title: Immunotherapy in MSI/dMMR Tumors in Perioperative Setting.

acronym: IMHOTEP

summary:
This trial is a multicenter, 4-cohort, prospective, Phase II trial conducted in patients with untreated resectable MSI/dMMR carcinomas or EBV+ gastric cancer and aiming to evaluate the safety and the efficacy of ICI (immune checkpoint inhibitor) as neoadjuvant treatment in these patients.

We hypothesize that immune checkpoint inhibitors (ICPi) will benefit to MSI/dMMR tumors from the early stages, whatever their anatomical origin. We assume that this neoadjuvant treatment would improve the response rate, providing even high rate of pathological complete responses and prolong patients survival.

We anticipated endometrial, colorectal and gastric cancers to be the most frequent recruited and constructed our statistical hypothesis with results in those 3 cancers. However patients with other localized MSI/dMMR tumors could be included.

lead_sponsor: Centre Leon Berard

location_facility: Institut de cancérologie Strasbourg Europe

location_facility: Groupe Hospitalier Diaconesses Croix Saint-Simon


study_start_date_type: Actual

acronym: SCLERITA

intervention_type: Drug

lead_sponsor: Assistance Publique - Hôpitaux de Paris

summary: The purpose of this study is to determine whether itacitinib is safe and effective in the treatment of systemic sclerosis in adults.

ReferenceType: background

ReferenceCitation: Almeida C, Almeida I, Vasconcelos C. Quality of life in systemic sclerosis. Autoimmun Rev. 2015 Dec;14(12):1087-96. doi: 10.1016/j.autrev.2015.07.012. Epub 2015 Jul 23.

ReferenceCitation: Mouthon L. SSc in 2011: From mechanisms to medicines. Nat Rev Rheumatol. 2012 Jan 10;8(2):72-4. doi: 10.1038/nrrheum.2011.203.

ReferenceCitation: Distler JH, Feghali-Bostwick C, Soare A, Asano Y, Distler O, Abraham DJ. Review: Frontiers of Antifibrotic Therapy in Systemic Sclerosis. Arthritis Rheumatol. 2017 Feb;69(2):257-267. doi: 10.1002/art.39865. No abstract available.

ReferenceCitation: Wang Y, Fan PS, Kahaleh B. Association between enhanced type I collagen expression and epigenetic repression of the FLI1 gene in scleroderma fibroblasts. Arthritis Rheum. 2006 Jul;54(7):2271-9. doi: 10.1002/art.21948.

ReferenceCitation: Landi C, Bargagli E, Bianchi L, Gagliardi A, Carleo A, Bennett D, Perari MG, Armini A, Prasse A, Rottoli P, Bini L. Towards a functional proteomics approach to the comprehension of idiopathic pulmonary fibrosis, sarcoidosis, systemic sclerosis and pulmonary Langerhans cell histiocytosis. J Proteomics. 2013 May 27;83:60-75. doi: 10.1016/j.jprot.2013.03.006. Epub 2013 Mar 23.

ReferenceCitation: Kubo M, Ihn H, Yamane K, Tamaki K. Up-regulated expression of transforming growth factor beta receptors in dermal fibroblasts in skin sections from patients with localized scleroderma. Arthritis Rheum. 2001 Mar;44(3):731-4. doi: 10.1002/1529-0131(200103)44:33.0.CO;2-U. No abstract available.

ReferenceCitation: Zhang Y, Liang R, Chen CW, Mallano T, Dees C, Distler A, Reich A, Bergmann C, Ramming A, Gelse K, Mielenz D, Distler O, Schett G, Distler JHW. JAK1-dependent transphosphorylation of JAK2 limits the antifibrotic effects of selective JAK2 inhibitors on long-term treatment. Ann Rheum Dis. 2017 Aug;76(8):1467-1475. doi: 10.1136/annrheumdis-2016-210911. Epub 2017 May 6.

ReferenceCitation: Migita K, Izumi Y, Torigoshi T, Satomura K, Izumi M, Nishino Y, Jiuchi Y, Nakamura M, Kozuru H, Nonaka F, Eguchi K, Kawakami A, Motokawa S. Inhibition of Janus kinase/signal transducer and activator of transcription (JAK/STAT) signalling pathway in rheumatoid synovial fibroblasts using small molecule compounds. Clin Exp Immunol. 2013 Dec;174(3):356-63. doi: 10.1111/cei.12190.

ReferenceCitation: Xu Y, Wang W, Tian Y, Liu J, Yang R. Polymorphisms in STAT4 and IRF5 increase the risk of systemic sclerosis: a meta-analysis. Int J Dermatol. 2016 Apr;55(4):408-16. doi: 10.1111/ijd.12839. Epub 2015 Dec 29.

ReferenceCitation: Avouac J, Furnrohr BG, Tomcik M, Palumbo K, Zerr P, Horn A, Dees C, Akhmetshina A, Beyer C, Distler O, Schett G, Allanore Y, Distler JH. Inactivation of the transcription factor STAT-4 prevents inflammation-driven fibrosis in animal models of systemic sclerosis. Arthritis Rheum. 2011 Mar;63(3):800-9. doi: 10.1002/art.30171.

ReferenceCitation: Kremer JM, Bloom BJ, Breedveld FC, Coombs JH, Fletcher MP, Gruben D, Krishnaswami S, Burgos-Vargas R, Wilkinson B, Zerbini CA, Zwillich SH. The safety and efficacy of a JAK inhibitor in patients with active rheumatoid arthritis: Results of a double-blind, placebo-controlled phase IIa trial of three dosage levels of CP-690,550 versus placebo. Arthritis Rheum. 2009 Jul;60(7):1895-905. doi: 10.1002/art.24567. Erratum In: Arthritis Rheum. 2012 May;64(5):1487.

ReferenceCitation: Fridman JS, Scherle PA, Collins R, Burn T, Neilan CL, Hertel D, Contel N, Haley P, Thomas B, Shi J, Collier P, Rodgers JD, Shepard S, Metcalf B, Hollis G, Newton RC, Yeleswaram S, Friedman SM, Vaddi K. Preclinical evaluation of local JAK1 and JAK2 inhibition in cutaneous inflammation. J Invest Dermatol. 2011 Sep;131(9):1838-44. doi: 10.1038/jid.2011.140. Epub 2011 Jun 16.

ReferenceCitation: Deverapalli SC, Rosmarin D. The use of JAK inhibitors in the treatment of progressive systemic sclerosis. J Eur Acad Dermatol Venereol. 2018 Aug;32(8):e328. doi: 10.1111/jdv.14876. Epub 2018 Mar 6. No abstract available.

ReferenceCitation: Gordon JK, Martyanov V, Franks JM, Bernstein EJ, Szymonifka J, Magro C, Wildman HF, Wood TA, Whitfield ML, Spiera RF. Belimumab for the Treatment of Early Diffuse Systemic Sclerosis: Results of a Randomized, Double-Blind, Placebo-Controlled, Pilot Trial. Arthritis Rheumatol. 2018 Feb;70(2):308-316. doi: 10.1002/art.40358. Epub 2017 Dec 29.

location_facility:
Hospital Pasteur - CHU Nice
Avicenne Hospital
CHU Annecy
Hospital Croix St Simon
Robert Debré Hospital
CHU Limoges
CHU Tours
Hôpital Sud
CH Amiens
CHU Dijon
CHU Rouen
CH Valenciennes
CHU Nancy
CHU Angers
CHU Nantes
La Timone Hospital
CHU Montpellier - St Eloi Hospital
CHU Gabriel Montpied
Saint Antoine Hospital
Hôpital Nord
CHU Lyon sud
Cochin Hospital
CHU Caen
Nouvel Hospital Civil
Rangueil Hospital
CHU Montpellier - rhumatology
CHU Grenoble
Henry Mondor hospital
CHU Poitiers
CHU Bordeaux
CHU Lille
Ambroise Paré hospital

status: Recruiting

title: Safety and Efficacy of Itacitinib in Adults With Systemic Sclerosis: a Phase II, Randomized, Controlled Trial

primary_purpose: Treatment

type: EudraCT Number

source: euctr

enrollment_type: Anticipated

design_allocation: Randomized

study_completion_date_type: Anticipated

study_type: Interventional

lead_sponsor_type: academique

status_simplified: Ongoing

appel_a_projets: PHRCN

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: SCLERITA

titre: Tolérance et efficacité de l'itacitinib dans la sclérodermie systémique : une étude de phase II, randomisée, controlée

discipline_principale: internal medicine

nom_porteur: CHAIGNE

prenom_porteur: Benjamin


title: Observational Study of Patients Treated With Hot AXIOS® Prosthesis in Real Life Conditions -

acronym: REALAXIOS

summary:
Regulatory Context The CNEDiMTS makes the renewal of registration conditional on the transmission of the results of a well-conducted prospective study, carried out with Hot AXIOS, the objective of which is to evaluate the interest of this device in real conditions of use with regard to effectiveness and complications after a minimum follow-up of 3 months.

Operators are trained in the use of the equipment (practice on ex-vivo model and/or prior stent placement) and undertake to comply with the rules and formalities of use.

Primary efficacy objective :

To evaluate the efficacy of endoscopic trans digestive drainage after use of the Hot AXIOS prosthesis in the treatment of pancreatic collections (incompletely fluid or necrotic) at 3 months.

Secondary Objectives :

Assessment of the following elements :

Morbidity (complication rates) and mortality per- and post-procedure
Recurrence rate of pancreatic collection
Evolution of the quality of life questionnaire (SQ5D5L)
Technical success rate of prosthesis placement and removal success rate of the prosthesis
Search for factors predictive of clinical success of endoscopic pancreatic drainage with the Hot Axios prosthesis.

Study design Non-interventional/observational (RIPH 3 type), multi-center, prospective study with consecutive inclusions evaluating the Hot AXIOS® prosthetic device.

Non-inclusion registry A minimum amount of information will be collected anonymously, including sex, age, indication of drainage and reason for non-inclusion (e.g. refusal of the patient, of the investigator for impossibility of following the patient in the centre or other reasons to be specified). Generic information will be affixed in each centre participating in the study indicating: "In application of the provisions of the Data Protection Act, general information on the possibility that personal data may be used for research purposes must be provided in any establishment or centre where prevention, diagnosis and care activities are carried out". This must be exhaustive and rigorously maintained.

Equipment used in endoscopy Hot AXIOS™ - self-expanding metal prosthesis with a lumen diameter of 6 to 20 mm and collar length of 8 and 10 mm or any future similar device marketed under the same name at the time of the study.

Technique Insertion of the material under echo-endoscopic control -- possible but not systematic dilatation -- guide wire with hydrophilic tip - Puncture and release under echo-endoscopic control according to the centre's usual practice.

Registration The data will be collected anonymously in an electronic computer database using eCRFs.

Statistical analysis The evaluation of the clinical success of endoscopic pancreatic necrosectomy with metallic prosthesis will first consist in describing its efficacy according to the criteria described above.

Analysis plan :

The statistical analysis will first include a description of the study population with the number of patients falling under the indication and treated with the Hot AXIOS system at the recruiting centers (source population), the number of eligible patients who consented to participate in the study, the number of patients included (study population), the number of subjects who made each visit and were analyzed, premature exits (deaths, lost to follow-up) will be reported and described in the form of a flow chart.

study_type: Observational

time_perspective: Prospective

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
Limoges hospital
Nice Hospital
Clermont-ferrand hospital
Polyclinique Saint Côme
European Hospital
Saint Etienne Hospital
Clinique Jean Mermoz
Hôpital privé des peupliers
Centre Hospitalier Jacques Lacarin
Lille Hospital
Avignon Hospital
Nancy Hospital
brest Hospital
St Joseph Hospital
APHM
APHP saint antoine
Poitiers Hospital

intervention_type: Procedure


title: A Prospective Non-interventional Study Documenting the Management and Outcomes of Adult Patients With Acute Myeloid Leukemia (AML)

acronym: ALFAPPP

summary: During the last fifteen years, the landscape of AML diagnosis and therapeutical options has markedly evolved. Refined genetic and prognostic characterizations, together with new drug approvals and new allogeneic hematopoietic stem cell transplantation (HSCT) procedures, have increased patient journey diversity.

lead_sponsor: Acute Leukemia French Association

location_facility: Centre Hospitalier de Versailles André Mignot

location_facility: Centre Hopsitalier de l'Est Francilien - Site de Meaux

lead_sponsor_type: industriel


title: Assessing the Safety and Benefit of Home-hospitalization Program in the Management of Natalizumab (Tysabri®) Medication in Multiple Sclerosis

acronym: Tys at Home

summary:
At-home use of Natalizumab in multiple sclerosis (MS) patients has been temporarily granted by French security agency of medicines and Health products (ANSM). The main objective of the study is to compare the safety of natalizumab administration at home vs at hospital based on retrospective and prospective data collection. Quality of life, patient perception of at-home natalizumab administration are also evaluated as secondary objectives as well as medico-economic assessment of the method.

