title: Evaluation Of Efficacy Of COVID-19 Convalescent Plasma Versus Standard Plasma In The Early Care Of COVID-19 Patients Hospitalized Outside Intensive Care Units.

acronym: PLASCOSSA

summary:
COVID-19 (Corona Virus Disease 2019) hospitalized patients evolution is marked by the risk of worsening of the respiratory system during the second week of the disease. To date, treatments are currently being evaluated and none of them have shown to be effective in the care of these patients. The use of convalescent plasma is a passive immunotherapy. It has often been used in respiratory virus epidemic situations (during the 1918 or 2009 influenza pandemic, or during SARS-CoV-1 or MERS-CoV pandemic). Effects reported in literature are in favour of a beneficial impact of transfusion of these plasma without serious adverse effects reported.

PlasCoSSA is a randomized, controlled, triple-blinded, parallel clinical trial. This study tests the efficacy of convalescent plasma transfusion therapy in the early care of COVID-19 hospitalized patients outside intensive care units.

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: Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585. Erratum in: JAMA. 2021 Mar 16;325(11):1113.

ReferenceCitation: Ahn DG, Shin HJ, Kim MH, Lee S, Kim HS, Myoung J, Kim BT, Kim SJ. Current Status of Epidemiology, Diagnosis, Therapeutics, and Vaccines for Novel Coronavirus Disease 2019 (COVID-19). J Microbiol Biotechnol. 2020 Mar 28;30(3):313-324. doi: 10.4014/jmb.2003.03011. Review.

ReferenceCitation: Shen C, Wang Z, Zhao F, Yang Y, Li J, Yuan J, Wang F, Li D, Yang M, Xing L, Wei J, Xiao H, Yang Y, Qu J, Qing L, Chen L, Xu Z, Peng L, Li Y, Zheng H, Chen F, Huang K, Jiang Y, Liu D, Zhang Z, Liu Y, Liu L. Treatment of 5 Critically Ill Patients With COVID-19 With Convalescent Plasma. JAMA. 2020 Apr 28;323(16):1582-1589. doi: 10.1001/jama.2020.4783.

ReferenceCitation: Zhang B, Liu S, Tan T, Huang W, Dong Y, Chen L, Chen Q, Zhang L, Zhong Q, Zhang X, Zou Y, Zhang S. Treatment With Convalescent Plasma for Critically Ill Patients With Severe Acute Respiratory Syndrome Coronavirus 2 Infection. Chest. 2020 Jul;158(1):e9-e13. doi: 10.1016/j.chest.2020.03.039. Epub 2020 Mar 31.

ReferenceCitation: Walls AC, Park YJ, Tortorici MA, Wall A, McGuire AT, Veesler D. Structure, Function, and Antigenicity of the SARS-CoV-2 Spike Glycoprotein. Cell. 2020 Apr 16;181(2):281-292.e6. doi: 10.1016/j.cell.2020.02.058. Epub 2020 Mar 9. Erratum in: Cell. 2020 Dec 10;183(6):1735.

ReferenceCitation: Zhang JS, Chen JT, Liu YX, Zhang ZS, Gao H, Liu Y, Wang X, Ning Y, Liu YF, Gao Q, Xu JG, Qin C, Dong XP, Yin WD. A serological survey on neutralizing antibody titer of SARS convalescent sera. J Med Virol. 2005 Oct;77(2):147-50.

ReferenceCitation: Subbarao K, McAuliffe J, Vogel L, Fahle G, Fischer S, Tatti K, Packard M, Shieh WJ, Zaki S, Murphy B. Prior infection and passive transfer of neutralizing antibody prevent replication of severe acute respiratory syndrome coronavirus in the respiratory tract of mice. J Virol. 2004 Apr;78(7):3572-7.

ReferenceCitation: Ko JH, Seok H, Cho SY, Ha YE, Baek JY, Kim SH, Kim YJ, Park JK, Chung CR, Kang ES, Cho D, Müller MA, Drosten C, Kang CI, Chung DR, Song JH, Peck KR. Challenges of convalescent plasma infusion therapy in Middle East respiratory coronavirus infection: a single centre experience. Antivir Ther. 2018;23(7):617-622. doi: 10.3851/IMP3243. Epub 2018 Jun 20.

ReferenceCitation: Guo L, Ren L, Yang S, Xiao M, Chang, Yang F, Dela Cruz CS, Wang Y, Wu C, Xiao Y, Zhang L, Han L, Dang S, Xu Y, Yang QW, Xu SY, Zhu HD, Xu YC, Jin Q, Sharma L, Wang L, Wang J. Profiling Early Humoral Response to Diagnose Novel Coronavirus Disease (COVID-19). Clin Infect Dis. 2020 Jul 28;71(15):778-785. doi: 10.1093/cid/ciaa310.

ReferenceCitation: Thevarajan I, Nguyen THO, Koutsakos M, Druce J, Caly L, van de Sandt CE, Jia X, Nicholson S, Catton M, Cowie B, Tong SYC, Lewin SR, Kedzierska K. Breadth of concomitant immune responses prior to patient recovery: a case report of non-severe COVID-19. Nat Med. 2020 Apr;26(4):453-455. doi: 10.1038/s41591-020-0819-2.

ReferenceCitation: Bouadma L, Lescure FX, Lucet JC, Yazdanpanah Y, Timsit JF. Severe SARS-CoV-2 infections: practical considerations and management strategy for intensivists. Intensive Care Med. 2020 Apr;46(4):579-582. doi: 10.1007/s00134-020-05967-x. Epub 2020 Feb 26.

ReferenceCitation: To KK, Tsang OT, Leung WS, Tam AR, Wu TC, Lung DC, Yip CC, Cai JP, Chan JM, Chik TS, Lau DP, Choi CY, Chen LL, Chan WM, Chan KH, Ip JD, Ng AC, Poon RW, Luo CT, Cheng VC, Chan JF, Hung IF, Chen Z, Chen H, Yuen KY. Temporal profiles of viral load in posterior oropharyngeal saliva samples and serum antibody responses during infection by SARS-CoV-2: an observational cohort study. Lancet Infect Dis. 2020 May;20(5):565-574. doi: 10.1016/S1473-3099(20)30196-1. Epub 2020 Mar 23.

ReferenceCitation: Liu L, Wei Q, Lin Q, Fang J, Wang H, Kwok H, Tang H, Nishiura K, Peng J, Tan Z, Wu T, Cheung KW, Chan KH, Alvarez X, Qin C, Lackner A, Perlman S, Yuen KY, Chen Z. Anti-spike IgG causes severe acute lung injury by skewing macrophage responses during acute SARS-CoV infection. JCI Insight. 2019 Feb 21;4(4). pii: 123158. doi: 10.1172/jci.insight.123158. eCollection 2019 Feb 21.

ReferenceCitation: Tirado SM, Yoon KJ. Antibody-dependent enhancement of virus infection and disease. Viral Immunol. 2003;16(1):69-86. Review.

ReferenceCitation: Chaichana P, Okabayashi T, Puiprom O, Sasayama M, Sasaki T, Yamashita A, Ramasoota P, Kurosu T, Ikuta K. Low levels of antibody-dependent enhancement in vitro using viruses and plasma from dengue patients. PLoS One. 2014 Mar 18;9(3):e92173. doi: 10.1371/journal.pone.0092173. eCollection 2014.

ReferenceCitation: Houser KV, Broadbent AJ, Gretebeck L, Vogel L, Lamirande EW, Sutton T, Bock KW, Minai M, Orandle M, Moore IN, Subbarao K. Enhanced inflammation in New Zealand white rabbits when MERS-CoV reinfection occurs in the absence of neutralizing antibody. PLoS Pathog. 2017 Aug 17;13(8):e1006565. doi: 10.1371/journal.ppat.1006565. eCollection 2017 Aug.

ReferenceCitation: van Griensven J, Edwards T, de Lamballerie X, Semple MG, Gallian P, Baize S, Horby PW, Raoul H, Magassouba N, Antierens A, Lomas C, Faye O, Sall AA, Fransen K, Buyze J, Ravinetto R, Tiberghien P, Claeys Y, De Crop M, Lynen L, Bah EI, Smith PG, Delamou A, De Weggheleire A, Haba N; Ebola-Tx Consortium. Evaluation of Convalescent Plasma for Ebola Virus Disease in Guinea. N Engl J Med. 2016 Jan 7;374(1):33-42. doi: 10.1056/NEJMoa1511812.

ReferenceCitation: Dufour-Gaume F, Delaune D, Martinaud C, Sailliol A. Early and repeated use of plasma for the management of Ebola patients: Reflection around a case. Transfus Clin Biol. 2017 Feb;24(1):5-8. doi: 10.1016/j.tracli.2016.08.005. Epub 2016 Sep 14.

ReferenceCitation: Tirumalai RS, Chan KC, Prieto DA, Issaq HJ, Conrads TP, Veenstra TD. Characterization of the low molecular weight human serum proteome. Mol Cell Proteomics. 2003 Oct;2(10):1096-103. Epub 2003 Aug 13.

ReferenceCitation: Tang N, Li D, Wang X, Sun Z. Abnormal coagulation parameters are associated with poor prognosis in patients with novel coronavirus pneumonia. J Thromb Haemost. 2020 Apr;18(4):844-847. doi: 10.1111/jth.14768. Epub 2020 Mar 13.

ReferenceCitation: Lippi G, Plebani M. Laboratory abnormalities in patients with COVID-2019 infection. Clin Chem Lab Med. 2020 Jun 25;58(7):1131-1134. doi: 10.1515/cclm-2020-0198.

ReferenceCitation: Sperry JL, Guyette FX, Brown JB, Yazer MH, Triulzi DJ, Early-Young BJ, Adams PW, Daley BJ, Miller RS, Harbrecht BG, Claridge JA, Phelan HA, Witham WR, Putnam AT, Duane TM, Alarcon LH, Callaway CW, Zuckerbraun BS, Neal MD, Rosengart MR, Forsythe RM, Billiar TR, Yealy DM, Peitzman AB, Zenati MS; PAMPer Study Group. Prehospital Plasma during Air Medical Transport in Trauma Patients at Risk for Hemorrhagic Shock. N Engl J Med. 2018 Jul 26;379(4):315-326. doi: 10.1056/NEJMoa1802345.

ReferenceCitation: Chen L, Li X, Chen M, Feng Y, Xiong C. The ACE2 expression in human heart indicates new potential mechanism of heart injury among patients infected with SARS-CoV-2. Cardiovasc Res. 2020 May 1;116(6):1097-1100. doi: 10.1093/cvr/cvaa078. Erratum in: Cardiovasc Res. 2020 Oct 1;116(12):1994.

ReferenceCitation: Recalcati S. Cutaneous manifestations in COVID-19: a first perspective. J Eur Acad Dermatol Venereol. 2020 May;34(5):e212-e213. doi: 10.1111/jdv.16387.

