title: MInimal Residual Disease Adapted Strategy: Frontline Therapy for Patients Eligible for Autologous Stem Cell Transplantation Less Than 66 Years; a Prospective Study

acronym: MIDAS

summary: IFM 2020-02 will enroll patients eligible for ASCT less than 66 years. All patients will receive induction based on 6 cycles (28-day) of KRD-Isatuximab (Isa-KRD), in order to achieve deep responses and high MRD negativity rates. Patients will be classified at diagnosis according to cytogenetics (standard vs high-risk cytogenetics defined by the LP score including 17p deletion, t(4;14), del(1p32), gain 1q, trisomy 21 and trisomy 5).

lead_sponsor: Intergroupe Francophone du Myelome

location_facility: CHRU - Hôpital du Haut Lévêque - Centre François Magendie

location_facility: Centre Hospitalier d'Argenteuil Victor Dupouy

location_facility: Centre Hospitalier Intercommunal de Cornouaille

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: CHRU Hôpital Haut Lévêque - Centre François Magendie

location_facility: Centre Hospitalier Universitaire (CHU) de Limoges

location_facility: CHV André Mignot - Université de Versailles

location_facility: CHU Poitiers - Pôle régional de Cancérologie


title: Constitution and Analysis of a Cohort of Patients Followed in Pain Clinics and at Home in Real Life

acronym: e-DOL cohort

summary:
Chronic pain affects approximately 20% of adults, 50% of the elderly population and over 1.5 billion people worldwide. Societal and economic issues are also crucial, as 60% of people with pain are less able or unable to work and 20% say they have lost their jobs because of pain. The overall cost of chronic pain is estimated at around 300 billion euros in the EU. Unfortunately, current treatments for chronic pain have limited effectiveness and important adverse effects. Pain clinics, which support the most complex and refractory cases of chronic pain, as well as general practitioners and patients expect improvements, both in terms of therapeutic efficacy and organization of care.

In order to allow the characterization and a personalized follow-up of chronic pain patients, we have created e-DOL, a smartphone application for patients and a web platform for healthcare professionals in pain clinics. The purpose of this study is to create an e-cohort for the research, and characterization and follow-up of chronic pain patients.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility:
APHP Ambroise Paré
Groupe Hospitalier Paris Saint Joseph
CHU bordeaux
Clermont-Ferrand University Hospital
CHU Limoges
Hôpital Civil de Strasbourg
Hospices civils Lyon
CHU Nîmes
Chu Rouen
Ch Lons Le Saunier
CHU Saint Etienne
CH Voiron
Chu Toulouse
CH Bayeux
APHP Saint Antoine
CHU Grenoble
CHU Nantes
APHP Cochin
CHU Rennes
CHU Amiens

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Ongoing


title: Impact of a Process Optimizing the Decision to Continue or Stop Cancer Treatments in Patients With Advanced Non-small Cell Lung Cancer.

summary: Sequential comparative prospective interventional study evaluating the impact of the use of an optimization device of the decision of cancer treatment on aggressiveness of end of life care. Comparison between a first period, period (A), of care as usual and a second period, period (B), of systematic and iterative use of a device for optimizing the decision to continue an anti-cancer treatment.

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Supportive Care

lead_sponsor: Institut Curie

location_facility:
AP-HP Tenon
AP-HP Cochin
AP-HP Bichat
Institut Curie
CHRU Lille
Clinique Tessier
CHU Amiens - Hôpital Sud
CHI de Compiègne-Noyon
Institut Sainte-Catherine
CHU Sud Francilien
CH Intercommunal de Créteil
Hôpital Foch
CH du Pays d'Aix
CHU Grenoble Alpes
CH Saint-Malo
CHD Vendée
CH Henri Duffaut Avignon
AP-HP Ambroise Paré
CHU Angers
Centre Léon Bérard
CH Abbeville
CHR Metz-Thionville - Hôpital de Mercy
Clinique des Cèdres
HP-HM Marseille


title: Frequency of SOD1 and C9orf72 Gene Mutations in French ALS

acronym: GENIALS

summary: The purpose of the study is to determine the frequency of mutations in the C9orf72 and SOD1 genes in the incident population of ALS patients followed in the FILSLAN centres

ipd_sharing: Undecided

lead_sponsor: University Hospital, Tours

location_facility: Paris - Groupe hospitalier de la Pitié Salpetrière

intervention_type: Genetic


title: Analysis of the Immune Parameters Involved in the Onset and Fate of SARS-CoV-2 Infection in Patients With Multiple Myeloma (COVIMMUNOMM) COVID-19 and Multiple Myeloma

acronym: Covimmunomm

summary: Among all MM patients included in the cohort at the time of diagnosis of SARS-CoV-2 infection, blood samples will be collected at inclusion, at time of the infection acute phase in the most severe cases (when admitted in intensive care units), and at recovery. The following immune function tests will be evaluated, gammaglobulin measurements, lymphocytes counts, B, T, and NK cells analyses by cytometry, including exhaustion analyses. In addition, T cell repertoire sequencing looking for SARS-CoV-2- specific T cells, and serologies, will be evaluated at recovery and 6 months after MM treatment re-initiation.

primary_purpose: Diagnostic

ipd_sharing: No

location_facility: CH Bretagne Atlantique Vannes et Auray-P.Chubert

location_facility: Institut Daniel Hollard - Groupe Hospitalier Mutualiste de Grenoble

lead_sponsor_type: industriel


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. Review.

