPIBRAINRAD

summary:
The survival time and the number of long time survivors after radiotherapy in brain cancer patients have increased for the last decades. Therefore the topic of late-delayed neurotoxic effects of this therapy gains more and more importance. Among these side effects, the main and most frequent one is the leukoencephalopathy, a diffused and progressive damage of the white matter characterized by myelin loss, loss of axons and vascular lesions. The incidence rate assessment, as well as the occurrence time, is based on retrospective studies with low numbers of patients, but seems to reach 30 to 50 % of the patients according to the follow-up. The risk seems to be increased during the first two years after the radiotherapy, but persists for decades.

To gain further insight in the radiation-induced leukoencephalopathy, the objective of this project is to study the onset and evolution of leukoencephalopathy in a 3-year prospective cohort of patients having undergone cerebral radiotherapy for glioma (stage 3-4), using specific cognitive tests, Magnetic Resonance Imagery (MRI) scans of the brain and predictive bio-markers of cognitive impairments.

ReferenceCitation: Durand T, Jacob S, Lebouil L, Douzane H, Lestaevel P, Rahimian A, Psimaras D, Feuvret L, Leclercq D, Brochet B, Tamarat R, Milliat F, Benderitter M, Vayatis N, Noel G, Hoang-Xuan K, Delattre JY, Ricard D, Bernier MO. EpiBrainRad: an epidemiologic study of the neurotoxicity induced by radiotherapy in high grade glioma patients. BMC Neurol. 2015 Dec 18;15:261. doi: 10.1186/s12883-015-0519-6.

lead_sponsor: Sophie JACOB

location_facility:
Hopital Pitié Salpétriere
Centre paul Strauss

intervention_type: Radiation


title: Management of Cognitive Difficulties After Cancer Treatments in Women Treated for Breast Cancer: Feasibility Study (Step 1 of the Cog-Stim Protocol)

acronym: COG STIM

summary: Investigator general objective is therefore to study and compare the benefit of several methods of management of cognitive difficulties reported by patients during treatment for breast cancer, among several treatments, offered independently in patients' homes and supervised from a distance: adapted physical activity only, cognitive stimulation only, and adapted physical activity coupled with cognitive stimulation (during separate sessions). The study will therefore be the first to include a group benefiting from these two management methods, which will make it possible to assess the individual benefit of cognitive stimulation sessions and adapted physical activity but also the benefit of combined sessions.As this type of combined management has never been the subject of a study, and previous studies relating to a single type of management having raised patient adhesion difficulties, it does not seem certain that this type of care is feasible in practice. Before studying its effectiveness, it is therefore essential to check the feasibility and acceptability of such a program combining sessions of adapted physical activity and cognitive stimulation sessions.Investigator will therefore first carry out a feasibility study, longitudinal and monocentric, which will assess the adherence of patients treated for breast cancer to the performance of cognitive stimulation sessions coupled with sessions of adapted physical activity.This feasibility study is a key stage of the Cog-Stim protocol because its results will probably highlight the obstacles to the intervention program, which will allow the investigator to propose adjustments to improve the study design for the following stages of the protocol. (design optimization).

lead_sponsor: Centre Francois Baclesse

sponsor_collaborators:
Centre Francois Baclesse
National Cancer Institute, France
Ligue contre le cancer, France


title: A Single-Dose, Double-Blind, Crossover, Placebo- and Moxifloxacin (Open-Label)-Controlled Study of the Effects of Lecozotan SR on Cardiac Repolarization in Healthy Adult Subjects

summary: This is a randomized, double-blind, placebo- and moxifloxacin (open-label)-controlled, 4-period crossover study.

lead_sponsor: Wyeth is now a wholly owned subsidiary of Pfizer


title: Study of the Performance of Ambulatory Nocturnal Polygraphy in the Diagnosis of Sleep Apnea in Multiple System Atrophy

summary: The purpose of this study is to determine whether ambulatory polygraphy during a short hospitalization in a neurology unit has the same performance than inpatient polysomnography, the actual gold standard, in the diagnosis of sleep apnea in patients suffering from multiple system atrophy (MSA).

location_facility: CHU de Bordeaux - Hôpital du Haut-Lévêque - Département de Neurologie - Centre de référence nationale maladie rare AMS

intervention_type: Device


title: Pilot Study on Efficacy and Tolerance of Peg-interferon Alpha-2a (Pegasys) Added to Tenofovir DF and Emtricitabine (Truvada) in AGHBe Positive HBV-HIV Co-infected Patients. ANRS HB 01 EMVIPEG.

summary: HBe seroconversion is an important goal for anti-HBV treatment, since it is associated with a non progressive liver infection and a better clinical outcome. However, the rate of HBe seroconversion is low in HIV-HBV co-infected patients, mostly treated by tenofovir and emtricitabine. This study will evaluate the efficacy and the safety of a one-year Peg-interferon alpha 2a additional treatment in patients already treated by tenofovir and emtricitabine without reaching HBe seroconversion.