ReferenceCitation: Wu F, Peng Z, Park PW, Kozar RA. Loss of Syndecan-1 Abrogates the Pulmonary Protective Phenotype Induced by Plasma After Hemorrhagic Shock. Shock. 2017 Sep;48(3):340-345. doi: 10.1097/SHK.0000000000000832.

ReferenceCitation: Whitney JE, Zhang B, Koterba N, Chen F, Bush J, Graham K, Lacey SF, Melenhorst JJ, Teachey DT, Mensinger JL, Yehya N, Weiss SL. Systemic Endothelial Activation Is Associated With Early Acute Respiratory Distress Syndrome in Children With Extrapulmonary Sepsis. Crit Care Med. 2020 Mar;48(3):344-352. doi: 10.1097/CCM.0000000000004091.

ReferenceCitation: Garraud O, Heshmati F, Pozzetto B, Lefrere F, Girot R, Saillol A, Laperche S. Plasma therapy against infectious pathogens, as of yesterday, today and tomorrow. Transfus Clin Biol. 2016 Feb;23(1):39-44. doi: 10.1016/j.tracli.2015.12.003. Epub 2016 Jan 6. Review.

ReferenceCitation: Dinsdale RJ, Hazeldine J, Al Tarrah K, Hampson P, Devi A, Ermogenous C, Bamford AL, Bishop J, Watts S, Kirkman E, Dalle Lucca JJ, Midwinter M, Woolley T, Foster M, Lord JM, Moiemen N, Harrison P. Dysregulation of the actin scavenging system and inhibition of DNase activity following severe thermal injury. Br J Surg. 2020 Mar;107(4):391-401. doi: 10.1002/bjs.11310. Epub 2019 Sep 10.

ReferenceCitation: Squizzato A, Hunt BJ, Kinasewitz GT, Wada H, Ten Cate H, Thachil J, Levi M, Vicente V, D'Angelo A, Di Nisio M. Supportive management strategies for disseminated intravascular coagulation. An international consensus. Thromb Haemost. 2016 May 2;115(5):896-904. doi: 10.1160/TH15-09-0740. Epub 2015 Dec 17. Review.

ReferenceCitation: Di Nisio M, Thachil J, Squizzato A. Management of disseminated intravascular coagulation: a survey of the International Society on Thrombosis and Haemostasis. Thromb Res. 2015 Aug;136(2):239-42. doi: 10.1016/j.thromres.2015.05.022. Epub 2015 May 23.

ReferenceCitation: Garraud O, Malot S, Herbrecht R, Ojeda-Uribe M, Lin JS, Veyradier A, Payrat JM, Liu K, Corash L, Coppo P. Amotosalen-inactivated fresh frozen plasma is comparable to solvent-detergent inactivated plasma to treat thrombotic thrombocytopenic purpura. Transfus Apher Sci. 2019 Dec;58(6):102665. doi: 10.1016/j.transci.2019.10.007. Epub 2019 Nov 5.

ReferenceCitation: van Griensven J, De Weiggheleire A, Delamou A, Smith PG, Edwards T, Vandekerckhove P, Bah EI, Colebunders R, Herve I, Lazaygues C, Haba N, Lynen L. The Use of Ebola Convalescent Plasma to Treat Ebola Virus Disease in Resource-Constrained Settings: A Perspective From the Field. Clin Infect Dis. 2016 Jan 1;62(1):69-74. doi: 10.1093/cid/civ680. Epub 2015 Aug 10.

ReferenceCitation: Brown JF, Dye JM, Tozay S, Jeh-Mulbah G, Wohl DA, Fischer WA 2nd, Cunningham CK, Rowe K, Zacharias P, van Hasselt J, Norwood DA, Thielman NM, Zak SE, Hoover DL. Anti-Ebola Virus Antibody Levels in Convalescent Plasma and Viral Load After Plasma Infusion in Patients With Ebola Virus Disease. J Infect Dis. 2018 Jul 13;218(4):555-562. doi: 10.1093/infdis/jiy199.

ReferenceCitation: Di Minno G, Navarro D, Perno CF, Canaro M, Gürtler L, Ironside JW, Eichler H, Tiede A. Pathogen reduction/inactivation of products for the treatment of bleeding disorders: what are the processes and what should we say to patients? Ann Hematol. 2017 Aug;96(8):1253-1270. doi: 10.1007/s00277-017-3028-4. Epub 2017 Jun 18. Review.

ReferenceCitation: Ahn JY, Sohn Y, Lee SH, Cho Y, Hyun JH, Baek YJ, Jeong SJ, Kim JH, Ku NS, Yeom JS, Roh J, Ahn MY, Chin BS, Kim YS, Lee H, Yong D, Kim HO, Kim S, Choi JY. Use of Convalescent Plasma Therapy in Two COVID-19 Patients with Acute Respiratory Distress Syndrome in Korea. J Korean Med Sci. 2020 Apr 13;35(14):e149. doi: 10.3346/jkms.2020.35.e149.

ReferenceCitation: Duan K, Liu B, Li C, Zhang H, Yu T, Qu J, Zhou M, Chen L, Meng S, Hu Y, Peng C, Yuan M, Huang J, Wang Z, Yu J, Gao X, Wang D, Yu X, Li L, Zhang J, Wu X, Li B, Xu Y, Chen W, Peng Y, Hu Y, Lin L, Liu X, Huang S, Zhou Z, Zhang L, Wang Y, Zhang Z, Deng K, Xia Z, Gong Q, Zhang W, Zheng X, Liu Y, Yang H, Zhou D, Yu D, Hou J, Shi Z, Chen S, Chen Z, Zhang X, Yang X. Effectiveness of convalescent plasma therapy in severe COVID-19 patients. Proc Natl Acad Sci U S A. 2020 Apr 28;117(17):9490-9496. doi: 10.1073/pnas.2004168117. Epub 2020 Apr 6.

ReferenceCitation: Hung IF, To KK, Lee CK, Lee KL, Chan K, Yan WW, Liu R, Watt CL, Chan WM, Lai KY, Koo CK, Buckley T, Chow FL, Wong KK, Chan HS, Ching CK, Tang BS, Lau CC, Li IW, Liu SH, Chan KH, Lin CK, Yuen KY. Convalescent plasma treatment reduced mortality in patients with severe pandemic influenza A (H1N1) 2009 virus infection. Clin Infect Dis. 2011 Feb 15;52(4):447-56. doi: 10.1093/cid/ciq106. Epub 2011 Jan 19.

ReferenceCitation: Cheng Y, Wong R, Soo YO, Wong WS, Lee CK, Ng MH, Chan P, Wong KC, Leung CB, Cheng G. Use of convalescent plasma therapy in SARS patients in Hong Kong. Eur J Clin Microbiol Infect Dis. 2005 Jan;24(1):44-6.

ReferenceCitation: Soo YO, Cheng Y, Wong R, Hui DS, Lee CK, Tsang KK, Ng MH, Chan P, Cheng G, Sung JJ. Retrospective comparison of convalescent plasma with continuing high-dose methylprednisolone treatment in SARS patients. Clin Microbiol Infect. 2004 Jul;10(7):676-8.

ReferenceCitation: Mair-Jenkins J, Saavedra-Campos M, Baillie JK, Cleary P, Khaw FM, Lim WS, Makki S, Rooney KD, Nguyen-Van-Tam JS, Beck CR; Convalescent Plasma Study Group. The effectiveness of convalescent plasma and hyperimmune immunoglobulin for the treatment of severe acute respiratory infections of viral etiology: a systematic review and exploratory meta-analysis. J Infect Dis. 2015 Jan 1;211(1):80-90. doi: 10.1093/infdis/jiu396. Epub 2014 Jul 16. Review.

ReferenceCitation: Shi Y, Wang Y, Shao C, Huang J, Gan J, Huang X, Bucci E, Piacentini M, Ippolito G, Melino G. COVID-19 infection: the perspectives on immune responses. Cell Death Differ. 2020 May;27(5):1451-1454. doi: 10.1038/s41418-020-0530-3. Epub 2020 Mar 23.

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: Chang L, Yan Y, Wang L. Coronavirus Disease 2019: Coronaviruses and Blood Safety. Transfus Med Rev. 2020 Apr;34(2):75-80. doi: 10.1016/j.tmrv.2020.02.003. Epub 2020 Feb 21. Review.

ReferenceCitation: Hashem AM, Hassan AM, Tolah AM, Alsaadi MA, Abunada Q, Damanhouri GA, El-Kafrawy SA, Picard-Maureau M, Azhar EI, Hindawi SI. Amotosalen and ultraviolet A light efficiently inactivate MERS-coronavirus in human platelet concentrates. Transfus Med. 2019 Dec;29(6):434-441. doi: 10.1111/tme.12638. Epub 2019 Nov 6.

ReferenceCitation: Lin L, Hanson CV, Alter HJ, Jauvin V, Bernard KA, Murthy KK, Metzel P, Corash L. Inactivation of viruses in platelet concentrates by photochemical treatment with amotosalen and long-wavelength ultraviolet light. Transfusion. 2005 Apr;45(4):580-90.

ReferenceCitation: Chang L, Zhao L, Gong H, Wang L, Wang L. Severe Acute Respiratory Syndrome Coronavirus 2 RNA Detected in Blood Donations. Emerg Infect Dis. 2020 Jul;26(7):1631-1633. doi: 10.3201/eid2607.200839. Epub 2020 Jun 21.

location_facility:
HIA Sainte Anne
HIA Bégin
HIA Laveran
HIA Percy


title: Analysis of the Coagulopathy Developed by COVID-19 Infected Patients: Thrombin Generation Potential in COVID-19 Infected Patients

acronym: COVID-TGT

summary: Increased D-dimers at admission of COVID-19 infected patients entering hospital due to a severe disease is a risk factor for death. Understanding this acquired coagulopathy is a prerequisite before specific interventional studies. The study investigators aim to apply a normalized and automated thrombin generation test (TGT), developed for testing the thrombotic risk (triggered by 5 pM Tissue Factor, with a purified thrombomodulin (TM) challenge) and to study its association with survival.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility:
CHU de Limoges
CHU de Montpellier
CHU de Nimes
CHU de Bordeaux

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


title: Characterization of Kidney Involvement in COVID-19 Disease: a French Multi-center Prospective Observational Study

acronym: COVKID

summary:
Novel coronavirus disease (COVID-19) is a newly discovered contagious disease caused by SARS-CoV-2 virus, primarily manifesting as an acute respiratory illness with pneumonia, but can affect multiple organs such as kidney, heart, digestive tract, blood and nervous system. In previous reports of SARS and MERS-CoV infections, acute kidney injury was described in 5 to 15% of patients and was associated with a high mortality rate (60-90%). Recent reports showed renal abnormalities in COVID-9 infected patients. A recent Chinese study also reported that acute kidney injury was an independent risk factor for mortality. However, the exact mechanism of kidney involvement remains unclear: sepsis-related cytokine storm or direct cellular injury from the virus. Also, kidney involvement has not yet been well characterized: heavy albuminuria, hematuria or interstitial nephropathy alone.