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. Review.

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.

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.

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. Review.

ReferenceCitation: Avouac J, Fürnrohr 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.

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.

design_allocation: Randomized

intervention_type: Drug

status: Not yet recruiting

study_start_date_type: Anticipated

lead_sponsor: Assistance Publique - Hôpitaux de Paris

primary_purpose: Treatment

acronym: SCLERITA

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

type: EudraCT Number

source: euctr

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

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


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 Hopsitalier de l'Est Francilien - Site de Meaux

location_facility: Centre Hospitalier de Versailles André Mignot


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

location_facility: Adolphe de Rothschild Ophthalmological Foundation


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, Rödel 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: Rödel C, Graeven U, Fietkau R, Hohenberger W, Hothorn T, Arnold D, Hofheinz RD, Ghadimi M, Wolff HA, Lang-Welzenbach M, Raab HR, Wittekind C, Ströbel 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. Review.

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.

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.

family: Rouanet

full_name: Philippe Rouanet

given: Philippe

sequence: first

family: Rullier

full_name: Eric Rullier

given: Eric

sequence: additional

family: Lelong

full_name: Bernard Lelong

given: Bernard

family: Maingon

full_name: Philippe Maingon

family: Tuech

full_name: Jean-Jacques Tuech

given: Jean-Jacques

family: Pezet

full_name: Denis Pezet

given: Denis

family: Castan

full_name: Florence Castan

given: Florence

family: Nougaret

full_name: Stéphanie Nougaret

given: Stéphanie

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Diseases of the Colon & Rectum

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: 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.

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, Rödel C. Outcome measures in multimodal rectal cancer trials. Lancet Oncol. 2020 May;21(5):e252-e264. doi: 10.1016/S1470-2045(20)30024-3. Review.

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

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

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).


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

intervention_type: Procedure


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.

lead_sponsor: Hospices Civils de Lyon

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

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

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

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

location_facility: CHU de Bordeaux, Service de Médecine Buccodentaire

location_facility: Hospices Civils de Lyon, Service d'Odontologie


lead_sponsor: ARCAGY/ GINECO GROUP

acronym: TEDOVA

location_facility: Groupe Hospitalier Diaconesses-Croix Saint-Simon

location_facility: Institut de Cancérologie de Strasbourg Europe - ICANS

type: Other Identifier

title: Randomized Phase II Study Comparing Neo-epitope Based Vaccine OSE2101 (TEDOPI®) With or Without Anti-PD1 (Pembrolizumab) Versus Best Supportive Care as Maintenance Treatment in Platinum-sensitive Recurrent Ovarian Cancer Patient With Controlled Disease After Platinum-based Chemotherapy

summary:
The proposed study is an international randomized phase II, multicenter, open-label, three arms trial to assess best supportive care (BSC) vs OSE2101 and vs OSE2101 + pembrolizumab as maintenance treatment for patients with platinum sensitive relapsed ovarian cancers, previously treated with 1 to 2 lines of chemotherapy, bevacizumab (if eligible) and a PARP inhibitor (if eligible).

Patients in Complete Response, Partial Response, or Stable Disease at the end of chemotherapy with at least 4 cycles of platinum based chemotherapy will be randomized in one of the three arms (randomization 1:1:2). They will receive one or the two study treatments or BSC until progression , or intolerance, or up to 2 years (from 1st study treatment dose).


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 et Hematologie (ICH) - CHRU Brest, Hopital Morvan

location_facility: Institut Universitaire du Cancer Toulouse Oncopole

location_facility: Institut de Cancérologie Strasbourg Europe


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


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 treatments.

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

location_facility: PARIS Fondation Ophtalmologique Adolphe de Rothschild

location_facility: MONTPELLIER CHU Hopital Arnaud De Villeneuve

intervention_type: Device


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.

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


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

enrollment_type: Actual

lead_sponsor: Laboratoires Coloplast S.A.S

location_facility: Centre Hospitalier Intercommunal Eure Seine

location_facility: Centre Hospitalier Universitaire La Miletrie

location_facility: Centre Hospitalier Annecy Genevois Site Annecy

location_facility: Centre Hospitalier Du Cotentin Site de Cherbourg

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: Nouvel Hôpital Civil - Hôpitaux Universitaires de Strasbourg

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Centre Hospitalier de Villefranche-sur-Saône


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

lead_sponsor: University Hospital, Rouen

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


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

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


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.

location_facility: CHRU de Besançon - Service de Médecine Intensive Réanimation

location_facility: CHR Orléans Service de Médecine Intensive Réanimation

location_facility: Institut Mutualiste Montsouris Service de Réanimation Polyvalente

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

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

location_facility: Hôpital DELAFONTAINE Service de Médecine Intensive Réanimation