Data will be collected for a 12-month retrospective period and a 12-month prospective period.

lead_sponsor: Nantes University Hospital

sponsor_collaborators:
Nantes University Hospital
Rennes University Hospital

location_facility: Adolphe de Rothschild Ophthalmological Foundation

intervention_type: Other


acronym: ATLAS

summary:
MaaT013 is still in clinical development phase and is not approved yet for marketing in any region. During the development program, MaaT Pharma has undertaken initial development with closely related product candidates, leading to the Phase II HERACLES study in which MaaT013 preliminary safety and efficacy were assessed in the context of steroid-resistant, gastrointestinal aGraft versus Host Disease (SR-GI-aGvHD). In addition, a pivotal Phase III study (ARES trial) is planned.

In the absence of medical options in patients with gastrointestinal acute GvHD refractory to multiple lines of treatment, this early access program has been implemented.

status: Available

study_type: Expanded Access

lead_sponsor: MaaT Pharma

location_facility:
Iuct - Oncopole
Chu Angers
Aphp - Hopital Sant Antoine
Crlcc Henri Becquerel
Chu Morvan
Chu de Caen
Institut de Cancerologie de Strabsourg
Institut Gustave Roussy
Chu Lyon Sud
Chu Montpellier - Hopital Saint Eloi
Chu Amiens Picardie Site Sud
Chu de Rennes - Hopital Pontchaillou
MaaT Pharma
Chu Rouen
Chu de Nice - L'Archet 1
Institut Paoli Calmettes
Chu Grenoble
Chu La Miletrie
Chu de Lille
Hopital Haut Leveque

status_simplified: Unknown


title: Observational Study of the Use of DBLG1 System in Real Life

summary:
This study will be conducted on human subjects and is observational, prospective and uncontrolled, defined as a category 3 according to the Jardé Law (RIPH3). It is a national and multicentric study. Enrolled patients are Type 1 Diabetes (T1D) patients who receive the DBLG1 System (CE marked medical device) to be treated. Patients have their regular visits with their own clinician. No change from their usual care must and will be done, including trainings and treatment. At the end of the study, patients will keep their system for their usual care and will continue having usual follow-up visits with their clinician.

Data related to their glycemia, complications and quality of life will be collected for 1 year from the beginning of their treatment. A comparison with data collected during the 2 weeks of run-in period, prior to the activation of loop mode, is planned. In case the run-in phase lasts longer than 2 weeks, data collected from the two last weeks only will be kept for analysis and comparison.

The study is completed when all patients have their "end of study" file completed in the electronic Case Report Form (eCRF).

status: Active, not recruiting

lead_sponsor: Diabeloop

location_facility: Groupe Hospitalier La Rochelle - Ré - Aunis

intervention_type: Device


lead_sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

summary:
Locally advanced rectal carcinoma raise the issue of both the oncological control, local and general, and the therapeutic morbidity. Surgery alone can cure only one out of two patients, radiochemotherapy improves the local control but the metastatic risk remains about 30% with enhanced postoperative morbidity and poor functional results. The tumor response to preoperative treatment is the major prognostic factor which revealed the aggressiveness of the tumor. To this day, there are no biologic predictive markers for tumor response.

The purpose of this trial is to tailor the management according to the early tumoral response after short and intensive induction chemotherapy. MRI volumetric tumor response will be used to distinguish between good responders and bad responders.

"Very good" responders will be randomized to either immediate surgery or radiochemotherapy followed by surgery (Standard arm: Cap 50).

ReferenceCitation: Sauer R, Liersch T, Merkel S, Fietkau R, Hohenberger W, Hess C, Becker H, Raab HR, Villanueva MT, Witzigmann H, Wittekind C, Beissbarth T, Rodel C. Preoperative versus postoperative chemoradiotherapy for locally advanced rectal cancer: results of the German CAO/ARO/AIO-94 randomized phase III trial after a median follow-up of 11 years. J Clin Oncol. 2012 Jun 1;30(16):1926-33. doi: 10.1200/JCO.2011.40.1836. Epub 2012 Apr 23.

ReferenceCitation: Rodel C, Graeven U, Fietkau R, Hohenberger W, Hothorn T, Arnold D, Hofheinz RD, Ghadimi M, Wolff HA, Lang-Welzenbach M, Raab HR, Wittekind C, Strobel P, Staib L, Wilhelm M, Grabenbauer GG, Hoffmanns H, Lindemann F, Schlenska-Lange A, Folprecht G, Sauer R, Liersch T; German Rectal Cancer Study Group. Oxaliplatin added to fluorouracil-based preoperative chemoradiotherapy and postoperative chemotherapy of locally advanced rectal cancer (the German CAO/ARO/AIO-04 study): final results of the multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2015 Aug;16(8):979-89. doi: 10.1016/S1470-2045(15)00159-X. Epub 2015 Jul 15.

ReferenceCitation: Martin ST, Heneghan HM, Winter DC. Systematic review and meta-analysis of outcomes following pathological complete response to neoadjuvant chemoradiotherapy for rectal cancer. Br J Surg. 2012 Jul;99(7):918-28. doi: 10.1002/bjs.8702. Epub 2012 Feb 23.

ReferenceCitation: Bregendahl S, Emmertsen KJ, Lous J, Laurberg S. Bowel dysfunction after low anterior resection with and without neoadjuvant therapy for rectal cancer: a population-based cross-sectional study. Colorectal Dis. 2013 Sep;15(9):1130-9. doi: 10.1111/codi.12244.

ReferenceCitation: Chen TY, Wiltink LM, Nout RA, Meershoek-Klein Kranenbarg E, Laurberg S, Marijnen CA, van de Velde CJ. Bowel function 14 years after preoperative short-course radiotherapy and total mesorectal excision for rectal cancer: report of a multicenter randomized trial. Clin Colorectal Cancer. 2015 Jun;14(2):106-14. doi: 10.1016/j.clcc.2014.12.007. Epub 2014 Dec 31.

ReferenceCitation: Schrag D, Weiser MR, Goodman KA, Gonen M, Hollywood E, Cercek A, Reidy-Lagunes DL, Gollub MJ, Shia J, Guillem JG, Temple LK, Paty PB, Saltz LB. Neoadjuvant chemotherapy without routine use of radiation therapy for patients with locally advanced rectal cancer: a pilot trial. J Clin Oncol. 2014 Feb 20;32(6):513-8. doi: 10.1200/JCO.2013.51.7904. Epub 2014 Jan 13.

ReferenceCitation: Weiser MR, Fichera A, Schrag D, Boughey JC, You YN. Progress in the PROSPECT trial: precision treatment for rectal cancer? Bull Am Coll Surg. 2015 Apr;100(4):51-2. No abstract available.

ReferenceCitation: Rouanet P, Rullier E, Lelong B, Maingon P, Tuech JJ, Pezet D, Castan F, Nougaret S; and the GRECCAR Study Group. Tailored Treatment Strategy for Locally Advanced Rectal Carcinoma Based on the Tumor Response to Induction Chemotherapy: Preliminary Results of the French Phase II Multicenter GRECCAR4 Trial. Dis Colon Rectum. 2017 Jul;60(7):653-663. doi: 10.1097/DCR.0000000000000849.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Kang JH, Kim YC, Kim H, Kim YW, Hur H, Kim JS, Min BS, Kim H, Lim JS, Seong J, Keum KC, Kim NK. Tumor volume changes assessed by three-dimensional magnetic resonance volumetry in rectal cancer patients after preoperative chemoradiation: the impact of the volume reduction ratio on the prediction of pathologic complete response. Int J Radiat Oncol Biol Phys. 2010 Mar 15;76(4):1018-25. doi: 10.1016/j.ijrobp.2009.03.066. Epub 2009 Aug 3.

ReferenceCitation: Rouanet P. Which Trial to Demonstrate the Truthfulness of a Tailored Strategy in Rectal Carcinoma? Dis Colon Rectum. 2018 Jan;61(1):e1-e2. doi: 10.1097/DCR.0000000000000977. No abstract available.

ReferenceCitation: Nougaret S, Castan F, de Forges H, Vargas HA, Gallix B, Gourgou S, Rouanet P; GRECCAR Study Group. Early MRI predictors of disease-free survival in locally advanced rectal cancer from the GRECCAR 4 trial. Br J Surg. 2019 Oct;106(11):1530-1541. doi: 10.1002/bjs.11233. Epub 2019 Aug 22.

ReferenceCitation: Fokas E, Glynne-Jones R, Appelt A, Beets-Tan R, Beets G, Haustermans K, Marijnen C, Minsky BD, Ludmir E, Quirke P, Sebag-Montefiore D, Garcia-Aguilar J, Gambacorta MA, Valentini V, Buyse M, Rodel C. Outcome measures in multimodal rectal cancer trials. Lancet Oncol. 2020 May;21(5):e252-e264. doi: 10.1016/S1470-2045(20)30024-3.

location_facility: Insitut Régional du Cancer de Montpellier

title: Multicentric Phase II-III Study Evaluating the Tailored Management of Locally-advanced Rectal Carcinoma After a Favorable Response to Induction Chemotherapy

ipd_sharing_description: All data will be available after publication of the results in peer-reviewed revues, and in national and international meetings. It includes all disidentified participants' data, the study protocol, the statistical analysis plan and the analytic code. The corresponding author will provide data and datasets generated and/or analyzed during the study upon reasonable request.

ipd_sharing: Yes

appel_a_projets: PHRCK

region: Occitanie

nom_etablissement: ICM MONTPELLIER

type_etablissement: CLCC

acronyme: GRECCAR 14

titre: GRECCAR 14-Essai phase II multicentrique évaluant la prise en charge personnalisée des cancers du rectum localement avancés ayant bien répondu à une  chimiothérapie d'induction

discipline_principale: cancer

nom_porteur: ROUANET

prenom_porteur: Philippe


title: Detection of ISUP≥2 Prostate Cancers Using Multiparametric MRI: Prospective Multicenter Comparison of the PI-RADS Score and an Artificial Intelligence System

acronym: CHANGE

summary:
Multiparametric MRI of the prostate is recommended before each prostate biopsy. It identifies suspicious areas which will then be the subject of targeted biopsies. However, MRI suffers from low specificity and moderate inter-reader reproducibility, including with the use of the PI-RADS version 2.1 score.

We are developing, within the framework of RHU PERFUSE, a computer-aided diagnosis system (CAD) for the detection of ISUP ≥2 cancers. This system has been trained on a database of patients who had prostate MRI and prostatectomy at the Hospices Civils de Lyon and performed well on a database of patients who had prostate MRI before biopsy at the Hopices civils de Lyon.

However, one of the weaknesses of artificial intelligence systems is their low robustness when tested on MRI images from different manufacturers or institutions.