A recent study identified viral RNA in kidney tissue and another study succeeded isolating SARS-CoV-2 from the urine sample of an infected patient. These data suggest that the kidney might be a target of this novel coronarivus.

The sponsor suggests characterizing kidney involvement in SARS-CoV-2 infection.

Study objectives are:

To give an accurate characterization of kidney involvement in COVID-19
To investigate the physiopathologic mechanism of kidney involvement in SARS-CoV-2 infection
To identify risk factors for kidney involvement in in SARS-CoV-2 infection
To evaluate the impact of kidney involvement in in SARS-CoV-2 infection
To assess the long-term health effect of kidney injury on survivors of in SARS-CoV-2 infection

status: Unknown status

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ipd_sharing: No

ipd_sharing_description: no data sharing plan has been established

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Centre hospitalier d'Antibes Juan les pins

status_simplified: Unknown


title: COVID-19: Nasal and Salivary Detection of the SARS-CoV-2 Virus After Antiviral Mouthrinses: Double-blind, Randomized, Placebo-controlled Clinical Study

acronym: BBCovid

summary: Given the current lack of effective COVID-19 treatment, it is necessary to explore alternative methods to contain the spread of the infection, focusing in particular on its mode of transmission. The modes of person-to-person transmission of SARS-CoV-2 are direct transmission, such as sneezing, coughing, transmission through inhalation of small droplets, and transmission through contact, such as contact with nasal, oral and eye mucous membranes. SARS-CoV-2 can also be transmitted directly or indirectly through saliva. The use of antiviral mouthrinses may be used as adjunctive therapy.

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

ReferenceType: background

ReferenceCitation: Carrouel F, Conte MP, Fisher J, Gonçalves LS, Dussart C, Llodra JC, Bourgeois D. COVID-19: A Recommendation to Examine the Effect of Mouthrinses with β-Cyclodextrin Combined with Citrox in Preventing Infection and Progression. J Clin Med. 2020 Apr 15;9(4). pii: E1126. doi: 10.3390/jcm9041126.

ReferenceCitation: Carrouel F, Gonçalves LS, Conte MP, Campus G, Fisher J, Fraticelli L, Gadea-Deschamps E, Ottolenghi L, Bourgeois D. Antiviral Activity of Reagents in Mouth Rinses against SARS-CoV-2. J Dent Res. 2021 Feb;100(2):124-132. doi: 10.1177/0022034520967933. Epub 2020 Oct 22. Review.

ReferenceType: derived

ReferenceCitation: Carrouel F, Viennot S, Valette M, Cohen JM, Dussart C, Bourgeois D. Salivary and Nasal Detection of the SARS-CoV-2 Virus After Antiviral Mouthrinses (BBCovid): A structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Nov 2;21(1):906. doi: 10.1186/s13063-020-04846-6.

ReferenceCitation: Burton MJ, Clarkson JE, Goulao B, Glenny AM, McBain AJ, Schilder AG, Webster KE, Worthington HV. Antimicrobial mouthwashes (gargling) and nasal sprays administered to patients with suspected or confirmed COVID-19 infection to improve patient outcomes and to protect healthcare workers treating them. Cochrane Database Syst Rev. 2020 Sep 16;9:CD013627. doi: 10.1002/14651858.CD013627.pub2.

lead_sponsor: Claude Bernard University

location_facility: Intercommunal Hospital Center of Mont de Marsan

location_facility: Clinic of the Protestant Infirmary in Lyon

intervention_type: Device


title: Management of Parapneumonic Pleurisy Guided by an Early Pleural Ultrasound

acronym: ECHOPP

summary: Parapneumonic pleurisies are a frequent complication of pneumopathies, but therapeutic management is poorly codified. Only the indication of thoracic drainage has benefited from expert recommendations. However, we find in the literature the major importance of early management of infectious pleurisy in order to minimize the sequelae. Pleural ultrasound, sensitive and specific in this pathology could bring us a real interest in terms of diagnostic speed and therefore of care. This study therefore seeks to show that pleural ultrasound can have a major interest in improving the management of patients with parapneumonic pleurisy, by reducing the number of medical treatment failures.

ReferenceType: result

ReferenceCitation: Light RW. Pleural diseases. Curr Opin Pulm Med. 2003 Jul;9(4):251-3.

ReferenceCitation: Miserocchi G. Physiology and pathophysiology of pleural fluid turnover. Eur Respir J. 1997 Jan;10(1):219-25. Review.

ReferenceCitation: Davies CW, Gleeson FV, Davies RJ; Pleural Diseases Group, Standards of Care Committee, British Thoracic Society. BTS guidelines for the management of pleural infection. Thorax. 2003 May;58 Suppl 2:ii18-28.

ReferenceCitation: Hamm H, Light RW. Parapneumonic effusion and empyema. Eur Respir J. 1997 May;10(5):1150-6. Review.

ReferenceCitation: LeMense GP, Strange C, Sahn SA. Empyema thoracis. Therapeutic management and outcome. Chest. 1995 Jun;107(6):1532-7.

ReferenceCitation: Bober K, Swietliński J. Diagnostic utility of ultrasonography for respiratory distress syndrome in neonates. Med Sci Monit. 2006 Oct;12(10):CR440-6. Epub 2006 Sep 25.

ReferenceCitation: Soldati G, Sher S. Bedside lung ultrasound in critical care practice. Minerva Anestesiol. 2009 Sep;75(9):509-17. Review.

ReferenceCitation: Ramnath RR, Heller RM, Ben-Ami T, Miller MA, Campbell P, Neblett WW 3rd, Holcomb GW, Hernanz-Schulman M. Implications of early sonographic evaluation of parapneumonic effusions in children with pneumonia. Pediatrics. 1998 Jan;101(1 Pt 1):68-71.

ReferenceCitation: Xirouchaki N, Magkanas E, Vaporidi K, Kondili E, Plataki M, Patrianakos A, Akoumianaki E, Georgopoulos D. Lung ultrasound in critically ill patients: comparison with bedside chest radiography. Intensive Care Med. 2011 Sep;37(9):1488-93. doi: 10.1007/s00134-011-2317-y. Epub 2011 Aug 2.

ReferenceCitation: Tokuda Y, Matsushima D, Stein GH, Miyagi S. Intrapleural fibrinolytic agents for empyema and complicated parapneumonic effusions: a meta-analysis. Chest. 2006 Mar;129(3):783-90.

ReferenceCitation: Stavas J, vanSonnenberg E, Casola G, Wittich GR. Percutaneous drainage of infected and noninfected thoracic fluid collections. J Thorac Imaging. 1987 Jul;2(3):80-7.

ReferenceCitation: Sahn SA. Management of complicated parapneumonic effusions. Am Rev Respir Dis. 1993 Sep;148(3):813-17. Review.

ReferenceCitation: Taryle DA, Potts DE, Sahn SA. The incidence and clinical correlates of parapneumonic effusions in pneumococcal pneumonia. Chest. 1978 Aug;74(2):170-3.

ReferenceCitation: Pothula V, Krellenstein DJ. Early aggressive surgical management of parapneumonic empyemas. Chest. 1994 Mar;105(3):832-6.

ReferenceCitation: Saito T, Kobayashi H, Kitamura S. Ultrasonographic approach to diagnosing chest wall tumors. Chest. 1988 Dec;94(6):1271-5.

ReferenceCitation: Lichtenstein DA. BLUE-protocol and FALLS-protocol: two applications of lung ultrasound in the critically ill. Chest. 2015 Jun;147(6):1659-1670. doi: 10.1378/chest.14-1313. Review.

ReferenceCitation: Lichtenstein DA, Menu Y. A bedside ultrasound sign ruling out pneumothorax in the critically ill. Lung sliding. Chest. 1995 Nov;108(5):1345-8.

ipd_sharing_description: the data will be collected on an electronic Ecrf, a single extraction is planned by the protocol, all the collected data will be analyzed centrally by the study cordernator,no data sharing is planned in the study

lead_sponsor: Central Hospital Saint Quentin

location_facility:
CH Pontoise
Chu Amiens
CH Creteil
Saint-Quentin Hospital

intervention_type: Diagnostic Test


title: Measurement of the Electromechanical Window to Improve the Diagnosis of Congenital Long QT Syndrome

acronym: FEMQT

summary: The goal of this research is to prospectively evaluate the performance of the electromechanical window according to a phonographic method, as a mean of diagnosis of long QT syndrome, and to compare its performance with routine tests used.

status: Recruiting

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Bordeaux

location_facility:
Toulouse University Hospital
Bordeaux University Hospital
La Réunion University Hospital
Nantes University Hospital

status_simplified: Ongoing


title: A Double-blind Randomized Trial of Interpectoral Nerve Block (Pecs 1 and 2) With Ropivacaine Versus Placebo Before Breast Cancer Surgery: Effects on Acute Postoperative Pain. (MIRs 04)

summary: Compare the effect of ropivacaine versus placebo pectoral nerve block (Pecs 1 and 2) on acute pain after tumorectomy plus sentinel lymph node dissection on one day surgery.

primary_purpose: Treatment

lead_sponsor: Institut Curie

location_facility:
Centre Jean Perrin
Institut Curie
Institut de Cancérologie de Lorraine
Hopital Tenon

intervention_type: Drug


title: Pilot Feasibility Study: Inflammation and Presence of M2 Macrophages Explorations With[18F]-DPA-714 PET/CT in Triple Negative Breast Cancers

acronym: EITHICS

summary: This phase II study is assessing the correlation between M1/M2 macrophage polarization determined by tumor immunohistochemistry analysis and [18F]DPA-714 PET/CT binding (qualitative and texture analysis) in patients with operable triple negative breast cancer.

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility: Institut de Cacerologie de l'ouest - site Paul Papin

lead_sponsor_type: industriel


title: Anticancer Therapeutic Vaccination Using Telomerase-derived Universal Cancer Peptides in Glioblastoma

acronym: UCPVax-Glio

summary:
Glioblastoma (GBM) is the most frequent primary brain tumor and the brain tumor with the poorest prognosis. The current treatment relies on surgical resection of gross tumor followed by radiochemotherapy and adjuvant therapy with temozolomide.

After such therapy, most patients experiment recurrence and few therapeutic option are available. Despite such therapies, median survival only reaches around fifteen months.

There is a strong rational to develop telomerase vaccine in GBM. Telomerase (TERT) is a major oncogene, particularly in primary brain tumors 24. Alterations in TERT are very frequent in central nervous system tumors, seen most commonly in gliomas25. Mutations in the TERT promoter are found in approximately 80% of primary glioblastoma (GBM). These findings strongly support the rational to develop vaccine targeting telomerase in GBM.

