title: Characterization of the Interruptions of the GAA Expansion and Study of Their Influence on the Severity of Friedreich's Ataxia : INTREP-AF

acronym: INTREP-AF

summary:
Friedreich's ataxia (FA) is the most frequent recessive genetic ataxia with an estimated prevalence of 1/50 000. The first symptoms appear around the age of 10 years with a progressive course and the need for an armchair 10- 15 years after the first symptoms. More rarely the disease can present with a late onset (after the age of 25) with a picture characterized by spastic paraparesis and slower progression ("LOFA" for "Late Onset Friedreich Ataxia" or VLOFA for "Very Late Appearance of Friedreich's ataxia ").

AF is caused in 96% of cases by an expansion of GAAN triplets (N> 100 repeats) located in intron 1 of the FXN gene, present on the two alleles, and, in the rest of the cases, by an associated expansion a point mutation or a deletion in trans. During molecular diagnostics, it is not uncommon to find the presence of interruptions within the GAA expansion. This results in the absence and / or the shift of peak (s) within the chromatogram.

To date, only the partial correlation between the size of the expansion and the age of onset of Friedreich's ataxia has been established. In particular, very atypical forms of AF with a late onset (after the age of 25) are in particular explained by the low number of repetitions in the expansion, typically between 100 and 500 repetitions. However, the presence of an interruption could stabilize the size of the expansion and, therefore, be mainly associated with expansions of small sizes and therefore with a late onset of the disease.

The objective of this study is therefore to analyse and caracterize the presence and the type of interruptions of the GAA expansions in a group of patients with FA ; this data will be correlated with the age at onset of FA.

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Prospective, Multicentric, Observational Cohort Study for the Evaluation of Implant Survival in Patients With a Metal-on-Metal Pinnacle(R) Ultamet(TM) Device in Conventional Total Hip Joint Replacement.

summary: The objective is to evaluate the implant survival rate for patients implanted with a PINNACLE® ULTAMET™ Metal-on-Metal implant for conventional total hip arthroplasty for the treatment of a severe hip disease and true femoral cervical fracture.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Harris WH. Traumatic arthritis of the hip after dislocation and acetabular fractures: treatment by mold arthroplasty. An end-result study using a new method of result evaluation. J Bone Joint Surg Am. 1969 Jun;51(4):737-55.

lead_sponsor: DePuy International

location_facility:
Centre Hospitalier Georges Renon
Clinique Mutualiste Saint Etienne
Clinique Herbert
Clinique Saint Hilaire
Clinique Pasteur
Clinique Bonnefon

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Completed


title: Evaluation of Reporting of Immune Checkpoint Inhibitor Associated Cardio-vascular Adverse Reactions Using International Pharmacovigilance Database

acronym: RAFALE

summary: Immune checkpoint inhibitors (ICIs) might have high grade immune-related adverse events (irAEs) on the cardio-vascular system. This study investigates reports of cardio-vascular toxicity with treatment including anti-PD1, Anti-PDL-1, and Anti CTLA4 classes using the World Health Organization (WHO) database VigiBase.

study_start_date_type: Actual

time_perspective: Cross-Sectional

ReferenceCitation: Dressler D, Potter H. Molecular mechanisms in genetic recombination. Annu Rev Biochem. 1982;51:727-61. Review.

ReferenceType: result

ReferenceCitation: Moslehi JJ, Salem JE, Sosman JA, Lebrun-Vignes B, Johnson DB. Increased reporting of fatal immune checkpoint inhibitor-associated myocarditis. Lancet. 2018 Mar 10;391(10124):933. doi: 10.1016/S0140-6736(18)30533-6.

ReferenceCitation: Moslehi JJ, Salem JE, Sosman JA, Lebrun-Vignes B, Johnson DB. Reporting of immune checkpoint inhibitor-associated myocarditis - Authors' reply. Lancet. 2018 Aug 4;392(10145):384-385. doi: 10.1016/S0140-6736(18)31556-3.

ReferenceCitation: Salem JE, Manouchehri A, Moey M, Lebrun-Vignes B, Bastarache L, Pariente A, Gobert A, Spano JP, Balko JM, Bonaca MP, Roden DM, Johnson DB, Moslehi JJ. Cardiovascular toxicities associated with immune checkpoint inhibitors: an observational, retrospective, pharmacovigilance study. Lancet Oncol. 2018 Dec;19(12):1579-1589. doi: 10.1016/S1470-2045(18)30608-9. Epub 2018 Nov 12.

ipd_sharing: Undecided

lead_sponsor: Groupe Hospitalier Pitie-Salpetriere

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

intervention_type: Drug

lead_sponsor_type: academique


title: Elderly Cancer Patient: ELCAPA Cohort Survey

acronym: ELCAPA

summary:
The management of older patients with cancer has become a major public health concern in Western countries because of the aging of the population and steady increase in cancer incidence with advancing age. Cancer treatment of aged patients is complex due to comorbidities, polypharmacy and functional status. The heterogeneity of the older population in terms of comorbidities and functional status may explain the difficulty in establishing management recommendations.

Study hypothesis is that a geriatric consultation using Geriatric Assessment (GA) can evaluate patient's resource and strengths, in order to help oncologist to define the most effective treatment. The GA developed by geriatricians and recommended by the International Society of Geriatric Oncology (SIOG), is a multidimensional assessment of general health status; comorbidities; functional status; nutritional, cognitive, psychological, and social parameters; and medications. The GA uses validated geriatric scales to produce an inventory of problems, which can then serve to develop an individualized geriatric intervention plan; it may be an important step in selecting elderly patients for cancer screening and treatment.

The objectives are:

To assess the role of GA for decision making process for older patients with cancer
To identify geriatric and oncologic factors associated with overall survival, treatment feasibility, toxicities, morbidities
To develop and/or validate screening tests for frailty in geriatric oncology
To develop and validate frailty classifications

Method: The ELCAPA (ELderly CAncer PAtient) survey is a French multicentric prospective study that includes all patients age 70 years or older who has a diagnosis of solid cancer or hematologic malignancies in French hospitals

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Gonzalez Serrano A, Laurent M, Barnay T, Martinez-Tapia C, Audureau E, Boudou-Rouquette P, Aparicio T, Rollot-Trad F, Soubeyran P, Bellera C, Caillet P, Paillaud E, Canoui-Poitrine F. A Two-Step Frailty Assessment Strategy in Older Patients With Solid Tumors: A Decision Curve Analysis. J Clin Oncol. 2022 Oct 28:JCO2201118. doi: 10.1200/JCO.22.01118. Online ahead of print.

ReferenceCitation: Martinez-Tapia C, Diot T, Oubaya N, Paillaud E, Poisson J, Gisselbrecht M, Morisset L, Caillet P, Baudin A, Pamoukdjian F, Broussier A, Bastuji-Garin S, Laurent M, Canouï-Poitrine F. The obesity paradox for mid- and long-term mortality in older cancer patients: a prospective multicenter cohort study. Am J Clin Nutr. 2020 Sep 5. pii: nqaa238. doi: 10.1093/ajcn/nqaa238. [Epub ahead of print]

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Other

status_simplified: Ongoing


type: Other Identifier

title: Validation of the French Version of the Pain Sensitivity Questionnaire

acronym: PSQ-F

summary: The Pain Sensitivity Questionnaire (PSQ) is a tool created in 2009 by Dr. R. Ruscheweyh in Germany. It aims at identifying the natural sensitivity to pain, through a set of 17 simple questions. These questions simulate daily life situations likely to induce pain of various intensities. The internal validity of the tool had been demonstrated both for the original version in German, and then for its English version. The external validity had also been demonstrated by correlation to real nociceptive stimulations applied to healthy volunteers (German version), and to patients before surgery (English version). A French validation of the questionnaire is needed, in order to integrate it in pain research programs in French-speaking countries.

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Other

ReferenceCitation: Dualé C, Bauer U, Storme B, Eljezi V, Ruscheweyh R, Eschalier S, Dubray C, Guiguet-Auclair C. Transcultural adaptation and French validation of the Pain Sensitivity Questionnaire. Can J Anaesth. 2019 Oct;66(10):1202-1212. doi: 10.1007/s12630-019-01377-w. Epub 2019 Apr 24.

ReferenceCitation: Duale C, Leray V, Giron F, Boulliau S, Macian N, Ruscheweyh R, Dubray C, Giraudet F. The Added Value of Sensitivity to Nonnoxious Stimuli to Predict an Individual's Sensitivity to Pain. Pain Physician. 2021 Sep;24(6):E783-E794.

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Behavioral


title: Measurement of the Clinical and Radiological Performance Impact of the Root Canal Treatment With BioRootTM RCS: a Retro-prospective, National and Multicentre Clinical Study

acronym: BioRoot

summary:
The aim of this retro-prospective Post-Market Clinical Follow-Up (PMCF) study is to collect long term clinical and safety data on root canal obturation after treatment, or retreatment, by BioRootTM RCS. The patients included in the study had received BioRootTM RCS 5 years ago. Participants will be followed prospectively at 5 and 10 years after root canal treatment.

Clinical data, radiographic data, adverse events (safety) and device performance will be collected by the dentist from the inclusion visit until the end of the study.

time_perspective: Other

ipd_sharing: No

lead_sponsor: Septodont

location_facility:
Cabinet dentaire
Cabinet Medical
Cabinet Dentaire


title: A Phase II Study of the BRAF Inhibitor Encorafenib in Combination With the MEK Inhibitor Binimetinib in Patients With BRAFV600E-mutant Metastatic Non-small Cell Lung Cancer

acronym: ENCO-BRAF

summary: A Phase II study of the BRAF inhibitor Encorafenib in combination with the MEK inhibitor Binimetinib in Patients with BRAFV600E-mutant metastatic Non-small Cell Lung Cancer

primary_purpose: Treatment

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

location_facility: Nouvel Hôpital Civil - Hôpitaux Universitaires de Strasbourg

location_facility: Villefranche-Sur-Saône - Hôpital Nord-Ouest

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Nancy - Institut de Cancérologie de Lorraine


status: Terminated

acronym: RALIB

title: Efficacy of Topical Rapamycin in Treatment of Chronic Erosive Oral Lichen Planus. Double Blind Randomised Controlled Trial Rapamycin vs Topical Steroids

lead_sponsor: University Hospital, Tours

type: EudraCT Number

source: euctr

design_allocation: Randomized

location_facility: University Hospital of Bordeaux-St.André

summary: The purpose of this study is to determine wether topical rapamycin is more efficient than topical steroids in the treatment of chronic erosive lichen planus.

status_simplified: Unknown


title: Phase II Randomised Multicenter Trial Evaluating a Sequential Treatment With Nab-paclitaxel+Gemcitabine /FOLFIRI.3 vs Nab-paclitaxel + Gemcitabine in First Line Metastatic Pancreatic Cancer

acronym: FIRGEMAX

summary: The main objective of this trial is to evaluate every 2 months alternating nab-paclitaxel/gemcitabine and FOLFIRI.3 versus nab-paclitaxel + gemcitabine, regarding the progression of disease at 6 months.

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_facility:
CH Pierre Oudot
Hôpital Haut Lévèque
Centre GF Leclerc
H Layné
Hôpital Cochin
CH
Centre Cario - Hpca Saint Brieuc
Centre François Baclesse
Hôpital Paul Brousse
Clinique Tivoli Ducos
Clinique Pasteur Groupe ONCORAD GARONNE
CHU
CH Pierre Benite
Clinique Privée
Ch Jacques Monod
CHR côte de Nacre
HEGP
CH de la Dracénie
Hôpital La Pitié Salpêtrière
Hopitaux Du Leman
Centre Hospitalier Sud Francilien
Clinique St Jean Languedoc
Hôpitaux Drome Nord
Gustave Roussy
CHP
Clinique Chenieux
Clinique Privée Saint Jean
Clinique Privée Claude Bernard
CH St Jean
Hôpital Duchenne
Clinique Privée Pasteur
Hopital Europeen Marseille


title: Cardiac Arrest Incidence and Outcome Among Patient With COVID-19 Pneumonia in French ICUs

acronym: ACICOVID

summary:
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is responsible for the novel coronavirus disease 2019 (COVID-19) pandemic. Among COVID-19 complications, in-hospital cardiac arrest (IHCA) was reported with a very poor outcome in a retrospective single-center study (0,7% of 30 days survival with good neurological outcome among IHCA patients with a resuscitation attempt), related to its natural course and management. The incidence of unexpected in-ICU cardiac arrest (ICUCA) due to COVID-19 is still unknown. Additionally, outcome of COVID-19 patients admitted in ICU for an out-of-hospital cardiac arrest (OHCA) is also undescribed.