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

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

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

location_facility: Hôpital Bicêtre - Service de Médecine Intensive Réanimation

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

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

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

location_facility: Centre Hospitalier Sud Francilien - Service de réanimation

location_facility: Hôpital Tenon - Service de Médecine Intensive Réanimation

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

location_facility: Hôpital Pitié Salpêtrière - Intensive care unit


title: Phase III Postneoadjuvant Study Evaluating Sacituzumab Govitecan, an Antibody Drug Conjugate in Primary HER2-negative Breast Cancer Patients With High Relapse Risk After Standard Neoadjuvant Treatment - SASCIA

summary:
Phase III, prospective, multi-center, randomized, open label, parallel group, study in patients with HER2-negative breast cancer with residual disease after neoadjuvant chemotherapy with 1:1 allocation to:

Arm A: Sacituzumab govitecan (days 1, 8 q3w for eight cycles);
Arm B: treatment of physician´s choice (TPC, defined as capecitabine or platinum-based chemotherapy for eight cycles or observation.

Treatment in either arm will be given for eight cycles.

In patients with HR-positive breast cancer, endocrine-based therapy will be administered according to local guidelines. The start of endocrine therapy will be at the discretion of the investigator; however, it will be encouraged to start after surgery/radiotherapy in patients without additional cytotoxic agents.

lead_sponsor: German Breast Group

location_country: Germany Ireland France

location_facility: Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden

location_facility: Hochwaldkrankenhaus, Gesundheitszentrum Wetterau gGmbH

location_facility: Sozialstiftung Bamberg, Klinik am Bruderwald

location_facility: Praxisklinik für Hämatologie und Onkologie

location_facility: St. Elisabeth-Krankenhaus, Brustzentrum Köln-Hohenlind

location_facility: Uniklinikum, Klinik für Geburtshilfe und Gynäkologie

location_facility: Hôpital Privé Des Côtes d'Armor- Centre CARIO-HPCA

location_facility: Institut de Cancérologie Strasbourg Europe-ICANS

location_facility: Gemeinschaftspraxis Dres. Heinrich / Bangerter

location_facility: Gemeinschaftspraxis Dr. U. Kronawitter/ Dr. C. Jung

location_facility: MVZ Nordhausen gGmbH im Südharz Krankenhaus

location_facility: SRH Wald-Klinikum Gera gGmbH, Brustzentrum Ostthüringen

location_facility: Centrum für Hämatologie und Onkologie am Bethanien-Krankenhaus

location_facility: Onkologische Schwerpunktpraxis, Studiengesellschaft Onkologie Bielefeld GbR

location_facility: Groupe Hospitalier Diaconesses Croix Saint Simon

location_facility: Schwerpunktpraxis der Gynäkologie und Onkologie

location_facility: Kliniken Essen-Mitte Evang. Huyssens-Stiftung/Knappschaft GmbH

location_facility: Charité Universitätsmedizin Campus Charité Mitte

location_facility: Institut régional du Cancer de Montpellier - ICM Val d'Aurelle

location_facility: Klinikum Kassel GmbH, Gynäkologische Ambulanz

location_facility: Institut de cancérologie de l'ouest (Angers)


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.

ReferenceType: derived

ReferenceCitation: Descourt R, Chouaid C, Pérol 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.

name: Cancer institue, A. Morvan Hospital, CHRU, 29200, Brest, France

family: Descourt

full_name: Renaud Descourt

given: Renaud

name: Department of Pneumology, CHI Créteil, 94000, Créteil, France

name: Inserm U955, UPEC, IMRB, équipe CEpiA, 94000, Créteil, France

family: Chouaid

full_name: Christos Chouaid

given: Christos

name: Léon-Bérard Anticancer Center, 69008, Lyon, France

family: Pérol

full_name: Maurice Pérol

given: Maurice

name: Department of Cancer Medicine, Gustave Roussy, Villejuif, Université Paris-Saclay, Orsay, 94805, Villejuif, France

family: Besse

full_name: Benjamin Besse

given: Benjamin

name: Department of Multidisciplinary Oncology & Therapeutic Innovations, APHM, Hôpital Nord, Aix-Marseille, University, 13000, Marseille, France

family: Greillier

full_name: Laurent Greillier

given: Laurent

name: Department of Pneumology, Military hospital, Sainte-Anne, 83800, Toulon, France

family: Bylicki

full_name: Olivier Bylicki

given: Olivier

name: Department of Pneumology, CHRU, 35000, Rennes, France

family: Ricordel

full_name: Charles Ricordel

given: Charles

name: Pneumology, Thoracic Oncology & Respiratory Intensive Care Medicine & CIC INSERM U 1404, Rouen University Hospital, 76000, Rouen, France

family: Guisier

full_name: Florian Guisier

given: Florian

name: Francois Baclesse Anticancer Center, 14000, Caen, France

family: Gervais

full_name: Radj Gervais

given: Radj

name: Paul Strauss Anticancer Center, 67000, Strasbourg, France

family: Schott

full_name: Roland Schott

given: Roland

family: Auliac

full_name: Jean-Bernard Auliac

given: Jean-Bernard

family: Robinet

full_name: Gilles Robinet

given: Gilles

name: Department of Pneumology & Thoracic Oncology, CH Annecy-Genevois, 74370, Metz-Tessy, France

family: Decroisette

full_name: Chantal Decroisette

given: Chantal

journal_name: Future Oncology

publisher: Future Medicine Ltd

publisher_dissemination: Future Science Ltd

publisher_group: Future Science Ltd

publisher_normalized: Future Science Ltd

title: First-line pembrolizumab with or without platinum doublet chemotherapy in non-small-cell lung cancer patients with PD-L1 expression ≥50%