The aim of this project is to evaluate UCPVax treatment in glioblastoma. UCPVax is a therapeutic anti-cancer vaccine based on the telomerase-derived helper peptides designed to induce strong TH1 CD4 T cell responses in cancer patients (NCT02818426).

design_allocation: Non-Randomized

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility:
CHU Besançon
Centre Georges François Leclerc
Hôpital Saint-Louis
CHU Bordeaux


title: Assessment of Metabolomic and Proteomic Phenotyping Associated With Amniotic Fluid Embolism

acronym: AMNIOPROFIL

summary:
Amniotic fluid embolism is a serious complication of the peri-partum period that is associated with high maternal mortality rate, ranging from 20 to 40%.

The pathophysiology of amniotic fluid embolism remains poorly known at this time.

The definition and diagnosis of amniotic fluid embolism is only clinical, based on different scores, the most used of which is the score proposed by the United Kingdom Obstetric Surveillance System (UKOSS). This score supports the diagnosis of amniotic fluid embolism in the event of acute maternal collapse associated with one or more of the following features: cardiac rhythm problems, acute fetal compromise, respiratory distress, maternal hemorrhage, coagulopathy, convulsions, premonitory symptoms (restlessness, numbness, tingling, agitation, etc.). ) seizure, in the absence of any other clear cause. Amniotic fluid embolism is a differential diagnosis of maternal collapse.

Determining specific biological markers for this disease would be very useful in order to be able to affirm the diagnosis and refute other diagnostic hypotheses with certainty. The detection of amniotic cells in the blood or bronchoalveolar lavage fluid seems to be of little help. The assay of plasma tryptase does not confirm the diagnosis of amniotic embolism, but is useful for ruling out the diagnosis of anaphylactic shock. The dosage of the complement lacks sensitivity and specificity to be useful in the diagnosis of amniotic fluid embolism. The maternal plasma assay of IGFBP-1 ("Insulin Growth Factor Binding Protein" type 1) has been proposed for the biological diagnosis of amniotic embolism. IGFBP-1 is present in high concentration in amniotic fluid, while its concentration is low in maternal plasma. High levels of IGFBP-1 in maternal blood would therefore make it possible to establish the diagnosis of amniotic fluid embolism with excellent sensitivity and specificity according to previous data collected from 25 patients. However, no study has confirmed this result to date. Other markers have also been suggested (zinc-coproporphyrin in particular), but to date, no specific marker for this disease has been formally identified.

Metabolic phenotyping consists in the identification of subtle and coordinated metabolic variations associated with various pathophysiological stimuli. Different analytical methods, such as nuclear magnetic resonance, allow the simultaneous quantification of a large number of metabolites. Statistical analyses of these spectra thus lead to the discrimination between samples and the identification of a metabolic phenotype corresponding to the effect under study. This approach allows the extraction of candidate biomarkers and the recovery of perturbed metabolic networks, driving to the generation of biochemical hypotheses (pathophysiological mechanisms, diagnostic tests, therapeutic targets,...).. It is thus possible to obtain biochemical characterizations of human biological samples (also called "metabolic profile or signature") which can be compared in order to identify distinctive elements of certain pathophysiological states, establishing a metabolic phenotype of the pathological state studied. This analysis can be supplemented by a study of the proteome (proteomics), in order to identify one or more biological markers associated with a disease.

The aim of this study is to determine the metabolic and proteomic phenotyping in three groups of women: women for whom the diagnosis of amniotic fluid embolism was retained according to the UKOSS clinical criteria (Group AFE), women admitted for prophylactic elective cesarean section (Group Control 1), women presenting acute collapse or shock in the peri- partum for which the diagnosis of amniotic fluid embolism has been excluded (severe hemorrhage, SEPSIS, pulmonary embolism for example; Group Control 2)

lead_sponsor: Hospices Civils de Lyon

location_facility: Service d'anesthésie réanimation Hôpital de la Croix Rousse

location_facility: Service d'anesthésie réanimation Centre Hospitalier Lyon-Sud

location_facility: Service Anesthésie Réanimation CHU de Hautepierre, Strasbourg

location_facility: Service Anesthésie réanimation - Centre Hospitalier Hôpital Femme Mère Enfant - Groupement Hospitalier Est - Hospices Civils de Lyon

intervention_type: Biological


title: Efficacy and Tolerance of the Combination of Methotrexate and Phototherapy Versus Phototherapy in Adults With Progressive Vitiligo: a Randomized Double-blind Prospective Study

acronym: METVI

summary: This is a phase 2, randomized, double blind, multicenter study evaluating the efficacy and safety of the combination of methotrexate plus UVB TL01 in vitiligo.

study_start_date_type: Anticipated

status: Not yet recruiting

ipd_sharing: Yes

location_facility: Service de Dermatologie - Hôpital Saint-André

location_facility: Service de Dermatologie - CHU de Toulouse - Hopital Purpan


title: Is Invasive Pulmonary Aspergillosis a Common Complication of Severe Influenza ?

acronym: ASPERGIGRIPP

summary:
Invasive pulmonary aspergillosis (IPA) has been reported in critically ill patients with influenza infection with a highly variable incidence between 1 to 21%. Studies investigating IPA in critically ill patients with influenza infection suffer limitations in their methods. It remains unknown whether patients with influenza are more at risk of IPA than other patients hospitalized in intensive care unit and whether patients with influenza who develop IPA have specific risk factors for this infection.

Our study aims to determine the incidence of IPA in a large multicenter cohort and to identify risk factors for IPA in these patients.

time_perspective: Retrospective

lead_sponsor: University Hospital, Brest

location_facility:
CHR
CHU de NANTES
CHU de Rennes
CHRU de Brest


type: Other Identifier

title: Effect of an 8-week Bifidobacterium Lactis HN019 Supplementation on Functional Constipation: A Double-blind, Randomized; Placebo-controlled Trial

acronym: BifidoDigest

summary: This prospective, two-arm (parallel groups), double-blind, randomized, placebo-controlled, multi-center clinical trial will investigate the effects of an 8-week Bifidobacterium lactis HN019 supplementation on stool frequency and on other constipation parameters in adults suffering from functional constipation according to ROME III criteria. The hypothesis is that Bifidobacterium lactis HN019 is superior, in comparison with a placebo, for the increase of stool frequency of at least 1 stool per week.

lead_sponsor: Danisco

location_facility:
Institut Pasteur de Lille
Biofortis
CEN
Eurofins Optimed

intervention_type: Dietary Supplement


title: Noninvasive 3D Mapping in Persistent Atrial Fibrillation, to Describe Modifications of the Arrhythmogenic Substrate After Pulmonary Vein Isolation and Identify Potential Predicting Factors of Ablation Success

acronym: CRYOVEST

summary:
Atrial fibrillation (AF) is the most common cardiac arrhythmia in adults. It is a major cause of ischemic stroke and heart failure. Intravascular cardiac ablation of the left atrium by catheter delivery is an efficient treatment to restore sinus rhythm. AF ablation is a class IIa treatment for patients with symptomatic persistent AF refractory or intolerant to antiarrhythmic medication. There are still many debates considering the ablation strategy. The pulmonary veins remain the cornerstone of AF ablation therapy, even in persistent AF. There is a large electrical remodeling occurring in the left atrium between paroxysmal AF, early persistent AF and long-standing persistent AF. However, no multicentric and randomized study has demonstrated so far the interest of targeting other left atrial substrate, such as rotors or focal sources.

Our study aims to describe with a noninvasive mapping system the arrhythmogenic substrate of persistent AF > 6 months pre- and post-cardioversion, and after pulmonary vein isolation.

lead_sponsor: University Hospital, Rouen

location_facility:
Rouen University Hospital
Caen University Hospital
Groupe Hospitalier du Havre
Dieppe Hospital

intervention_type: Procedure


title: Interest of Auriculotherapy in the Treatment of Xerostomia.

acronym: AURICULOXERO

summary: The aim of the study is to show that auriculotherapy is effective in the treatment of xerostomia

lead_sponsor: Hopital Foch

location_facility: Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan


title: A Prospective Randomized Multicenter Study to Evaluate the Efficacy of a Polyamine-deficient Diet for the Treatment of Postoperative Pain After Abdominal Surgery.

acronym: POLYAMAL

summary: The aim of this study is to evaluate if a polyamine deficient diet started 7 days prior to a major abdominal surgery (eventration cure and digestive continuity) and followed 7 days post-surgery reduces the area under the curve of the numerical pain rating scale in the 72 hours post-surgery.

lead_sponsor: Nantes University Hospital

location_facility:
CHU Nancy Hôpital Brabois
CHD Vendée
CHRU Brest La Cavale Blanche
CHU Nantes Hôtel Dieu


title: Multicenter, Controlled, Randomized, Open Label, Clinical Study to Assess the Efficacy of Auto-Adjustable MOBIDERM® Autofit NIGHT-time Compression Armsleeve in the Management of Upper Limb LYMphedema in Maintenance Phase: LYMphoNIGHT Study

acronym: LYMphoNIGHT

summary:
This study aims to assess Auto-Adjustable MOBIDERM® Autofit Armsleeve effect on upper limb volume excess after 3 months of maintenance phase treatment in patients with secondary upper limb lymphedema following breast cancer.

Half of the patient will wear a day-time and night time compression garment (MOBIDERM Autofit) for 3 months during the maintenance phase, while the other half will only wear day-time compression garment.

ReferenceCitation: Quéré I, Presles E, Coupé M, Vignes S, Vaillant L, Eveno D, Laporte S, Leizorovicz A; POLIT Study investigators. Prospective multicentre observational study of lymphedema therapy: POLIT study. J Mal Vasc. 2014 Jul;39(4):256-63. doi: 10.1016/j.jmv.2014.05.004. Epub 2014 Jun 12.

ReferenceCitation: Mestre S, Calais C, Gaillard G, Nou M, Pasqualini M, Ben Amor C, Quere I. Interest of an auto-adjustable nighttime compression sleeve (MOBIDERM® Autofit) in maintenance phase of upper limb lymphedema: the MARILYN pilot RCT. Support Care Cancer. 2017 Aug;25(8):2455-2462. doi: 10.1007/s00520-017-3652-5. Epub 2017 Mar 9.

ReferenceCitation: Brown JC, Cheville AL, Tchou JC, Harris SR, Schmitz KH. Prescription and adherence to lymphedema self-care modalities among women with breast cancer-related lymphedema. Support Care Cancer. 2014 Jan;22(1):135-43. doi: 10.1007/s00520-013-1962-9. Epub 2013 Sep 7.

lead_sponsor: Thuasne

location_facility:
Chu Montpellier
Chu Toulouse
CHRU Tours
Ghr Mulhouse


title: Randomized, Comparative Study to Evaluate the Effects of Cosmetic Balm on Xerosis and Associated Signs and Symptoms, Induced by Systemic Anticancer Treatments in Subjects Receiving Targeted Educational Action Compared to a Control Group

summary:
Xerosis is one of the most common adverse events in patients treated with new cancer therapies and chemotherapies, such as multi-kinase inhibitors and more specifically, immunological checkpoint inhibitors used in the treatment of several cancers.