lead_sponsor: French National Agency for Research on AIDS and Viral Hepatitis

collaborators:
Gilead Sciences
Roche Pharma AG

location_facility: Service d'Hépato-Gastroentérologie Hopital Hôtel-Dieu


title: Building of a Diagnostic/Prognostic Database by High-throughput Multiplexed Assays for Human ERG Variant Effects

acronym: CarDiag

summary: Cardiac channelopathies induce severe heart rhythm or conduction disorders. Mutations of the KCNH2 gene, that encodes the human (h) ERG channel, is responsible for 30-40% of all cases of long QT syndrome (inherited LQT2). Besides, hERG is frequently responsible for off-target effects of several pharmacological agents (acquired LQT2). With the advent of Next Generation Sequencing, hundreds of new KCNH2 variants are accumulating in regional databases including those developed by french centers of references. Worldwide, we estimate there are more than 1000 variants for hERG channel. Unfortunately, many of these new variants appear to be of unknown functional significance in spite of available clinical and genetic information. Little is known on whether they affect the channel biophysical properties, its expression at the cell surface and/or its structure. Yet, this information is crucial to determine the real degree of pathogenicity of these variants, and therefore to make the proper diagnosis on inherited LQT2, counsel the patient for his treatment and improve the management of the patient's life. Our ambition is therefore to tackle this issue of variant significance by (i) launching a large-scale multi-functional evaluation of hERG variants, (ii) introducing for the first time a formatted large-scale pathogenicity annotation score for all variants that have been functionally evaluated by this multi-parametric approach, and (iii) regrouping all the relevant information collected in every French Regional centers of reference into a single National database hosted by an infrastructure that possesses enough flexibility for continuous data implementation and cross-referencing. The database will integrate the latest International guidelines for functional pathogenicity annotation. This project will also include the pharmacological characterization of several drugs susceptible to produce acquired LQT2 with variable severities. We aim to understand whether there are structural regions within hERG channel in which the introduction of a variant is more prone to increase the risk of acquired LQT2 or if, on the contrary, a set of variants may relatively protect some patients against LQT2-inducing drugs.

time_perspective: Retrospective

ipd_sharing: Yes

ipd_sharing_description: Implementation of a new web-accessible variant-centric database

lead_sponsor: Nantes University Hospital

collaborators: Institut National de la Santé Et de la Recherche Médicale, France

location_facility:
Nantes university hospital
Hôpital Bichat - Claude Bernard


title: The COVISTRESS Study: Influence of the COvid-19 Epidemic on STRESS

acronym: COVISTRESS

summary: The Coronavirus has a major influence on stress for the general population. However, data are currently non-existent concerning the perception and knowledge of the epidemic, the feeling of information from companies / establishments / governments, the means of protection used, the feelings of fear generated and their impact on feelings of stigmatization towards certain ethnic groups or categories of patients (those who cough ...), or relationships with socio-demographic factors or lifestyle.

lead_sponsor: University Hospital, Clermont-Ferrand

collaborators: UMR CNRS 6024 LaPSCo, Clermont-Ferrand, France


title: Monitoring of Arrhythmias and Heart Rate Variability in Patients With Congestive Heart Failure Treated With the Cardiac Resynchronisation Pacemaker Renewal TR2

summary: The objective of this study is to evaluate the prevalence of sustained ventricular and supraventricular rhythm disorders in patients implanted with a CONTAK RENEWAL TR2 ventricular resynchronization therapy (CRT) device

ReferenceCitation: Boveda S, Marijon E, Jacob S, Defaye P, Winter JB, Bulava A, Gras D, Albenque JP, Combes N, Pavin D, Delarche N, Teubl A, Lambiez M, Chevalier P; Mona Lisa Study Group. Incidence and prognostic significance of sustained ventricular tachycardias in heart failure patients implanted with biventricular pacemakers without a back-up defibrillator: results from the prospective, multicentre, Mona Lisa cohort study. Eur Heart J. 2009 May;30(10):1237-44. doi: 10.1093/eurheartj/ehp071. Epub 2009 Mar 4.

lead_sponsor: Guidant Corporation

location_facility:
Nouvelle Clinique Nantaise
CHG Perigueux
CHG Albi
CHU Nîmes
Hôpital Pontchaillou
CHU Michalon
Centre Cardiologique du Nord
Clinique Pasteur
Hôpital Louis Pradel
CH La Croix Rousse


title: A Phase II Study Evaluating the Non-inferiority of the Device FLEXITHERALIGHT Compared to the Conventional Photodynamic Therapy (PDT)

acronym: Flexithera

summary: This study compares the efficacy and tolerance of a new device (FLEXITHERALIGHT) for photodynamic therapy in the treatment of keratosis actinic in comparison of classical PDT with Aktilite®.

ReferenceCitation: Lecomte F, Vignion-Dewalle AS, Vicentini C, Thecua E, Deleporte P, Duhamel A, Mordon S, Mortier L. Evaluating the Noninferiority of a New Photodynamic Therapy (Flexitheralight) Compared With Conventional Treatment for Actinic Keratosis: Protocol for a Phase 2 Study. JMIR Res Protoc. 2019 Apr 26;8(4):e11530. doi: 10.2196/11530.

evidence: oa repository (via OAI-PMH title and first author match)

repository_institution: Université de Lille (University Of Lille) - LillOA

repository_normalized: LillOA (Lille Open Archive)

repositories:
HAL
LillOA (Lille Open Archive)
PubMed Central

repositories_concat: HAL;LillOA (Lille Open Archive);PubMed Central

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inserm

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

publisher_dissemination: JMIR Publications

lead_sponsor: University Hospital, Lille

sponsor_collaborators: Institut National de la Santé Et de la Recherche Médicale, France


title: Study of the Effects of a Sartan on Hepatic Fibrosis Progression in Chronic Viral Hepatitis C

acronym: Fibrosar

summary:
The purpose of this study is to examine the efficacy of irbesartan on the progression of liver fibrosis in adult patients with chronic hepatitis C.