The goal of the CHANGE study is to build a prospective multicenter cohort of patients who underwent prostate multiparametric MRI followed by systematic and targeted prostate biopsies. The cohort will be used for the final external validation of the CAD developed in PERFUSE.

primary_purpose: Diagnostic

ReferenceType: derived

ReferenceCitation: Rouviere O, Souchon R, Lartizien C, Mansuy A, Magaud L, Colom M, Dubreuil-Chambardel M, Debeer S, Jaouen T, Duran A, Rippert P, Riche B, Monini C, Vlaeminck-Guillem V, Haesebaert J, Rabilloud M, Crouzet S. Detection of ISUP >/=2 prostate cancers using multiparametric MRI: prospective multicentre assessment of the non-inferiority of an artificial intelligence system as compared to the PI-RADS V.2.1 score (CHANGE study). BMJ Open. 2022 Feb 9;12(2):e051274. doi: 10.1136/bmjopen-2021-051274.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: British Medical Journal

ipd_sharing_description: After publication of the results of the trial, the CHANGE cohort will be made partially accessible to other investigators wishing to test a CAD system aimed at detecting/localizing prostate cancer on MR images while respecting patient information. Request for access to pseudonymized data will be reviewed by the Trial Steering Committee that will grant access or not. To gain access, requestors will be required to sign a data access agreement. Of note, investigators will have access only to the MR images and not to the histological findings. After analysis of the CHANGE MR images by their CAD system, the investigator will be requested to send the results to the Hospices Civils de Lyon. The comparison between the CAD findings and the targeted and systematic biopsy findings will be made by the Hospices Civils de Lyon that will then inform the investigator of the CAD diagnostic performance.

lead_sponsor: Hospices Civils de Lyon

location_facility: Department of radiology and urology, Hôpital Edouard Herriot

location_facility: Department of radiology and urology, Hôpital Saint Joseph Saint Luc

location_facility: Department of radiology and urology, CHU Pellegrin

location_facility: Department of Radiology and Urology, Hopital Européen Marseille

location_facility: Department of Radiology and Urology, Nouvel Hôpital Civil - CHU de Strasbourg

location_facility: Department of radiology and urology, CHU de Lille

location_facility: Department of urology and radiology, CHLS

location_facility: Department of Urology, Quint Fonsegrives

location_facility: Department of urology, CHU de Saint-Étienne Hôpital Nord

location_facility: Department of Radiology adn Urology, Institut Universitaire du Cancer ,Toulouse

location_facility: Department Urology, Clinique urologique Nantes Atlantis

location_facility: Department of Urology, Clinique Beausoleil Montpellier

location_facility: Department of Radiology and Urology, Institut Paoli-Calmettes Marseille

location_facility: Department of radiology and urology, Hôpital la Pitié Salpêtrière

location_facility: Department of urology and Radiology, CHU Grenoble Alpes


title: Randomized, Multicenter, Phase III Trial to Assess Conformal Post-operative Radiotherapy vs. Surveillance After Complete Resection of Stage II/III Thymoma

acronym: RADIO-RYTHMIC

summary: The primary objective of the study : to compare the Recurrence-Free survival (RFS) between arms. RFS is defined as time from randomisation to the first recurrence (either local-regional or distant) or death of any cause.

lead_sponsor: Institut Curie

location_facility: Institut de Cancérologie de Lorraine Nancy


title: Analysis of the Efficacy and Safety of Two Combination Treatment Regimens of Nivolumab and Ipilimumab in Patients With dMMR and / or MSI Metastatic Colorectal Cancer: A GERCOR Open-label, Randomized, Non-comparative, Two-stage Phase II Trial (NIPISAFE).

acronym: NIPISAFE

summary: NIPISAFE is open-label, phase II study to identify a combination scheme of nivolumab and ipilimumab with a high level of clinical activity, but with a lower toxicity in MSI/dMMR metastatic colorectal cancer patients.

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility: Hopital Franco-Britannique - Fondation Cognacq-Jay

location_facility: Clinique Victor Hugo-Centre jean Bernard


title: Neoadjuvant Atezolizumab and Adjuvant Atezolizumab + Bevacizumab in Combination With Percutaneous Radiofrequency Ablation of Small HCC: a Multicenter Randomized Phase II Trial

summary:
Following the results of study IMbrave150, the combination Atezolizumab + Bevacizumab is a promising treatment option for patients with HCC.

In addition, the high intrahepatic distant recurrence rate and accumulating evidence for a metastatic mechanism encourages exploring adjuvant/neoadjuvant strategies targeting tumor growth and metastatic escape in the context of percutaneous thermal ablation for small HCC.

Local ablation of HCC is therefore an "ideal" setting for testing atezolizumab + bevacizumab in combination with ablation, with the aim of reducing the risk of recurrence.

lead_sponsor: University Hospital, Montpellier

location_facility:
Hôpital Jean Verdier
CHU de Poitiers
Hôpital Saint Joseph
CHU de Rennes
CHU Amiens
CHRU de Nancy
CHU de Lille
CHU Nîmes
CH Perpignan
CHU d'Angers
CHU Dijon
Institut Gustave Roussy
CHU de Nantes
Centre Georges François Leclerc
Hôpital Cochin
CHU de Nice
CHU de Montpellier
CHU de Grenoble
Hôpital Beaujon


title: Creation of a Prospective Endodontics Database

acronym: REone

summary:
Endodontic treatment is necessary after certain dental trauma or in the presence of a large carious lesion, associated with signs of irreversible pulpal inflammation. The treatment of apical periodontitis is a real public health issue. The endodontic success rate is between 68 and 85%. Indeed, some studies show that systemic diseases such as diabetes can increase the prevalence and bone loss associated with apical periodontitis. Other studies identify apical periodontitis as a factor that can potentiate symptoms caused by inflammatory diseases such as cardiovascular disease and diabetes by increasing the level of inflammatory cells in the blood.

However, since 2014 the European Society of Endodontology has recommended establishing a higher level of evidence to ensure the link that these pathologies may have. For this, it is necessary to assess the criteria that may influence the healing of apical periodontitis.

Endodata has been developed by dental surgeons specializing in endodontics. The purpose of this software is to improve the clinical follow-up of patients and to establish a clinical and radiological database. In this context, the creation of a clinical database including data for all root canal treatment is of high interest.

status: Unknown status

location_facility: Hospices Civils de Lyon, Service d'Odontologie

location_facility: CHU de Bordeaux, Service de Médecine Buccodentaire

location_facility: Assistance Publique des Hôpitaux de Paris, Hôpital Bretonneau, Service d'Odontologie

location_facility: UFR d'Odontologie, Laboratoire des Multimatériaux et Interfaces

location_facility: Assistance Publique des Hôpitaux de Paris, Hôpital Pitié Salpêtrière, Service d'Odontologie

location_facility: Assistance Publique des Hôpitaux de Paris, Hôpital Henri Mondor, Service d'Odontologie

location_facility: Assistance Publique des Hôpitaux de Paris, Hôpital Charles Foix, Service d'Odontologie


type: Other Identifier

title: A Randomized Trial of Delayed Radiotherapy in Patients 1p/19q Codeleted Low-grade Oligodendrogliomas Requiring a Treatment Other Than Surgery

acronym: POLO

summary: Because of their prolonged survival, patients with 1p/19q-codeleted low-grade oligodendrogliomas treated with RT + PCV are at risk of neurocognitive deterioration. We make the hypothesis that withholding radiotherapy until tumor progression could reduce the risk of neurocognitive deterioration without impairing overall survival.

location_facility: Hôpital Pasteur - Hôpitaux civils de Colmar

location_facility: Institut de Cancérologie Strasbourg Europe

location_facility: Institut de Cancérologie et Hematologie (ICH) - CHRU Brest, Hopital Morvan

location_facility: Institut Universitaire du Cancer Toulouse Oncopole


title: Optimization of the Parameters of Vagal Nerve Stimulation in Pharmaco- Resistant Epileptic Patients Based on a Surface EEG Index of Functional Connectivity (PLI: Phase Lag Index): a Randomized Double-blind Multicenter Controlled Study.

acronym: OPSTIMVAG

summary: Vagal nerve stimulation (VNS) is one of the neuromodulation techniques that can be indicated in patients suffering from refractory epilepsies, especially when an open resection has failed or is not indicated. However to date it is not possible to predict which patients will respond and what are the best parameters of stimulation to be set (pulse width, frequency and intensity). It has been shown that responders to VNS have reduced interictal cortical synchronicity on scalp EEG based on phase lag index (PLI), a marker of functional connectivity (Fc) The aim of this study is to test the following hypothesis: setting the parameters of stimulation on the basis of the lowest values of Phase Lag Index (PLI) obtained on scalp EEG with different settings of parameters (as compared with a randomly chosen set of commonly used parameters) will increase the rate of responders to VNS.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Epilepsy neurophysiopathology department, CHU Grenoble

location_facility: Department of clinical neurophysiology, Hôpital La Timone, APHM

location_facility: Department of functional explorations of the nervous system, CHU

location_facility: Neurology and clinical neurophysiology, CHU Bretonneau

location_facility: Neurophysiological explorations, Hôpital Pierre Paul Riquet, Purpan

region: Provence-Alpes-Côte d'Azur

nom_etablissement: APHM DIRECTION GENERALE

acronyme: OPSTIMVAG

titre: Optimisation des paramètres de stimulation du nerf vague dans les épilepsies pharmaco-résistantes sur la base d'un index de connectivité fonctionnelle EEG de surface (PLI) : étude comparative randomisée en double aveugle.

discipline_principale: neurologie

nom_porteur: Carron

prenom_porteur: Romain


title: Ocular Conservative Treatment for Retinoblastoma: Efficacy of the New Management Strategies and Visual Outcome - RETINO 2018

summary:
This protocol includes 2 independent studies. Both studies are multicenter studies, evaluating different therapeutic approaches in two different populations of patients:

Study 1, a randomized phase-II study evaluating the efficacy of Intra-Arterial Chemotherapy (IAC) with melphalan and topotecan versus melphalan alone, both in association with ophthalmologic treatments.
Study 2, a minimally invasive interventional study evaluating the results on visual function following reference treatment with intravenous (IV) chemotherapy in association with ophthalmologic or local ophthalmological treatment without IV chemotherapy.

sponsor_collaborators:
Institut Curie
Fondation Rothschild Paris

location_facility: CHU ESTAING Centre Régional de Cancérologie et Therapie Cellulaire Pediatrique (CRCTCP)

location_facility: MONTPELLIER CHU Hopital Arnaud De Villeneuve

location_facility: PARIS Fondation Ophtalmologique Adolphe de Rothschild


title: Observational Register of Patients With haEmophilia A tReated With Afstyla®

acronym: OPERA

summary: Record real life data of patients with Hemophilia A and treated with Afstyla® to assess the effectiveness and the safety of the treatment used as prophylaxis, prevention of bleeding (e.g. surgery) or on-demand treatment during 3 years after patient inclusion

enrollment_type: Actual

lead_sponsor: CSL Behring

location_facility:
CHU Nantes
CHU Montpellier
CHU Rouen
CRC-MHC Hôpital Kremlin Bicêtre
CHU Clermont-Ferrand
CHU Rennes
CHRU Lille
CHU Saint-Etienne
CHRU de Tours
CHU Caen
Hôpital Simone Veil
CHU Brest
CHU Limoges
CHU Chambéry
Hôpital Mignot
Hôpital Hautepierre
Hôpital Necker

intervention_type: Biological


title: Hizentra® in Inflammatory Neuropathies - pHeNIx Study

acronym: pHeNIx

summary: The pHeNIx study, a national multicentre prospective non-interventional study, should help to describe the conditions of use for Hizentra® and the methods for switching from the IV to SC route in everyday practice, together with the tolerability and efficacy of treatment, which is monitored using a patient application (PRO: Patient-Reported Outcomes).

location_facility:
CHRU Brest
Hôpital Pierre Wertheimer,HCL
CHU Toulouse
CH Libourne
Hôpital Pellegrin
Hôpital Roger Salengro, CHU Lille
Hôpital privé de La Casamance
La Pitié-Salpêtrière
CHR Tours
CH de Valence
CHU Saint-Etienne
Hôpital Bicêtre
Hôpital de la Timone
Hôpital Charles Nicolle
CHU Angers
CHU Nantes
CHU Montpellier
CHRU Nancy
Hôpital Henri Mondor
Hôpital Pasteur
Hôpital Lariboisière
Hôpital Dupuytren
CHU Poitiers
CH Bayonne


title: Rifabutin Versus Rifampicin for Treatment of Staphylococcal Prosthetic Joint Infection Treated With Debridement, Antibiotics and Implant Retention (DAIR Strategy): a Multicenter Randomized, Open-label, Non-inferiority Trial

acronym: RIFAMAB

summary: Rifampicin, is key in the treatment of staphylococcal PJIs. Rifabutin has a better profile of tolerance than rifampicin regarding the risk of interaction with concomitant medications and liver disorders. The hypothesis is that rifabutin may be an alternative antibiotic option as efficient as rifampicin for the treatment of staphylococcal PJIs, with a better safety profile. The investigator aim to demonstrate the non-inferiority of rifabutin as compared with rifampicin prescribed in combination treatment for PJIs.