Xerosis appears as a result of a deterioration of the stratum corneum which results in a reduction of the hydric power of the skin. It reaches the trunk and limbs, with an incidence of 4-35%, and gradually disappears after the end of treatment.

Preventive targeted educational action is essential before initiation of cancer treatment. Once the xerosis is installed, the management is based on the use of emollients to contribute to the hydric correction of the skin. In the case of inflammation or associated infection, the administration of topical corticosteroids and / or local or oral antibiotic therapy is prescribed.

The aim of this study is to evaluate the efficacy of the cosmetic product (balm) on the improvement of xerosis induced by systemic anticancer treatments, in participants receiving targeted educational action compared to a control group.

Clinical, biological and biometrological assessments will be performed to characterized the effects in both induced xerosis and associated signs and symptoms.

Each group will include 40 participants.

time_perspective: Other

lead_sponsor: Pierre Fabre Dermo Cosmetique

location_facility: Institut Universitaire du Cancer Toulouse- Oncopole


title: Superiority, Prospective, Multicentric, Randomized, Single-blind, Cross-over Study Comparing 2 Modes of Transcutaneous Electrical Nerve Stimulation (TENS) in Chronic Neuropathic Radiculalgia

acronym: CROSS-TENS

summary: This study will compare 2 types of Transcutaneous Electrical Nerve Stimulation (TENS) to treat chronic neuropathic pain. TENS involves the application of electrical stimulation to the skin via surface electrodes to stimulate nerve fibres for pain relief.

lead_sponsor: Lille Catholic University

location_facility:
GHICL
CH Béthune
CHU Lille
CH Roubaix


title: Comparison of Scores for Early Brain Damage Assessment at Intensive Care Unit Admission After Out of Hospital Cardiac Arrest

summary: Even in patients with successful return of spontaneous circulation (ROSC), outcome after cardiac arrest remains poor. The overall in-hospital survival rate widely varies both worldwide and across communities, from 1 to 4 folds according to circumstances of arrest and post-resuscitation interventions. Several studies have already shown that early interventions performed after ROSC, such as treatment of the cause, targeted temperature management, optimal hemodynamic management and extra-corporeal life support in selected patients, could improve the outcome in post-cardiac arrest patients. However, the decision process regarding the allocation of these resources, in parallel with the management of patients' proxies, remains a complex challenge for physicians facing these situations. Consequently, several prediction models and scores have been developed in order to stratify the risk of unfavorable outcome and to discriminate the best candidates for post-resuscitation interventions. Overall, several scores exist, but external validation are lacking and direct comparisons are needed to assess relative interest of scoring systems. Indeed, establishing the optimal scoring system is crucial, for optimal treatment allocation and appropriate information to relatives.

lead_sponsor: AfterROSC

location_facility:
Hopital Privé Jacques Cartier
CH Versailles
CHU Nantes
CHU Cochin


title: Evaluation of the Performance and Safety of a Scintillating Lamp Developed to Improve the Reading of Dyslexic Patients

acronym: DysLight

summary: The aim of this study is to evaluate the efficacy and safety of a new medical device on the improvement of reading skills of dyslexic patients.

lead_sponsor: SATT Ouest Valorisation

location_facility:
Dr Laurence Derieux
Dr Hugo Peyre
Dr Catherine ALLAIRE
Dr Luc-Marie Virlet


title: Safety Phase I Evaluation of MaaT033, a Lyophilized Full-ecosystem Gut Microbiota Delayed-release Capsule, In HeMatOlogy Malignant Patients Under iNtensive Chemotherapy (CIMON)

acronym: CIMON

summary:
Richness and diversity of gut microbiota are increasingly found to be associated with cancer outcomes. Moreover, an adequately responsive immune system seems to rely on the existence of a functioning gut ecosystem that includes the microbiota and its natural environment.

Cancer by itself, but also cancer treatments - in particular chemotherapy - induce gut dysbiosis, impair the constant reparation mechanisms of the gut epithelium, disrupt immune homeostasis, and stunt immune responsiveness.

The objective of MaaT033 is to (1) prevent the decay of the gut ecosystem (dysbiosis) to preserve immune homeostasis, (2) restore and optimize the gut ecosystem to full functionality including its role in repairing the gut epithelium and healthy gut barrier, and (3) maintain a restored gut ecosystem and fully functional immune homeostasis.

Restoring the full gut ecosystem and its associated microbiota could become an important therapeutic option to improve clinical outcomes and control adverse events of conventional approaches, including immunotherapy in cancer patients.

As a first step, MaaT033 capsules containing lyophilized, pooled, full-ecosystem microbiota in its natural environment are to be tested for their safety and tolerability in hematological malignant patients, who are exposed to intensive rounds of chemotherapy and antibiotics.

primary_purpose: Supportive Care

lead_sponsor: MaaT Pharma

location_facility:
IUCT
CHU Angers
CHU Nice
APHP St Antoine


title: Is it Better to Add Supination Osteotomy, Varisation Osteotomy, or Both to Distal Chevron as Part of Hallux Valgus Management : a Prospective Randomized Trial

summary:
Deviation of the big toe in valgus at the level of the first metatarsophalangeal joint is called Hallux Valgus. In case of significant pain especially due to a conflict with the shoes, surgery could be indicated. Angle between the first metatarsal (M1) and the first phalangeal (P1) is named Hallux Valgus Angle (HVA). Angle between M1 and the second metatarsal (M2) is named InterMetatarsal Angle (IMA). Angle between M1 distal articular surface and M1 shaft axis in a frontal plane is named Distal Metatarsal Articular Angle (DMAA).

Insufficient surgical correction is a risk factor of recurrence (HVA>20° after surgery). According to Okuda et al in a 67 patients group treated by proximal osteotomies correction, postoperative risk factors of recurrence at 33 month of follow-up are : HVA>40° before the surgery and HVA>15° with an IMA>10° 10 weeks (3-24) after the surgery.

Currently, one of the most common used procedure is a translated (lateraly) distal chevron associated with a release of the metatarsosesamoid suspensory ligament and a Akin procedure on P1. Nevertheless this procedure does not correct déformation in all plans. HVA and IMA are corrected but DMAA and M1 pronation angle are not.

Surgeons can add three different osteotomies in this type of chevron. In the dorsal saw cut a varisation wedge osteotomy is possible , in the plantar saw cut a supination wedge osteotomy is possible, and both are possible. No studies have tried to assess these three possibilities.

The investigators hypothesize that the addition of a varisation and/or a supination wedge osteotomies in a distal chevron decrease risk factors of recurrence at six months of follow-up

status: Active, not recruiting

lead_sponsor: Klouche-Clinical-Research

location_facility:
Clinique Mégival
Clinique de l'Union
Clinique du Parc Lyon
Clinique Lille sud


title: Study of the Facial Nerve in MRI 3T in the Preoperative Assessment of Parotid Tumors

acronym: FACPAR

summary: Preoperative evaluation of the precise localization of the intrapartotic facial nerve is essential for the ENT surgeon to assess the risk of nerve damage during parotid tumor excision, and inform the patient of the risk of post-paralyzed facial nerve palsy. procedure

status: Withdrawn

time_perspective: Cross-Sectional

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility:
Hôpital FOCH
Fondation Adolphe De Rothschild
Institut Arthur Vernes
Hôpital Saint Joseph


title: Diagnostic Performance of the Ultra Low-Dose (ULD) Scanner vs. Diagnostic Performance With Standard X-rays in the Emergency Department Compared With Performance of the Standard Classical-dose Scanner for Trauma of the Dorsolumbar Spine, Pelvis and Extremities

acronym: ULD-Traumato

summary: The conventional standard-dose scanner leads to a significantly greater X-ray exposure than the standard X-ray. Recently, technological innovations like the ULD ("Ultra Low Dose") scanner have been developed to reduce the dose of X-rays delivered to the patient. The general purpose of this study is to validate the ULD scanner in case of emergency trauma of the dorsolumbar spine, pelvis and / or extremities.

ipd_sharing: Undecided

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility:
Clinique du Parc
Clinique de l'Union
Centre Hospitalier de Mont-de-Marsan
Centre Hospitalier Universitaire


title: Phase III Trial Comparing 2 Diagnostic Strategies for Preoperative Localization of Parathyroid Adenoma in Primary Hyperparathyroidism:TEMP / CT With Tc99m-sestaMIBI or PET / CT With F18-choline in First Intention

summary: The investigators hypothesize that positron emission tomography with fluorocholline (F18-choline PET) will reduce the proportion of unnecessary invasive surgery decisions and that the higher cost of positron emission tomography versus MIBI scintigraphy (Tc99m-sestaMIBI ) will be offset by lower cost in terms of type. surgery performed wisely and complications.

ReferenceCitation: Quak E, Lasne Cardon A, Ciappuccini R, Lasnon C, Bastit V, Le Henaff V, Lireux B, Foucras G, Jaudet C, Berchi C, Grellard JM, Lequesne J, Clarisse B, Bardet S. Upfront F18-choline PET/CT versus Tc99m-sestaMIBI SPECT/CT guided surgery in primary hyperparathyroidism: the randomized phase III diagnostic trial APACH2. BMC Endocr Disord. 2021 Jan 7;21(1):3. doi: 10.1186/s12902-020-00667-5.

lead_sponsor: Centre Francois Baclesse

location_facility:
Centre François Baclesse
Centre Eugène Marquis
CHU Brest
CHU


title: Assessement of the Diagnostic Interest in Insulin Resistance of the Specific and Quantitative ELISA Assay of a Plasma Biomarker of Cellular Glucose Capture: the Secreted IRAP Protein (Regulated Amino Peptidase Insulin)

acronym: IRAP-IR

summary:
There is currently no reliable, diagnostic tests of insulin resistance other than the hyperinsulinemic euglycemic clamp which, due to its constraints and cost, is reserved for research. The insulin-Regulated aminopeptidase (IRAP) protein is a direct marker of insulin-dependent glucose cell capture and thus it blood concentration seems to be a good diagnostic test of insulin resistance.