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

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

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

location_facility: Institut de Cancérologie Strasbourg Europe

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.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

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

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

location_facility: Hôpitaux civils de Lyon, Hôpital Edouard Herriot

location_facility: Intesive Care Unit CHRU de Strasbourg, Hôpital Hautepierre

location_facility: CHU de Montpellier, Hôpital St Eloi SAR B

location_facility: Intensive care Unit CHU de Brest Hôpital Cavale Blanche

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

location_facility: AP-HM, Hôpital Timone adultes, Neurotraumatology

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

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

location_facility: Intesive Care Unit CHRU de Strasbourg, Hôpital civil

location_facility: Hôpitaux civils de Lyon, Hôpital Louis Pradel

location_facility: Intensive CAre Unit CHRU de Nancy, Hôpital Central

location_facility: CHU de Montpellier, Hôpital Guy de chauliac

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

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


lead_sponsor: UNICANCER

acronym: SOREGATT

location_facility: APHP - Hôpital Européen Georges Pompidou

location_facility: Hôpital Privé des Côtes d'Armor - Centre CARIO-HPCA

title: A Randomized, Phase II Study Comparing the Sequences of Regorafenib and Trifluridine/Tipiracil, After Failure of Standard Therapies in Patients With Metastatic Colorectal Cancer

summary: A randomized, phase II study comparing the sequences of regorafenib and trifluridine/tipiracil, after failure of standard therapies in patients with metastatic colorectal cancer


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.

lead_sponsor: Rennes University Hospital

location_facility: APHP Hopital Européen Georges Pompidou - Paris University Hospital

location_facility: APHP Henri Mondor Paris University Hospital

location_facility: APHM la Timone- Marseille University Hospital

location_facility: Toulouse University Hospital - Rangueil Hospital

location_facility: APHP Kremli Bicetre Paris University Hospital

location_facility: APHP La Pitié Salpêtrière Paris 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.

status: Active, not recruiting

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_facility: PRIVE - Institut de Cancérologie de Bourgogne GRReCC

location_facility: CHR - Centre Hospitalier Régional La Source

location_facility: CH - Germon et Gauthier - Service de Gastroentérologie

location_facility: PRIVE - La Louvière Institut de Cancérologie Lille Métropole

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

location_facility: Groupe Hospitalier Diaconesses Croix Saint Simon

location_facility: PRIVE - Clinique Mutualiste de l'Estuaire

location_facility: ICAN - Institut de Cancérologie de Strasbourg Europe


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: Martinique France Mayotte Réunion

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, Tadié JM, Reizine F, Houzé 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, Mégarbane 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, François N, Richard JC, Paulus S, Argaud L, Dupont D, Menotti J, Morio F, Soulié 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. 2021 Nov 26. pii: S2213-2600(21)00442-2. doi: 10.1016/S2213-2600(21)00442-2. [Epub ahead of print]

family: Gangneux

full_name: Jean-Pierre Gangneux

given: Jean-Pierre

family: Dannaoui

full_name: Eric Dannaoui

given: Eric

family: Fekkar

full_name: Arnaud Fekkar

given: Arnaud

family: Luyt

full_name: Charles-Edouard Luyt

given: Charles-Edouard

family: Botterel

full_name: Françoise Botterel

given: Françoise

family: De Prost

full_name: Nicolas De Prost

given: Nicolas

family: Tadié

full_name: Jean-Marc Tadié

given: Jean-Marc

family: Reizine

full_name: Florian Reizine

family: Houzé

full_name: Sandrine Houzé

given: Sandrine

family: Timsit

full_name: Jean-François Timsit

given: Jean-François

family: Iriart

full_name: Xavier Iriart

given: Xavier

family: Riu-Poulenc

full_name: Béatrice Riu-Poulenc

given: Béatrice

family: Sendid

full_name: Boualem Sendid

given: Boualem

family: Nseir

full_name: Saad Nseir

given: Saad

family: Persat

full_name: Florence Persat

family: Wallet

full_name: Florent Wallet

given: Florent

family: Le Pape

full_name: Patrice Le Pape

given: Patrice

family: Canet

full_name: Emmanuel Canet

given: Emmanuel

family: Novara

full_name: Ana Novara

given: Ana

family: Manai

full_name: Melek Manai

given: Melek

family: Cateau

full_name: Estelle Cateau

given: Estelle

family: Thille

full_name: Arnaud W Thille

given: Arnaud W

family: Brun

full_name: Sophie Brun

given: Sophie

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


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.

family: Assaad

full_name: Souad Assaad

given: Souad

family: Zrounba

full_name: Philippe Zrounba

given: Philippe

family: Cropet

full_name: Claire Cropet

given: Claire

family: Blay

full_name: Jean-Yves Blay

given: Jean-Yves

journal_name: British Journal of Cancer

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

repository_normalized: PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Centre Leon Berard

location_facility: Groupement Hospitalier Porte de Provence

location_facility: Institut Universitaire du Cancer de Toulouse - IUCT Oncopole

location_facility: Institut de cancérologie Strasbourg Europe (ICANS)


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.