The objective this study is :

to report the incidence of ICUCA among patients hospitalized in French ICU for COVID-19.
to report morbidity and mortality among COVID-19 patients admitted alive in ICU for an OHCA or an IHCA.

The secondary objective is to assess outcome and identify risk factors of ICUCA occurrence among patients admitted for COVID-19.

ReferenceCitation: Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24.

ReferenceCitation: Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.

ReferenceCitation: Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24. Erratum in: Lancet Respir Med. 2020 Apr;8(4):e26.

ReferenceCitation: Grasselli G, Zangrillo A, Zanella A, Antonelli M, Cabrini L, Castelli A, Cereda D, Coluccello A, Foti G, Fumagalli R, Iotti G, Latronico N, Lorini L, Merler S, Natalini G, Piatti A, Ranieri MV, Scandroglio AM, Storti E, Cecconi M, Pesenti A; COVID-19 Lombardy ICU Network. Baseline Characteristics and Outcomes of 1591 Patients Infected With SARS-CoV-2 Admitted to ICUs of the Lombardy Region, Italy. JAMA. 2020 Apr 28;323(16):1574-1581. doi: 10.1001/jama.2020.5394. Erratum in: JAMA. 2021 May 25;325(20):2120.

ReferenceCitation: Leloup M, Briatte I, Langlois A, Cariou A, Lesieur O; ACIR study group. Unexpected cardiac arrests occurring inside the ICU: outcomes of a French prospective multicenter study. Intensive Care Med. 2020 May;46(5):1005-1015. doi: 10.1007/s00134-020-05992-w. Epub 2020 Mar 9.

ReferenceCitation: Bansal M. Cardiovascular disease and COVID-19. Diabetes Metab Syndr. 2020 May - Jun;14(3):247-250. doi: 10.1016/j.dsx.2020.03.013. Epub 2020 Mar 25. Review.

ReferenceCitation: Chen C, Zhou Y, Wang DW. SARS-CoV-2: a potential novel etiology of fulminant myocarditis. Herz. 2020 May;45(3):230-232. doi: 10.1007/s00059-020-04909-z.

ReferenceCitation: Guo T, Fan Y, Chen M, Wu X, Zhang L, He T, Wang H, Wan J, Wang X, Lu Z. Cardiovascular Implications of Fatal Outcomes of Patients With Coronavirus Disease 2019 (COVID-19). JAMA Cardiol. 2020 Jul 1;5(7):811-818. doi: 10.1001/jamacardio.2020.1017. Erratum in: JAMA Cardiol. 2020 Jul 1;5(7):848.

ReferenceCitation: Madjid M, Safavi-Naeini P, Solomon SD, Vardeny O. Potential Effects of Coronaviruses on the Cardiovascular System: A Review. JAMA Cardiol. 2020 Jul 1;5(7):831-840. doi: 10.1001/jamacardio.2020.1286. Review.

ReferenceCitation: Wu CI, Postema PG, Arbelo E, Behr ER, Bezzina CR, Napolitano C, Robyns T, Probst V, Schulze-Bahr E, Remme CA, Wilde AAM. SARS-CoV-2, COVID-19, and inherited arrhythmia syndromes. Heart Rhythm. 2020 Sep;17(9):1456-1462. doi: 10.1016/j.hrthm.2020.03.024. Epub 2020 Mar 31. Review.

ReferenceCitation: Shao F, Xu S, Ma X, Xu Z, Lyu J, Ng M, Cui H, Yu C, Zhang Q, Sun P, Tang Z. In-hospital cardiac arrest outcomes among patients with COVID-19 pneumonia in Wuhan, China. Resuscitation. 2020 Jun;151:18-23. doi: 10.1016/j.resuscitation.2020.04.005. Epub 2020 Apr 10.

ReferenceCitation: Chan PS, Berg RA, Nadkarni VM. Code Blue During the COVID-19 Pandemic. Circ Cardiovasc Qual Outcomes. 2020 May;13(5):e006779. doi: 10.1161/CIRCOUTCOMES.120.006779. Epub 2020 Apr 7.

ReferenceCitation: Mahase E, Kmietowicz Z. Covid-19: Doctors are told not to perform CPR on patients in cardiac arrest. BMJ. 2020 Mar 29;368:m1282. doi: 10.1136/bmj.m1282.

ReferenceCitation: Perkins GD, Jacobs IG, Nadkarni VM, Berg RA, Bhanji F, Biarent D, Bossaert LL, Brett SJ, Chamberlain D, de Caen AR, Deakin CD, Finn JC, Gräsner JT, Hazinski MF, Iwami T, Koster RW, Lim SH, Ma MH, McNally BF, Morley PT, Morrison LJ, Monsieurs KG, Montgomery W, Nichol G, Okada K, Ong ME, Travers AH, Nolan JP; Utstein Collaborators. Cardiac Arrest and Cardiopulmonary Resuscitation Outcome Reports: Update of the Utstein Resuscitation Registry Templates for Out-of-Hospital Cardiac Arrest: A Statement for Healthcare Professionals From a Task Force of the International Liaison Committee on Resuscitation (American Heart Association, European Resuscitation Council, Australian and New Zealand Council on Resuscitation, Heart and Stroke Foundation of Canada, InterAmerican Heart Foundation, Resuscitation Council of Southern Africa, Resuscitation Council of Asia); and the American Heart Association Emergency Cardiovascular Care Committee and the Council on Cardiopulmonary, Critical Care, Perioperative and Resuscitation. Resuscitation. 2015 Nov;96:328-40. doi: 10.1016/j.resuscitation.2014.11.002. Epub 2014 Nov 11.

ReferenceCitation: Chelly J, Plantefève G, Kamel T, Bruel C, Nseir S, Lai C, Cirillo G, Skripkina E, Ehrminger S, Berdaguer-Ferrari FD, Le Marec J, Paul M, Autret A, Deye N; ACICOVID-19 study group. Incidence, clinical characteristics, and outcome after unexpected cardiac arrest among critically ill adults with COVID-19: insight from the multicenter prospective ACICOVID-19 registry. Ann Intensive Care. 2021 Nov 13;11(1):155. doi: 10.1186/s13613-021-00945-y.

lead_sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

location_country: France Martinique

location_facility: Centre Hospitalier Intercommunal Toulon La Seyne sur Mer


type: Registry Identifier

title: Therapeutic and Support Oncologic Medical Care Evaluation in Patients With Multiple Myeloma in West-Occitanie Region. Factors Influencing Medical Care and Predictive and Prognostic Impact.

acronym: VAMOS

summary:
Actually very few real life data are available for patients with multiple myeloma (MM), whereas they're playing a more and more important role in health care decisions. Treatments choice for medical care of patient with MM depends of their age, their general status, their eligibility to high dose treatment (autograft), and also based on cytogenetic risk (standard/high risk). Therapeutic strategies are multple and based on drugs associations including proteasome inhibitors, immuno-modulators and monoclonal antibodies.

Therapeutic medical care objective is to improve quality and response duration through more effective induction schemas, systematic consolidation for patients who have undergone high dose therapy and/or maintenance treatment, ensuring patients safety and well-being in the health care pathway.

Quality of life evaluation has to take in consideration disease outcome and secondary effects impact from treatments prescribed for MM.

With clinical trials, new therapeutic strategies are proposed with innovative drugs but participants are selected and do not represent all patients with MM. Therefore, there is a large gap between clinical trials and real life data.

That's why the CHU Toulouse intends to set up a prospective cohort to evaluate the health care pathway of patients with MM in West-Occitanie region and studies impact of treatments prescribed on the disease and on the patients' quality of life.

With this research, standard of care practices for patients with MM will be followed, prognostic scores and clinical trials results will be validated in real life, impact of outpatient support procedure will be assessed (AMA procedure) and sociodemographic/quality of life data will be available for research teams.

time_perspective: Retrospective

lead_sponsor: University Hospital, Toulouse

location_facility: IUCT-Oncopole - Toulouse University Hospital


title: Seroprevalence and Antibody Profiling Against SARS-CoV2 in Children and Their Parents

acronym: PED-COVID

summary: The purpose of this study is to provide data on the proportion of seroconverted children and their immune status. It will also provide insight into the number of children currently infected at each time point including healthy carriers. Investigators will provide similar data on their parents in an ancillary study.

status: Active, not recruiting

primary_purpose: Diagnostic

intervention_type: Biological


title: MIF : a New Target to Eradicate the Pre-leukemic Clone in Acute Myeloid Leukemia

acronym: MIFAML

summary:
This study is an observational study of MIF involvement in retrospectively and prospectively included adult acute myeloid leukemia (AML). Standard care samples collected at diagnosis, after one course of treatment, at time of remission controls, and at time of relapse will be used.

The first objective is to determine which AMLs have pre-leukemic stem cells that overexpress MIF. Cytogenetic and molecular (NGS) profiling will be performed at diagnosis. Blood and bone marrow plasma, as well as bone marrow mononuclear cells will be collected and stored. The expression of MIF and its receptor (CD74 and CXCR4) will be analysed. Their prognostic value will be also tested.

The second objective is to test whether patients in complete remission have persistent pre-leukemic stem cells that overexpress MIF. Blood and bone marrow plasma, bone marrow mononuclear cells from patients in complete remission will be collected. MIF, CD74, and CXCR4 expression by hematopoietic cells at time of diagnosis and remission will be compared to determine which patients have a persistent overexpression/secretion of MIF. In the meantime, the persistence of initiating lesions in complete remission samples will be tested by NGS, digital PCR, FISH, or RT-PCR methods.

The third objective is to develop a pre-clinical model to target MIF in immuno-compromised mice (NSG mice) transplanted with primary AML cells and cells with pre-leukemic lesions. TET2 depletion leads to MIF over-expression/secretion by hematopoietic cells and improved multi-lineage NSG-repopulation capacity. MIF inhibitors and anti-MIF antibodies will be tested in these pre-clinical TET2-depleted models. Xenotransplantation of selected primary AML samples and xenotransplantation of TET2 depleted hematopoietic stem cells into NSG mice will be used.

The fourth objective is to understand how MIF is deregulated in pre-leukemic stem cells and how the MIF-dependent crosstalk between mesenchymal stromal cells (MSCs) and pre-leukemic stem cells or normal hematopoietic cells works.

The molecular mechanisms of MIF overexpression will be analyzed in hematopoietic stem and progenitor cells from normal and leukemic bone marrow, with a focus on cells depleted in TET2 or DNMT3A. To study the cross-talk between hematopoietic stem and progenitor cells, pre-leukemic stem cells, and bone marrow MSCs, co-culture experiments will be performed using available MSC cell lines and primary MSCs from healthy donors.

location_facility: Laboratoire d'hématologie Hôpital Saint Antoine


title: The NutriNet-Santé Study. A Web-based Prospective Cohort Study of the Relationship Between Nutrition and Health and of Dietary Patterns and Nutritional Status Predictors

summary:
The NutriNet-Santé study was set up to investigate nutrition and health relationships. Specifically, it was the first web-based cohort worldwide on such a large scale (n=171 000 as of 2021) focused on the complex link between nutrition and health status. It is characterized by a very detailed assessment of nutritional exposure and dietary behavior.

https://etude-nutrinet-sante.fr/ https://info.etude-nutrinet-sante.fr/en

ReferenceCitation: Hercberg S, Castetbon K, Czernichow S, Malon A, Mejean C, Kesse E, Touvier M, Galan P. The Nutrinet-Santé Study: a web-based prospective study on the relationship between nutrition and health and determinants of dietary patterns and nutritional status. BMC Public Health. 2010 May 11;10:242. doi: 10.1186/1471-2458-10-242.

ReferenceCitation: Kesse-Guyot E, Allès B, Brunin J, Fouillet H, Dussiot A, Mariotti F, Langevin B, Berthy F, Touvier M, Julia C, Hercberg S, Lairon D, Barbier C, Couturier C, Pointereau P, Baudry J. Nutritionally Adequate and Environmentally Respectful Diets Are Possible for Different Diet Groups: an Optimized Study from the NutriNet-Santé Cohort. Am J Clin Nutr. 2022 Sep 16. pii: nqac253. doi: 10.1093/ajcn/nqac253. [Epub ahead of print]

ReferenceCitation: Bellicha A, Wendeu-Foyet G, Coumoul X, Koual M, Pierre F, Guéraud F, Zelek L, Debras C, Srour B, Sellem L, Kesse-Guyot E, Julia C, Galan P, Hercberg S, Deschasaux-Tanguy M, Touvier M. Dietary exposure to acrylamide and breast cancer risk: results from the NutriNet-Santé cohort. Am J Clin Nutr. 2022 Oct 6;116(4):911-919. doi: 10.1093/ajcn/nqac167.