The purpose of this study is to assess a plasma essay of IRAP protein for evaluation of insulin resistance during an oral glucose tolerance test (OGTT).

status: Terminated

lead_sponsor: University Hospital, Grenoble

location_facility: CRNH Rhône-Alpes et Centre Hospitalier LYON Sud

location_facility: Service de Nutrition clinique et CRNH Auvergne

location_facility: Inserm CIC1406, clinical research center, Grenoble Alpes university hospital

location_facility: Endocrinologie-Diabétologie-Nutrition et CIC, CHU DE MONTPELLIER


title: The Strategy of "Pulmonary Opening by Titration of Positive End-expiratory Pressure" Means of a Pulmonary Recruitment Maneuver in Patients With Acute Respiratory Distress Syndrome: for Which Patients?

acronym: OPPRED

summary: Pulmonary recruitment maneuvers open these lung areas and appropriate adjustment of positive expiratory pressure (PEP) helps to stabilize recruitment and reduce the stress associated with alveolar opening and closing. Its beneficial effects in the lung affected by Acute Respiratory Distress Syndrome (ARDS) remain unclear. The hypothesis is that there is a heterogeneous effect of the recruitment maneuver according to the phenotype of ARDS. It is important to be able to define responder patients from non-responders to this recruiting maneuver.

primary_purpose: Other

lead_sponsor: Centre Hospitalier de Lens

location_facility:
Chu Amiens
Ch Germon Et Gauthier
Hospital Dr Schaffner
CH Arras


title: Study of the Parameters of Quantified Gait Analysis in Moderate Hemophiliac Patients (AQM-Hemophile)

summary: The management of moderate hemophilia is less codified than those of severe patients; because these patients are theoretically less likely to bleed and therefore less likely to develop arthropathies. Nowaways, the question arises as to the appropriateness of this "symptomatic" management for the prevention of the occurrence of hemophilic arthropathies. Indeed, a significant number of moderate hemophiliacs seems to develop severe arthropathies that cause significant disability. However, because of the very small proportion of these patients in the total number of hemophiliacs, data are lacking on the impact of arthropathies on this population. The investigators therefore propose to include moderate hemophiliac patients in the study to carry out an evaluation of gait, using a gait analysis to determine the consequences of arthropathies, even sub-clinical ones, according to the duration of the disease's progression. In an associated way, the analysis of different clinical (joint assessment; quality of life score;...), radiological (radiographic; ultrasound (synovial thickness)), biological (level of associated factors ; other associated marker), in order to provide a complete picture of the articular situation in these patients with moderate haemophilia.

location_facility: Rheumatology department (Nantes University Hospital)

location_facility: Department of Physical Medicine and Locomotive Rehabilitation (Nantes University Hospital)

location_facility: Department of Physical Medicine and Neurological Rehabilitation (Nantes University Hospital)

location_facility: Regional Hemophilia Treatment Centre (Nantes University Hospital)


title: Combination Therapy Associating CPAP and Mandibular Advancement Device ( MAD) in Obstructive Sleep Apnea (OSA) Low CPAP Compliers: A Randomized Controlled Trial

acronym: PPC-OAM

summary:
The aim of this study is to evaluate the efficacy of a combination of Continuous Positive Airway Pressure (CPAP) and a Mandibular Advancement Device (MAD) on nocturnal Blood Pressure control in hypertensive patients in obstructive sleep apnea low CPAP compliers (less than 4 hours per night).

Hypertensive patients demonstrating low CPAP adherence will be selected during a screening visit; they will be then randomized to one of the three following arms: Education to CPAP ("CPAP only"), Treatment by a MAD ("MAD only") or a combination of both CPAP and MAD ("CPAP+MAD"). Mean systolic, diastolic, diurnal and nocturnal blood pressure will be assessed during 24-h Ambulatory Blood Pressure monitoring, before and after a 3-month treatment intervention. Biological laboratory parameters, patients reported outcomes (daytime sleepiness and Quality of Life), will also be evaluated before and after 3 months of treatment.

ReferenceCitation: Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med. 1993 Apr 29;328(17):1230-5.

ReferenceCitation: Marin JM, Carrizo SJ, Vicente E, Agusti AG. Long-term cardiovascular outcomes in men with obstructive sleep apnoea-hypopnoea with or without treatment with continuous positive airway pressure: an observational study. Lancet. 2005 Mar 19-25;365(9464):1046-53.

ReferenceCitation: Kendzerska T, Gershon AS, Hawker G, Leung RS, Tomlinson G. Obstructive sleep apnea and risk of cardiovascular events and all-cause mortality: a decade-long historical cohort study. PLoS Med. 2014 Feb 4;11(2):e1001599. doi: 10.1371/journal.pmed.1001599. eCollection 2014 Feb.

ReferenceCitation: Bailly S, Destors M, Grillet Y, Richard P, Stach B, Vivodtzev I, Timsit JF, Lévy P, Tamisier R, Pépin JL; scientific council and investigators of the French national sleep apnea registry (OSFP). Obstructive Sleep Apnea: A Cluster Analysis at Time of Diagnosis. PLoS One. 2016 Jun 17;11(6):e0157318. doi: 10.1371/journal.pone.0157318. eCollection 2016.

ReferenceCitation: Lévy P, Kohler M, McNicholas WT, Barbé F, McEvoy RD, Somers VK, Lavie L, Pépin JL. Obstructive sleep apnoea syndrome. Nat Rev Dis Primers. 2015 Jun 25;1:15015. doi: 10.1038/nrdp.2015.15. Review.

ReferenceCitation: Bratton DJ, Gaisl T, Schlatzer C, Kohler M. Comparison of the effects of continuous positive airway pressure and mandibular advancement devices on sleepiness in patients with obstructive sleep apnoea: a network meta-analysis. Lancet Respir Med. 2015 Nov;3(11):869-78. doi: 10.1016/S2213-2600(15)00416-6. Epub 2015 Oct 20. Erratum in: Lancet Respir Med. 2015 Dec;3(12):e44.

ReferenceCitation: Pépin JL, Tamisier R, Baguet JP, Lepaulle B, Arbib F, Arnol N, Timsit JF, Lévy P. Fixed-pressure CPAP versus auto-adjusting CPAP: comparison of efficacy on blood pressure in obstructive sleep apnoea, a randomised clinical trial. Thorax. 2016 Aug;71(8):726-33. doi: 10.1136/thoraxjnl-2015-207700. Epub 2016 Apr 18.

ReferenceCitation: Pépin JL, Tamisier R, Barone-Rochette G, Launois SH, Lévy P, Baguet JP. Comparison of continuous positive airway pressure and valsartan in hypertensive patients with sleep apnea. Am J Respir Crit Care Med. 2010 Oct 1;182(7):954-60. doi: 10.1164/rccm.200912-1803OC. Epub 2010 Jun 3.

ReferenceCitation: Malhotra A, Orr JE, Owens RL. On the cutting edge of obstructive sleep apnoea: where next? Lancet Respir Med. 2015 May;3(5):397-403. doi: 10.1016/S2213-2600(15)00051-X. Epub 2015 Apr 14. Review.

ReferenceCitation: Bratton DJ, Gaisl T, Wons AM, Kohler M. CPAP vs Mandibular Advancement Devices and Blood Pressure in Patients With Obstructive Sleep Apnea: A Systematic Review and Meta-analysis. JAMA. 2015 Dec 1;314(21):2280-93. doi: 10.1001/jama.2015.16303. Review.

ReferenceCitation: Mokhlesi B, Hagen EW, Finn LA, Hla KM, Carter JR, Peppard PE. Obstructive sleep apnoea during REM sleep and incident non-dipping of nocturnal blood pressure: a longitudinal analysis of the Wisconsin Sleep Cohort. Thorax. 2015 Nov;70(11):1062-9. doi: 10.1136/thoraxjnl-2015-207231. Epub 2015 Aug 25.

location_facility:
University Hospital Grenoble
Nouvelle Clinique Bel Air
Cabinet Médical
University Hospital Montpellier


title: French Prospective Clinical Database of Colorectal Robotic Surgery

acronym: ROBOT CR

summary: Evaluation of robot Da Vinci Xi by determining its learning curve.The operating time will be defined by patient then the operating average will be calculated.

ReferenceCitation: Colombo PE, Bertrand MM, Alline M, Boulay E, Mourregot A, Carrère S, Quénet F, Jarlier M, Rouanet P. Robotic Versus Laparoscopic Total Mesorectal Excision (TME) for Sphincter-Saving Surgery: Is There Any Difference in the Transanal TME Rectal Approach? : A Single-Center Series of 120 Consecutive Patients. Ann Surg Oncol. 2016 May;23(5):1594-600. doi: 10.1245/s10434-015-5048-4. Epub 2015 Dec 29.

ReferenceCitation: Bertrand MM, Colombo PE, Mourregot A, Traore D, Carrère S, Quénet F, Rouanet P. Standardized single docking, four arms and fully robotic proctectomy for rectal cancer: the key points are the ports and arms placement. J Robot Surg. 2016 Jun;10(2):171-4. doi: 10.1007/s11701-015-0551-y. Epub 2015 Dec 8.

ReferenceCitation: Nagtegaal ID, van de Velde CJ, van der Worp E, Kapiteijn E, Quirke P, van Krieken JH; Cooperative Clinical Investigators of the Dutch Colorectal Cancer Group. Macroscopic evaluation of rectal cancer resection specimen: clinical significance of the pathologist in quality control. J Clin Oncol. 2002 Apr 1;20(7):1729-34.

ReferenceCitation: Chen SL, Steele SR, Eberhardt J, Zhu K, Bilchik A, Stojadinovic A. Lymph node ratio as a quality and prognostic indicator in stage III colon cancer. Ann Surg. 2011 Jan;253(1):82-7. doi: 10.1097/SLA.0b013e3181ffa780.

ReferenceCitation: Zhang X, Wei Z, Bie M, Peng X, Chen C. Robot-assisted versus laparoscopic-assisted surgery for colorectal cancer: a meta-analysis. Surg Endosc. 2016 Dec;30(12):5601-5614. Epub 2016 Jul 11. Review.

ReferenceCitation: Parc Y, Reboul-Marty J, Lefevre JH, Shields C, Chafai N, Tiret E. Factors influencing mortality and morbidity following colorectal resection in France. Analysis of a national database (2009-2011). Colorectal Dis. 2016 Feb;18(2):205-13. doi: 10.1111/codi.13099.

ReferenceCitation: Bege T, Lelong B, Esterni B, Turrini O, Guiramand J, Francon D, Mokart D, Houvenaeghel G, Giovannini M, Delpero JR. The learning curve for the laparoscopic approach to conservative mesorectal excision for rectal cancer: lessons drawn from a single institution's experience. Ann Surg. 2010 Feb;251(2):249-53. doi: 10.1097/SLA.0b013e3181b7fdb0.

ReferenceCitation: Poloniecki J, Valencia O, Littlejohns P. Cumulative risk adjusted mortality chart for detecting changes in death rate: observational study of heart surgery. BMJ. 1998 Jun 6;316(7146):1697-700. Erratum in: BMJ 1998 Jun 27;316(7149):1947.

ReferenceCitation: Guend H, Widmar M, Patel S, Nash GM, Paty PB, Guillem JG, Temple LK, Garcia-Aguilar J, Weiser MR. Developing a robotic colorectal cancer surgery program: understanding institutional and individual learning curves. Surg Endosc. 2017 Jul;31(7):2820-2828. doi: 10.1007/s00464-016-5292-0. Epub 2016 Nov 4.

ReferenceCitation: Bokhari MB, Patel CB, Ramos-Valadez DI, Ragupathi M, Haas EM. Learning curve for robotic-assisted laparoscopic colorectal surgery. Surg Endosc. 2011 Mar;25(3):855-60. doi: 10.1007/s00464-010-1281-x. Epub 2010 Aug 24.

ReferenceCitation: Bolsin S, Colson M. The use of the Cusum technique in the assessment of trainee competence in new procedures. Int J Qual Health Care. 2000 Oct;12(5):433-8.