lead_sponsor: Tourcoing Hospital

location_facility: Hôpital d'instruction des armées Sainte Anne

region: Hauts-de-France

nom_etablissement: CH TOURCOING

type_etablissement: CH

acronyme: RIFAMAB

titre: Comparaison de la rifabutine et de la rifampicine dans le traitement des infections ostéoarticulaires sur prothèse à staphylocoque prises en charge par synovectomie-lavage et antibiothérapie : un essai multicentrique randomisé ouvert de non infériorité

discipline_principale: infectiologie / biologie des agents infectieux / hygiène

nom_porteur: SENNEVILLE

prenom_porteur: Eric


title: A Prospective, Multicenter, Open-label, Phase II Study to Evaluate Efficacy and Safety of Selective Internal Radiation Therapy Plus Xelox, Bevacizumab and Atezolizumab (Immune Chekpoint Inhibitor) in Patients With Liver-dominant Metastatic Colorectal Cancer

acronym: SIRTCI

summary: The main objective of the SIRTCI study is to evaluate the safety and efficacy of the combination chemotherapy (XELOX: Capecitabine plus oxaliplatin), anti-angiogenic (Bevacizumab), SIRT (TheraSphere®) and ICI (Atezolizumab) in patients with CRC with predominant liver metastases. SIRTCI is a single-arm, prospective, multi-centre phase II study. The main inclusion criteria are patients with MSS mRCC with predominantly non-operable liver metastases and measurable disease. Patients with extra-hepatic metastases can be included since the objective of the study is to induce local and abscopal effects of radiotherapy combined with ICI by stimulating the anti-tumour immune response to destroy both hepatic and extra-hepatic metastases.

ReferenceCitation: Wasan HS, Gibbs P, Sharma NK, Taieb J, Heinemann V, Ricke J, Peeters M, Findlay M, Weaver A, Mills J, Wilson C, Adams R, Francis A, Moschandreas J, Virdee PS, Dutton P, Love S, Gebski V, Gray A; FOXFIRE trial investigators; SIRFLOX trial investigators; FOXFIRE-Global trial investigators; van Hazel G, Sharma RA. First-line selective internal radiotherapy plus chemotherapy versus chemotherapy alone in patients with liver metastases from colorectal cancer (FOXFIRE, SIRFLOX, and FOXFIRE-Global): a combined analysis of three multicentre, randomised, phase 3 trials. Lancet Oncol. 2017 Sep;18(9):1159-1171. doi: 10.1016/S1470-2045(17)30457-6. Epub 2017 Aug 3.

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by

license_normalized: cc-by

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

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: PubMed Central - Europe PMC

repository_institution: Ghent University - Ghent University Academic Bibliography

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

repository_normalized: irua

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

repository_institution: Cardiff University - ORCA Online Research @Cardiff

version: acceptedVersion

version: submittedVersion

repositories_concat: PubMed Central;UCL Discovery;University of Melbourne - Minerva Access;archive.ugent.be;irua;ora.ox.ac.uk;orca.cardiff.ac.uk

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

ReferenceCitation: Venook AP, Niedzwiecki D, Lenz HJ, Innocenti F, Fruth B, Meyerhardt JA, Schrag D, Greene C, O'Neil BH, Atkins JN, Berry S, Polite BN, O'Reilly EM, Goldberg RM, Hochster HS, Schilsky RL, Bertagnolli MM, El-Khoueiry AB, Watson P, Benson AB 3rd, Mulkerin DL, Mayer RJ, Blanke C. Effect of First-Line Chemotherapy Combined With Cetuximab or Bevacizumab on Overall Survival in Patients With KRAS Wild-Type Advanced or Metastatic Colorectal Cancer: A Randomized Clinical Trial. JAMA. 2017 Jun 20;317(23):2392-2401. doi: 10.1001/jama.2017.7105.

ReferenceCitation: Heinemann V, von Weikersthal LF, Decker T, Kiani A, Vehling-Kaiser U, Al-Batran SE, Heintges T, Lerchenmuller C, Kahl C, Seipelt G, Kullmann F, Stauch M, Scheithauer W, Hielscher J, Scholz M, Muller S, Link H, Niederle N, Rost A, Hoffkes HG, Moehler M, Lindig RU, Modest DP, Rossius L, Kirchner T, Jung A, Stintzing S. FOLFIRI plus cetuximab versus FOLFIRI plus bevacizumab as first-line treatment for patients with metastatic colorectal cancer (FIRE-3): a randomised, open-label, phase 3 trial. Lancet Oncol. 2014 Sep;15(10):1065-75. doi: 10.1016/S1470-2045(14)70330-4. Epub 2014 Jul 31.

ReferenceCitation: Saltz LB, Clarke S, Diaz-Rubio E, Scheithauer W, Figer A, Wong R, Koski S, Lichinitser M, Yang TS, Rivera F, Couture F, Sirzen F, Cassidy J. Bevacizumab in combination with oxaliplatin-based chemotherapy as first-line therapy in metastatic colorectal cancer: a randomized phase III study. J Clin Oncol. 2008 Apr 20;26(12):2013-9. doi: 10.1200/JCO.2007.14.9930. Erratum In: J Clin Oncol. 2008 Jun;26(18):3110. J Clin Oncol. 2009 Feb 1;27(4):653.

ReferenceCitation: Loupakis F, Cremolini C, Masi G, Lonardi S, Zagonel V, Salvatore L, Cortesi E, Tomasello G, Ronzoni M, Spadi R, Zaniboni A, Tonini G, Buonadonna A, Amoroso D, Chiara S, Carlomagno C, Boni C, Allegrini G, Boni L, Falcone A. Initial therapy with FOLFOXIRI and bevacizumab for metastatic colorectal cancer. N Engl J Med. 2014 Oct 23;371(17):1609-18. doi: 10.1056/NEJMoa1403108.

ReferenceCitation: van Hazel GA, Heinemann V, Sharma NK, Findlay MP, Ricke J, Peeters M, Perez D, Robinson BA, Strickland AH, Ferguson T, Rodriguez J, Kroning H, Wolf I, Ganju V, Walpole E, Boucher E, Tichler T, Shacham-Shmueli E, Powell A, Eliadis P, Isaacs R, Price D, Moeslein F, Taieb J, Bower G, Gebski V, Van Buskirk M, Cade DN, Thurston K, Gibbs P. SIRFLOX: Randomized Phase III Trial Comparing First-Line mFOLFOX6 (Plus or Minus Bevacizumab) Versus mFOLFOX6 (Plus or Minus Bevacizumab) Plus Selective Internal Radiation Therapy in Patients With Metastatic Colorectal Cancer. J Clin Oncol. 2016 May 20;34(15):1723-31. doi: 10.1200/JCO.2015.66.1181. Epub 2016 Feb 22. Erratum In: J Clin Oncol. 2016 Nov 20;34(33):4059.

oa_host_type: repository

repositories_concat: irua

unpaywall_oa_status: green

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Gruenberger T, Bridgewater J, Chau I, Garcia Alfonso P, Rivoire M, Mudan S, Lasserre S, Hermann F, Waterkamp D, Adam R. Bevacizumab plus mFOLFOX-6 or FOLFOXIRI in patients with initially unresectable liver metastases from colorectal cancer: the OLIVIA multinational randomised phase II trial. Ann Oncol. 2015 Apr;26(4):702-708. doi: 10.1093/annonc/mdu580. Epub 2014 Dec 23.

license: publisher-specific-oa

license_normalized: publisher-specific

repository_institution: reroDoc Digital Library

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_facility: Privé - Cac - Centre Georges François Leclerc


title: Observational Registry of Patients With Von WilLEbrand Disease Treated With Voncento®

acronym: OPALE

summary: Description of the long-term evolution of patients with von Willebrand disease and treated with Voncento® and of the hemostatic efficacy in the prevention and the treatment of non-surgical bleeding episodes and prevention of surgical bleeding during 2 years after patient inclusion.

location_facility:
CHU Nantes
CHU Lariboisière
Hôpital Cochin
CHU Rouen
CHU Strasbourg
CHRU Nancy
CHU Besançon
CHU Rennes
Hôpital Saint-Eloi
CHU Bordeaux
CHU Caen
CHU Lyon
Hôpital Simone Veil
Hôpital Bicêtre
Hôpital Mignot
CHU Morvan Brest
Hôpital Necker


title: Validation Study of a New Cytokine-based Dynamic Stratification Based on FLt3 Ligand Plasma Concentration Kinetic Profile and IL-6 Concentration During Induction of Acute Myeloid Leukemia

acronym: FLAMVAL

summary:
The investigators have recently demonstrated the strong impact in terms of survivals of Fms-like tyrosine kinase 3 ligand (FL) levels evaluated during intensive induction in acute myeloid leukemia (AML) patients. Indeed, three FL kinetic profiles were delineated: i) sustained increase of FL concentrations between day (D) 1 and D22 (FLI group, n=26, good-risk), ii) increase from D1 to D15, then decrease at D22 (FLD group, n=22, intermediate-risk) and iii) stagnation of low levels (<1000 pg/mL, FLL group, n=14, high-risk). However, with longer follow-up, the investigators have observed that FLI and FLD shared similar outcomes while FLL sub-group kept a very bad prognostic.

Because serum samples from this previous study (called the FLAM/FLAL study) had been frozen-stored, the investigators were able to conduct an ancillary study assessing the potential impact of the kinetics of 6 other cytokines: TNFalpha, stem-cell factor, IL-1beta, IL-6, IL-10 and granulocyte-monocyte colony-stimulating factor (GM-CSF).. Only Il-6 level at D22 (< or >15.5 pg/mL) was associated with outcome allowing to distinguish between higher and lower survivals within the combined FLI/FLD sub-group.

A new prognostic risk-stratification can thus be proposed as follows: FLI/FLD with IL-6 <15.5 pg/mL (favorable), FLI/FLD with IL-6 >15.5 pg/mL (intermediate) and FLL (high-risk).

The aim of this new FLAMVAL study is to validate prospectively in a larger and independent cohort this prognostic risk-stratification i.e. that kinetic profile of FLT3L plasma level from D1 to D22 and Il6 plasma level at day 22 during induction of AML patients are predictive of overall and disease free survivals.

For that purpose, 201 newly diagnosed AML patients treated intensively in the 25 centres of the French Innovative Leukemia Organisation (FILO) will be included in the FLAMVAL study.

ipd_sharing: Undecided

location_facility:
Reims University Hospital
Toulouse University Cancer Institute
Nantes University Hospital
Lyon University Hospital
Poitiers University Hospital
Besançon University Hospital
Grenoble University Hospital
Saint-Etienne University Hospital
Paoli-Calmette Institute
Mercy Regional Hospital
Montpellier University Hospital
Nancy University Hospital
Strasbourg University Hospital
Nîmes University Hospital
Clermont-Ferrand University Hospital
Tours University Hospital
Brest University Hospital
Mulhouse Hospital Center
Rennes University Hospital
Saint-Jean Hospital Center
Bordeaux University Hospital
AP-HP Cochin Hospital
Angers University Hospital
Béziers Hospital Center
Basque coast hospital center


title: Observational Study of the Quality of Life of Patients With New Stoma Formation and Users of a Stoma Appliance From the SenSura Mio Range With Bodyfit® Technology

acronym: QoLMio

summary:
An ostomy is defined by the connection of a viscera to the skin, outside its natural location, by diversion from the digestive or urinary tract. The bodily injury, i.e. the creation of a stoma, has familiar, social and professional consequences. Personalized care, with the help of an ostomy nurse, is essential to accompany the ostomy patient in the changes of his or her life habits. In addition, the progress made in the various appliances, pouching and irrigation systems, contribute to improving the quality of life of these people.

In this context of adapted support, COLOPLAST has developed a range of ostomy pouches, the SenSura Mio BodyFit® technology range, for digestive or urinary stomas. The diversity of the devices makes it possible to find the most suitable combination to adapt to the morphology thanks to an elastic adhesive for a secure fit to individual body shape, and the textile materials used make it possible to optimize wearing comfort.