ReferenceCitation: Reuzé A, Méjean C, Carrère M, Sirieix L, Druesne-Pecollo N, Péneau S, Touvier M, Hercberg S, Kesse-Guyot E, Allès B. Rebalancing meat and legume consumption: change-inducing food choice motives and associated individual characteristics in non-vegetarian adults. Int J Behav Nutr Phys Act. 2022 Sep 1;19(1):112. doi: 10.1186/s12966-022-01317-w.

ReferenceCitation: Berthy F, Brunin J, Allès B, Fezeu LK, Touvier M, Hercberg S, Galan P, Pointereau P, Lairon D, Baudry J, Kesse-Guyot E. Association between adherence to the EAT-Lancet diet and risk of cancer and cardiovascular outcomes in the prospective NutriNet-Santé cohort. Am J Clin Nutr. 2022 Oct 6;116(4):980-991. doi: 10.1093/ajcn/nqac208.

ReferenceCitation: Gisch UA, Robert M, Berlin N, Nebout A, Etilé F, Teyssier S, Andreeva VA, Hercberg S, Touvier M, Péneau S. Mastery Is Associated With Weight Status, Food Intake, Snacking, and Eating Disorder Symptoms in the NutriNet-Santé Cohort Study. Front Nutr. 2022 May 25;9:871669. doi: 10.3389/fnut.2022.871669. eCollection 2022.

ReferenceCitation: Robert M, Shankland R, Bellicha A, Kesse-Guyot E, Deschasaux-Tanguy M, Andreeva VA, Srour B, Hercberg S, Touvier M, Leys C, Péneau S. Associations between Resilience and Food Intake Are Mediated by Emotional Eating in the NutriNet-Santé Study. J Nutr. 2022 Aug 9;152(8):1907-1915. doi: 10.1093/jn/nxac124.

ReferenceCitation: Rebouillat P, Vidal R, Cravedi JP, Taupier-Letage B, Debrauwer L, Gamet-Payrastre L, Guillou H, Touvier M, Fezeu LK, Hercberg S, Lairon D, Baudry J, Kesse-Guyot E. Prospective association between dietary pesticide exposure profiles and type 2 diabetes risk in the NutriNet-Santé cohort. Environ Health. 2022 May 25;21(1):57. doi: 10.1186/s12940-022-00862-y.

ReferenceCitation: Debras C, Chazelas E, Srour B, Druesne-Pecollo N, Esseddik Y, Szabo de Edelenyi F, Agaësse C, De Sa A, Lutchia R, Gigandet S, Huybrechts I, Julia C, Kesse-Guyot E, Allès B, Andreeva VA, Galan P, Hercberg S, Deschasaux-Tanguy M, Touvier M. Artificial sweeteners and cancer risk: Results from the NutriNet-Santé population-based cohort study. PLoS Med. 2022 Mar 24;19(3):e1003950. doi: 10.1371/journal.pmed.1003950. eCollection 2022 Mar.

ReferenceCitation: Deschasaux-Tanguy M, Srour B, Bourhis L, Arnault N, Druesne-Pecollo N, Esseddik Y, de Edelenyi FS, Allègre J, Allès B, Andreeva VA, Baudry J, Fezeu LK, Galan P, Julia C, Kesse-Guyot E, Péneau S, Hercberg S, Bajos N, Severi G, Zins M, de Lamballerie X, Carrat F, Touvier M; SAPRIS-SERO study group. Nutritional risk factors for SARS-CoV-2 infection: a prospective study within the NutriNet-Santé cohort. BMC Med. 2021 Nov 30;19(1):290. doi: 10.1186/s12916-021-02168-1.

ReferenceCitation: Debras C, Chazelas E, Srour B, Julia C, Kesse-Guyot E, Zelek L, Agaësse C, Druesne-Pecollo N, Andreeva VA, Galan P, Hercberg S, Latino-Martel P, Deschasaux-Tanguy M, Touvier M. Glycaemic index, glycaemic load and cancer risk: results from the prospective NutriNet-Santé cohort. Int J Epidemiol. 2022 Feb 18;51(1):250-264. doi: 10.1093/ije/dyab169.

ReferenceCitation: Carra MC, Fessi S, Detzen L, Darnaud C, Julia C, Hercberg S, Touvier M, Andreeva VA, Bouchard P. Self-reported periodontal health and incident hypertension: longitudinal evidence from the NutriNet-Santé e-cohort. J Hypertens. 2021 Dec 1;39(12):2422-2430. doi: 10.1097/HJH.0000000000002941.

ReferenceCitation: Schneider E, Sabate JM, Bouchoucha M, Debras C, Touvier M, Hercberg S, Benamouzig R, Buscail C, Julia C. FODMAP Consumption by Adults from the French Population-Based NutriNet-Santé Cohort. J Nutr. 2021 Oct 1;151(10):3180-3186. doi: 10.1093/jn/nxab207.

ReferenceCitation: Courtois F, Péneau S, Salanave B, Andreeva VA, Roland-Cachera MF, Touvier M, Galan P, Hercberg S, Fezeu LK. Trends in breastfeeding practices and mothers' experience in the French NutriNet-Santé cohort. Int Breastfeed J. 2021 Jul 2;16(1):50. doi: 10.1186/s13006-021-00397-x.

ReferenceCitation: Julia C, Leroy P, Adjibade M, Assmann KE, Touvier M, Hercberg S, Soler LG, Kesse-Guyot E. Public health potential of guidelines-based dietary scores for non-communicable diseases mortality prevention: simulation study using the Preventable Risk Integrated ModEl (PRIME) model. Public Health Nutr. 2021 Nov;24(16):5539-5549. doi: 10.1017/S1368980021002871. Epub 2021 Jul 2.

ReferenceCitation: Deschasaux-Tanguy M, Druesne-Pecollo N, Esseddik Y, de Edelenyi FS, Alles B, Andreeva VA, Baudry J, Charreire H, Deschamps V, Egnell M, Fezeu LK, Galan P, Julia C, Kesse-Guyot E, Latino-Martel P, Oppert JM, Peneau S, Verdot C, Hercberg S, Touvier M. Diet and physical activity during the coronavirus disease 2019 (COVID-19) lockdown (March-May 2020): results from the French NutriNet-Sante cohort study. Am J Clin Nutr. 2021 Apr 6;113(4):924-938. doi: 10.1093/ajcn/nqaa336.

ReferenceCitation: Egnell M, Boutron I, Peneau S, Ducrot P, Touvier M, Galan P, Buscail C, Porcher R, Ravaud P, Hercberg S, Kesse-Guyot E, Julia C. Randomised controlled trial in an experimental online supermarket testing the effects of front-of-pack nutrition labelling on food purchasing intentions in a low-income population. BMJ Open. 2021 Feb 8;11(2):e041196. doi: 10.1136/bmjopen-2020-041196.

ReferenceCitation: Mervant L, Tremblay-Franco M, Jamin EL, Kesse-Guyot E, Galan P, Martin JF, Guéraud F, Debrauwer L. Osmolality-based normalization enhances statistical discrimination of untargeted metabolomic urine analysis: results from a comparative study. Metabolomics. 2021 Jan 2;17(1):2. doi: 10.1007/s11306-020-01758-z.

ReferenceCitation: Kesse-Guyot E, Rebouillat P, Payrastre L, Allès B, Fezeu LK, Druesne-Pecollo N, Srour B, Bao W, Touvier M, Galan P, Hercberg S, Lairon D, Baudry J. Prospective association between organic food consumption and the risk of type 2 diabetes: findings from the NutriNet-Santé cohort study. Int J Behav Nutr Phys Act. 2020 Nov 9;17(1):136. doi: 10.1186/s12966-020-01038-y.

ReferenceCitation: Chazelas E, Debras C, Srour B, Fezeu LK, Julia C, Hercberg S, Deschasaux M, Touvier M. Sugary Drinks, Artificially-Sweetened Beverages, and Cardiovascular Disease in the NutriNet-Santé Cohort. J Am Coll Cardiol. 2020 Nov 3;76(18):2175-2177. doi: 10.1016/j.jacc.2020.08.075.

ReferenceCitation: Debras C, Chazelas E, Srour B, Kesse-Guyot E, Julia C, Zelek L, Agaësse C, Druesne-Pecollo N, Galan P, Hercberg S, Latino-Martel P, Deschasaux M, Touvier M. Total and added sugar intakes, sugar types, and cancer risk: results from the prospective NutriNet-Santé cohort. Am J Clin Nutr. 2020 Nov 11;112(5):1267-1279. doi: 10.1093/ajcn/nqaa246.

ReferenceCitation: Beslay M, Srour B, Méjean C, Allès B, Fiolet T, Debras C, Chazelas E, Deschasaux M, Wendeu-Foyet MG, Hercberg S, Galan P, Monteiro CA, Deschamps V, Calixto Andrade G, Kesse-Guyot E, Julia C, Touvier M. Ultra-processed food intake in association with BMI change and risk of overweight and obesity: A prospective analysis of the French NutriNet-Santé cohort. PLoS Med. 2020 Aug 27;17(8):e1003256. doi: 10.1371/journal.pmed.1003256. eCollection 2020 Aug.

ReferenceCitation: Rebouillat P, Vidal R, Cravedi JP, Taupier-Letage B, Debrauwer L, Gamet-Payrastre L, Touvier M, Hercberg S, Lairon D, Baudry J, Kesse-Guyot E. Estimated dietary pesticide exposure from plant-based foods using NMF-derived profiles in a large sample of French adults. Eur J Nutr. 2021 Apr;60(3):1475-1488. doi: 10.1007/s00394-020-02344-8. Epub 2020 Jul 30.

ReferenceCitation: Gehring J, Touvier M, Baudry J, Julia C, Buscail C, Srour B, Hercberg S, Péneau S, Kesse-Guyot E, Allès B. Consumption of Ultra-Processed Foods by Pesco-Vegetarians, Vegetarians, and Vegans: Associations with Duration and Age at Diet Initiation. J Nutr. 2021 Jan 4;151(1):120-131. doi: 10.1093/jn/nxaa196.

ReferenceCitation: Partula V, Deschasaux M, Druesne-Pecollo N, Latino-Martel P, Desmetz E, Chazelas E, Kesse-Guyot E, Julia C, Fezeu LK, Galan P, Hercberg S, Mondot S, Lantz O, Quintana-Murci L, Albert ML, Duffy D; Milieu Intérieur Consortium, Srour B, Touvier M. Associations between consumption of dietary fibers and the risk of cardiovascular diseases, cancers, type 2 diabetes, and mortality in the prospective NutriNet-Santé cohort. Am J Clin Nutr. 2020 Jul 1;112(1):195-207. doi: 10.1093/ajcn/nqaa063.

ReferenceCitation: Chaltiel D, Julia C, Adjibade M, Touvier M, Hercberg S, Kesse-Guyot E. Adherence to the 2017 French dietary guidelines and adult weight gain: A cohort study. PLoS Med. 2019 Dec 30;16(12):e1003007. doi: 10.1371/journal.pmed.1003007. eCollection 2019 Dec.

ReferenceCitation: Srour B, Fezeu LK, Kesse-Guyot E, Allès B, Debras C, Druesne-Pecollo N, Chazelas E, Deschasaux M, Hercberg S, Galan P, Monteiro CA, Julia C, Touvier M. Ultraprocessed Food Consumption and Risk of Type 2 Diabetes Among Participants of the NutriNet-Santé Prospective Cohort. JAMA Intern Med. 2020 Feb 1;180(2):283-291. doi: 10.1001/jamainternmed.2019.5942.

ReferenceCitation: Seconda L, Egnell M, Julia C, Touvier M, Hercberg S, Pointereau P, Lairon D, Allès B, Kesse-Guyot E. Association between sustainable dietary patterns and body weight, overweight, and obesity risk in the NutriNet-Santé prospective cohort. Am J Clin Nutr. 2020 Jul 1;112(1):138-149. doi: 10.1093/ajcn/nqz259.

ReferenceCitation: Andrianasolo RM, Hercberg S, Kesse-Guyot E, Druesne-Pecollo N, Touvier M, Galan P, Varraso R. Association between dietary fibre intake and asthma (symptoms and control): results from the French national e-cohort NutriNet-Santé. Br J Nutr. 2019 Nov 14;122(9):1040-1051. doi: 10.1017/S0007114519001843.

ReferenceCitation: Chazelas E, Srour B, Desmetz E, Kesse-Guyot E, Julia C, Deschamps V, Druesne-Pecollo N, Galan P, Hercberg S, Latino-Martel P, Deschasaux M, Touvier M. Sugary drink consumption and risk of cancer: results from NutriNet-Santé prospective cohort. BMJ. 2019 Jul 10;366:l2408. doi: 10.1136/bmj.l2408.