The expected total enrollment is 200 patients. Patients who meet the study criteria and accept to participate at this study will take by day one tablet of 150 mg of treatment (irbesartan or placebo) during two years. The assessment of efficacy will be make by evaluation of area of liver fibrosis and blood markers of liver fibrosis

lead_sponsor: ANRS, Emerging Infectious Diseases

sponsor_collaborators:
ANRS, Emerging Infectious Diseases
Sanofi

location_facility: CHU Angers, Service d'hépato-gastroentérologie


title: 3 T Multimodal MRI in Idiopathic RBD

acronym: ALICE

summary: Idiopathic rapid eye movement sleep behavior disorder (iRBD) is characterized by nocturnal violence, increased muscle tone during REM sleep and the lack of any other neurological disease. However, iRBD can precede parkinsonism and dementia by several years. The causes of the loss of muscle atonia during REM sleep in these patients are unclear. Using 3 T MRI and neuromelanin- sensitive sequences, the signal intensity was previously found to be reduce in the locus coeruleus/subcoeruleus area of patients with Parkinson's disease and RBD. Here, the investigators aimed at studying the integrity of the locus coeruleus/ subcoeruleus complex with neuromelanin-sensitive imaging in 21 patients with iRBD and compared the results with those from 21 age- and gender-matched healthy volunteers. All subjects will undergo a clinical examination, motor, cognitive, autonomous, psychological, olfactory and color vision tests, and rapid eye movement sleep characterization using video-polysomnography and 3 T magnetic resonance imaging.

ReferenceCitation: Ehrminger M, Latimier A, Pyatigorskaya N, Garcia-Lorenzo D, Leu-Semenescu S, Vidailhet M, Lehericy S, Arnulf I. The coeruleus/subcoeruleus complex in idiopathic rapid eye movement sleep behaviour disorder. Brain. 2016 Apr;139(Pt 4):1180-8. doi: 10.1093/brain/aww006. Epub 2016 Feb 26.

publisher_dissemination: Oxford University Press

lead_sponsor: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil

collaborators:
NRJ Foundation - Institute of France
National Research Agency, France


title: Postoperative Pain After Medical Abortion Under Local Anesthesia : a Prospective and Randomized Trial Comparing Several Analgesic Regimen

summary:
To compare postoperative analgesia by paracetamol 1gr or ketoprofen 100 mg or the combination of these two analgesics
each treatment beeing allocated by randomization

lead_sponsor: University Hospital, Angers


title: The Clinical Evaluation of the Stereotactic, MR Guided, Laser Interstitial Thermal Therapy (LITT ) for the "Minimal Invasive" Treatment of Brain Metastasis and Primary Brain Tumors - a Phase I Study With Direct Patient Benefice

summary: The purpose of this study is to determine if the stereotactic, MR guided, laser interstitial thermal therapy treatment technique can be safety and efficiently used for human brain metastasis and primary brain tumors.

ReferenceCitation: Carpentier A, McNichols RJ, Stafford RJ, Guichard JP, Reizine D, Delaloge S, Vicaut E, Payen D, Gowda A, George B. Laser thermal therapy: real-time MRI-guided and computer-controlled procedures for metastatic brain tumors. Lasers Surg Med. 2011 Dec;43(10):943-50. doi: 10.1002/lsm.21138. Epub 2011 Nov 22.

lead_sponsor: BioTex, Inc.


title: Adverse Childhood Experiences, AdaPtatiOn and Breast Cancer

acronym: CAPONE

summary:
Adverse Childhood Experiences (ACEs) have long been linked to mental health problems in adulthood. In the case of cancer, no study has considered that such an anteriority could make patients more vulnerable emotionally, even though the presence of reactionary disorders such as stress, anxiety or depression are characteristic of such a pathology. Activated during periods of stress and therefore during the illness, even the attachment system is mobilized and must be considered to allow more understanding of the illness experience. The attachment style can be seen here as an individual dimension that plays a role in the emotional regulation and resilience of patients. It is also particularly solicited during the remission phase, a complex and singular period of cancer disease that confronts patients with an ambivalence of hope and fear. The fear of recurrence is a concern that the cancer may return or progress in the same organ or in another part of the body. This is a determining factor in the occurrence of anxiety-depressive disorders. Finally, several studies have shown a strong association between depression/anxiety and Cancer-Related Fatigue (CRF) after treatment, especially during the remission phase.

ACEs leave physiological and epigenetic impact that can nowadays be easily evaluated, thus providing additional evidence between adversity, physiological and epigenetic vulnerability and the ability to adapt to life's challenges such as cancer. Life history changes are mediated by changes in cellular mechanisms affecting genome expression. It is currently widely demonstrated that ACEs increases epigenetic modifications.

The interest of this project is therefore to highlight the psychological consequences related to the occurrence of cancer in the developmental history (in terms of adversities) of patients who have completed adjuvant chemotherapy for breast cancer, taking into account the patients' previous attachments, resilience, fear of recurrence and perceived fatigue in order to consider their interactions and their effects on their psychological health and ultimately on their quality of life.

lead_sponsor: University of Lorraine

sponsor_collaborators:
University of Lorraine
Ligue contre le cancer, France

intervention_type: Genetic


title: Optimize the Support of Patients in Pelvic Onco-gynecology Through Adapted Support Care in the Post-cancer Period. AFTERGYN Pilot Phase

acronym: AFTERGYN

summary:
While the sequelae and toxicities after ovarian and endometrial cancer treatments are well described in the literature, the actual needs of patients for supportive oncology care remain poorly documented. Moreover, there is no data available to estimate the complexity of the oncological support care actions to be implemented.