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

location_facility: Institut régional du cancer de Montpellier


title: PLANning Your Every Day Life I Virtual REality : a Study Schizophrenia. Mathurin Serious Game

acronym: PlaniRev

summary:
Patients with schizophrenia , who visit frenquently day-care or day-care activities clinics, often experience difficulties of daily living and cognitive deficits. Living independently is a key for recovery. Cognitive remediation is a therapy which reduces deficit and improves daily living. Nowadays no program exists targeting neurocognitive functions in virtual reality which could mimic everyday life in a virtual town.

Hypotheses :

Persons with schizophrenia experience difficulties in daily living and disabilities to plan in everyday life. PLANI-REV program, a serious game with a navigation in a virtual town, in a 15 weekly group sessions could reduce these difficulties compared to the initial assessment. This improvement could be maintained 6 months after the end of the program.
PLANI-REV could also improve prospective memory, attention, working memory, and visuospatial organization.
PLANI-REV could induce a clinical improvement, as well as better perception of self-efficiency, self esteem, quality of life, and conversation skills.

lead_sponsor: Centre Hospitalier St Anne

location_facility:
Hopital les Murets
Centre Hospitalier DURANT
Centre Hospitalier Sainte Anne
Centre Hospitalier Guillaume Régnier


title: Retrospective Study of Renal Biopsies Indications and Their Results in Patients With Type-2 Diabetes : a Multicenter Study

summary:
The WHO (World Health Organisation) estimated the prevalence of diabetes to be 422 million people in 2014, compared to 108 million in 1980. This has led to an increasing number of diabetic patients referred to nephrologists for diagnostic purposes. Diabetic nephropathy is the most common renal disease in this population and is usually a presumptive diagnosis based on clinical and biological features although microscopic examination of a renal sample acquired through renal biopsy is the only way to be certain of this diagnosis. However, kidney biopsy is an invasive procedure carrying a low but incontestable risk of adverse event such as post-procedural pain and bleeding. Consequently, nephrologist around the world feel that renal biopsy should only be performed in patients with type 2 diabetes to detect non-diabetic renal disease, when the diagnosis of diabetic nephropathy is dubious or unlikely. This likeliness is based on the presence or absence of typical feature such as diabetic retinopathy, hematuria, progressive decline of renal function or increase of proteinuria, long duration of diabetes, nephrotic syndrome. These feature were identified by the comparison of patients with type 2 diabetes and non-diabetic renal disease (alone or associated to diabetic nephropathy) and isolated diabetic nephropathy.

However, it is not known if the presence (or absence) of these atypical features by themselves are indeed signs of non-diabetic renal disease and necessitate to perform renal biopsy. The aim of the study is to determine if these atypical features are relevant indications to perform renal biopsy. To answer this question, will be analyze the medical records of patients with type 2 diabetes who underwent renal biopsy in five French nephrology center to determine, in each case, the indication of the biopsy and if this latter benefitted the patients.

In addition, will be evaluate the prognosis value of the Renal Pathology Society classification of diabetic nephropathy in patients with type 2 diabetes and diabetic nephropathy.

lead_sponsor: Rennes University Hospital

location_facility:
AP-HP, Hôpital Bichat-Claude Bernard
Hôpital Bretonneau
AP-HM, Hôpital de la Conception
Rennes University Hospital


title: Lack of Decision-making in Patients With Alzheimer's Disease : Functions Involved and the Daily Consequences

acronym: MAPdP

summary:
Early in its development, Alzheimer's disease causes not only brain damage affecting different regions of the brain, such as the entorhinal cortex, the anterior cingulate cortex, and the prefrontal lobe, but also a cognitive deficit affecting several functions, such as episodic memory, executive functions, or working memory. Although these different areas and functions are involved in the decision-making process, few studies have focused their research on this subject in the context of Alzheimer's disease. However, a 2008 study showed an early decline in decision-making skills in the disease, but did not link this deficit to cognitive impairment. In addition, decision-making is generally assessed using a test called the Iowa Gambling Task (IGT), which, despite its many advantages, does not have established ecological validity.

In the context of pathology, however, it seems essential to evaluate decision-making in relation to daily life, especially since a deficit in this process would have considerable repercussions on quality of life.

In this study, the investigators seek to better define the disorder by decision-making in early Alzheimer's disease, to understand the links between them with the deficit of other cognitive functions, and to highlight the the consequences that this decline has on patients' daily lives.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Laboratoire d'Etude des Mécanismes Cognitifs


type: Registry Identifier

title: Validation and Optimization Methods for a Quantitative Characterization of Motion Abnormalities of the Larynx With Echography

acronym: VOCALE

summary:
One of the major risks of endocrine surgery is recurrent nerve palsy (RNP), leading to vocal folds (VF) immobility. It happens in 5% of cases, leading to high morbidity: dysphonia, aspirations, impossibility to work. Guidelines recommend to systematically perform a nasofibroscopy before and after surgery to check vocal fold mobility. However, due to the decreasing number of specialists, the cost of decontamination, and discomfort of this procedure, these guidelines are insufficiently followed.

Transcutaneous Laryngeal Ultrasonography (TLU) appears a good alternative to nasofibroscopy in evaluating VF mobility, as assessed by the recent flourishing literature. Our team is a leader in this research by having developed a dedicated software, which provides objective measures of VF mobility. The aim of the present protocol is to validate the power of TLU for the diagnosis of RNP on a large cohort of patients operated on endocrine surgery. It is a prospective multicentric study that will blindly compare TLU and nasofibroscopy, the latter being the gold standard. TLU is cost effective and painless; its learning curve is fast. If validated, it may be offered as a good alternative to nasofibroscopy in RNP detection and prognosis.

ReferenceCitation: Bergeret-Cassagne H, Lazard DS, Lefort M, Hachi S, Leenhardt L, Menegaux F, Russ G, Trésallet C, Frouin F. Sonographic Dynamic Description of the Laryngeal Tract: Definition of Quantitative Measures to Characterize Vocal Fold Motion and Estimation of Their Normal Values. J Ultrasound Med. 2017 May;36(5):1037-1044. doi: 10.7863/ultra.16.05014. Epub 2017 Jan 10.

ReferenceCitation: Lazard DS, Bergeret-Cassagne H, Lefort M, Leenhardt L, Russ G, Frouin F, Trésallet C. Transcutaneous Laryngeal Ultrasonography for Laryngeal Immobility Diagnosis in Patients with Voice Disorders After Thyroid/Parathyroid Surgery. World J Surg. 2018 Jul;42(7):2102-2108. doi: 10.1007/s00268-017-4428-2.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: CHU Nantes - Clinique de chirurgie Digestive et Endocrinienne


title: Evaluation of Efficacy of Cryotherapy for Skin Anesthesia During Arterial Puncture for Blood Gas in Critically Ill Patients. SNOW Study

acronym: SNOW

summary: the purpose of this study is to evaluate the cryotherapy effect by vapocoolant spray to reducing pain during puncture for artérial blood gas

lead_sponsor: Versailles Hospital

location_facility:
Hopital Nord Franche-Comte
Ch Versailles
CHU Saint LOUIS
Hopital Européèn Georges Pompidou


title: Detection of Colistin-resistant Isolates From Patients Admitted in Intensive Care Units and Oncohaematology Wards in the Region Nouvelle Aquitaine: Diagnostic Accuracy of the Detection Methods, Estimation of the Prevalence and Description of the Resistance Mechanisms.

acronym: RESCO

summary: The increasing use of colistin in multidrug resistant strains, as Enterobacteriaceae producing extended-spectrum β-lactamases or carbapenemases, is associated with the emergence of colistin resistant isolates. The main objective of this project is to estimate the diagnostic accuracy (sensitivity and specificity) of a new rapid detection test of colistin resistant strains (Rapid Polymyxin NP test) isolated in clinical settings.

lead_sponsor: University Hospital, Bordeaux

location_facility:
CHU de Limoges
CH de Dax
CH de Mont de Marsan
CHU de Bordeaux


title: Evaluation of the Interest of Pulmonary Ultrasound in the Diagnosis and Early Detection of Acute Thoracic Syndrome in Hospitalized Children for Vaso-occlusive Sickle Cell Crisis: Multicenter Prospective Study

acronym: ECHO-STA

summary:
ATS (acute thoracic syndrome) refers to acute pulmonary involvement in a sickle cell patient. The diagnosis is based on the association of clinical signs (fever or respiratory symptoms) with a recent pulmonary infiltrate on the chest x-ray.

The main objective of the study is to evaluate the place of the pulmonary ultrasound for the diagnosis of ATS, in comparison with frontal chest x-ray.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility: Centre Hospitalier Intercommunal Créteil


title: Human and Bacterial Protease Activity as Prognostic Tool of Foot Infections in Diabetic Patients

acronym: CHEK BAC

summary: This study will establish whether human and bacterial protease activity can aid therapeutic decision-making, including targeted treatments.

location_facility:
CHU de Nimes
CHU de Montpellier
CH de Bagnols sur Céze
CH d'Alès


title: Assessment of Outpatient Digital Follow-up of Patients Over 70 Years of Age Undergoing Chemotherapy Treatment

acronym: E-SN@P PROJECT

summary: adherence of digital follow-up in a population of elderly patients.

lead_sponsor: Institut Paoli-Calmettes

location_facility:
CHU Nice
Institut Paoli-Calmettes
CHI des Alpes du Sud
Institut Sainte Catherine


title: Constitution d'Une Cohorte Prospective de Sujets Sains et Malades et d'Une Collection de Ressources Biologiques associées Pour l'étude du système Immunitaire et de Ses déterminants Génétiques et Environnementaux"

acronym: CoSImmGEn

summary: CoSImmGEn is a protocol set up to respond to the current lack of healthy and sick population cohorts. Biological resources from these cohorts allow researchers to study the immune system and its genetic and environmental determinants. Those cohorts and collections are open not only to the Pasteurian community but also to the worldwide scientific community (both public and private) working in the field.

primary_purpose: Basic Science

ReferenceCitation: Iglesias MC, Briceno O, Gostick E, Moris A, Meaudre C, Price DA, Ungeheuer MN, Saez-Cirion A, Mallone R, Appay V. Immunodominance of HLA-B27-restricted HIV KK10-specific CD8(+) T-cells is not related to naïve precursor frequency. Immunol Lett. 2013 Jan;149(1-2):119-22. doi: 10.1016/j.imlet.2012.10.002. Epub 2012 Oct 13.

ReferenceCitation: Duffy D, Rouilly V, Libri V, Hasan M, Beitz B, David M, Urrutia A, Bisiaux A, Labrie ST, Dubois A, Boneca IG, Delval C, Thomas S, Rogge L, Schmolz M, Quintana-Murci L, Albert ML; Milieu Intérieur Consortium. Functional analysis via standardized whole-blood stimulation systems defines the boundaries of a healthy immune response to complex stimuli. Immunity. 2014 Mar 20;40(3):436-50. doi: 10.1016/j.immuni.2014.03.002.