The aim of this study is to evaluate the quality of life of patients with recent ostomies with one of COLOPLAST's SenSura Mio devices at three months after discharge from the hospital. The condition of the skin around the stoma and the level of satisfaction of the patients will also be evaluated. Finally, the results obtained aim to identify factors predictive of a better quality of life in order to improve management.

status: Completed

study_completion_date_type: Actual

lead_sponsor: Laboratoires Coloplast S.A.S

location_facility: Centre Hospitalier Intercommunal Eure Seine

location_facility: Centre Hospitalier Du Cotentin Site de Cherbourg

location_facility: Centre Hospitalier Annecy Genevois Site Annecy

location_facility: Centre Hospitalier Universitaire La Miletrie

status_simplified: Completed


title: A Phase II Single-group Assignment, Multicenter Study of Efficacy and Safety of Lorlatinib Monotherapy After Failure of First-line Tyrosine Kinase Inhibitor in Patients With Advanced ROS1-positive Non-small Cell Lung Cancer (ALBATROS)

summary:
ROS1 rearrangements are present in 1-2% of NSCLC cases and define a distinct molecular subgroup. Like ALK (anaplastic lymphoma kinase) rearrangements in NSCLC, ROS1 fusions confer sensitivity to the inhibitor crizotinib. Crizotinib, which is a tyrosine kinase inhibitor (TKI), has been shown to be effective in tumors in several retrospective studies.

Recently the FDA approved entrectinib for the treatment of patients with ROS1-positive metastatic NSCLC. This indication is based on the results of pooled data from several trials. Together, these studies demonstrate the efficacy for entrectinib across a variety of solid tumor types including NSCLC with ROS1 fusion.

However, despite the efficacy of crizotinib or entrectinib in ROS1-positive NSCLC, patients will develop resistance to these tyrosine kinase inhibitors.

Lorlatinib is a new and potent ROS1 / ALK inhibitor optimized to penetrate the blood-brain barrier. A recent study has investigated the activity of lorlatinib against the crizotinib-resistant ROS1G2032R mutation. In this situation, lorlatinib effectively inhibited the catalytic activity of recombinant ROS1G2032R resulting in an antiproliferative response. Because of its potency as an ROS1 inhibitor and its ability to suppress the resistant ROS1 mutations, lorlatinib could be a treatment of choice in ROS1-positive NSCLC.

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Nouvel Hôpital Civil - Hôpitaux Universitaires de Strasbourg


title: Role of Protective Stoma After Primary Anastomosis for Generalized Peritonitis Due to Perforated Diverticulitis: a Prospective Multicenter Randomized Trial

acronym: DIVERTI 2

summary:
This study is designed to be a multicentre, prospective, comparative, randomised trial, evaluating the efficacy of two surgical strategies for the treatment of generalised peritonitis due to perforated diverticulitis. Results will be analysed according to an intention to treat principle (after selection and patient consent). Immediately before surgery, the patient will be randomly assigned to sigmoidectomy with primary anastomosis or to sigmoidectomy with primary anastomosis and diverting stoma. Sigmoidectomy will be performed through a midline laparotomy or laparoscopically according to the standard technique. In the control arm, a protective stoma will be performed at the end of surgery. A stoma reversal operation will be performed at least 3 months after the first operation and after performing a cologram by water soluble contrast between 4 and 8 weeks to check for the absence of fistula or stenosis at the level of the anastomosis. Stoma reversal will be performed with a trephine incision.

Post-stoma closure follow-ups will be planned and all morbidity/mortality will be recorded. All patients will be examined at 6, 12, and 24 weeks after the initial surgery, in the surgical department where they were operated; a final study visit will be carried out 12 months (evaluation of primary endpoint) after surgery. The parameters explored at medical examinations will be: • Occurrence of complications • Quality of life assessment

ReferenceCitation: Pinson J, Tuech JJ, Ouaissi M, Mathonnet M, Mauvais F, Houivet E, Lacroix E, Rondeaux J, Sabbagh C, Bridoux V. Role of protective stoma after primary anastomosis for generalized peritonitis due to perforated diverticulitis-DIVERTI 2 (a prospective multicenter randomized trial): rationale and design (nct04604730). BMC Surg. 2022 May 16;22(1):191. doi: 10.1186/s12893-022-01589-w.

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

repository_normalized: HAL

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

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

publisher_dissemination: Springer-Nature

lead_sponsor: University Hospital, Rouen

location_facility:
CHU Nimes
CHU Brest
CHU Limoges
CHU Lyon
CHU Tours
CHU Amiens
APHM La Timone
APHM Hôpital Nord
APHP Henri Mondor
CHU Rouen
CHU Nancy
CHU Nantes
CHU Caen
CHU Clermont Ferrand
APHP St Antoine
CHU Grenoble
APHP Avicenne
CHU Besançon
CH Beauvais

region: Normandie

nom_etablissement: CHU ROUEN

titre: Intérêt de la stomie de protection après résection-anastomose pour péritonite d'origine diverticulaire : essai prospectif randomisé multicentrique

discipline_principale: chirurgie viscérale et digestive

nom_porteur: BRIDOUX

prenom_porteur: Valérie


title: JAKINIB Study: " 'Observational', Multicentre Trial Collecting Prospective and On-going Clinical and Laboratory Data for Patients Treated With JAK Inhibitors for Inflammatory Rheumatism According to EMA."

acronym: MAJIK

summary:
Janus kinase (JAK) inhibitors are a new class of molecules available to the therapeutic arsenal for chronic inflammatory rheumatic diseases.The tolerance profile of this new class needs to be better defined and its use in real life further established.

The French Society of Rheumatologists intends to coordinate a prospective national registry study for this follow-up.

This registry will include at least 1500 Rheumatoid Arthritis (RA) and 150 patients with psoriatic arthritis from the start of treatment with JAK inhibitor and then followed for 5 years.

This registry is a longitudinal, multicentre, observational registry study. The objective of this national registry is to get a better understanding of the safety profiles of JAK inhibitors and get knowledge of their use in daily practice in order to optimize this use and potentially integrate JAK inhibitors into personalised medicine strategies.

This registry will generate efficacy data, especially therapeutic maintenance, observation, allowing inter-registry comparisons with other biologic compounds in the French population, and can be aggregated with other similar registries in other countries.

lead_sponsor: Societe Francaise de Rhumatologie

sponsor_collaborators:
Societe Francaise de Rhumatologie
Bordeaux PharmacoEpi

location_facility:
CHRU Brest
CH Niort
AP-HP Lariboisiere
CH de Dijon
CHU Toulouse
CHU Nice
AP-HP Bichat
CH Franche Comte
Hôpital Saint Joseph
CHU Lyon
CHU Tours
CH Mont de Marsan
CHU Marseille Sainte-Marguerite
CH Troyes
Hopital La Croix Saint Simon
CH Morlaix
CH La Rochelle
AP-HP Henri Mondor
CH Chartres
CHU de Besançon
CHU Rouen
CH Valenciennes
CH Cannes
CH Saint Philibert
CH Le Mans
CH Antibes
CHU Nantes
Hôpital Cochin
AP-HP Saint Antoine
CHU Reims
Infirmerie protestante de Lyon
CHU Saint Etienne
CH Colombes
CHU de Montpellier
CHG Jacques Monod
CHU Caen
CH Nevers
AP-HP Bicetre
CHU Clermont Ferrand
AP-HP Ambroise Pare
CH Bégin
CHD de Vendee
CHU de Bordeaux
CH Saint Nazaire
CHU Strasbourg
GH de Mulhouse
CH Dax
AP-HP Pitie-Salpetriere
CH Bourg-en-Bresse
CH Pau
AP-HP Avicenne
Private office
CHU de la Reunion
CH Valence
CH Cholet
CHU Lille
CH de Douai
CH Orleans
Polyclinique Vauban


title: Evaluation of the Efficacy of Nicotine Patches in SARS-CoV2 (COVID-19) Infection in Intensive Care Unit Patients

acronym: NICOVID-REA

summary:
There is currently no known treatment for COVID19. Active smokers are infrequent among patients with COVID-19 which has led our team to hypothesize that nicotine is responsible for this protective effect via the nicotinic acetylcholine receptor (nAChR). In fact, nAChR possess the ability to modulate ACE2 expression, the cellular doorway for SARS-CoV2. nAChR modulation by the virus would be responsible for the numerous clinical signs observed in COVID-19, including the cytokine storm manifested in intensive care hyperinflammatory patients.

Based on epidemiological data and experimental data from scientific literature, our team hypothesize that nicotine could inhibit the penetration and propagation of SARS-CoV2. Our team also claim that nicotine could attenuate the hyperinflammatory response and cytokine storm leading to acute respiratory failure and a probable multi-organ failure associated with COVID19.

ReferenceCitation: Labro G, Tubach F, Belin L, Dubost JL, Osman D, Muller G, Quenot JP, Da Silva D, Zarka J, Turpin M, Mayaux J, Lamer C, Doyen D, Chevrel G, Plantefeve G, Demeret S, Piton G, Manzon C, Ochin E, Gaillard R, Dautzenberg B, Baldacini M, Lebbah S, Miyara M, Pineton de Chambrun M, Amoura Z, Combes A; NICOVID-REA Trial Group. Nicotine patches in patients on mechanical ventilation for severe COVID-19: a randomized, double-blind, placebo-controlled, multicentre trial. Intensive Care Med. 2022 Jul;48(7):876-887. doi: 10.1007/s00134-022-06721-1. Epub 2022 Jun 9.

oa_colors: green other

evidence: open (via free pdf)

unpaywall_oa_status: bronze

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Centre Hospitalier Victor Dupouy - Service de Réanimation polyvalente et USC

location_facility: CHR Orléans Service de Médecine Intensive Réanimation

location_facility: Centre Hospitalier Sud Francilien - Service de réanimation

location_facility: Hôpital Bicêtre - Service de Médecine Intensive Réanimation

location_facility: Hôpital Tenon - Service de Médecine Intensive Réanimation

location_facility: Groupement Hospitalier de la Région de Mulhouse Sud Alsace - Hop Emile MULLER

location_facility: Médipôle Hôpital Privé - MHP Service de Médecine Intensive Réanimation

location_facility: CHU Nice - Hôpital L'Archet 1 - Service de Médecine Intensive Réanimation

location_facility: Hôpital Pitié Salpêtrière - Intensive care unit

location_facility: Hôpital Simone VEIL - Service d'Anesthésie-Réanimation

location_facility: CHU Dijon - Hôpital François Miterrand Service de Médecine Intensive Réanimation

location_facility: CHRU de Besançon - Service de Médecine Intensive Réanimation

location_facility: Grand Hôpital de l'Est Francilien - Site Jossigny - Réanimation

location_facility: Centre Hospitalier René Dubos - Service de Réanimation Médico-Chirurgicale

location_facility: Hôpital DELAFONTAINE Service de Médecine Intensive Réanimation

location_facility: Grand Hôpital de l'Est Francilien Site Meaux - Service de Réanimation Médico-Chirurgicale

location_facility: Institut Mutualiste Montsouris Service de Réanimation Polyvalente


title: Randomized, Open-label, Controlled Phase III Trial Comparing Pembrolizumab-platinum Based Chemotherapy Combination With Pembrolizumab Monotherapy in First Line Treatment of Non-small-cell Lung Cancers (NSCLC) With PDL1 Expression ≥50%

acronym: PERSEE

summary:
PERSEE is a French national phase 3 academic study comparing the chemotherapy-pembrolizumab combination to pembrolizumab alone as a first-line treatment for advanced NSCLC molecularly defined by a PDL1 expression ≥ 50% of tumour cells and no EGFR mutations or ALK rearrangement.

The main hypothesis is the superiority of the chemo-immunotherapy combination over mono-immunotherapy in terms of progression-free survival evaluated by an independent review committee.

One of the anticipated benefits of using the chemotherapy-pembrolizumab combination starting from the first line setting for NSCLC patients with PD L1 ≥ 50% is a reduced risk of early progression, which is known to occur with pembrolizumab monotherapy, and therefore, a better PFS.