It is expected that an evaluation of the needs for supportive oncology care and its organization in day hospitalization for supportive oncology care will lead to an improvement in personalized post-cancer follow-up for these patients and to an improvement in their long-term quality of life.

primary_purpose: Supportive Care

sponsor_collaborators:
Centre Francois Baclesse
Ligue contre le cancer, France


title: Before and After Study, Evaluating the Efficiency of an Anticipated Personalization of the Management in Day Hospital Unit Based on a Collection of the PROs Via a Digital Tool

acronym: ANTICIPRO

summary:
The present study proposes a new organization of the Day Hospital unit with several possible pathways defined by PRO.

The organization realies on a platform composed of nurses supervised by an IPA and a doctor one day before a treatment in the day hospitalization unit admission, results of PROs collectyed through the CEM@santé application (a French health care application) are reviewed by nurses from the platform and chemotherapy delivery is confirmed.

The study is planed in 2 steps.

st stage: the current circuit remains unchanged (with systematic medical or nursing validation to confirm chemotherapy administration. Patient satisfaction is collected at each visit to the day hospital unit for chemotherapy. 73 patients will be included in this phase.
nd stage: a short circuit is set up. If no contraindications are identified by the plateform with the remote PRO collection, patients will undergo chemotherapy directly the next day (without any medical validation. Patient satisfaction is also collected at each visit to the day hospital unit for chemotherapy. 73 patients will be included in this phase.

lead_sponsor: Center Eugene Marquis

sponsor_collaborators:
Center Eugene Marquis
Ligue contre le cancer, France

location_facility: Centre de lutte contre le cancer Eugène Marquis


title: Accompaniment of Patients by Dental Assistants in the Evaluation of Oral Hygiene During and After Radiotherapy Treatment: a Feasibility Study.

acronym: RadioT HBD

summary:
Feasibility, prospective, monocentric study aiming to evaluate the interest of a written information guide, given and explained by the dental assistant, on the improvement of the oral hygiene of patients with ORL cancer at 3 months post-radiotherapy.

The study will be conducted on a population of 44 patients with ORL cancer requiring radiation treatment.

Each patient will be followed during 3 months.

lead_sponsor: Institut Claudius Regaud

sponsor_collaborators:
Institut Claudius Regaud
Ligue contre le cancer, France

location_facility: Institut Universitaire du Cancer Toulouse - Oncopole


title: Feasibility of at Home Remote Monitoring Following a Stay in Intensive Rehabilitation in Patients With Chronic Swallowing Disorders Caused by Treatment for Cancer of the Aero-digestive Tract: Pilot Study

summary: The study will assess the feasibility of monthly post rehabilitation remote monitoring, using the "MAX Educ" webvision app, in patients with sequelae of aerodigestive cancer treatments.

lead_sponsor: University Hospital, Toulouse

sponsor_collaborators:
University Hospital, Toulouse
Ligue contre le cancer, France


title: Interest of CALR Allele Burden in Diagnosis and Follow-up of Patients With CALR Mutated Myeloproliferative Syndromes (CALRSUIVI)

acronym: CALRSUIVI

summary: Prospective study to evaluate the relevance of CALR allele burden monitoring as a molecular marker of disease progression.

ReferenceCitation: Cottin L, Riou J, Orvain C, Ianotto JC, Boyer F, Renard M, Truchan-Graczyk M, Murati A, Jouanneau-Courville R, Allangba O, Mansier O, Burroni B, Rousselet MC, Quintin-Roue I, Martin A, Sadot-Lebouvier S, Delneste Y, Chretien JM, Hunault-Berger M, Blanchet O, Lippert E, Ugo V, Luque Paz D. Sequential mutational evaluation of CALR -mutated myeloproliferative neoplasms with thrombocytosis reveals an association between CALR allele burden evolution and disease progression. Br J Haematol. 2020 Mar;188(6):935-944. doi: 10.1111/bjh.16276. Epub 2019 Nov 11.

sponsor_collaborators:
University Hospital, Angers
Ligue contre le cancer, France

intervention_type: Biological


title: Tobacco and Alcohol Risk Reduction for Women Treated for Breast Cancer and Partner Involvement : Benefits of a Brief Motivational Couple-based Intervention.

acronym: IBMC

summary: This study will examine the benefits of involving partner in a Screening, Brief Intervention and Referral to Treatment (SBIRT) program for tobacco and alcohol for women treated for breast cancer. Using a two-arm randomized trial (couple brief motivational intervention (CBMI) versus individual brief motivational intervention (IBMI) with repeated measures at 6 weeks, 3 and 6 months.

lead_sponsor: Institut Bergonié

sponsor_collaborators:
Institut Bergonié
Ligue contre le cancer, France


title: Nutrition and Chemotherapy, Representation and Practice in a Cancer Care Centre (JEUNETCHIMIO)

acronym: JEUNETCHIMIO

summary:
Patients treated for cancer nowadays have many means of information and tend to become more and more involved in their health. The interest of a therapeutic fast with detoxifying or even curative properties, with a specific indication for cancer patients treated by chemotherapy, is nowadays relayed by the media. To date, there are no studies conducted on the scope of this information in cancer patients or on the attitudes of oncologists towards this practice and possible positioning requests from patients.

We hypothesize that the choice of this practice and its modalities are rarely discussed with oncologists, although it may have deleterious repercussions on the patient's health.

We propose a research based on the principles of sociological intervention. Its objectives are a first review of the issue and the establishment of a joint working group, including patients, carers and researchers, which will propose solutions to improve the patient/carer dialogue on this issue.

lead_sponsor: Institut de Cancérologie de la Loire

sponsor_collaborators:
Institut de Cancérologie de la Loire
Ligue contre le cancer, France

location_facility: Institut de Cancérologie Lucien Neuwirth


title: Effectiveness of Screening and Brief Interventions for Alcohol and/or Tobacco During Breast Cancer Treatment: A Phase III, Pilot Prospective Randomized Trial (ONKODETOX)

acronym: ONKODETOX

summary:
Despite scientific, clinical and political incentives, alcohol and/or tobacco screening and brief intervention (SBI) services are poorly implemented in oncology settings. Motivational brief interventions are recognized as particularly effective in changing health behaviors, especially consumption behaviors. The motivational approach is more and more used in primary care setting but still few studies explore its effectiveness with breast cancer patients.