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.

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;:.

family: Huang

full_name: Chaolin Huang

given: Chaolin

family: Wang

full_name: Yeming Wang

given: Yeming

family: Li

full_name: Xingwang Li

given: Xingwang

family: Ren

full_name: Lili Ren

given: Lili

family: Zhao

full_name: Jianping Zhao

given: Jianping

family: Hu

full_name: Yi Hu

given: Yi

family: Zhang

full_name: Li Zhang

given: Li

family: Fan

full_name: Guohui Fan

given: Guohui

family: Xu

full_name: Jiuyang Xu

given: Jiuyang

family: Gu

full_name: Xiaoying Gu

given: Xiaoying

family: Cheng

full_name: Zhenshun Cheng

given: Zhenshun

family: Yu

full_name: Ting Yu

given: Ting

family: Xia

full_name: Jiaan Xia

given: Jiaan

family: Wei

full_name: Yuan Wei

given: Yuan

family: Wu

full_name: Wenjuan Wu

given: Wenjuan

family: Xie

full_name: Xuelei Xie

given: Xuelei

family: Yin

full_name: Wen Yin

given: Wen

full_name: Hui Li

given: Hui

family: Liu

full_name: Min Liu

given: Min

family: Xiao

full_name: Yan Xiao

given: Yan

family: Gao

full_name: Hong Gao

given: Hong

family: Guo

full_name: Li Guo

full_name: Jungang Xie

given: Jungang

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.

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

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

location_facility: CH de PERPIGNAN - Service Maladies infectieuses

location_facility: HOPITAL LARIBOISIERE - Service diabétologie, endocrinologie, nutrition


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 Aug 20. pii: S2213-2600(21)00356-8. doi: 10.1016/S2213-2600(21)00356-8. [Epub ahead of print]

family: Ehrmann

full_name: Stephan Ehrmann

given: Stephan

family: Li

full_name: Jie Li

given: Jie

family: Ibarra-Estrada

full_name: Miguel Ibarra-Estrada

given: Miguel

family: Perez

full_name: Yonatan Perez

given: Yonatan

family: Pavlov

full_name: Ivan Pavlov

given: Ivan

family: McNicholas

full_name: Bairbre McNicholas

given: Bairbre

family: Roca

full_name: Oriol Roca

given: Oriol

family: Mirza

full_name: Sara Mirza

given: Sara

family: Vines

full_name: David Vines

given: David

family: Garcia-Salcido

full_name: Roxana Garcia-Salcido

given: Roxana

family: Aguirre-Avalos

full_name: Guadalupe Aguirre-Avalos

given: Guadalupe

family: Trump

full_name: Matthew W Trump

given: Matthew W

family: Nay

full_name: Mai-Anh Nay

given: Mai-Anh

family: Dellamonica

full_name: Jean Dellamonica

given: Jean

family: Nseir

full_name: Saad Nseir

given: Saad

family: Mogri

full_name: Idrees Mogri

given: Idrees

family: Cosgrave

full_name: David Cosgrave

family: Jayaraman

full_name: Dev Jayaraman

given: Dev

family: Masclans

full_name: Joan R Masclans

given: Joan R

family: Laffey

full_name: John G Laffey

given: John G

family: Tavernier

full_name: Elsa Tavernier

given: Elsa

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.