ReferenceCitation: Adjibade M, Lemogne C, Touvier M, Hercberg S, Galan P, Assmann KE, Julia C, Kesse-Guyot E. The Inflammatory Potential of the Diet is Directly Associated with Incident Depressive Symptoms Among French Adults. J Nutr. 2019 Jul 1;149(7):1198-1207. doi: 10.1093/jn/nxz045.

ReferenceCitation: Srour B, Fezeu LK, Kesse-Guyot E, Allès B, Méjean C, Andrianasolo RM, Chazelas E, Deschasaux M, Hercberg S, Galan P, Monteiro CA, Julia C, Touvier M. Ultra-processed food intake and risk of cardiovascular disease: prospective cohort study (NutriNet-Santé). BMJ. 2019 May 29;365:l1451. doi: 10.1136/bmj.l1451.

ReferenceCitation: Bénard M, Bellisle F, Kesse-Guyot E, Julia C, Andreeva VA, Etilé F, Reach G, Dechelotte P, Tavolacci MP, Hercberg S, Péneau S. Impulsivity is associated with food intake, snacking, and eating disorders in a general population. Am J Clin Nutr. 2019 Jan 1;109(1):117-126. doi: 10.1093/ajcn/nqy255.

ReferenceCitation: Méjean C, Lampuré A, Si Hassen W, Gojard S, Péneau S, Hercberg S, Castetbon K. Influence of food preparation behaviors on 5-year weight change and obesity risk in a French prospective cohort. Int J Behav Nutr Phys Act. 2018 Nov 26;15(1):120. doi: 10.1186/s12966-018-0747-4.

ReferenceCitation: Andreeva VA, Tavolacci MP, Galan P, Ladner J, Buscail C, Péneau S, Galmiche M, Hercberg S, Déchelotte P, Julia C. Sociodemographic correlates of eating disorder subtypes among men and women in France, with a focus on age. J Epidemiol Community Health. 2019 Jan;73(1):56-64. doi: 10.1136/jech-2018-210745. Epub 2018 Oct 9.

ReferenceCitation: Si Hassen W, Castetbon K, Péneau S, Tichit C, Nechba A, Lampuré A, Bellisle F, Hercberg S, Méjean C. Socio-economic and demographic factors associated with snacking behavior in a large sample of French adults. Int J Behav Nutr Phys Act. 2018 Mar 15;15(1):25. doi: 10.1186/s12966-018-0655-7.

ReferenceCitation: Si Hassen W, Castetbon K, Tichit C, Péneau S, Nechba A, Ducrot P, Lampuré A, Bellisle F, Hercberg S, Méjean C. Energy, nutrient and food content of snacks in French adults. Nutr J. 2018 Feb 27;17(1):33. doi: 10.1186/s12937-018-0336-z.

ReferenceCitation: Fiolet T, Srour B, Sellem L, Kesse-Guyot E, Allès B, Méjean C, Deschasaux M, Fassier P, Latino-Martel P, Beslay M, Hercberg S, Lavalette C, Monteiro CA, Julia C, Touvier M. Consumption of ultra-processed foods and cancer risk: results from NutriNet-Santé prospective cohort. BMJ. 2018 Feb 14;360:k322. doi: 10.1136/bmj.k322.

lead_sponsor: University of Paris 13


title: Phase 1 Study Evaluating the Relevance and Reliability of Gastrointestinal Temperature Measurements From a New Device (E-celsius)

acronym: e-TEMP

summary:
E-Celsius device used for measuring the gastrointestinal temperature is composed of an ingestible capsule measuring the temperature as well as a transportable module receiving data from the capsule. This device allows to measure the body temperature (± 0.2 ° C) during transit of the pill in the digestive tract to a maximum sampling frequency of 30 seconds. The main risks related to such devices are related to biocompatibility (in materials used for the capsule shell, or level of contamination of the gastrointestinal environment due to a defect in the plastic envelope the pill or a lack of hygiene, previously tested in clinical trials; see section 10.2).

It will compare conventional methods of estimating the central temperature continuously with gastrointestinal data obtained from the e-Celsius device. The main objective of the research is to validate the extent of gastrointestinal temperature obtained from the device under test consists of an ingestible electronic capsule and a data reception monitor.

Secondary objectives will be pursued:

Assess the effects of ingestion of cold drinks on temperature readings taken via e-device Celsius, esophageal probe and a rectal probe.
Explore the thermal homogeneity of the digestive tract.
Evaluate the internal memory of the capsule and its data forwarding capacity. This protocol will also measure the reliability of the measurement system while comparing it to the standards used by health staff today.

primary_purpose: Basic Science

lead_sponsor: University Hospital, Caen


title: Ontogeny of MAIT Cells in Neonates and Hematopoietic Stem Cell Transplant Recipients

acronym: NEOMAIT

summary: The objective of this study is 1/ to determine the rate and kinetics of MAIT cell expansion and maturation in neonates in relation with gestational age, and in HSCT recipient children in relation with the source of donor stem cells, 2/ to correlate gut microbiota diversity and function with MAIT cell maturation and function in neonates and HSCT recipients; and 3/ to link MAIT cells and gut microbiota composition with microbial infections and severe intestinal inflammatory events in term and preterm neonates, and in HSCT recipients

ReferenceCitation: Tourret M, Talvard-Balland N, Lambert M, Ben Youssef G, Chevalier MF, Bohineust A, Yvorra T, Morin F, Azarnoush S, Lantz O, Dalle JH, Caillat-Zucman S. Human MAIT cells are devoid of alloreactive potential: prompting their use as universal cells for adoptive immune therapy. J Immunother Cancer. 2021 Oct;9(10). pii: e003123. doi: 10.1136/jitc-2021-003123.


title: Impact of Exercise Training on Skeletal Muscle Capillary Maturation During Angiogenesis in COPD Patients

acronym: COPDµvasc

summary:
COPD patients experiment a peripheral muscle dysfunction which impact their exercise tolerance and health-related quality of life. The capillary to fiber interface is reduced and impact the exercise capacity of the patients. While the muscle capillary creation in response to exercise training is blunted in COPD patients, the maturation of the neo-capillaries could also be blunted and contribute to the impaired aniogionenesis in patients. Because the capillary maturation is a sensitive and dynamic process, only different modalities of exercise training and multiple time-points of measures would allow to capture this microvascular adaptation.

Aim of the study : Compare the muscle capillary maturation in response to training at 5 and 10 weeks, in sedentary healthy subject trained at the intensity of the ventilatory threshold (60-65% of VO2max), versus :- COPD patients trained at a similar intensity (60-65% of VO2max)- COPD patients trained at a similar absolute intensity (90% of VO2max).

ReferenceCitation: Souweine JS, Gouzi F, Badia É, Pomies P, Garrigue V, Morena M, Hayot M, Mercier J, Ayoub B, Quintrec ML, Raynaud F, Cristol JP. Skeletal Muscle Phenotype in Patients Undergoing Long-Term Hemodialysis Awaiting Kidney Transplantation. Clin J Am Soc Nephrol. 2021 Nov;16(11):1676-1685. doi: 10.2215/CJN.02390221.

location_facility: Department of clinical Physiology - University Hospital


title: The Anti-inflammatory Effect of Vagus Nerve Stimulation (VNS): a New Approach in the Treatment of Crohn's Disease

acronym: VNS

summary: The purpose of this study is to determine whether (VNS) Vagus Nerve Stimulation , is effective in the treatment of Crohn's disease.

ReferenceCitation: Meregnani J, Clarençon D, Vivier M, Peinnequin A, Mouret C, Sinniger V, Picq C, Job A, Canini F, Jacquier-Sarlin M, Bonaz B. Anti-inflammatory effect of vagus nerve stimulation in a rat model of inflammatory bowel disease. Auton Neurosci. 2011 Feb 24;160(1-2):82-9. doi: 10.1016/j.autneu.2010.10.007. Epub 2010 Nov 11.

ReferenceCitation: Borovikova LV, Ivanova S, Zhang M, Yang H, Botchkina GI, Watkins LR, Wang H, Abumrad N, Eaton JW, Tracey KJ. Vagus nerve stimulation attenuates the systemic inflammatory response to endotoxin. Nature. 2000 May 25;405(6785):458-62.

lead_sponsor: University Hospital, Grenoble


title: Effects of Two Hypocaloric Diets on Weight Loss and Inflammatory Markers

summary: The investigators evaluated whether an energy-restricted protein diet with low glycaemic index carbohydrates and soluble fibers (LC-P-LGI) would be more effective than a conventional diet (LC-CONV) on weight-loss and related metabolic variables.

primary_purpose: Health Services Research

ReferenceCitation: Rizkalla SW, Prifti E, Cotillard A, Pelloux V, Rouault C, Allouche R, Laromiguière M, Kong L, Darakhshan F, Massiera F, Clement K. Differential effects of macronutrient content in 2 energy-restricted diets on cardiovascular risk factors and adipose tissue cell size in moderately obese individuals: a randomized controlled trial. Am J Clin Nutr. 2012 Jan;95(1):49-63. doi: 10.3945/ajcn.111.017277. Epub 2011 Dec 14.

lead_sponsor: Ceprodi S.A. Kot


title: PILOT STUDY OF GENE THERAPY FOR LOCALLY ADVANCED PANCREATIC ADENOCARCINOMA WITH INTRATUMOURAL INJECTION OF JetPEI/DNA COMPLEXES WITH ANTITUMOURAL EFFECT AND CHEMOSENSITIZING ACTIVITY FOR GEMCITABINE

acronym: TherGAP

summary: Near 85% of patients with pancreatic adenocarcinoma are diagnosed with a locally advanced and/or metastatic unresectable tumor. In these patients chemotherapy (such as gemcitabine) is given as a palliative therapy. Aim of the present study is to evaluate the feasibility, tolerance and antitumor effect of repeated intratumoral injection of a gene therapy product (with antitumor and chemo sensitizing effects) combined with gemcitabine in patients with unresectable pancreatic carcinoma.

location_facility: Toulouse Universitary Hospital (Rangueil), Department of Gastroenterology At Rangueil Hospital

intervention_type: Genetic


title: Assessment of the Axone Micro Quadripolar Lead for Enhanced Cardiac Resynchronization Therapy

summary: The primary objective of this study is to assess the chronic safety and performance of the Axone left ventricular (LV) micro-lead.

ReferenceCitation: Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, González-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. Erratum in: Eur Heart J. 2016 Dec 30;:.

ReferenceCitation: Cleland JG, Daubert JC, Erdmann E, Freemantle N, Gras D, Kappenberger L, Tavazzi L; Cardiac Resynchronization-Heart Failure (CARE-HF) Study Investigators. The effect of cardiac resynchronization on morbidity and mortality in heart failure. N Engl J Med. 2005 Apr 14;352(15):1539-49. Epub 2005 Mar 7.

ReferenceCitation: Linde C, Abraham WT, Gold MR, St John Sutton M, Ghio S, Daubert C; REVERSE (REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction) Study Group. Randomized trial of cardiac resynchronization in mildly symptomatic heart failure patients and in asymptomatic patients with left ventricular dysfunction and previous heart failure symptoms. J Am Coll Cardiol. 2008 Dec 2;52(23):1834-1843. doi: 10.1016/j.jacc.2008.08.027. Epub 2008 Nov 7.

ReferenceCitation: Zeitler EP, Friedman DJ, Daubert JP, Al-Khatib SM, Solomon SD, Biton Y, McNitt S, Zareba W, Moss AJ, Kutyifa V. Multiple Comorbidities and Response to Cardiac Resynchronization Therapy: MADIT-CRT Long-Term Follow-Up. J Am Coll Cardiol. 2017 May 16;69(19):2369-2379. doi: 10.1016/j.jacc.2017.03.531.

ReferenceCitation: Healey JS, Hohnloser SH, Exner DV, Birnie DH, Parkash R, Connolly SJ, Krahn AD, Simpson CS, Thibault B, Basta M, Philippon F, Dorian P, Nair GM, Sivakumaran S, Yetisir E, Wells GA, Tang AS; RAFT Investigators. Cardiac resynchronization therapy in patients with permanent atrial fibrillation: results from the Resynchronization for Ambulatory Heart Failure Trial (RAFT). Circ Heart Fail. 2012 Sep 1;5(5):566-70. Epub 2012 Aug 14.

ReferenceCitation: Daubert C, Behar N, Martins RP, Mabo P, Leclercq C. Avoiding non-responders to cardiac resynchronization therapy: a practical guide. Eur Heart J. 2017 May 14;38(19):1463-1472. doi: 10.1093/eurheartj/ehw270. Review.

ReferenceCitation: Okamura H. Up-to-date cardiac resynchronization therapy. J Gen Fam Med. 2017 May 17;18(5):195-199. doi: 10.1002/jgf2.24. eCollection 2017 Oct. Review.