This study aims to compare two intervention arms : educational advices intervention (EAI) versus brief motivational intervention (BMI) for alcohol and/or tobacco consumption in breast cancer women, during their treatment.

In this pilot prospective randomized trial, various psychological and behavioral, variables are measured (alcohol and tobacco consumption, distress, anxiety and depressive disorders, quality of life, motivation for change, empowerment) before the brief intervention, and after 3 and 6 month.


title: High Intensity Focused Ultrasound Treatment of Breast Tumors. BRIFU Study (Breast Resection By HIFU)

acronym: BRIFU

summary: Monocentric prospective study evaluating the efficacy of High intensity focused ultrasound (HIFU) in breast tumors.


type: Registry Identifier

title: Potential Role of CD9 and Implication of Motility Process in Pathogenesis of TEL/ALM1-positive ALL Relapses (LAL TEL/ALM1 and CD9).

acronym: LAL TEL/ALM1

summary: Down regulation of CD9 in TEL/AML1-positive ALL is addressed in motility assays to explore its role in B-ALL pathogenesis and its potential implication in relapses (and prognosis).

ReferenceCitation: Debaize L, Jakobczyk H, Avner S, Gaudichon J, Rio AG, Serandour AA, Dorsheimer L, Chalmel F, Carroll JS, Zornig M, Rieger MA, Delalande O, Salbert G, Galibert MD, Gandemer V, Troadec MB. Interplay between transcription regulators RUNX1 and FUBP1 activates an enhancer of the oncogene c-KIT and amplifies cell proliferation. Nucleic Acids Res. 2018 Nov 30;46(21):11214-11228. doi: 10.1093/nar/gky756.

repository_institution: Goethe University Frankfurt - Publication Server of Goethe University Frankfurt am Main

repository_institution: CCSD (Centre pour la Communication Scientifique Directe) - HAL - Nantes Université

ReferenceCitation: Arnaud MP, Vallee A, Robert G, Bonneau J, Leroy C, Varin-Blank N, Rio AG, Troadec MB, Galibert MD, Gandemer V. CD9, a key actor in the dissemination of lymphoblastic leukemia, modulating CXCR4-mediated migration via RAC1 signaling. Blood. 2015 Oct 8;126(15):1802-12. doi: 10.1182/blood-2015-02-628560. Epub 2015 Aug 28.

oa_host_type: publisher

evidence: open (via free article)

publisher_dissemination: American Society of Hematology

ReferenceCitation: Gaudichon J, Jakobczyk H, Debaize L, Cousin E, Galibert MD, Troadec MB, Gandemer V. Mechanisms of extramedullary relapse in acute lymphoblastic leukemia: Reconciling biological concepts and clinical issues. Blood Rev. 2019 Jul;36:40-56. doi: 10.1016/j.blre.2019.04.003. Epub 2019 Apr 17.

evidence: open (via crossref license, author manuscript)

version: acceptedVersion

evidence: open (author manuscript)

ReferenceCitation: Rouger-Gaudichon J, Cousin E, Jakobczyk H, Debaize L, Rio AG, Forestier A, Arnaud MP, Villacreces A, Praloran V, Jacamo R, Galibert MD, Troadec MB, Gandemer V. Hypoxia regulates CD9 expression and dissemination of B lymphoblasts. Leuk Res. 2022 Dec;123:106964. doi: 10.1016/j.leukres.2022.106964. Epub 2022 Sep 28.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Bretagne Occidentale

ReferenceCitation: Debaize L, Jakobczyk H, Rio AG, Gandemer V, Troadec MB. Optimization of proximity ligation assay (PLA) for detection of protein interactions and fusion proteins in non-adherent cells: application to pre-B lymphocytes. Mol Cytogenet. 2017 Jul 20;10:27. doi: 10.1186/s13039-017-0328-2. eCollection 2017.

repository_institution: CERN European Organization for Nuclear Research - Zenodo

ReferenceCitation: Jakobczyk H, Debaize L, Soubise B, Avner S, Rouger-Gaudichon J, Commet S, Jiang Y, Serandour AA, Rio AG, Carroll JS, Wichmann C, Lie-A-Ling M, Lacaud G, Corcos L, Salbert G, Galibert MD, Gandemer V, Troadec MB. Reduction of RUNX1 transcription factor activity by a CBFA2T3-mimicking peptide: application to B cell precursor acute lymphoblastic leukemia. J Hematol Oncol. 2021 Mar 20;14(1):47. doi: 10.1186/s13045-021-01051-z.

repositories:
HAL
PubMed Central
Zenodo
www.repository.cam.ac.uk

sponsor_collaborators:
Rennes University Hospital
Ligue contre le cancer, France


title: Dose Escalation Radiotherapy With Modulation of Intensity and Integrated Boost in Association With a Temozolomide in the Treatment of Glioblastoma

acronym: SIB-IMRT

summary: The main goal of this study is to evaluate and to determine the dose of a highly accurate irradiation (allowing to increase the dose delivered while restricting the risk of complication) in association with temozolomide.