ReferenceCitation: Descourt R, Chouaid C, Perol M, Besse B, Greillier L, Bylicki O, Ricordel C, Guisier F, Gervais R, Schott R, Auliac JB, Robinet G, Decroisette C. First-line pembrolizumab with or without platinum doublet chemotherapy in non-small-cell lung cancer patients with PD-L1 expression >/=50. Future Oncol. 2021 Aug;17(23):3007-3016. doi: 10.2217/fon-2020-1202. Epub 2021 Jun 22.

publisher_dissemination: Future Science Ltd

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

sponsor_collaborators:
University Hospital, Brest
Groupe Français de Pneumo-Cancérologie

location_facility: Hôpital d'Instruction des Armées Toulon - Saint Anne

location_facility: Institut de Cancérologie Strasbourg Europe

location_facility: SAINT-PRIEST EN JAREZ - Institut de Cancérologie de la Loire

location_facility: Centre de lutte contre le cancer - Centre François Baclesse


title: Psychological Impact of COVID-19 Outbreak on Caregivers Involved in Intensive Care Unit Patient Management: Impact on the Occurrence of Post-traumatic Stress Disorder, Anxiety, Depression and Burn Out Syndrome

acronym: PSY-CO-ICU

summary:
Based on the experience of previous pandemics, countries reacted by applying different upgrade strategies to prevent or delay the widespread of the disease. Therefore, measures such as border closure, school closure, restrict social gathering (even shutdown of workplaces), limit population movements, and confinement meaning quarantines at the scale of cities or regions. In public hospitals, several measures have been decided to concentrate the power of care on potential wave of admissions of patients with severe forms of Covid-19. In this purpose, the number of available beds in Intensive Care Units (ICU) has been increased by two-fold and scheduled non-emergency surgical procedure have been cancelled. That means:

For the most severe patients, new personals (physician such as anesthesiologists, nurses of other units) have been transferred in ICUs.
For the less severe patients, personals of non-busy units have been transferred in busier ones.

All these measures lead to major daily-life change sets that could be stressful. In the general population, it has been well documented that quarantine or confinement or isolation could lead to the occurrence of Post-Traumatic Stress Disorder (PTSD) syndrome in about 30% overall population. Importantly, high depressive symptoms have been reported in 9% of hospital staff. Numerous symptoms have been reported after quarantine or isolation such as emotional disturbance, depression, stress, low mood, irritability, insomnia, and post-traumatic stress symptoms.

In hospital setting, few studies have been performed for assessing the psychological impact of quarantine and isolation. However, two studies reported a high prevalence of burn-out syndrome (BOS) in ICU physician and PTSD syndrome and depression in ICU nurses. As the consequences of all the measures decided and applied during Covid-19 pandemic could be important on caregivers, the present study primarily aims at assessing the prevalence of PTSD syndrome in a large population of caregivers implied or not in Intensive Care Units. The secondary objective were 1) to assess the prevalence of severe depression and anxiety and BOS 2) to isolate potential factors associated with PTSD, severe depression, anxiety or BOS.

study_start_date_type: Anticipated

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU De Montpellier, Hôpital St Eloi-DAR B

location_facility: Intesive Care Unit CHRU de Strasbourg, Hôpital Hautepierre

location_facility: Intensive CAre Unit CHRU de Nancy, Hôpital Central

location_facility: AP-HM, Hôpital Timone adultes, Neurotraumatology

location_facility: Intensive CAre Unit CHRU de Nancy, Hôpital de Brabois

location_facility: AP-HM, Hôpital Timone adultes, Intensive Care Unit

location_facility: Intensive Care Unit, CHU de Nantes, Hôtel Dieu

location_facility: Hôpitaux civils de Lyon, Hôpital de la Croix Rousse

location_facility: CHU de Montpellier, Hôpital St Eloi SAR B

location_facility: Intensive care Unit CHU de Brest Hôpital Cavale Blanche

location_facility: Hôpitaux civils de Lyon, Hôpital Louis Pradel

location_facility: Intensive Care Unit, CHU de Nantes, Hôpital Laennec

location_facility: Hôpitaux civils de Lyon, Hôpital Edouard Herriot

location_facility: CHU de Montpellier, Hôpital Guy de chauliac

location_facility: Intensive care Unit, Hôpitaux civils de Lyon, Lyon Sud

location_facility: Intesive Care Unit CHRU de Strasbourg, Hôpital civil


title: Intérêt du Traitement de la fièvre Par Refroidissement Externe Pour la Survie Des Patients ventilés en Choc Septique

summary:
The best strategy for managing fever in patients with septic shock remains unknown. In a pilot study, the investigators showed that fever control at normothermia allowed a better control of shock and evolution of organ failures. In this second trial the investigators will conduct a multicentre, open-label, randomized controlled, superiority trial in which two strategies will be compared:

Respect of fever
Fever control at normothermia using external cooling The primary end point will be d-60 mortality.

ipd_sharing_description: Strictly anonymized data will be available upon justified request from the coordinating investigator and the study sponsor

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility: Hôpital Lariboisière -Réanimation chirurgicale

location_facility: Centre hospitalier intercommunal de Créteil

location_facility: Hopital Lariboisière - Réanimation Médicale

nom_etablissement: CENTRE HOSPITALIER INTERCOM DE CRETEIL

acronyme: SEPSISCOOL-II

titre: Intérêt du traitement de la fièvre par refroidissement externe pour la survie des patients ventilés en choc septique

discipline_principale: anesthésiologie / réanimation

nom_porteur: Schortgen

prenom_porteur: Frederique


title: Securing Access to Innovative Molecules in Oncology and Hematology for Children, Adolescents and Young Adults in Therapeutic Failure or Relapse and Not Eligible for a Clinical Trial: a Project of the SFCE

acronym: SACHA

summary: It involves collecting safety and efficacy data, under the actual conditions of use of medicines in children and adolescents, using a validated tool (Ennov EDC) and relying on the network of Interregional pediatric oncology appeal organizations (OIR) identified by INCa since 2010 and responsible for the organization of Pluridisciplinary Pediatric Interregional (RCPPI) and National Consultative Meetings which discuss each case of relapse in order to define the best therapeutic options.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_facility:
Centre Léon Bérard
CHU Toulouse
CHU CAEN
CHU Nice
Hôpital de La Timone
CHU Rennes
CHU Limoges
CHU Lyon
CHU Tours
CHU Amiens
Institut Curie
Gustave Roussy
CHU Saint-Etienne
CHU Dijon
Centre Oscar Lambret
CHU Rouen
CHU Nancy
CHU Angers
CHU La Réunion
CHU Nantes
CHU Montpellier
CHU Reims
CHU Clermont-Ferrand
Hôpital Armand Trousseau
CHU Strasbourg
CHU Grenoble
Hôpital Robert-Debré
CHU Besançon
CHU Poitiers
CHU Bordeaux
CHU Lille


title: Consolidative Radiotherapy for Metastatic Urothelial Bladder Cancer Patients Without Progression and With no More Than Three Residual Metastatic Lesions Following First Line Systemic Therapy: a Prospective Randomized Comparative Phase II Trial

summary:
This is a phase II, multicenter, randomized open-label and comparative study designed to evaluate whether local consolidative radiotherapy plus standard of care improves overall survival as compared to standard of care in patients with limited metastatic urothelial bladder cancer and without progression following the initial phase of first-line systemic therapy.

Each patient will be followed during 4 years from the date of randomization.

lead_sponsor: Institut Claudius Regaud

location_facility: Institut de Cancerologie Lucien Neuwirth

location_facility: Groupement de Radiothérapie et d'Oncologie des Pyrénées

location_facility: Institut Universitaire du Cancer Toulouse Oncopole

intervention_type: Radiation

nom_etablissement: INSTITUT CLAUDIUS REGAUD ONCOPOLE

titre: BLAD-RAD01: Etude prospective de phase II randomisée évaluant la radiothérapie de clôture chez les patients porteurs d'un carcinome urothélial de vessie métastatique en réponse partielle ou complète et avec au plus trois lésions métastatiques résiduelles après traitement systémique de première ligne.

nom_porteur: KHALIFA

prenom_porteur: Jonathan


title: Extracorporeal Membrane Oxygenation (ECMO) as a Therapeutic Option in Severe Form of COVID-19: a Nationwide Cohort Study

acronym: ECMO-SARS

summary: The role of ECMO in the treatment of patients with severe COVID-19 (Acute Respiratory Distress Syndrome (ARDS) and/or acute refractory heart failure) is not yet known. The present study will aim to report the results of the ECMO management of the most severe forms of COVID-19 through the first French ECMO registry.

ReferenceCitation: Mansour A, Flecher E, Schmidt M, Rozec B, Gouin-Thibault I, Esvan M, Fougerou C, Levy B, Porto A, Ross JT, Para M, Manganiello S, Lebreton G, Vincentelli A, Nesseler N; ECMOSARS Investigators. Bleeding and thrombotic events in patients with severe COVID-19 supported with extracorporeal membrane oxygenation: a nationwide cohort study. Intensive Care Med. 2022 Aug;48(8):1039-1052. doi: 10.1007/s00134-022-06794-y. Epub 2022 Jul 13.

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

repositories_concat: HAL

lead_sponsor: Rennes University Hospital

location_facility: APHP Henri Mondor Paris University Hospital

location_facility: APHP Kremli Bicetre Paris University Hospital

location_facility: APHP La Pitié Salpêtrière Paris University Hospital

location_facility: Toulouse University Hospital - Rangueil Hospital

location_facility: APHP Hopital Européen Georges Pompidou - Paris University Hospital

location_facility: APHM la Timone- Marseille University Hospital


title: Cohorte Non Interventionnelle Ambispective Nationale Multicentrique de Patients Suivis Pour Cancer et infectés Par le SARS-CoV-2

summary:
Since December 2019, China and then the rest of the world have been affected by the rapid development of a new coronavirus, SARS-CoV-2 (severe acute respiratory syndrome corona virus 2). The disease caused by this coronavirus (COVID-19), which is transmitted by air via droplets, is potentially responsible for a severe respiratory syndrome but also for a multivisceral deficiency that can lead to death.

Cancer patients are generally more susceptible to infections than people without cancer due to immunosuppression caused by their tumor disease and/or conventional anti-cancer treatments used such as cytotoxic chemotherapy, several targeted therapies, radiotherapy or recent surgery. These patients may therefore be at particular risk for COVID-19.

This is suggested by the very first analysis on the subject, which reports data from the Chinese prospective database of 2007 patients with proven COVID-19 infection in 575 hospitals in 31 Chinese provinces. The authors of this publication conclude with 3 measures to be proposed to patients undergoing cancer follow-up: 1/ consider postponing adjuvant chemotherapy or surgery in the case of localized and stable cancer, 2/ reinforce protective measures for these patients, and 3/ monitor very closely and treat these patients more intensively when they have a COVID-19.

However, the increased risk of SARS-CoV-2 infection and severe forms of COVID-19 in cancer patients suggested by this first study remains to be demonstrated given its limitations, already highlighted by other authors. Indeed, the number of patients is small and the population of cancer patients is very heterogeneous, with in particular 12 patients out of 16 who had recovered from initial cancer treatments (therefore without immunosuppression), half of whom had a disease course of more than 4 years.

Nevertheless, a second Chinese study has just recently been published, reporting COVID-19 data among 1524 cancer patients admitted between December 30, 2019 and February 17, 2020 in the Department of Radiotherapy and Medical Oncology of the University Hospital of Wuhan, the source city of the COVID-19 epidemic. Although the rate of CoV-2 SARS infection was lower than that reported in the first study, it was still 0.79% (n=12), which is much higher than the rate of COVID-19 diagnosed in Wuhan City during the same period (0.37%, 41 152/11 081 000). Again, lung cancer was the main tumour location observed in 7 patients (58%), of which 5 (42%) were undergoing chemotherapy +/- immunotherapy. Three deaths (25%) were reported. Patients over 60 years of age with lung cancer had a higher incidence of COVID-19 (4.3% vs. 1.8%). Thus, it appears that the risk of COVID-19 is actually increased in cancer patients, although again, less than half of the patients with lung cancer had a higher incidence of COVID-19.

Moreover, two more recent studies performed in patients treated in Hubei Province of China and in New-York city found that patients with cancer had significantly increased risk of death compared to non-cancer COVID-19 patients, especially patients with metastatic cancer and those who had recent surgery.