ReferenceCitation: Macías A, Gavira JJ, Alegría E, Azcárate PM, Barba J, García-Bolao I. [Effect of the left ventricular pacing site on echocardiographic parameters of ventricular dyssynchrony in patients receiving cardiac resynchronization therapy]. Rev Esp Cardiol. 2004 Feb;57(2):138-45. Spanish.

ReferenceCitation: Butter C, Auricchio A, Stellbrink C, Fleck E, Ding J, Yu Y, Huvelle E, Spinelli J; Pacing Therapy for Chronic Heart Failure II Study Group. Effect of resynchronization therapy stimulation site on the systolic function of heart failure patients. Circulation. 2001 Dec 18;104(25):3026-9.

ReferenceCitation: Umar F, Taylor RJ, Stegemann B, Marshall H, Flannigan S, Lencioni M, De Bono J, Griffith M, Leyva F. Haemodynamic effects of cardiac resynchronization therapy using single-vein, three-pole, multipoint left ventricular pacing in patients with ischaemic cardiomyopathy and a left ventricular free wall scar: the MAESTRO study. Europace. 2016 Aug;18(8):1227-34. doi: 10.1093/europace/euv396. Epub 2015 Dec 30.

ReferenceCitation: Bonadei I, Vizzardi E, Gorga E, Carubelli V, Pagnoni M, Sciatti E, Raweh A, Cerini M, Bontempi L, Curnis A, Metra M. Role of the old and new echocardiographic technologies in cardiac resynchronization therapy. Minerva Cardioangiol. 2016 Oct;64(5):572-80. Epub 2015 Jun 23. Review.

ReferenceCitation: O'Brien T, Park MS, Youn JC, Chung ES. The Past, Present and Future of Cardiac Resynchronization Therapy. Korean Circ J. 2019 May;49(5):384-399. doi: 10.4070/kcj.2019.0114. Review.

ReferenceCitation: Leclercq C, Burri H, Curnis A, Delnoy PP, Rinaldi CA, Sperzel J, Lee K, Calò L, Vicentini A, Concha JF, Thibault B. Cardiac resynchronization therapy non-responder to responder conversion rate in the more response to cardiac resynchronization therapy with MultiPoint Pacing (MORE-CRT MPP) study: results from Phase I. Eur Heart J. 2019 Sep 14;40(35):2979-2987. doi: 10.1093/eurheartj/ehz109.

ReferenceCitation: Auricchio A, Heggermont WA. Technology Advances to Improve Response to Cardiac Resynchronization Therapy: What Clinicians Should Know. Rev Esp Cardiol (Engl Ed). 2018 Jun;71(6):477-484. doi: 10.1016/j.rec.2018.01.006. Epub 2018 Feb 14. Review. English, Spanish.

ReferenceCitation: Antoniadis AP, Behar JM, Sieniewicz B, Gould J, Niederer S, Rinaldi CA. A comparison of the different features of quadripolar left ventricular pacing leads to deliver cardiac resynchronization therapy. Expert Rev Med Devices. 2017 Sep;14(9):697-706. doi: 10.1080/17434440.2017.1369404. Epub 2017 Aug 23. Review.

ReferenceCitation: Tomassoni G, Baker J, Corbisiero R, Love C, Martin D, Niazi I, Sheppard R, Worley S, Beau S, Greer GS, Aryana A, Cao M, Harbert N, Zhang S; Promote® Q CRT-D and Quartet® Left Ventricular Heart Lead Study Group. Postoperative performance of the Quartet® left ventricular heart lead. J Cardiovasc Electrophysiol. 2013 Apr;24(4):449-56. doi: 10.1111/jce.12065. Epub 2013 Jan 22.

ReferenceCitation: Crossley GH, Biffi M, Johnson B, Lin A, Gras D, Hussin A, Cuffio A, Collier JL, El-Chami M, Li S, Holloman K, Exner DV. Performance of a novel left ventricular lead with short bipolar spacing for cardiac resynchronization therapy: primary results of the Attain Performa quadripolar left ventricular lead study. Heart Rhythm. 2015 Apr;12(4):751-8. doi: 10.1016/j.hrthm.2014.12.019. Epub 2014 Dec 19.

ReferenceCitation: Mittal S, Nair D, Padanilam BJ, Ciuffo A, Gupta N, Gallagher P, Goldner B, Hammill EF, Wold N, Stein K, Burke M. Performance of Anatomically Designed Quadripolar Left Ventricular Leads: Results from the NAVIGATE X4 Clinical Trial. J Cardiovasc Electrophysiol. 2016 Oct;27(10):1199-1205. doi: 10.1111/jce.13044. Epub 2016 Aug 19.

lead_sponsor: MicroPort CRM

location_country: Portugal Spain Italy Austria Netherlands France Germany

location_facility: Universitätsklinikum Schleswig-Holstein Campus Kiel

location_facility: Centro Hospitalar Universitário do Porto

location_facility: Centro Hospitalar Universitário Lisboa Norte - Hospital de Santa Maria

location_facility: Hospital Universitario General de Alicante


title: Prospective Study Evaluating the Olfactory Recovery of Anosmia Post COVID-19 by Olfactory Rehabilitation Assisted by Web-application

acronym: COVIDANOSMIA

summary:
Anosmia is a symptom present in 40 to 80% of patients and usually only lasts 1 to 2 weeks. However, in nearly one in five patients, it can last beyond or even several months with consequences in terms of undernutrition and depression. However, olfactory rehabilitation is a technique validated in post-infectious anosmia since 2014 and recommended by international learned societies to accelerate recovery with nearly 63% improvement in anosmia In the context of the health crisis linked to the coronavirus, approximately 1 million French people will have persistent anosmia following an infection with COVID-19. A web-application to support the olfactory coaching of anosmic patients and help with follow-up seems relevant to promote recovery and the proper conduct of this coaching.

covidanosmie.fr is a web application dedicated to olfactory rehabilitation, accessible free of charge.

lead_sponsor: Weprom


title: Observational, Multicenter, Prospective Clinical Study, Measuring the Performance and Safety of the Surgical Hemostatic Agent "HEMOCOLLAGENE®" in Patients Requiring Oral Surgery

summary:
The aim of this study is to collect performance and safety data relating to the use and the follow-up of the HEMOCOLLAGENE® medical device in routine clinical practice from various hospitals and medical centers in oral dental surgery.

Patients will The data collected from the Post-Market Clinical Follow-up study will be used to support the regulatory requirements of post-market monitoring (risk management, residual risks, instructions for use...) and to increase the manufacturer's clinical data. Patients will be followed for 1 month.

Adverse events (safety) and device performance will be collected by the dentist during the routine follow-up visits.

location_country: France Belgium

location_facility: Cabinet Dento Médical, cabinet de Nivelles


title: Diagnostic Value of Copeptin Assay for Acute Coronary Syndrome Without ST-segment Elevation

summary:
The purpose of this study is to determine whether the combination of copeptine and troponin adds diagnosis information to that provided by troponin alone or the combination of troponin and myoglobin.

Hypothesis : If the values of troponin and copeptin are not elevated, diagnosis of acute myocardial infarction can be ruled out without prolonged monitoring and serial blood sampling.

ReferenceCitation: Duchenne J, Mestres S, Dublanchet N, Combaret N, Marceau G, Caumon L, Dutoit L, Ughetto S, Motreff P, Sapin V, Schmidt J; NSTEMI Study. Diagnostic accuracy of copeptin sensitivity and specificity in patients with suspected non-ST-elevation myocardial infarction with troponin I below the 99th centile at presentation. BMJ Open. 2014 Mar 24;4(3):e004449. doi: 10.1136/bmjopen-2013-004449. Erratum in: BMJ Open. 2014;4(4):e004449corr1.


title: Virtual Reality and Subjective Tinnitus

summary: The purpose of this study is to test if virtual reality immersion has the potential to significantly decrease subjective tinnitus intrusiveness when compared to standard care.

study_start_date_type: Anticipated

status: Not yet recruiting

ReferenceCitation: Malinvaud D, Londero A, Niarra R, Peignard P, Warusfel O, Viaud-Delmon I, Chatellier G, Bonfils P. Auditory and visual 3D virtual reality therapy as a new treatment for chronic subjective tinnitus: Results of a randomized controlled trial. Hear Res. 2016 Mar;333:127-135. doi: 10.1016/j.heares.2015.12.023. Epub 2016 Jan 8.

ipd_sharing: Yes

ipd_sharing_description: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared


title: COPANA - A09 PCSK 9 Substudy: Impact of Protease Inhibitors on PCSK9 Levels in Naive HIV-Infected Patients

acronym: COPANA

summary: Evaluation of the impact of initiation of protease inhibitor/ritonavir on PCSK9 levels in HIV-infected antiretroviral-naïve patients from the ANRS C09 COPANA cohort.

ReferenceCitation: Boccara F, Ghislain M, Meyer L, Goujard C, Le May C, Vigouroux C, Bastard JP, Fellahi S, Capeau J, Cohen A, Cariou B; ANRS-COPANA Study Group. Impact of protease inhibitors on circulating PCSK9 levels in HIV-infected antiretroviral-naive patients from an ongoing prospective cohort. AIDS. 2017 Nov 13;31(17):2367-2376. doi: 10.1097/QAD.0000000000001633.

ipd_sharing_description: no plan to share IPD

lead_sponsor: Franck Boccara

location_facility: Cardiology Department, Saint Antoine University Hospital


title: Dose-escalation Study to Assess the Safety and Tolerability of Sub-cutaneous Injections of a Peptide-loaded Plasmacytoid Dendritic Cell Line (GeniusVac-Mel4) in Patients With Melanoma

summary: The primary objective of this study is to evaluate the safety and tolerability of multiple sub-cutaneous injections of GeniusVac-Mel4, a dendritic cell-based cancer vaccine, in patients with melanoma. The secondary objectives are to determine immune response and clinical efficacy of such injections in patients with melanoma.

ReferenceCitation: Aspord C, Leccia MT, Salameire D, Laurin D, Chaperot L, Charles J, Plumas J. HLA-A(*)0201(+) plasmacytoid dendritic cells provide a cell-based immunotherapy for melanoma patients. J Invest Dermatol. 2012 Oct;132(10):2395-2406. doi: 10.1038/jid.2012.152. Epub 2012 Jun 14.

ReferenceCitation: Aspord C, Charles J, Leccia MT, Laurin D, Richard MJ, Chaperot L, Plumas J. A novel cancer vaccine strategy based on HLA-A*0201 matched allogeneic plasmacytoid dendritic cells. PLoS One. 2010 May 4;5(5):e10458. doi: 10.1371/journal.pone.0010458.


acronym: HBC

title: Placebo-controlled Evaluation of the Homeopathic Drug BRN01 for the Treatment of Hot Flashes in Women With Non Metastatic Breast Cancer Treated by Adjuvant Hormonal Therapy

lead_sponsor: Centre Leon Berard

ReferenceCitation: Remontet L, Estève J, Bouvier AM, Grosclaude P, Launoy G, Menegoz F, Exbrayat C, Tretare B, Carli PM, Guizard AV, Troussard X, Bercelli P, Colonna M, Halna JM, Hedelin G, Macé-Lesec'h J, Peng J, Buemi A, Velten M, Jougla E, Arveux P, Le Bodic L, Michel E, Sauvage M, Schvartz C, Faivre J. Cancer incidence and mortality in France over the period 1978-2000. Rev Epidemiol Sante Publique. 2003 Feb;51(1 Pt 1):3-30.

ReferenceCitation: Ménégoz F, Black RJ, Arveux P, Magne V, Ferlay J, Buémi A, Carli PM, Chapelain G, Faivre J, Gignoux M, Grosclaude P, Mace-Lesec'h J, Raverdy N, Schaffer P. Cancer incidence and mortality in France in 1975-95. Eur J Cancer Prev. 1997 Oct;6(5):442-66.

ReferenceCitation: Coleman MP. Trends in breast cancer incidence, survival, and mortality. Lancet. 2000 Aug 12;356(9229):590-1; author reply 593. Erratum in: Lancet 2000 Aug 26;356(9231):774.

ReferenceCitation: Breast International Group (BIG) 1-98 Collaborative Group, Thürlimann B, Keshaviah A, Coates AS, Mouridsen H, Mauriac L, Forbes JF, Paridaens R, Castiglione-Gertsch M, Gelber RD, Rabaglio M, Smith I, Wardley A, Price KN, Goldhirsch A. A comparison of letrozole and tamoxifen in postmenopausal women with early breast cancer. N Engl J Med. 2005 Dec 29;353(26):2747-57. Erratum in: N Engl J Med. 2006 May 18;354(20):2200. Wardly, Andrew [corrected to Wardley, Andrew ].