lead_sponsor: Centre Georges Francois Leclerc

sponsor_collaborators:
Centre Georges Francois Leclerc
Ligue contre le cancer, France


title: Pilot Study on the Identification of Cortical Excitability Changes Measured by Transcranial Magnetic Stimulation (TMS) as Markers of Antidepressant Response

acronym: EXCIPSY

summary: Depression is a common issue but there is no marker of response to an antidepressant treatment.The measurement of variation of the cortical excitability in responders to a selective serotonin reuptake inhibitor (SSRI) (compared to no-responders) had never been done before. In the study of Robol et al. (2004) concerning the acute effects of citalopram on markers of cortical excitability, the authors have pointed out an increase on the cortical silent period (CSP) after administration of citalopram (2.5 hours). The investigators hypothesize that this effect remains later and that the diminution of cortical excitability could be a biomarker of antidepressant response. In this case, they expect that the variation of CSP between day 1 and day 28 is higher in responders to a SSRI (citalopram) compared to non-responders. the investigators lead a pilot, prospective, multicentric study in drug-naive patients to compare the variation of the markers of cortical excitability (the CSP but to the resting motor threshold RMT, the motor evoked potential MEP, the intra-cortical inhibition ICI and the intra-cortical facilitation ICF) between day 1 and day 28 in responders to citalopram, compared to non-responders.

lead_sponsor: Centre Hospitalier du Rouvray

collaborators: Centre hospitalier de Ville-Evrard, France


title: Study of Postoperative Ileus in Digestive Surgery

acronym: IPCID

summary: Post-operative ileus is a temporary stoppage of bowel function following surgery. Indeed it can occur in 20% of cases during post-operative follow-up of bowel surgery. The absence of resumption of transit can lead to the implementation of specific treatments such as the placement of a nasogastric tube and drug treatments. To date, the definition of this event is not accepted by everyone and is not based on reproducible evaluation criteria. The main objective of this study is to evaluate a score used to date to define postoperative ileus, the IFEED score, and to compare it to the length of postoperative stay.

location_facility:
INSERM
CHU de Toulouse


title: Cardiac Rehabilitation of Children and Adolescent With Long QT Syndrome

acronym: RYTHMO'FIT

summary:
Children and adolescents with inherited cardiac arrhythmia su ch Long QT Syndrome (LQTS) have lower physical and quality of life than their healthy peers. A multi-component cardiac rehabilitation, including an exercise training program and education program, might counteract those effects.

The goal of this pilot study is to evaluate the security, feasibility, and benefits of a cardiac rehabilitation program in children with LQTS aged between 6 to 18 years old.

The main question[s] it aims to answer are:

Is center-based cardiac rehabilitation safe and feasible for children with LQTS?
Does a 12-week cardiac rehabilitation program improve physical fitness and quality of life?

ReferenceCitation: Souilla L, Avesani M, Boisson A, Requirand A, Matecki S, Vincenti M, Werner O, De La Villeon G, Pommier V, Pasquie JL, Guillaumont S, Amedro P. Cardiorespiratory fitness, muscle fitness, and physical activity in children with long QT syndrome: A prospective controlled study. Front Cardiovasc Med. 2023 Jan 11;9:1081106. doi: 10.3389/fcvm.2022.1081106. eCollection 2022.

ReferenceCitation: Amedro P, Werner O, Abassi H, Boisson A, Souilla L, Guillaumont S, Calderon J, Requirand A, Vincenti M, Pommier V, Matecki S, De La Villeon G, Lavastre K, Lacampagne A, Picot MC, Beyler C, Delclaux C, Dulac Y, Guitarte A, Charron P, Denjoy-Urbain I, Probst V, Baruteau AE, Chevalier P, Di Filippo S, Thambo JB, Bonnet D, Pasquie JL. Health-related quality of life and physical activity in children with inherited cardiac arrhythmia or inherited cardiomyopathy: the prospective multicentre controlled QUALIMYORYTHM study rationale, design and methods. Health Qual Life Outcomes. 2021 Jul 28;19(1):187. doi: 10.1186/s12955-021-01825-6.

lead_sponsor: University Hospital, Montpellier

location_facility: University Hospital of Montpellier - Arnaud de Villeneuve Hospita


title: Analysis of Bronchial Remodeling Using Resonance Magnetic Imaging in Severe Asthmatic childrEn

acronym: ARISE

summary: This study is a diagnostic imaging pilot study evaluating performance of 3D-Ultrashort Time Echo (3D-UTE) Magnetic Resonance Imaging (MRI) for the diagnosis of bronchial remodeling in children with severe asthma. The primary objective is to compare bronchial parameters measured by 3D-UTE MRI according to the presence or the absence of bronchial remodeling determined on bronchial biopsies using immunohistochemistry, in severe asthmatic children.

ReferenceCitation: Bara I, Ozier A, Tunon de Lara JM, Marthan R, Berger P. Pathophysiology of bronchial smooth muscle remodelling in asthma. Eur Respir J. 2010 Nov;36(5):1174-84. doi: 10.1183/09031936.00019810.

ReferenceCitation: Girodet PO, Ozier A, Bara I, Tunon de Lara JM, Marthan R, Berger P. Airway remodeling in asthma: new mechanisms and potential for pharmacological intervention. Pharmacol Ther. 2011 Jun;130(3):325-37. doi: 10.1016/j.pharmthera.2011.02.001. Epub 2011 Feb 17.

ReferenceCitation: Bossley CJ, Fleming L, Gupta A, Regamey N, Frith J, Oates T, Tsartsali L, Lloyd CM, Bush A, Saglani S. Pediatric severe asthma is characterized by eosinophilia and remodeling without T(H)2 cytokines. J Allergy Clin Immunol. 2012 Apr;129(4):974-82.e13. doi: 10.1016/j.jaci.2012.01.059. Epub 2012 Mar 3.