Therefore, many questions remain to date on the level of risk and the severity of COVID-19 in patients with active cancer, in particular those under anti-cancer treatment and in patients recently operated for localized cancer.

collaborators: GERCOR - Multidisciplinary Oncology Cooperative Group

collaborators: Intergroupe Francophone de Cancerologie Thoracique

collaborators: Association de Neuro-Oncologues d'Expression Francaise

sponsor_collaborators: Federation Francophone de Cancerologie Digestive

location_facility: CH - GHI de l'Est Francilien Site de Meaux

location_facility: ICAN - Institut de Cancérologie de Strasbourg Europe

location_facility: PRIVE - Clinique Mutualiste de l'Estuaire

location_facility: CHR - Centre Hospitalier Régional La Source

location_facility: CH - Germon et Gauthier - Service de Gastroentérologie

location_facility: Groupe Hospitalier Diaconesses Croix Saint Simon

location_facility: PRIVE - Institut de Cancérologie de Bourgogne GRReCC

location_facility: PRIVE - La Louvière Institut de Cancérologie Lille Métropole


title: Hospital Registry of Acute Myocarditis: Evolution of the Proportion of Positive SARS-COV-2 Cases During the Covid-19 Pandemic, Case Characteristics and Prognoses

acronym: MYOCOVID

summary: To date, the effects of SARS-Cov-2 (Covid-19) on the myocardium and the role it plays in the evolution towards an acute myocarditis are badly understood. The current pandemic of this emerging virus is an opportunity to assess the proportion of acute myocarditis attributable to SARS-Cov-2(Covid-19) and to assess the clinical, biological and imaging presentations, by means of a national prospective multicentre hospital registry of cases of acute myocarditis.

lead_sponsor: University Hospital, Toulouse

location_country: Mayotte Réunion Martinique France

location_facility: Robert Debré Hospital - Pediatric cardiology

location_facility: Marie Lannelongue Hospital - Pediatric Cardiology

intervention_type: Diagnostic Test


title: Characterization of Fungal Infections in COVID-19 Infected and Mechanically Ventilated Patients in ICU

acronym: MY-CO-VID

summary: Characterization of fungal infections in COVID-19 infected and mechanically ventilated patients in ICU

time_perspective: Other

ReferenceCitation: Gangneux JP, Dannaoui E, Fekkar A, Luyt CE, Botterel F, De Prost N, Tadie JM, Reizine F, Houze S, Timsit JF, Iriart X, Riu-Poulenc B, Sendid B, Nseir S, Persat F, Wallet F, Le Pape P, Canet E, Novara A, Manai M, Cateau E, Thille AW, Brun S, Cohen Y, Alanio A, Megarbane B, Cornet M, Terzi N, Lamhaut L, Sabourin E, Desoubeaux G, Ehrmann S, Hennequin C, Voiriot G, Nevez G, Aubron C, Letscher-Bru V, Meziani F, Blaize M, Mayaux J, Monsel A, Boquel F, Robert-Gangneux F, Le Tulzo Y, Seguin P, Guegan H, Autier B, Lesouhaitier M, Pelletier R, Belaz S, Bonnal C, Berry A, Leroy J, Francois N, Richard JC, Paulus S, Argaud L, Dupont D, Menotti J, Morio F, Soulie M, Schwebel C, Garnaud C, Guitard J, Le Gal S, Quinio D, Morcet J, Laviolle B, Zahar JR, Bougnoux ME. Fungal infections in mechanically ventilated patients with COVID-19 during the first wave: the French multicentre MYCOVID study. Lancet Respir Med. 2022 Feb;10(2):180-190. doi: 10.1016/S2213-2600(21)00442-2. Epub 2021 Nov 26.

evidence: open (via crossref license, author manuscript)

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

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

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

location_facility:
CHU Toulouse
Hôpital Lariboisière/ St Louis
CHU Rennes
CHU Lyon
CHU Tours
CHU Marseille
CHU Paris - Tenon
CHU Paris - HEGP
CHU de Dijon
CHU Paris - Avicenne
CHU Paris - Mondor
CHU Paris - Bichat
CHU Angers
CHU Nantes
CHU de Nice
Hôpital Pitié-Salpêtrière
CHU de Brest
Hôpital Necker-Enfants Malades
CHU Strasbourg
CHU Grenoble
CHU Poitiers
CHU Lille


title: Prospective Analysis of Morbi-mortality of Patients With Cancers in Active Phase of Treatment Suspected or Diagnosed of a SARS-CoV-2 Infection

summary: National multicentre epidemiological study to describe retrospectively and prospectively the clinical outcomes of patients with a suspected coronavirus infection (either confirmed or not) while receiving a medical treatment for the underlying cancer

ReferenceCitation: Assaad S, Zrounba P, Cropet C; ONCOVID-19 study Consortium; Blay JY. Mortality of patients with solid and haematological cancers presenting with symptoms of COVID-19 with vs without detectable SARS-COV-2: a French nationwide prospective cohort study. Br J Cancer. 2021 Aug;125(5):658-671. doi: 10.1038/s41416-021-01452-4. Epub 2021 Jun 16.

lead_sponsor: Centre Leon Berard

location_facility: Groupement Hospitalier Porte de Provence

location_facility: Institut de cancérologie Strasbourg Europe (ICANS)

location_facility: Institut Universitaire du Cancer de Toulouse - IUCT Oncopole


title: Impact of Prone Position in Patients Under Spontaneous Breathing on Intubation or Non-invasive Ventilation or Death Incidence During COVID-19 Acute Respiratory Distress

summary:
The SARS-Cov2 viral pandemic is responsible for a new infectious disease called COVID-19 (CoronaVIrus Disease), is a major health problem. Respiratory complications occur in 15 to 40%, the most serious is acute respiratory distress syndrome (ARDS).

The management of COVID-19 is essentially symptomatic with respiratory oxygen supplementation in mild forms to invasive mechanical ventilation in the most severe forms.

Prone position (PP) reduced mortality in patients with ARDS in intensive care. Ding et al showed that PP and high flow oxygenation reduced the intubation in patients with moderate to severe ARDS.

The investigators hypothesize that the use of PP in spontaneously ventilation patients under oxygen standard could decrease incidence of intubation or non-invasive ventilation or death compared to conventional positioning management in medical departments.

primary_purpose: Supportive Care

ReferenceCitation: Murthy S, Gomersall CD, Fowler RA. Care for Critically Ill Patients With COVID-19. JAMA. 2020 Apr 21;323(15):1499-1500. doi: 10.1001/jama.2020.3633. No abstract available.

ReferenceCitation: Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24. Erratum In: Lancet. 2020 Jan 30;:

ReferenceCitation: Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. Erratum In: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038.

ReferenceCitation: Wu C, Chen X, Cai Y, Xia J, Zhou X, Xu S, Huang H, Zhang L, Zhou X, Du C, Zhang Y, Song J, Wang S, Chao Y, Yang Z, Xu J, Zhou X, Chen D, Xiong W, Xu L, Zhou F, Jiang J, Bai C, Zheng J, Song Y. Risk Factors Associated With Acute Respiratory Distress Syndrome and Death in Patients With Coronavirus Disease 2019 Pneumonia in Wuhan, China. JAMA Intern Med. 2020 Jul 1;180(7):934-943. doi: 10.1001/jamainternmed.2020.0994. Erratum In: JAMA Intern Med. 2020 Jul 1;180(7):1031.

ReferenceCitation: Nay MA, Planquette B, Perrin C, Clement J, Plantier L, Seve A, Druelle S, Morrier M, Laine JB, Colombain L, Corvaisier G, Bizien N, Pouget-Abadie X, Bigot A, Bernard L, Nyamankolly E, Fossat G, Boulain T. Does awake prone positioning prevent the use of mechanical respiratory support or death in COVID-19 patients on standard oxygen therapy hospitalised in general wards? A multicentre randomised controlled trial: the PROVID-19 protocol. BMJ Open. 2022 Jul 8;12(7):e060320. doi: 10.1136/bmjopen-2021-060320.

lead_sponsor: Centre Hospitalier Régional d'Orléans

location_country: Monaco France

location_facility: HOPITAL LARIBOISIERE - Service diabétologie, endocrinologie, nutrition

location_facility: CHRU de Tours - Service Médecine interne et immunologie Clinique

location_facility: CH de PERPIGNAN - Service Maladies infectieuses

location_facility: CHR d'Orleans - Service Maladies Infectieuses

location_facility: Centre Hospitalier Intercommunal de Cornouaille - Quimper Concarneau

location_facility: CHRU DE TOURS - Service Médecine interne et maladies infectieuses


title: Effect of Two Methotrexate Injections in Sync With the First Adalimumab Injection to Prevent the Immunisation Anti Adalimumab During Treatment of Spondyloarthritis

acronym: MESYNAD

summary: Preliminary report have demonstrated that methotrexate induces an anti bio-medicament tolerization whan administrated just before the first administration of the bio-medicament. Once this tolerization is obtained it seems useless to continue the methotrexate because this treatment has no efficacity in cases of spondyloarthritis.

primary_purpose: Prevention

location_facility:
CH Le Mans
CHU Nantes
CHR Orléans
CH Pontoise
CH Sud Francilien
Kremlin Bicetre hospital
CHU Trousseau
Hopital la Pitié Salpétrière
Hopital Bichat
Hopital Mondor
Hopital La Cavale Blanche
Hopital Saint Philibert
Hopital Cochin
CHU Rouen
Hopital Saint Antoine
Hopital Pellegrin
Hopital Ambroise Paré

appel_a_projets: PHRCI

acronyme: MESYNAD

titre: Effet de deux injections de MEthotrexate SYNchronisées avec la première injection d'ADalimumab pour prévenir l'immunisation anti-adalimumab dans les spondyloarthrites

discipline_principale: autre

nom_porteur: NOCTURNE

prenom_porteur: Gaetane


title: Evaluation of Prone Position in Conscious Patients on Nasal High-flow Oxygen Therapy for COVID-19 Disease Induced Acute Respiratory Distress Syndrome

summary:
Acute Respiratory Distress Syndrome (ARDS) induces high mortality, particularly in the context of COVID-19 disease. Preliminary data from patients with ARDS related to COVID-19 disease appear to show significant effectiveness of prone positioning in intubated patients in terms of oxygenation as well as nasal high flow therapy before intubation. It should be noted that in Jiangsu province, secondarily affected, nasal high flow combined with the prone position was successfully integrated into care protocols.

The investigators hypothesize that the combined application of nasal high flow and prone positioning can significantly improve the outcome of patients suffering from COVID-19 pneumonia by reducing the need for tracheal intubation and associated therapeutics such as sedation and paralysis, resulting in both individual and collective benefits in terms of use of scarce critical care resources.

Investigators hypothesize that the combined application of nasal high-flow and prone positioning can significantly improve the outcome of patients suffering from COVID-19 pneumonia by reducing the need for intubation and associated therapeutics such as sedation and paralysis, resulting in both individual and collective benefits in terms of use of scarce critical care resources.

ReferenceCitation: Ehrmann S, Li J, Ibarra-Estrada M, Perez Y, Pavlov I, McNicholas B, Roca O, Mirza S, Vines D, Garcia-Salcido R, Aguirre-Avalos G, Trump MW, Nay MA, Dellamonica J, Nseir S, Mogri I, Cosgrave D, Jayaraman D, Masclans JR, Laffey JG, Tavernier E; Awake Prone Positioning Meta-Trial Group. Awake prone positioning for COVID-19 acute hypoxaemic respiratory failure: a randomised, controlled, multinational, open-label meta-trial. Lancet Respir Med. 2021 Dec;9(12):1387-1395. doi: 10.1016/S2213-2600(21)00356-8. Epub 2021 Aug 20.