ReferenceCitation: Finck G, Barton DL, Loprinzi CL, Quella SK, Sloan JA. Definitions of hot flashes in breast cancer survivors. J Pain Symptom Manage. 1998 Nov;16(5):327-33.

ReferenceCitation: Stearns V, Ullmer L, López JF, Smith Y, Isaacs C, Hayes D. Hot flushes. Lancet. 2002 Dec 7;360(9348):1851-61. Review.

ReferenceCitation: Couzi RJ, Helzlsouer KJ, Fetting JH. Prevalence of menopausal symptoms among women with a history of breast cancer and attitudes toward estrogen replacement therapy. J Clin Oncol. 1995 Nov;13(11):2737-44.

ReferenceCitation: Fellowes D, Fallowfield LJ, Saunders CM, Houghton J. Tolerability of hormone therapies for breast cancer: how informative are documented symptom profiles in medical notes for 'well-tolerated' treatments? Breast Cancer Res Treat. 2001 Mar;66(1):73-81.

ReferenceCitation: Lower EE, Blau R, Gazder P, Tummala R. The risk of premature menopause induced by chemotherapy for early breast cancer. J Womens Health Gend Based Med. 1999 Sep;8(7):949-54.

ReferenceCitation: McPhail G, Smith LN. Acute menopause symptoms during adjuvant systemic treatment for breast cancer: a case-control study. Cancer Nurs. 2000 Dec;23(6):430-43.

ReferenceCitation: Loprinzi CL, Zahasky KM, Sloan JA, Novotny PJ, Quella SK. Tamoxifen-induced hot flashes. Clin Breast Cancer. 2000 Apr;1(1):52-6.

ReferenceCitation: Love RR, Cameron L, Connell BL, Leventhal H. Symptoms associated with tamoxifen treatment in postmenopausal women. Arch Intern Med. 1991 Sep;151(9):1842-7.

ReferenceCitation: Linde K, Clausius N, Ramirez G, Melchart D, Eitel F, Hedges LV, Jonas WB. Are the clinical effects of homeopathy placebo effects? A meta-analysis of placebo-controlled trials. Lancet. 1997 Sep 20;350(9081):834-43. Erratum in: Lancet 1998 Jan 17;351(9097):220.

ReferenceCitation: Jonas WB, Kaptchuk TJ, Linde K. A critical overview of homeopathy. Ann Intern Med. 2003 Mar 4;138(5):393-9. Review.

ReferenceCitation: Cucherat M, Haugh MC, Gooch M, Boissel JP. Evidence of clinical efficacy of homeopathy. A meta-analysis of clinical trials. HMRAG. Homeopathic Medicines Research Advisory Group. Eur J Clin Pharmacol. 2000 Apr;56(1):27-33.

ReferenceCitation: Jonas WB. Researching alternative medicine. Nat Med. 1997 Aug;3(8):824-7.

ReferenceCitation: Guyatt GH, Sackett DL, Cook DJ. Users' guides to the medical literature. II. How to use an article about therapy or prevention. A. Are the results of the study valid? Evidence-Based Medicine Working Group. JAMA. 1993 Dec 1;270(21):2598-601.

ReferenceCitation: Grol R, Grimshaw J. Evidence-based implementation of evidence-based medicine. Jt Comm J Qual Improv. 1999 Oct;25(10):503-13.

ReferenceCitation: Barnes J, Ernst E. Complementary medicine. Br J Gen Pract. 1997 May;47(418):329.

ReferenceCitation: Clover A, Ratsey D. Homeopathic treatment of hot flushes: a pilot study. Homeopathy. 2002 Apr;91(2):75-9.

ReferenceCitation: Thompson EA, Reilly D. The homeopathic approach to the treatment of symptoms of oestrogen withdrawal in breast cancer patients. A prospective observational study. Homeopathy. 2003 Jul;92(3):131-4.

ReferenceCitation: Thompson EA, Montgomery A, Douglas D, Reilly D. A pilot, randomized, double-blinded, placebo-controlled trial of individualized homeopathy for symptoms of estrogen withdrawal in breast-cancer survivors. J Altern Complement Med. 2005 Feb;11(1):13-20.

ReferenceCitation: Relton C, Weatherley-Jones E. Homeopathy service in a National Health Service community menopause clinic: audit of clinical outcomes. J Br Menopause Soc. 2005 Jun;11(2):72-3.

ReferenceCitation: Bordet MF, Colas A, Marijnen P, Masson J, Trichard M. Treating hot flushes in menopausal women with homeopathic treatment--results of an observational study. Homeopathy. 2008 Jan;97(1):10-5. doi: 10.1016/j.homp.2007.11.005.

ReferenceCitation: Sloan JA, Loprinzi CL, Novotny PJ, Barton DL, Lavasseur BI, Windschitl H. Methodologic lessons learned from hot flash studies. J Clin Oncol. 2001 Dec 1;19(23):4280-90.

ReferenceCitation: Heudel PE, Van Praagh-Doreau I, Duvert B, Cauvin I, Hardy-Bessard AC, Jacquin JP, Stefani L, Vincent L, Dramais D, Guastalla JP, Blanc E, Belleville A, Lavergne E, Pérol D. Does a homeopathic medicine reduce hot flushes induced by adjuvant endocrine therapy in localized breast cancer patients? A multicenter randomized placebo-controlled phase III trial. Support Care Cancer. 2019 May;27(5):1879-1889. doi: 10.1007/s00520-018-4449-x. Epub 2018 Sep 7.

location_facility: Institut de Cancérologie Lucien Neuwirth

summary: The purpose of this study is to evaluate the efficacy of a homeopathic treatment (BRN01) in reducing hot flash scores after 4 weeks of treatment.


title: Insulin Resistance in Multiple System Atrophy

acronym: IRAMS

summary: Multiple system atrophy (MSA) is a rare and fatal neurodegenerative disorder. The pathologic hallmark is the accumulation of aggregated alpha-synuclein in oligodendrocytes forming glial cytoplasmic inclusions. Some symptomatic treatments are available while disease-modification remains an unmet treatment need. Post-mortem findings suggest insulin resistance, i.e. reduced insulin signaling, in the brains of MSA patients. The aim of this study is to complete the target validation of insulin resistance for future treatment trials.

lead_sponsor: University Hospital, Bordeaux


title: Safety of Autologous Adipose Derived Stroma/Stem Cells to Treat Critical Leg Ischemia.

acronym: ACELLDREAM

summary: The main purpose of this study is to evaluate the safety and feasibility of regenerative therapy with expanded adipose derived stroma/stem cells sue, administered intramuscularly in patients with critical leg ischemia.

ReferenceCitation: Planat-Benard V, Silvestre JS, Cousin B, André M, Nibbelink M, Tamarat R, Clergue M, Manneville C, Saillan-Barreau C, Duriez M, Tedgui A, Levy B, Pénicaud L, Casteilla L. Plasticity of human adipose lineage cells toward endothelial cells: physiological and therapeutic perspectives. Circulation. 2004 Feb 10;109(5):656-63. Epub 2004 Jan 20.

location_facility: University Hospital of Toulouse, Rangueil


title: Cerebral Toxoplasmosis and AIDS in the French Departments of America (DFA). Diagnostic Contribution of a PCR Assay and Genetic Diversity of Toxoplasma Gondii.

acronym: TOXODFA

summary:
With a HIV incidence much higher in the DFA than in European French territory, this disease is a major public health problem in these areas, especially in French Guiana.

Cerebral toxoplasmosis is a priority among the opportunistic infections in AIDS patients from the DFA because of its frequency (French West Indies) and of its lethality (French Guiana).

The diagnosis of cerebral toxoplasmosis may be difficult because based only on presumptive clinical and radiological features. The response to specific antitoxoplasmic therapy confirms a posteriori the diagnosis.

In reference to the data collected by the Biological Resource Centre Toxoplasma, in particular in French Guiana, we think that T. gondii strains reactivating in AIDS patients from DFA are genetically different from those reactivating in AIDS patients from Europe, with an increased capacity for dissemination via peripheral blood in the first ones. This more frequent or more prolonged parasitemia could facilitate the diagnosis of cerebral toxoplasmosis by PCR test from peripheral blood samples in AIDS patients from the French departments of America.

ReferenceCitation: Ajzenberg D, Lamaury I, Demar M, Vautrin C, Cabié A, Simon S, Nicolas M, Desbois-Nogard N, Boukhari R, Riahi H, Dardé ML, Massip P, Dupon M, Preux PM, Labrunie A, Boncoeur MP. Performance Testing of PCR Assay in Blood Samples for the Diagnosis of Toxoplasmic Encephalitis in AIDS Patients from the French Departments of America and Genetic Diversity of Toxoplasma gondii: A Prospective and Multicentric Study. PLoS Negl Trop Dis. 2016 Jun 29;10(6):e0004790. doi: 10.1371/journal.pntd.0004790. eCollection 2016 Jun.

lead_sponsor: University Hospital, Limoges

location_facility: Service des Maladies Infectieuses - CHU de Pointe à Pitre

location_facility: Dermatologie et CISIH- CH Andrée Rosemon

location_facility: Services Maladies Infectieuses et Tropicales- CHU Fort-de-France

location_facility: Maladies Infectieuses et Tropicales - CH Andrée Rosemon


title: Diffusion-Weighted Magnetic Resonance Imaging Assessment of Liver Metastasis to Improve Surgical Planning

acronym: DREAM

summary: The DREAM study will assess the diagnostic accuracy of diffusion-weighted MRI in combination with other imaging modalities (multiparametric MRI and CT Scan) in determining the true status of disappearing liver metastasis (DLM) detected after conversion systemic therapy for unresectable or borderline resectable colorectal liver metastasis (CRLM).

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

location_country:
Austria
United States
France
Belgium
Japan

location_facility: Jichi Medical University Saitama Medical Center

location_facility: Osaka Medical Center for Cancer and Cardiovascular Diseases

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Niigata Prefectural Cancer Center Hospital

intervention_type: Procedure


title: Protocole Evaluant Chez Des Patients Porteurs de Cancers Colorectaux Metastatiques l'Interet Des Determinants Genotypiques Pour l'Optimisation de l'Efficacite et de la Tolerance de la Chimiotherapie Par Irinotecan et 5-fluorouracile

summary:
This study intends to optimize a fluorouracil/irinotecan chemotherapy regimen by the identification of individual thymidylate synthase (TS) and UDP-glucuronosyltransferase 1 (UGT1A1) polymorphisms before the first administration.

The results of this identification determine the chemotherapy type: high-dose irinotecan or not.

ReferenceCitation: Iyer L, Das S, Janisch L, Wen M, Ramírez J, Karrison T, Fleming GF, Vokes EE, Schilsky RL, Ratain MJ. UGT1A1*28 polymorphism as a determinant of irinotecan disposition and toxicity. Pharmacogenomics J. 2002;2(1):43-7.

lead_sponsor: Institut de Recherche Clinique sur les Cancers et le Sang

location_facility:
Department of Gastroenterology, CHLS
Department of Oncology, CHU
Department of Oncology, IPC
Department of Oncology - CHLS
Institut Claudius Regaud
Department of Oncology, ICL


type: Other Grant/Funding Number

title: Soluble Neprilysin, NT-proBNP, and Growth-Differentiation-Factor-15 as Biomarkers for Heart Failure in Dialysis Patients

acronym: SONGBIRD

summary:
Objectives: The aim of this study is to determine whether growth differentiation factor-15 (GDF15) and circulating neprilysin (cNEP) improve the diagnosis of congestive heart failure (HF) in patients on dialysis.

Background: Dialysis patients are at increased risk of HF. However, diagnostic utility of NT-proBNP as a biomarker is decreased in patients on dialysis. GDF15 and cNEP are biomarkers of distinct mechanisms that may contribute to HF pathophysiology in such cohorts.

Methods: We compare circulating concentrations of NT-proBNP, GDF15, and cNEP along with NEP activity in patients on chronic dialysis without and with HF, as diagnosed by clinical parameters and post-dialysis echocardiography. We use correlation, linear and logistic regression as well as receiver operating characteristic (ROC) analyses.

lead_sponsor: Hannover Medical School

location_country: Germany France

location_facility:
Inserm Umr S-942
Hannover Medical School

intervention_type: Diagnostic Test


title: Secondary Prevention of Atrial Fibrillation With an Alpha-Linolenic Enriched Diet : a Randomized Study

summary:
An alpha linolenic acid (ALA) rich diet in the Lyon Diet Heart Study reduced sudden cardiac deaths possibly by reducing cardiac arrhythmias and ventricular fibrillation (Lancet 1994).