ReferenceCitation: Benlala I, Dournes G, Girodet PO, Benkert T, Laurent F, Berger P. Evaluation of bronchial wall thickness in asthma using magnetic resonance imaging. Eur Respir J. 2021 Dec 31;59(1):2100329. doi: 10.1183/13993003.00329-2021. Print 2022 Jan. No abstract available.

publisher_dissemination: European Respiratory Society

ReferenceCitation: Dournes G, Yazbek J, Benhassen W, Benlala I, Blanchard E, Truchetet ME, Macey J, Berger P, Laurent F. 3D ultrashort echo time MRI of the lung using stack-of-spirals and spherical k-Space coverages: Evaluation in healthy volunteers and parenchymal diseases. J Magn Reson Imaging. 2018 Dec;48(6):1489-1497. doi: 10.1002/jmri.26212. Epub 2018 Sep 11.

publisher_dissemination: Wiley

lead_sponsor: University Hospital, Bordeaux

location_facility: CHU de Bordeaux - Explorations Fonctionnelles


acronym: BRAINSTORM

summary: Emerging evidence indicates that SARS-CoV-2, the etiologic agent of COVID-19, can cause neurological, neuropsychological and psychiatric complications. Given the global dimensions of the current pandemic, there is to consider the possible large-scale neurocognitive impact of COVID-19. Therefore, there is an urgent need for longitudinal studies to determine the acute and chronic effects that COVID-19 may have on the Central Nervous System. These putative effects include the possibility that the CNS serves as a reservoir for the virus, and that COVID-19 triggers CNS deleterious inflammatory cascades and neurodegenerative process. The public implications of these effects are very important in the long term.

location_facility:
University Hospital of Toulouse
CHRU Tours

title: SARS-CoV-2 Neurotropism, micRoglial ActivatioN and Cytokine dySregulaTiOn in COVID-19 Patients With Delirium


title: Symptoms of Depression, Stress and Burnout, and Long-term Psychological Impact in Health Care Professionals Exposed to the Novel Coronavirus Disease 2019 Outbreak (HARD-COVID-19 - Health cAre woRkers exposeD to covID-19)

summary:
Health care workers working in hospital or nursing home for elderly people involved in the coronavirus epidemic are facing several challenges such as direct exposure and involvement in the resolution of major public health emergencies, exposure to potentially fatal contamination, physical exhaustion, unadjusted work organizations, the unusual number of deaths among patients, colleagues and close relatives, and significant ethical challenges in decision-making.

Preliminary data suggests that frontline and lay professionals suffer from different types of psychological distress. These data highlight the importance of screening for psychological distress in response to the scale of the pandemic and the provision of targeted psychological interventions, such as Eye Movement Desensitization and Reprocessing (EMDR, desensitization and neuro-emotional integration by eye movements), to improve the psychological well-being of healthcare workers exposed to COVID-19.

This project is both a cohort study with the proposal of a randomized trial to evaluate an intervention adapted to the exceptional circumstances of the crisis. As such, it is designed as Trial(s) Within Cohort design (TWIC).

lead_sponsor: University Hospital, Tours

location_facility: Bretonneau Regional Universitary Hospital


title: Measurement and Relationships of Proprioceptive Isokinetic Repositioning With Muscle Strength, Functional Testing, and Self-reported Questionaires Before and After Anterior Cruciate Ligament Reconstruction: A Prospective Study With 12-months Post Operative Follow-up.

acronym: PRO-ACL

summary: This prospectively study aims to evaluate the evolution of knee joint proprioception on isokinetic dynamometer before and after Anterior Cruciate Ligament (ACL) reconstruction and its relationships with muscle strength, self reported questionnaire and return to sport. This study will include 30 athletes with isolated ACL rupture, and treated with ACL reconstruction surgery and 15 healthy volunteers.

lead_sponsor: University Hospital, Caen


title: Monitoring the HeMAtological TOXicity of Drugs

acronym: HeMATOX

summary: Several drugs and chemotherapies seem to have an impact on the hematological system. This study investigates reports of hematological toxicities, including the International classification of disease ICD-10 for treatments in the World Health Organization (WHO) global Individual Case Safety Report (ICSR) database (VigiBase).

lead_sponsor: Groupe Hospitalier Pitie-Salpetriere

location_facility: AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM

location_facility: Rhumatology department, CHU Strasbourg, Hautepierre hospital


title: Monitoring the IMmUological TOXicity of Drugs

acronym: MIMUTOX

summary: Several drugs and chemotherapies seem to have an impact on the immunological system. This study investigates reports of immunological toxicities, including the International classification of disease ICD-10 codes M05, M32, I78 for treatments in the World Health Organization (WHO) global Individual Case Safety Report (ICSR) database (VigiBase).

ReferenceCitation: Arnaud L, Lebrun-Vignes B, Salem JE. Checkpoint inhibitor-associated immune arthritis. Ann Rheum Dis. 2019 Jul;78(7):e68. doi: 10.1136/annrheumdis-2018-213470. Epub 2018 May 3. No abstract available.

ReferenceCitation: Mertz P, Lebrun-Vignes B, Salem JE, Arnaud L. Characterizing drug-induced capillary leak syndromes using the World Health Organization VigiBase. J Allergy Clin Immunol. 2019 Jan;143(1):433-436. doi: 10.1016/j.jaci.2018.09.001. Epub 2018 Sep 20. No abstract available.