ReferenceCitation: Tavernier E, McNicholas B, Pavlov I, Roca O, Perez Y, Laffey J, Mirza S, Cosgrave D, Vines D, Frat JP, Ehrmann S, Li J. Awake prone positioning of hypoxaemic patients with COVID-19: protocol for a randomised controlled open-label superiority meta-trial. BMJ Open. 2020 Nov 11;10(11):e041520. doi: 10.1136/bmjopen-2020-041520.

repository_institution: Universitat Autònoma de Barcelona - Dipòsit Digital de Documents de la UAB

repositories_concat: PubMed Central;ddd.uab.cat

ipd_sharing_description: Individual participant data after de-identification can be obtained by contacting the corresponding author.

lead_sponsor: University Hospital, Tours

location_facility: Medical Intensive Care Unit, Hospital, Béthune

location_facility: Medical Intensive Care Unit, University Hospital, Amiens

location_facility: Intensive Care Unit, Hospital, La Roche-sur-Yon

location_facility: Medical Intensive Care Unit, University Hospital, Poitiers

location_facility: Medical Intensive Care Unit, University Hospital, Nancy

location_facility: Intensive Care Unit, University Hospital, Lille

location_facility: Medical Intensive Care Unit, University Hospital, Grenoble

location_facility: Medical Intensive Care Unit, University Hospital, Brest

location_facility: Medical Intensive Care Unit, University Hospital, Tours

location_facility: Surgical Intensive Care Unit, University Hospital, Tours

location_facility: Medical Intensive Care Unit, University Hospital, Dijon

location_facility: Medical Intensive Care Unit, University Hospital, Caen

location_facility: Intensive Care Unit, University Hospital, Aix

location_facility: Intensive Care Unit, Hospital, Argenteuil

location_facility: Medical Intensive Care Unit, University Hospital, Nice

location_facility: Medical Intensive Care Unit, Hospital, Orléans

location_facility: Medical Intensive Care Unit, University Hospital, Nantes


title: Chronic Hypertension and Acetyl Salicylic Acid in Pregnancy, a Multicenter Prospective Randomized Double-blind Placebo-controlled Trial.

acronym: CHASAP

summary: A randomized clinical trial to assess the efficiency of acetylsalicylic acid (aspirin) 150 mg/day started before 20 weeks of gestation in the prevention on maternal and fœtal complications in pregnant women with chronic hypertension.

sponsor_collaborators: Centre Hospitalier Intercommunal Creteil

location_facility: Centre Hospitalier Intercommunal de Créteil

acronyme: CHASAP

titre: Prévention des complications de l'hypertension chronique pendant la grossesse par l'aspirine à faible dose: essai multicentrique contrôlé randomisée en double aveugle.

discipline_principale: obstétrique

nom_porteur: HADDAD

prenom_porteur: Bassam


title: A National, Multicenter, Randomized Controlled Trial to Assess the Efficacy of a Physical Activity Program to Improve Quality of Life and Reduce Fatigue in Women With Metastatic Breast Cancer

summary:
INTRODUCTION: Patients with a metastatic breast cancer suffer from a deteriorated quality of life and numerous symptoms such as pain, severe fatigue and a decrease of their physical fitness. As the feasibility of a physical activity program has been demonstrated in this population, ABLE02 aims to assess the efficacy of a 6 month-physical activity program based on connected devices to improve health-related quality of life and to reduce fatigue in women with metastatic breast cancer.

METHODS/ANALYSIS: ABLE02 is a prospective, multicenter, randomized, controlled and, open-label study. 244 patients with a metastatic breast cancer , at least one positive hormone receptor and a first-line chemotherapy planned will be randomly assigned (1:1 ratio) to: (i) the intervention arm to receive physical activity recommendations, an activity tracker to wear 24 hours a day during the whole intervention (6 months) with at least three walking sessions weekly and quizzes to answer each week on physical activity and nutrition (ii) the control arm to receive physical activity recommendations only. Assessments will be conducted at baseline, M3, M6, M12 and M18 to evaluate the clinical, physical, biological and psychological parameters and survival of participants. All questionnaires will be completed on a dedicated application.

DISCUSSION: An activity program based on smartphone application linked to an activity tracker may help to improve quality of life and reduce fatigue of patients with a metastatic breast cancer. The growth of e-health offers the opportunity to get real-time data as well as improving patient empowerment in order to change long-term behaviors.

ReferenceCitation: Delrieu L, Anota A, Tredan O, Freyssenet D, Maire A, Canada B, Fournier B, Febvey-Combes O, Pilleul F, Bouhamama A, Caux C, Joly F, Fervers B, Pialoux V, Perol D, Perol O. Design and methods of a national, multicenter, randomized and controlled trial to assess the efficacy of a physical activity program to improve health-related quality of life and reduce fatigue in women with metastatic breast cancer: ABLE02 trial. BMC Cancer. 2020 Jul 3;20(1):622. doi: 10.1186/s12885-020-07093-9.

collaborators:
Fondation ARC
Janssen, LP

sponsor_collaborators:
Centre Leon Berard
Fondation ARC
Janssen, LP

location_facility: Institut de Cancérologie Lucien Neuwirth (ICLN)

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


acronym: ICAR

lead_sponsor: Centre Hospitalier St Anne

summary: As of 30/03/2020, 715600 people have been infected with COVID-19 worldwide and 35500 people died, essentially due to respiratory distress syndrome (ARDS) complicated in 25% of the with acute renal failure. No specific pharmacological treatment is available yet. The lung lesions are related to both the viral infection and to an intense inflammatory reaction. Because of it's action, as an immunomodulatory agent that can attenuate the inflammatory reaction and also strengthen the antiviral response, it is proposed to evaluate the effectiveness and safety of intravenous immunoglobulin administration (IGIV) in patients developing ARDS post-SARS-CoV2. IGIV modulates immunity, and this effect results in a decrease of pro-inflammatory activity, key factor in the ARDS related to the COVID-19. It should be noted that IGIV is part of the treatments in various diseases such as autoimmune and inflammatory diffuse interstitial lung diseases. In addition, they have been beneficial in the post-influenza ARDS but also have been in 3 cases of post-SARS-CoV2 ARDS. IGIV is a treatment option because it is well tolerated, especially concerning the kidney. These elements encourage a placebo-controlled trial testing the benefit of IGIV in ARDS post-SARS-CoV2.

ReferenceCitation: Xu Z, Shi L, Wang Y, Zhang J, Huang L, Zhang C, Liu S, Zhao P, Liu H, Zhu L, Tai Y, Bai C, Gao T, Song J, Xia P, Dong J, Zhao J, Wang FS. Pathological findings of COVID-19 associated with acute respiratory distress syndrome. Lancet Respir Med. 2020 Apr;8(4):420-422. doi: 10.1016/S2213-2600(20)30076-X. Epub 2020 Feb 18. No abstract available. Erratum In: Lancet Respir Med. 2020 Feb 25;:

license: unspecified-oa

license_normalized: unspecified-oa

ReferenceCitation: Chaigne B, Mouthon L. Mechanisms of action of intravenous immunoglobulin. Transfus Apher Sci. 2017 Feb;56(1):45-49. doi: 10.1016/j.transci.2016.12.017. Epub 2016 Dec 30.

ReferenceCitation: Arish N, Eldor R, Fellig Y, Bogot N, Laxer U, Izhar U, Rokach A. Lymphocytic interstitial pneumonia associated with common variable immunodeficiency resolved with intravenous immunoglobulins. Thorax. 2006 Dec;61(12):1096-7. doi: 10.1136/thx.2004.029819.

ReferenceCitation: Oates-Whitehead RM, Baumer JH, Haines L, Love S, Maconochie IK, Gupta A, Roman K, Dua JS, Flynn I. Intravenous immunoglobulin for the treatment of Kawasaki disease in children. Cochrane Database Syst Rev. 2003;2003(4):CD004000. doi: 10.1002/14651858.CD004000.

ReferenceCitation: Alejandria MM, Lansang MA, Dans LF, Mantaring JB 3rd. Intravenous immunoglobulin for treating sepsis, severe sepsis and septic shock. Cochrane Database Syst Rev. 2013 Sep 16;2013(9):CD001090. doi: 10.1002/14651858.CD001090.pub2.

ReferenceCitation: Mazeraud A, Jamme M, Mancusi RL, Latroche C, Megarbane B, Siami S, Zarka J, Moneger G, Santoli F, Argaud L, Chillet P, Muller G, Bruel C, Asfar P, Beloncle F, Reignier J, Vinsonneau C, Schimpf C, Amour J, Goulenok C, Lemaitre C, Rohaut B, Mateu P, De Rudnicki S, Mourvillier B, Declercq PL, Schwebel C, Stoclin A, Garnier M, Madeux B, Gaudry S, Bailly K, Lamer C, Aegerter P, Rieu C, Sylla K, Lucas B, Sharshar T. Intravenous immunoglobulins in patients with COVID-19-associated moderate-to-severe acute respiratory distress syndrome (ICAR): multicentre, double-blind, placebo-controlled, phase 3 trial. Lancet Respir Med. 2022 Feb;10(2):158-166. doi: 10.1016/S2213-2600(21)00440-9. Epub 2021 Nov 11.

ReferenceCitation: Mazeraud A, Goncalves B, Aegerter P, Mancusi L, Rieu C, Bozza F, Sylla K, Siami S, Sharshar T. Effect of early treatment with polyvalent immunoglobulin on acute respiratory distress syndrome associated with SARS-CoV-2 infections (ICAR trial): study protocol for a randomized controlled trial. Trials. 2021 Feb 28;22(1):170. doi: 10.1186/s13063-021-05118-7.

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

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

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

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

sponsor_collaborators: Groupe Hospitalier Universitaire Paris psychiatrie & neurosciences

sponsor_collaborators: Laboratoire français de Fractionnement et de Biotechnologies

location_facility: Service de Médecine Intensive-Réanimation, CHU

location_facility: CHU Pitié Salpétriere Service de réanimation chirurgicale

location_facility: Grand hopital de l'est Francilien - site de Jossigny

location_facility: Pôle de Médecine intensive/réanimation Hôpital Salengro, CHRU de Lille

location_facility: Hôpital de la Croix Rousse Novembre 2019

location_facility: Service de réanimation polyvalente, rond point de Girac

title: Value of Early Treatment With Polyvalent Immunoglobulin in the Management of Acute Respiratory Distress Syndrome Associated With SARS-CoV-2 Infections


title: MAZEPPA: Phase II PRODIGE-GERCOR Study to Evaluate MAintenance Therapy With Olaparib or Selumetinib Plus Durvalumab According to BRCAness and KRAS Somatic Status Personalized in Metastatic Pancreatic Adenocarcinoma Patients

summary:
MAZEPPA is open-label, phase II study to assess the efficacy of a genomic-driven maintenance therapy in terms of PFS in Pancreatic ductal adenocarcinoma (PDAC) patients with disease controlled after 4 months of mFOLFIRINOX chemotherapy as following:

Patients with a BRCAness somatic profile: olaparib Arm A. Patients with no BRCAness profile and with KRAS mutation randomization between durvalumab plus selumetinib Arm B, versus FOLFIRI Arm C.

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility:
Hôpital Européen Georges Pompidou
Hôpital Saint Joseph Saint Luc
CHRU Jean Minjoz
Institut Mutualiste Montsouris
ICO Site de Saint Herblain
CHU Grenoble Alpes Hôpital Michallon
Institut Sainte Catherine
Hôpital Nord Franche Comté
GHPSO Site de Creil
Hôpital Pitié Salpêtrière
CHU La Timone
Hôpital Trousseau
CHU Dijon
Hôpital Privé Jean Mermoz
CHU Robert Debré
Centre Paul Strauss
Centre Georges François Leclerc
Hôpital Franco-Britannique
Institut Paoli Calmette
centre Léon Bérard
CHRU Lille
CHU Toulouse IUCT Rangueil
Hôpital Européen
Centre François Baclesse
Hôpital Saint Antoine
Polyclinique Bordeaux Nord Aquitaine
CHU Poitiers
Hôpital Beaujon
GH Diaconesses Croix Saint Simon


title: Prospective Descriptive Study on the Evolution of Pulmonary Ultrasound in Patients Hospitalized for Covid19

summary:
Clinical thoracic ultrasound plays an important role in the exploration, diagnosis and follow-up of thoracic pathologies.

The COVID (Coronavirus Disease) epidemic is leading to a large influx of patients in the emergency department with respiratory disorders. The rapid diagnosis of respiratory disorders in infected patients is important for further management.

Chest ultrasound has already demonstrated its value in the diagnosis of pneumonia in the emergency department with superiority over chest X-ray.

However, there is little data on the thoracic ultrasound semiology of viral pneumonia in general and of COVID in particular.