Since then, there has been a growing interest in ALA, ω-3 fatty acid family precursor, as a cardioprotective nutrient. Much of the interest has focused on the potential antiarrhythmic effect of longer chain ω-3 fatty acids, DHA and EPA, derived from fish.

We therefore concluded it important to test wether vegetable source ω-3 also had antiarrhythmic effects, as shown in animals by Leaf and McLennan, since this might also explain the beneficial effects seen on cardiovascular mortality in the Lyon Diet Heart Study.

primary_purpose: Prevention

ReferenceCitation: de Lorgeril M, Renaud S, Mamelle N, Salen P, Martin JL, Monjaud I, Guidollet J, Touboul P, Delaye J. Mediterranean alpha-linolenic acid-rich diet in secondary prevention of coronary heart disease. Lancet. 1994 Jun 11;343(8911):1454-9. Erratum in: Lancet 1995 Mar 18;345(8951):738.

ReferenceCitation: Renaud S, de Lorgeril M, Delaye J, Guidollet J, Jacquard F, Mamelle N, Martin JL, Monjaud I, Salen P, Toubol P. Cretan Mediterranean diet for prevention of coronary heart disease. Am J Clin Nutr. 1995 Jun;61(6 Suppl):1360S-1367S. doi: 10.1093/ajcn/61.6.1360S.

ReferenceCitation: Renaud S, Nordøy A. "Small is beautiful": alpha-linolenic acid and eicosapentaenoic acid in man. Lancet. 1983 May 21;1(8334):1169.

ReferenceCitation: Lanzmann-Petithory D, Pueyo S, Renaud S. Primary prevention of cardiovascular diseases by alpha-linolenic acid. Am J Clin Nutr. 2002 Dec;76(6):1456; author reply 1456-7. doi: 10.1093/ajcn/76.6.1456.

ReferenceCitation: Renaud SC, Lanzmann-Petithory D. alpha-linolenic acid in the prevention of cardiovascular diseases. World Rev Nutr Diet. 2001;88:79-85. Review.

ReferenceCitation: Renaud SC, Lanzmann-Petithory D. The beneficial effect of alpha-linolenic acid in coronary artery disease is not questionable. Am J Clin Nutr. 2002 Oct;76(4):903-4; author reply 904-6.

ReferenceCitation: Singh RB, Dubnov G, Niaz MA, Ghosh S, Singh R, Rastogi SS, Manor O, Pella D, Berry EM. Effect of an Indo-Mediterranean diet on progression of coronary artery disease in high risk patients (Indo-Mediterranean Diet Heart Study): a randomised single-blind trial. Lancet. 2002 Nov 9;360(9344):1455-61.

ReferenceCitation: Lanzmann-Petithory D. Alpha-linolenic acid and cardiovascular diseases. J Nutr Health Aging. 2001;5(3):179-83. Review.

ReferenceCitation: Kang JX, Leaf A. Protective effects of free polyunsaturated fatty acids on arrhythmias induced by lysophosphatidylcholine or palmitoylcarnitine in neonatal rat cardiac myocytes. Eur J Pharmacol. 1996 Feb 15;297(1-2):97-106.

ReferenceCitation: McLennan PL, Dallimore JA. Dietary canola oil modifies myocardial fatty acids and inhibits cardiac arrhythmias in rats. J Nutr. 1995 Apr;125(4):1003-9.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Hôpital du Haut-Lévêque
Girac Hospital
Robert Boulin Hospital


title: A Phase 2 Study of Aflibercept and Chemotherapy as First Line Treatment for Metastatic Colorectal Cancer Assessable With DCE-US.

acronym: PULSAR

summary: The PULSAR trial is an international, investigator-initiated, single arm open-label phase II study. The aim of this study is to measure the clinical activity of the combination FOLFIRI-aflibercept in an homogeneous group of patients with metastatic colorectal cancer, and treated with a FOLFIRI-aflibercept regimen as first line treatment.

lead_sponsor: Centre Oscar Lambret

location_facility:
Institut Bergonié
Centre Georges François Leclerc
Institut Paoli Calmettes
Hôpital Universitaire Paul Brousse
CHRU
Centre Oscar Lambret
Kremlin Bicetre
Gustave Roussy


title: AssocIation of PULSatility and Occurrence of Complications Related to Mechanically Assisted Circulatory Support

acronym: IMPULSMACS

summary: The primary objective of this study is to determine whether preserved pulsatility for patients supported by CF-LVAD (continuous flow Left Ventricular Assist Device) is associated with less acquired deficiency of the Von Willebrand factor, a blood glycoprotein involved in hemostasis.

location_facility: Groupement Hospitalier pitié Salpêtrière


title: Predictive Factors and Consequences of Myocardial Fibrosis in Hypertrophic Cardiomyopathy

acronym: HCM

summary: Fibrosis, myocardial deformation and biomarkers in hypertrophic cardiomyopathy (HCM)

lead_sponsor: Nantes University Hospital


title: Early Detection and Prediction of Cardiotoxicity in Radiotherapy-treated Breast Cancer Patients

acronym: BACCARAT

summary: Breast radiotherapy RT used until the 1990s was clearly responsible for increased mortality due to long term cardiac complications. Since the 2000s, improvements have appeared in dose distributions to organ at risks such as heart, but now, little is known on the risk of potential cardiac impairment in this population, in particular for chemotherapy naive patients. Based on the state that clinically detectable cardiotoxicity is generally preceded by subclinical cardiac dysfunctions, the aim of the BACCARAT study (BreAst Cancer and Cardiotoxicity induced by RAdioTherapy) is to evaluate whether adjuvant 3DCRT induces cardiac toxicity that could be detected in the first two years after treatment based on a global approach with repeated analysis of subclinical functional and anatomical cardiac lesions in myocardial and coronary levels and circulating biomarkers.

status: Unknown status

primary_purpose: Screening

ReferenceCitation: Walker V, Lairez O, Fondard O, Jimenez G, Camilleri J, Panh L, Broggio D, Bernier MO, Laurier D, Ferrières J, Jacob S. Myocardial deformation after radiotherapy: a layer-specific and territorial longitudinal strain analysis in a cohort of left-sided breast cancer patients (BACCARAT study). Radiat Oncol. 2020 Aug 20;15(1):201. doi: 10.1186/s13014-020-01635-y.

ReferenceCitation: Walker V, Lairez O, Fondard O, Pathak A, Pinel B, Chevelle C, Franck D, Jimenez G, Camilleri J, Panh L, Broggio D, Derreumaux S, Bernier MO, Laurier D, Ferrières J, Jacob S. Early detection of subclinical left ventricular dysfunction after breast cancer radiation therapy using speckle-tracking echocardiography: association between cardiac exposure and longitudinal strain reduction (BACCARAT study). Radiat Oncol. 2019 Nov 14;14(1):204. doi: 10.1186/s13014-019-1408-8.

ReferenceCitation: Jacob S, Camilleri J, Derreumaux S, Walker V, Lairez O, Lapeyre M, Bruguière E, Pathak A, Bernier MO, Laurier D, Ferrieres J, Gallocher O, Latorzeff I, Pinel B, Franck D, Chevelle C, Jimenez G, Broggio D. Is mean heart dose a relevant surrogate parameter of left ventricle and coronary arteries exposure during breast cancer radiotherapy: a dosimetric evaluation based on individually-determined radiation dose (BACCARAT study). Radiat Oncol. 2019 Feb 7;14(1):29. doi: 10.1186/s13014-019-1234-z.

ReferenceCitation: Jacob S, Pathak A, Franck D, Latorzeff I, Jimenez G, Fondard O, Lapeyre M, Colombier D, Bruguiere E, Lairez O, Fontenel B, Milliat F, Tamarat R, Broggio D, Derreumaux S, Ducassou M, Ferrières J, Laurier D, Benderitter M, Bernier MO. Early detection and prediction of cardiotoxicity after radiation therapy for breast cancer: the BACCARAT prospective cohort study. Radiat Oncol. 2016 Apr 7;11:54. doi: 10.1186/s13014-016-0627-5.

lead_sponsor: Sophie JACOB


title: Efficiency of rTMS in Bulimia: a Controlled Randomized Study

acronym: rTMS&bulimia

summary:
Bulimia nervosa is defined by recurrent episodes of binge eating followed by compensatory behaviors (such as induced vomiting) to prevent weight gain. It is a common and serious disease for which current treatment strategies have to be improved.

The aim of this study is to assess whether a transcranial magnetic stimulation reduces bulimic symptoms in a short term.

ReferenceCitation: Van den Eynde F, Guillaume S, Broadbent H, Campbell IC, Schmidt U. Repetitive transcranial magnetic stimulation in anorexia nervosa: a pilot study. Eur Psychiatry. 2013 Feb;28(2):98-101. doi: 10.1016/j.eurpsy.2011.06.002. Epub 2011 Aug 30.

ReferenceCitation: Van den Eynde F, Broadbent H, Guillaume S, Claudino A, Campbell IC, Schmidt U. Handedness, repetitive transcranial magnetic stimulation and bulimic disorders. Eur Psychiatry. 2012 May;27(4):290-3. doi: 10.1016/j.eurpsy.2010.08.015. Epub 2010 Nov 9.

ReferenceCitation: Guillaume S, Gay A, Jaussent I, Sigaud T, Billard S, Attal J, Seneque M, Galusca B, Thiebaut S, Massoubre C, Courtet P. Improving decision-making and cognitive impulse control in bulimia nervosa by rTMS: An ancillary randomized controlled study. Int J Eat Disord. 2018 Sep;51(9):1103-1106. doi: 10.1002/eat.22942. Epub 2018 Sep 21.

lead_sponsor: University Hospital, Montpellier


title: Impact du Vieillissement (VI) Sur le Compartiment Circulant et Sur la Mobilisation (MO) Des progéniteurs endothéliaux (PE) Par ischémie Locale (IL) : étude Pilote

acronym: VIMOPEIL

summary: This part of the project aims to describe changes in markers of vascular competence (Endothelial Microparticles Platelet (EMP), Circulating endothelial cells (CEC) and Circulating endothelial progenitors (EPC)) at different ages of lifespan both in physiological state and in response to hypoxia-induced vascular stress.

ReferenceCitation: HoWangYin KY, Loinard C, Bakker W, Guérin CL, Vilar J, d'Audigier C, Mauge L, Bruneval P, Emmerich J, Lévy BI, Pouysségur J, Smadja DM, Silvestre JS. HIF-prolyl hydroxylase 2 inhibition enhances the efficiency of mesenchymal stem cell-based therapies for the treatment of critical limb ischemia. Stem Cells. 2014 Jan;32(1):231-43. doi: 10.1002/stem.1540. Erratum in: Stem Cells. 2014 Apr;32(4):1055-7. D'Audigier, Clément [corrected to d'Audigier, Clément].

ReferenceCitation: Evrard SM, d'Audigier C, Mauge L, Israël-Biet D, Guerin CL, Bieche I, Kovacic JC, Fischer AM, Gaussem P, Smadja DM. The profibrotic cytokine transforming growth factor-β1 increases endothelial progenitor cell angiogenic properties. J Thromb Haemost. 2012 Apr;10(4):670-9. doi: 10.1111/j.1538-7836.2012.04644.x.


title: Chronic Micro-inflammation and Bone and Muscular Status in Elderly

acronym: Compalimage

summary: This project aims to assess the impact of chronic micro-inflammation on age-related loss of muscle (sarcopenia) and bone (osteopenia). The hypothesis is that chronic micro-inflammation and oxidative stress, which prevalence increases during ageing, may participate in the pathogenesis of both sarcopenia and osteopenia.

lead_sponsor: University Hospital, Clermont-Ferrand


title: A French, Multicenter, Prospective, Observational, "Real Life" Assessment of the Safety and Efficacy of the Low Profile Visualized Intraluminal Support (LVIS and LVIS JR) Devices in the Treatment of Intracranial Aneurysms

summary: A French, multicenter, prospective, observational, "real life" assessment of the safety and efficacy of LVIS and LVIS JR devices in the treatment of intracranial aneurysms

lead_sponsor: Microvention-Terumo, Inc.

location_facility: Hôpital d'instruction des Armées Saint-Anne


title: A Phase II Study Evaluating the Non-inferiority and Better Tolerability of the Device PHOS-ISTOS Compared to the Conventional Photodynamic Therapy (PDT)

acronym: PHOS-ISTOS

summary: This study aims to compare the efficacy and tolerance of a new photodynamic therapy device (PHOS-ISTOS) with the conventional PDT device (Aktilite®) for the treatment of actinic keratosis of the scalp