ReferenceCitation: Arnaud L, Mertz P, Gavand PE, Martin T, Chasset F, Tebacher-Alt M, Lambert A, Muller C, Sibilia J, Lebrun-Vignes B, Salem JE. Drug-induced systemic lupus: revisiting the ever-changing spectrum of the disease using the WHO pharmacovigilance database. Ann Rheum Dis. 2019 Apr;78(4):504-508. doi: 10.1136/annrheumdis-2018-214598. Epub 2019 Feb 4.

location_facility: AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM.


title: Study of the Functioning of Prospective Memory in Breast Cancer and the Influence of Sleep

acronym: PROSOM-K

summary: The results of this study will contribute to a better understanding of prospective memory deficit processes in breast cancer in relation to sleep disorders frequently reported in this pathology. In the long term, a better understanding will make it possible to envisage appropriate treatments to compensate for these memory difficulties and to improve the autonomy of the patients.

ReferenceCitation: Duivon M, Perrier J, Joly F, Licaj I, Grellard JM, Clarisse B, Levy C, Fleury P, Madeleine S, Lefevre N, Rauchs G, Lecouvey G, Fraisse F, Viader F, Eustache F, Desgranges B, Giffard B. Impact of breast cancer on prospective memory functioning assessed by virtual reality and influence of sleep quality and hormonal therapy: PROSOM-K study. BMC Cancer. 2018 Sep 3;18(1):866. doi: 10.1186/s12885-018-4762-2.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Mines Nantes

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris 1 Panthéon-Sorbonne

lead_sponsor: Centre Francois Baclesse

location_facility:
Centre François Baclesse
Inserm-Ephe-Unicaen U1077 (


title: Ex Vivo and in Vitro Assessment of the Pharmacological Properties of Molecule Prima in the Restoration of Physiological Differentiation of Gene p63 Dependant Epithelium

acronym: PRIMAculture

summary:
Ectodermal dysplasia associated with p63 is a rare disease which, in addition to limbic abnormalities, primarily affects the skin and cornea. The most common forms are called Ectrodactyly, Ectodermal dysplasia, palate Key for cleft lip and palate (EEC) and Ankyloblepharon, Ectodermal dysplasia, cleft lip and palate (AEC). Apart from symptomatic treatment, no cure is available. To understand the molecular defects associated with this disease and to identify therapeutic tools, a research team modelized the disease by reprograming EEC and AEC patient fibroblasts in pluripotent stem cells (iPSC), then induced iPSC differentiation in patients and controls epidermal (skin) and limbic (cornea) cells and demonstrated that the mutated cells can reproduce in vitro the abnormalities observed in patients.

P63 gene belongs to the family of p53 gene. The functions of the two proteins are very similar. Data suggest that molecule Prima could reactivate the p63 protein mutated in patients and thus alleviate skin defect healing and limbic regeneration.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation Opthalmologique A de Rothschild


title: Evaluation of the Cardioprotective Effect of Intracoronary Injection of Morphine During Reperfusion in Acute Myocardial Infarction

acronym: MIAMI

summary: The purpose of this study is to determine whether intracoronary injection of morphine chlorhydrate is effective to limit ischemia-reperfusion lesion during percutaneous coronary angioplasty in patients with acute myocardial infarction (AMI).

ReferenceCitation: Le Corvoisier P, Gallet R, Lesault PF, Audureau E, Paul M, Ternacle J, Ghostine S, Champagne S, Arrouasse R, Bitari D, Mouillet G, Dubois-Rande JL, Berdeaux A, Ghaleh B, Deux JF, Teiger E. Intra-coronary morphine versus placebo in the treatment of acute ST-segment elevation myocardial infarction: the MIAMI randomized controlled trial. BMC Cardiovasc Disord. 2018 Oct 19;18(1):193. doi: 10.1186/s12872-018-0936-8.

lead_sponsor: French Cardiology Society

location_facility:
Henri Mondor Hospital
Hopital Marie Lannelongue


title: Upper Airways in Pregnancy: Evaluation by the Acoustic Reflection Method

acronym: MAVAG

summary:
It is well known that airway management can be difficult during pregnancy. Increased risks for difficult intubation in pregnant women have been often reported. Thus, pregnancy is regarded as a period of high anesthesiologic risk.

Generalized weight gain is a well known factor influencing the upper airway in pregnant women. However, the modifications of the airway itself are less well documented.

The acoustic reflection method is based on the analysis of the reflection of a single transient planar wave allowing the analysis of the longitudinal cross-sectional area profile of the examined cavity. It is a noninvasive and harmless method.

The aim of the study is to evaluate by acoustic reflection method the physiological modifications of the upper airways during pregnancy.

Women enrolled in the study will undergo an acoustic recording during the first, second, and third trimester of pregnancy, as well as two days and one month after delivery. Forty pregnant women will be included in this monocentric, prospective, open labelled study.

Moreover, a single acoustic recording will be performed in 10 other pregnant women undergoing an MRI for obstetrical purpose. The estimated caliber of the upper airways by MRI and acoustic method will be compared.

ReferenceCitation: Kodali BS, Chandrasekhar S, Bulich LN, Topulos GP, Datta S. Airway changes during labor and delivery. Anesthesiology. 2008 Mar;108(3):357-62. doi: 10.1097/ALN.0b013e31816452d3.

ReferenceCitation: Louis B, Fodil R, Jaber S, Pigeot J, Jarreau PH, Lofaso F, Isabey D. Dual assessment of airway area profile and respiratory input impedance from a single transient wave. J Appl Physiol (1985). 2001 Feb;90(2):630-7. doi: 10.1152/jappl.2001.90.2.630.

lead_sponsor: Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau

location_facility:
Hôpital d'Enfants Armand Trousseau
Armand Trousseau University Hospital