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

location_facility: Intensive Care Unit, University Hospital, Lille

location_facility: Medical Intensive Care Unit, University Hospital, Nancy

location_facility: Medical Intensive Care Unit, University Hospital, Nantes

location_facility: Medical Intensive Care Unit, Hospital, Béthune

location_facility: Surgical Intensive Care Unit, University Hospital, Tours

location_facility: Intensive Care Unit, University Hospital, Aix

location_facility: Medical Intensive Care Unit, University Hospital, Tours

location_facility: Medical Intensive Care Unit, University Hospital, Grenoble

location_facility: Medical Intensive Care Unit, University Hospital, Nice

location_facility: Intensive Care Unit, Hospital, Argenteuil

location_facility: Medical Intensive Care Unit, University Hospital, Amiens

location_facility: Medical Intensive Care Unit, University Hospital, Dijon

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

location_facility: Medical Intensive Care Unit, University Hospital, Caen

location_facility: Medical Intensive Care Unit, Hospital, Orléans

location_facility: Medical Intensive Care Unit, University Hospital, Poitiers

location_facility: Medical Intensive Care Unit, University Hospital, Brest


family: Huang

full_name: Chaolin Huang

given: Chaolin

family: Wang

full_name: Yeming Wang

given: Yeming

family: Li

full_name: Xingwang Li

given: Xingwang

family: Ren

full_name: Lili Ren

given: Lili

family: Zhao

full_name: Jianping Zhao

given: Jianping

family: Hu

full_name: Yi Hu

given: Yi

family: Zhang

full_name: Li Zhang

given: Li

family: Fan

full_name: Guohui Fan

given: Guohui

family: Xu

full_name: Jiuyang Xu

given: Jiuyang

family: Gu

full_name: Xiaoying Gu

given: Xiaoying

family: Cheng

full_name: Zhenshun Cheng

given: Zhenshun

family: Yu

full_name: Ting Yu

given: Ting

family: Xia

full_name: Jiaan Xia

given: Jiaan

family: Wei

full_name: Yuan Wei

given: Yuan

family: Wu

full_name: Wenjuan Wu

given: Wenjuan

family: Xie

full_name: Xuelei Xie

given: Xuelei

family: Yin

full_name: Wen Yin

given: Wen

full_name: Hui Li

given: Hui

family: Liu

full_name: Min Liu

given: Min

family: Xiao

full_name: Yan Xiao

given: Yan

family: Gao

full_name: Hong Gao

given: Hong

family: Guo

full_name: Li Guo

full_name: Jungang Xie

given: Jungang

full_name: Guangfa Wang

given: Guangfa

family: Jiang

full_name: Rongmeng Jiang

given: Rongmeng

title: Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China

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. Erratum in: Lancet Respir Med. 2020 Feb 25;:.

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. Review.

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.

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;(4):CD004000. Review.

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;(9):CD001090. doi: 10.1002/14651858.CD001090.pub2. Review.

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. 2021 Nov 11. pii: S2213-2600(21)00440-9. doi: 10.1016/S2213-2600(21)00440-9. [Epub ahead of print]

ReferenceCitation: Mazeraud A, Gonçalves 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.

location_facility: CHU Pitié Salpétriere Service de réanimation chirurgicale

location_facility: Hôpital de la Croix Rousse Novembre 2019

location_facility: Service de réanimation polyvalente, rond point de Girac

location_facility: Service de Médecine Intensive-Réanimation, CHU

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

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

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

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.


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


title: French Register Of Patients With Hemopathy Eligible For CAR-T Cell Treatment

summary: This study is a registry including prospective and retrospective data on all patients who have been presented in a Multidisciplinary tumor board or RCP to be eligible for CAR-T cell treatment.

lead_sponsor: The Lymphoma Academic Research Organisation

location_facility: Institut d'Hématologie et d'Oncologie Pédiatrique (IHOP)

location_facility: Hôpital de la Milétrie - CHU de Poitiers

location_facility: Institut d'Hématologie de Basse Normandie

location_facility: ICANS (Institut de Cancérologie Strasbourg Europe)

location_facility: Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O)

location_facility: APHP - Hôpital Universitaire Robert Debré


title: Hydroxychloroquine Versus Placebo in Patients Presenting COVID-19 Infection and at Risk of Secondary Complication: a Prospective, Multicentre, Randomised, Double-blind Study

acronym: HYCOVID

summary:
A new human coronavirus responsible for pneumonia, SARS-CoV-2, emerged in China in December 2019 and has spread rapidly. COVID-19, the disease caused by this virus, has a very polymorphous clinical presentation, which ranges from upper respiratory tract infections to acute respiratory distress syndrome. It may appear serious straightaway or may evolve in two stages, with a worsening 7 to 10 days after the first clinical signs, potentially linked to a cytokine storm and accompanied by a high risk of thrombosis. The global mortality rate of COVID-19 is between 3% and 4%, with severe forms being more frequent among older patients. Management is symptomatic as no antiviral treatment has demonstrated any clinical benefit in this condition. Hydroxychloroquine is a derivative of chloroquine commonly used in some autoimmune diseases, such as systemic lupus erythematosus. It is active in vitro in cellular models of infection by many viruses such as HIV, hepatitis C or SARS-CoV. However, its interest in viral infections in humans has not been demonstrated.

Very recently, a preliminary uncontrolled study evaluated the effect of hydroxychloroquine on viral shedding in subjects with COVID-19. Among 20 patients treated with hydroxychloroquine at a dose of 600 mg per day, the percentage of patients with detectable SARS-CoV-2 RNA in the nasopharynx decreased from 100% at inclusion (start of treatment) to 43% six days later. In comparison, 15 of 16 untreated patients had a positive RT-PCR six days after inclusion. Furthermore, hydroxychloroquine has immunomodulating and anti-inflammatory properties, which could theoretically prevent or limit secondary worsening.