ReferenceCitation: Vignion-Dewalle AS, Abi Rached H, Thecua E, Lecomte F, Deleporte P, Béhal H, Hommel T, Duhamel A, Szeimies RM, Mortier L, Mordon S. A New Light-Emitting, Fabric-Based Device for Photodynamic Therapy of Actinic Keratosis: Protocol for a Randomized, Controlled, Multicenter, Intra-Individual, Phase II Noninferiority Study (the Phosistos Study). JMIR Res Protoc. 2019 Apr 26;8(4):e12990. doi: 10.2196/12990.

lead_sponsor: University Hospital, Lille

location_facility:
Klinikum Vest Gmbh
CHRU, Hôpital Claude Huriez


title: Evaluation of Intermittent Pneumatic Compression Associated With Elastic Stockings and Anticoagulant Prophylaxis Versus Anticoagulant Prophylaxis Alone on Venous Thromboembolism Incidence in ICU Patients Without High Risk of Bleeding

summary: This multicentre open-label randomized parallel-group trial aims to compare the association of intermittent pneumatic compression of the lower limbs + elastic stockings + anticoagulant prophylaxis to anticoagulant prophylaxis alone on the incidence of venous thromboembolism systematically evaluated at day 6, in patients hospitalized in intensive care units and without high bleeding risk.

lead_sponsor: University Hospital, Brest

location_country: France Monaco

location_facility:
CH de St Malo
CH de Corbeil Essonne
CHU d'Angers
CH de Morlaix
CHU de Poitiers
CH d'Angoulême
HIA Clermont-Tonnerre
CHU de Dijon
CH Montauban
CH de Quimper
CHU de Tours
CH Monaco
Medical Intensive Care Unit


title: Evaluation of Intermittent Pneumatic Compression (IPC) of the Lower Limbs Associated With Elastic Stockings (ES) Compared to ES Alone on Venous Thromboembolism Incidence in Patients With High Bleeding Risk Hospitalized in Intensive Medical Care Units

summary: This multicentre open-label randomized parallel-group trial aims to evaluate the association intermittent pneumatic compression + elastick stockings versus elasting stockings alone on symptomatic or asymptomatic venous thromboembolism incidence, evaluated systematically at day 6 (+/-2days), in patients hospitalized in intensive care units and with high bleeding risk.

location_facility:
Intensive Care Unit
HIA Clermont-Tonnerre
Medical Intensive Care Unit
Medical intensive care unit


title: Interest of Continuous Non-Steroidal Anti-Inflammatory Drug Treatment in Ankylosing Spondylitis Patients Treated by Anti-TNF Therapy in the Prevention of Radiographic Outcomes

acronym: STOP

summary:
Ankylosing spondylitis (AS) is a frequent chronic inflammatory rheumatic disease that affects the axial skeleton, starting in the sacroiliac joints and spreading to the spine in most patients. Non-steroidal anti-inflammatory drugs (NSAIDs) are the primary treatment for AS. Even if the use of anti-TNF agents has demonstrated good clinical efficacy in controlling inflammation, in contrast to other conditions such as rheumatoid arthritis and psoriatic arthritis, anti-TNF treatment has failed to demonstrate any benefit on the structural progression of AS, some data even suggesting that it may accelerate the formation of syndesmophytes that seems to be an independent process of TNF. Conversely, NSAIDs inhibit ossification phenomena independently of their anti-inflammatory properties, owing to a specific action on bone formation via prostaglandin inhibition.

Several features suggest that a continuous NSAID therapy is needed, in addition to anti-TNF treatment, to prevent syndesmophyte formation in AS patients.

location_facility: service de rhumatologie - AP-HP - Hôpital Henri Mondor

location_facility: service de rhumatologie - CHU de Saint-Etienne

location_facility: service de rhumatologie - CHU de Toulouse

location_facility: service de rhumatologie - CHU de Strasbourg

location_facility: Service de rhumatologie - CHU de Besançon

location_facility: service de Rhumatologie - CH Princesse Grace

location_facility: Service de Rhumatologie - CHU de Bordeaux

location_facility: service de rhumatologie - CHU de Montpellier

location_facility: Service de rhumatologie - AP-HP - Hôpital Lariboisière

location_facility: service de rhumatologie - AP-HP- Hôpital La Pitié Salpétrière

location_facility: service de rhumatologie - AP-HP - Hôpital Ambroise Paré

location_facility: service de rhumatologie - CHU de Limoges


title: Safety and Efficacy of Ibritumomab Tiuxetan (Zevalin®) in Association With a Fludarabine Based Reduced Conditioning Regimen and Allogenic Stem Cell Support in Chemo-sensitive Relapsed CD20 Positive Aggressive Non-Hodgkin's Lymphoma Patients.

acronym: ZEVALLO

summary: The purpose of this study is to evaluate the safety and efficacy of Zevalin® in a Reduced Intensity Conditioning regimen followed by allogenic stem cell support in patients with aggressive lymphomas who are responsive to a salvage chemotherapy regimen.

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ReferenceCitation: Gopal AK, Pagel JM, Rajendran JG, Maloney DG, Appelbaum FR, Sorror ML, Sandmaier BM, Storb R, Press OW. Improving the efficacy of reduced intensity allogeneic transplantation for lymphoma using radioimmunotherapy. Biol Blood Marrow Transplant. 2006 Jul;12(7):697-702. Review.

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ReferenceCitation: Khouri IF, Keating M, Körbling M, Przepiorka D, Anderlini P, O'Brien S, Giralt S, Ippoliti C, von Wolff B, Gajewski J, Donato M, Claxton D, Ueno N, Andersson B, Gee A, Champlin R. Transplant-lite: induction of graft-versus-malignancy using fludarabine-based nonablative chemotherapy and allogeneic blood progenitor-cell transplantation as treatment for lymphoid malignancies. J Clin Oncol. 1998 Aug;16(8):2817-24.

ReferenceCitation: Khouri IF, Lee MS, Romaguera J, Mirza N, Kantarjian H, Korbling M, Albitar M, Giralt S, Samuels B, Anderlini P, Rodriguez J, von Wolff B, Gajewski J, Cabanillas F, Champlin R. Allogeneic hematopoietic transplantation for mantle-cell lymphoma: molecular remissions and evidence of graft-versus-malignancy. Ann Oncol. 1999 Nov;10(11):1293-9.

ReferenceCitation: Khouri IF, Lee MS, Saliba RM, Jun G, Fayad L, Younes A, Pro B, Acholonu S, McLaughlin P, Katz RL, Champlin RE. Nonablative allogeneic stem-cell transplantation for advanced/recurrent mantle-cell lymphoma. J Clin Oncol. 2003 Dec 1;21(23):4407-12.

ReferenceCitation: Maris MB, Sandmaier BM, Storer BE, Chauncey T, Stuart MJ, Maziarz RT, Agura E, Langston AA, Pulsipher M, Storb R, Maloney DG. Allogeneic hematopoietic cell transplantation after fludarabine and 2 Gy total body irradiation for relapsed and refractory mantle cell lymphoma. Blood. 2004 Dec 1;104(12):3535-42. Epub 2004 Aug 10.

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ReferenceCitation: Morris E, Thomson K, Craddock C, Mahendra P, Milligan D, Cook G, Smith GM, Parker A, Schey S, Chopra R, Hatton C, Tighe J, Hunter A, Peggs K, Linch D, Goldstone A, Mackinnon S. Outcomes after alemtuzumab-containing reduced-intensity allogeneic transplantation regimen for relapsed and refractory non-Hodgkin lymphoma. Blood. 2004 Dec 15;104(13):3865-71. Epub 2004 Aug 10.

ReferenceCitation: Nademanee A, Forman SJ. Role of hematopoietic stem cell transplantation for advanced-stage diffuse large cell B-cell lymphoma-B. Semin Hematol. 2006 Oct;43(4):240-50. Review.

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ReferenceCitation: Ratanatharathorn V, Uberti J, Karanes C, Abella E, Lum LG, Momin F, Cummings G, Sensenbrenner LL. Prospective comparative trial of autologous versus allogeneic bone marrow transplantation in patients with non-Hodgkin's lymphoma. Blood. 1994 Aug 15;84(4):1050-5.

ReferenceCitation: Reyes F, Lepage E, Ganem G, Molina TJ, Brice P, Coiffier B, Morel P, Ferme C, Bosly A, Lederlin P, Laurent G, Tilly H; Groupe d'Etude des Lymphomes de l'Adulte (GELA). ACVBP versus CHOP plus radiotherapy for localized aggressive lymphoma. N Engl J Med. 2005 Mar 24;352(12):1197-205.

ReferenceCitation: Rodriguez R, Nademanee A, Ruel N, Smith E, Krishnan A, Popplewell L, Zain J, Patane K, Kogut N, Nakamura R, Sarkodee-Adoo C, Forman SJ. Comparison of reduced-intensity and conventional myeloablative regimens for allogeneic transplantation in non-Hodgkin's lymphoma. Biol Blood Marrow Transplant. 2006 Dec;12(12):1326-34.

ReferenceCitation: Schimmer AD, Jamal S, Messner H, Keating A, Meharchand J, Huebsch L, Walker I, Benger A, Gluck S, Smith A. Allogeneic or autologous bone marrow transplantation (BMT) for non-Hodgkin's lymphoma (NHL): results of a provincial strategy. Ontario BMT Network, Canada. Bone Marrow Transplant. 2000 Oct;26(8):859-64.

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ReferenceCitation: Slavin S, Nagler A, Naparstek E, Kapelushnik Y, Aker M, Cividalli G, Varadi G, Kirschbaum M, Ackerstein A, Samuel S, Amar A, Brautbar C, Ben-Tal O, Eldor A, Or R. Nonmyeloablative stem cell transplantation and cell therapy as an alternative to conventional bone marrow transplantation with lethal cytoreduction for the treatment of malignant and nonmalignant hematologic diseases. Blood. 1998 Feb 1;91(3):756-63.

ReferenceCitation: Vandenberghe E, Ruiz de Elvira C, Loberiza FR, Conde E, López-Guillermo A, Gisselbrecht C, Guilhot F, Vose JM, van Biesen K, Rizzo JD, Weisenburger DD, Isaacson P, Horowitz MM, Goldstone AH, Lazarus HM, Schmitz N. Outcome of autologous transplantation for mantle cell lymphoma: a study by the European Blood and Bone Marrow Transplant and Autologous Blood and Marrow Transplant Registries. Br J Haematol. 2003 Mar;120(5):793-800.

ReferenceCitation: Winter JN. Combining yttrium 90-labeled ibritumomab tiuxetan with high-dose chemotherapy and stem cell support in patients with relapsed non-Hodgkin's lymphoma. Clin Lymphoma. 2004 Oct;5 Suppl 1:S22-6. Review.

ReferenceCitation: Bouabdallah K, Furst S, Asselineau J, Chevalier P, Tournilhac O, Ceballos P, Vigouroux S, Tabrizi R, Doussau A, Bouabdallah R, Mohty M, Le Gouill S, Blaise D, Milpied N. 90Y-ibritumomab tiuxetan, fludarabine, busulfan and antithymocyte globulin reduced-intensity allogeneic transplant conditioning for patients with advanced and high-risk B-cell lymphomas. Ann Oncol. 2015 Jan;26(1):193-198. doi: 10.1093/annonc/mdu503. Epub 2014 Oct 30.

location_facility: Service d'hématologie clinique - Hôpital l'Archet 1

location_facility: Service d'Oncologie Hématologie, Institut Paoli Calmettes - 232 Bd Ste Marguerite

location_facility: Pôle hématologie et immunologie clinique - Hôpital Saint-Louis

location_facility: Service de médecine nucléaire - Centre de Lutte contre le Cancer de la Région Auvergne Jean Perrin

location_facility: Service d'hématologie - CHU Hôtel Dieu Clermont-Ferrand

location_facility: Service des maladies du sang - Hôpital Haut-Lévêque - avenue de magellan

location_facility: Service d'Hématologie Adultes - Hôpital Necker-Enfants Malade

location_facility: Département d'hématologie et d'Oncologie - CHRU Hautepierre

location_facility: Service d'Hématologie, Hôpital Hôtel Dieu, CHU Nantes - 1 Place Alexis Ricordeau

location_facility: Hématologie et Oncologie médicale - CHU Lapeyronie


acronym: DOSINDYGO

title: A Multi-center Phase II Study With Light Dose Escalation During Intraoperative Photodynamic Therapy of Glioblastoma

location_facility: Hôpital Erasme, Clinique Universitaire de Bruxelles

summary: The phase II study evaluate a light dose escalation in a classical intraoperative PDT regimen mediated by 5-ALA-PpIX, in glioblastoma patients with access to full surgical removal of the contrast enhancement. This treatment will be performed in addition to the current reference treatment of glioblastoma: maximum removal surgery followed by radiochemotherapy according to the Stupp protocol.