The research hypothesis is that treatment with hydroxychloroquine improves prognosis and reduces the risk of death or use for invasive ventilation in patients with COVID-19.

status: Terminated

ReferenceCitation: Dubée V, Roy PM, Vielle B, Parot-Schinkel E, Blanchet O, Darsonval A, Lefeuvre C, Abbara C, Boucher S, Devaud E, Robineau O, Rispal P, Guimard T, d'Anglejean E, Diamantis S, Custaud MA, Pellier I, Mercat A; HYCOVID study group; HYCOVID investigators; Angers University Hospital; Cholet Hospital; Laval Hospital; Le Mans Hospital; Tours University Hospital; Quimper Hospital; La Roche sur Yon Hospital; Tourcoing Hospital; Orléans Hospital; Nantes University Hospital; Niort Hospital; Lorient Hospital; Brest University Hospital; Cherbourg Hospital; Saint-Brieuc Hospital; Créteil - APHP University Hospital; Saint-Antoine - APHP University Hospital; Saint-Etienne University Hospital; Toulouse University Hospital; Melun Hospital; Dijon University Hospital; Princesse Grace - Monaco Hospital; Versailles Hospital; Colmar Hospital; Agen-Nerac Hospital; Caen University Hospital; Saint-Nazaire Hospital; Nantes - Confluent Hospital; Limoges University Hospital; Poitiers University Hospital; Amiens University Hospital; Bobigny - APHP University Hospital; Cergy-Pontoise Hospital; Valencienne Hospital; Valencienne - Clinique Tessier Hospital; Henri-Mondor - APHP University Hospital; Chalon-sur-Saône Hospital; Marseille European Hospital; Auxerre Hospital; Diaconnesses Croix-Saint-Simon Hospital; Marseille - Saint Joseph Hospital; HYCOVID management team: Steering committee (authors); HYCOVID management team: Independant data safety and monitoring board; HYCOVID management team: Independent adjudication of clinical events committee; Study management: Coordination; Study management: Data management. Hydroxychloroquine in mild-to-moderate coronavirus disease 2019: a placebo-controlled double blind trial. Clin Microbiol Infect. 2021 Aug;27(8):1124-1130. doi: 10.1016/j.cmi.2021.03.005. Epub 2021 Apr 1.

family: Dubée

full_name: Vincent Dubée

given: Vincent

family: Roy

full_name: Pierre-Marie Roy

given: Pierre-Marie

family: Vielle

full_name: Bruno Vielle

given: Bruno

family: Parot-Schinkel

full_name: Elsa Parot-Schinkel

given: Elsa

family: Blanchet

full_name: Odile Blanchet

given: Odile

family: Darsonval

full_name: Astrid Darsonval

given: Astrid

family: Lefeuvre

full_name: Caroline Lefeuvre

given: Caroline

family: Abbara

full_name: Chadi Abbara

given: Chadi

family: Boucher

full_name: Sophie Boucher

given: Sophie

family: Devaud

full_name: Edouard Devaud

given: Edouard

family: Robineau

full_name: Olivier Robineau

given: Olivier

family: Rispal

full_name: Patrick Rispal

given: Patrick

family: Guimard

full_name: Thomas Guimard

given: Thomas

family: d’Anglejean

full_name: Emma d’Anglejean

given: Emma

family: Diamantis

full_name: Sylvain Diamantis

given: Sylvain

family: Custaud

full_name: Marc-Antoine Custaud

given: Marc-Antoine

family: Pellier

full_name: Isabelle Pellier

given: Isabelle

family: Mercat

full_name: Alain Mercat

given: Alain

family: Brangier

full_name: Antoine Brangier

given: Antoine

family: Codron

full_name: Philippe Codron

given: Philippe

family: Lemée

full_name: Jean Michel Lemée

given: Jean Michel

family: Pichon

full_name: Virginie Pichon

given: Virginie

family: Dhersin

full_name: Robin Dhersin

given: Robin

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

location_facility:
CH Le Mans
CH Agen
CHU Poitiers
Clinique Tessier Valenciennes
Hôpital Saint-Joseph
APHP Joffre Dupuytren
CH Melun
CH Saint-Brieuc
CH Laval
APHP Emile ROUX
CHU Saint-Etienne
CHU Nantes
CH Emile Roux
CH Lorient
GH Croix Saint Simon
CH Versailles
CH Saint-Nazaire
CHU Amiens
CH Cholet
CH Quimper
CH Auxerre
CH Compiègne
CH Valenciennes
CHU Dijon
Hôpital Privé du Confluent
CH Chalon Sur Saône
CHU Brest
La Pitié-Salpétrière
CH Vannes
APHP Avicenne
CHU Toulouse
CHU Limoges
APHP Saint-Antoine
CH Intercommunal Créteil
CH Colmar
Hôpital Européen - Marseille
CHD Vendée
APHP Henri Mondor
CHU Angers
CHU Caen
CHR Orléans
CHU Tours
CH Tourcoing
CH Pointoise
CH Princesse Grace
CH Niort
CH Cherbroug


title: Interest of Peri Operative CHemotherapy In Patients With CINSARC High-risk Localized Grade 1 or 2 Soft Tissue Sarcoma

summary:
Phase III, multicenter, randomized open-label and comparative study designed to demonstrate whether adding 4 cycles of peri-operative doxorubicin-based chemotherapy improves metastasis-free survival as compared with standard management in patients with resectable FNCLCC grade 1/2 STS, considered as high-risk according to CINSARC (Complexity Index in SARComas) signature.

After signed informed consent, patients considered as eligible to CHIC-STS study by the investigator will be enrolled in the study and a molecular screening will be performed (600 patients will be screened).

Patients considered as low-risk according to CINSARC signature will be treated at the discretion of the clinicians (prospective cohort).

Patients considered as high-risk according to CINSARC signature will be randomized in the open-label multicenter phase III trial and assigned in one of the two following treatments arms:

Arm A (control arm): Standard of care (surgical excision +/- external radiotherapy).
Arm B (experimental arm): Standard of care + 4 cycles of intravenous chemotherapy during 12 weeks.

A total of 250 patients will have to be randomized with 125 patients in each arm.

ReferenceCitation: Filleron T, Le Guellec S, Chevreau C, Cabarrou B, Lesluyes T, Lodin S, Massoubre A, Mounier M, Poublanc M, Chibon F, Valentin T. Value of peri-operative chemotherapy in patients with CINSARC high-risk localized grade 1 or 2 soft tissue sarcoma: study protocol of the target selection phase III CHIC-STS trial. BMC Cancer. 2020 Jul 31;20(1):716. doi: 10.1186/s12885-020-07207-3.

family: Filleron

full_name: Thomas Filleron

family: Le Guellec

full_name: Sophie Le Guellec

family: Chevreau

full_name: Christine Chevreau

given: Christine

family: Cabarrou

full_name: Bastien Cabarrou

given: Bastien

family: Lesluyes

full_name: Tom Lesluyes

given: Tom

family: Lodin

full_name: Sabrina Lodin

given: Sabrina

family: Massoubre

full_name: Angélique Massoubre

given: Angélique

family: Mounier

full_name: Muriel Mounier

given: Muriel

family: Poublanc

full_name: Muriel Poublanc

family: Chibon

full_name: Frédéric Chibon

given: Frédéric

family: Valentin

full_name: Thibaud Valentin

given: Thibaud

currency_apc_doaj: GBP

journal_name: BMC Cancer

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

lead_sponsor: Institut Claudius Regaud

location_facility: Institut de Cancérologie de Lorraine - Centre Alexis Vautrin

location_facility: Institut Universitaire du Cancer Toulouse Oncopole

location_facility: Institut de Cancérologie Strasbourg Europe


title: EVALUATION OF HIGH INTENSITY FOCUSED ULTRASOUND (HIFU) IN CURATIVE TREATMENT OF LOCALIZED PROSTATE CANCER AT LOW OR INTERMEDIATE RISK AND IN TREATMENT OF RECURRENCE AFTER RADIOTHERAPY (FORFAIT INNOVATION ART L165-1-1 Social Security Code)

acronym: HIFI

summary:
to compare the efficacy of HIFU treatment with standard treatment in two situations:

as first-line cancer treatment, HIFU is compared to radical prostatectomy.
for patients with recurrence after external beam radiotherapy, HIFU treatment is compared to radical prostatectomy.

lead_sponsor: Association Francaise d'Urologie

location_country: France Guadeloupe

location_facility: Fondation St Jean de Dieu - Clinique Oudinot


title: A One-year, Single-arm, Open-label, Multicenter Study Assessing the Effect of Brolucizumab on Disease Control in Adult Patients With Suboptimal Anatomically Controlled Neovascular Age-related Macular Degeneration (SWIFT)

acronym: SWIFT

summary:
Neovascular age-related macular degeneration is characterized by the presence of choroidal neovascularization (CNV), which consists of abnormal blood vessels originating from the choroid that can lead to hemorrhage, fluid exudation, and fibrosis, resulting in photoreceptor damage and vision loss.

The safety and efficacy of brolucizumab were assessed in 2 randomized, multicenter, double-masked, active treatment-controlled Phase 3 studies in nAMD patients (the HAWK study (RTH258-C001 [NCT02307682]) and the HARRIER study (RTH258-C002 [NCT02434328]). Accordingly, a new Phase 3b study (TALON, CRTH258A2303) is being conducted to evaluate the efficacy and safety of brolucizumab in a Treat-to-Control (TtC) regimen for the treatment of naïve patients with nAMD. In this TtC regimen, patients receive 3 consecutive injections every 4 weeks and then the injection interval is extended by 4 weeks up to a maximum of a 16-week interval. The decision to extend or reduce the injection interval is taken by the Investigator at each visit based on his/her judgment of disease activity, according to the patient visual and/or anatomic outcomes. If there is no disease activity, the injection interval can be extended by 4 weeks ; if disease activity occurs or recurs, the injection interval should be shortened accordingly by 4 weeks at a time or to a minimal interval of 4 weeks. The injection interval can also be maintained if the Investigator deems that the patient do not benefit from injection interval adjustment.

Since all these studies were conducted in a naïve nAMD patient population, no data are available on the efficacy and safety of brolucizumab in pretreated nAMD patients who still present active exudation.

ipd_sharing_description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

lead_sponsor: Novartis Pharmaceuticals