ReferenceCitation: Thomas S, Rouilly V, Patin E, Alanio C, Dubois A, Delval C, Marquier LG, Fauchoux N, Sayegrih S, Vray M, Duffy D, Quintana-Murci L, Albert ML; Milieu Intérieur Consortium. The Milieu Intérieur study - an integrative approach for study of human immunological variance. Clin Immunol. 2015 Apr;157(2):277-93. doi: 10.1016/j.clim.2014.12.004. Epub 2015 Jan 3.

ReferenceCitation: Monceaux V, Chiche-Lapierre C, Chaput C, Witko-Sarsat V, Prevost MC, Taylor CT, Ungeheuer MN, Sansonetti PJ, Marteyn BS. Anoxia and glucose supplementation preserve neutrophil viability and function. Blood. 2016 Aug 18;128(7):993-1002. doi: 10.1182/blood-2015-11-680918. Epub 2016 Jul 8.

ReferenceCitation: Urrutia A, Duffy D, Rouilly V, Posseme C, Djebali R, Illanes G, Libri V, Albaud B, Gentien D, Piasecka B, Hasan M, Fontes M, Quintana-Murci L, Albert ML; Milieu Intérieur Consortium. Standardized Whole-Blood Transcriptional Profiling Enables the Deconvolution of Complex Induced Immune Responses. Cell Rep. 2016 Sep 6;16(10):2777-2791. doi: 10.1016/j.celrep.2016.08.011. Epub 2016 Aug 25.

ReferenceCitation: Hamimi C, David A, Versmisse P, Weiss L, Bruel T, Zucman D, Appay V, Moris A, Ungeheuer MN, Lascoux-Combe C, Barré-Sinoussi F, Muller-Trutwin M, Boufassa F, Lambotte O, Pancino G, Sáez-Cirión A; ANRS CO21 CODEX cohort. Dendritic Cells from HIV Controllers Have Low Susceptibility to HIV-1 Infection In Vitro but High Capacity to Capture HIV-1 Particles. PLoS One. 2016 Aug 9;11(8):e0160251. doi: 10.1371/journal.pone.0160251. eCollection 2016.

ReferenceCitation: Duffy D, Rouilly V, Braudeau C, Corbière V, Djebali R, Ungeheuer MN, Josien R, LaBrie ST, Lantz O, Louis D, Martinez-Caceres E, Mascart F, Ruiz de Morales JG, Ottone C, Redjah L, Guen NS, Savenay A, Schmolz M, Toubert A, Albert ML; Multinational FOCIS Centers of Excellence. Standardized whole blood stimulation improves immunomonitoring of induced immune responses in multi-center study. Clin Immunol. 2017 Oct;183:325-335. doi: 10.1016/j.clim.2017.09.019. Epub 2017 Sep 22.

ReferenceCitation: Piasecka B, Duffy D, Urrutia A, Quach H, Patin E, Posseme C, Bergstedt J, Charbit B, Rouilly V, MacPherson CR, Hasan M, Albaud B, Gentien D, Fellay J, Albert ML, Quintana-Murci L; Milieu Intérieur Consortium. Distinctive roles of age, sex, and genetics in shaping transcriptional variation of human immune responses to microbial challenges. Proc Natl Acad Sci U S A. 2018 Jan 16;115(3):E488-E497. doi: 10.1073/pnas.1714765115. Epub 2017 Dec 27.

ReferenceCitation: Patin E, Hasan M, Bergstedt J, Rouilly V, Libri V, Urrutia A, Alanio C, Scepanovic P, Hammer C, Jönsson F, Beitz B, Quach H, Lim YW, Hunkapiller J, Zepeda M, Green C, Piasecka B, Leloup C, Rogge L, Huetz F, Peguillet I, Lantz O, Fontes M, Di Santo JP, Thomas S, Fellay J, Duffy D, Quintana-Murci L, Albert ML; Milieu Intérieur Consortium. Publisher Correction: Natural variation in the parameters of innate immune cells is preferentially driven by genetic factors. Nat Immunol. 2018 Jun;19(6):645. doi: 10.1038/s41590-018-0105-3.

ReferenceCitation: Scepanovic P, Alanio C, Hammer C, Hodel F, Bergstedt J, Patin E, Thorball CW, Chaturvedi N, Charbit B, Abel L, Quintana-Murci L, Duffy D, Albert ML, Fellay J; Milieu Intérieur Consortium. Human genetic variants and age are the strongest predictors of humoral immune responses to common pathogens and vaccines. Genome Med. 2018 Jul 27;10(1):59. doi: 10.1186/s13073-018-0568-8.

ReferenceCitation: Kilens S, Meistermann D, Moreno D, Chariau C, Gaignerie A, Reignier A, Lelièvre Y, Casanova M, Vallot C, Nedellec S, Flippe L, Firmin J, Song J, Charpentier E, Lammers J, Donnart A, Marec N, Deb W, Bihouée A, Le Caignec C, Pecqueur C, Redon R, Barrière P, Bourdon J, Pasque V, Soumillon M, Mikkelsen TS, Rougeulle C, Fréour T, David L; Milieu Intérieur Consortium. Parallel derivation of isogenic human primed and naive induced pluripotent stem cells. Nat Commun. 2018 Jan 24;9(1):360. doi: 10.1038/s41467-017-02107-w.

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

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

ReferenceCitation: Prigent J, Lorin V, Kök A, Hieu T, Bourgeau S, Mouquet H. Scarcity of autoreactive human blood IgA(+) memory B cells. Eur J Immunol. 2016 Oct;46(10):2340-2351. doi: 10.1002/eji.201646446. Epub 2016 Aug 25.

ReferenceCitation: Bouchet J, Del Río-Iñiguez I, Vázquez-Chávez E, Lasserre R, Agüera-González S, Cuche C, McCaffrey MW, Di Bartolo V, Alcover A. Rab11-FIP3 Regulation of Lck Endosomal Traffic Controls TCR Signal Transduction. J Immunol. 2017 Apr 1;198(7):2967-2978. doi: 10.4049/jimmunol.1600671. Epub 2017 Feb 24.

ReferenceCitation: Agüera-González S, Burton OT, Vázquez-Chávez E, Cuche C, Herit F, Bouchet J, Lasserre R, Del Río-Iñiguez I, Di Bartolo V, Alcover A. Adenomatous Polyposis Coli Defines Treg Differentiation and Anti-inflammatory Function through Microtubule-Mediated NFAT Localization. Cell Rep. 2017 Oct 3;21(1):181-194. doi: 10.1016/j.celrep.2017.09.020.

lead_sponsor: Institut Pasteur

location_facility:
Institut Pasteur
Hôpital Tenon
Hopital sainte Périne
Centre médical de l'Institut Pasteur


title: Interest of Strain Ultrasound in the Diagnosis of Pneumothorax: Prospective Multicenter Observational Study

summary: The objective of this study is to investigate whether the use of strain ultrasound can improve the lung ultrasound accuracy for the diagnosis of pneumothorax, particularly for inexperienced physicians.

location_facility:
Nimes University hospital
AP-HM - Hopital Nord
CHU Nîmes
Hôpital La Timone


title: Multi-elemental Imaging of Lung Tissues With LIBS (Laser-induced Breakdown Spectroscopy) : a Feasibility Study

acronym: MEDICO-LIBS

summary: Evaluate the feasibility of performing a multi-elemental imaging analysis of lung specimens from patients with ILDs, with an technology named LIBS (Laser Induced-Breakdown Spectroscopy)

ReferenceCitation: Busser B, Moncayo S, Trichard F, Bonneterre V, Pinel N, Pelascini F, Dugourd P, Coll JL, D'Incan M, Charles J, Motto-Ros V, Sancey L. Characterization of foreign materials in paraffin-embedded pathological specimens using in situ multi-elemental imaging with laser spectroscopy. Mod Pathol. 2018 Mar;31(3):378-384. doi: 10.1038/modpathol.2017.152. Epub 2017 Nov 17.

ReferenceCitation: Busser et al., Coord Chem Rev, 2018, 358, p70

location_facility:
CHU de Lyon HCL - GH Sud
CHRU de LILLE
Hôpital Louis Pradel
Grenoble Alpes University Hospital


title: Impulse Oscillometry for Prognostication in Idiopathic Pulmonary Fibrosis

acronym: OSCILLO

summary:
A 5-point decline of forced vital capacity expressed as % predicted, over 6 months, is the current definition of disease progression (fast decline in lung function) in idiopathic pulmonary fibrosis. There is a need for techniques allowing to characterize disease progression earlier, so that treatment may be adapted as early as possible in the lack of a response.

Hypothesis. Our hypothesis is that 3-month changes of lung function parameters measured by a novel technique, impulse oscillometry, predicts 6-month changes in forced vital capacity in idiopathic pulmonary fibrosis.

lead_sponsor: University Hospital, Tours

location_facility: Department of digestive physiology, urinary, respiratory and exercise, University Hospital, Rouen

location_facility: Pulmonology Department, University Hospital, Tours

location_facility: Respiratory Functional Explorations, University Hospital, Lille

location_facility: Respiratory Functional Explorations, University Hospital, Nantes


title: Domain 1 of β2-Glycoprotein 1 Autoantibodies and Thrombin Generation Capacity in Patients With Antiphospholipid Antibodies

acronym: LYON SAPL

summary:
Antiphospholipid syndrome (APS) is an autoimmune disease characterized by thromboembolic events or pregnancy complications associated with circulating antiphospholipid antibodies (aPL-Abs). APS diagnosis needs the presence of both clinical and serological criteria (SAPORRO criteria, updated with Sydney criteria in 2006). However, no correlation between laboratory assays and the clinical thrombosis risk in patients with aPL-Abs was observed as only few patients with aPL-Abs developed clinical manifestations. Thrombin generation assays (TGA) is a global coagulation test that may represent a certain interest to evaluate thrombosis risk as a high thrombin generation capacity seems to be an independent risk factor for recurrent thromboembolic events. Another point of interest to assess the thrombotic risk is the detection of autoantibodies recognizing domain 1 of β2Gp1 (aβ2GP1-dm1). These autoantibodies are strongly related correlated with thrombotic and pregnancy manifestations. Recently, a commercial chemiluminescence immunoassay (CLIA) for detection of aβ2GP1-dm1 became available on Acustar® analyzer (HemosIL Acustar®, Instrument Laboratory, Bedford, USA) to facilitate aβ2GP1-dm1 research.

The aim of this study is to evaluate two additional laboratory assays to improve the correlation between laboratory assays and the clinical thrombosis risk in patients with antiphospholipid (APL): thrombin generation assay and aβ2GP1-dm1. Each biological result (Antibodies to Domain 1 (Dm1) of β2-Glycoprotein 1 (aβ2GP1-dm1) and Thrombin Generation Test (TGT) parameters: endogen thrombin potential (ETP), lag time and time to peak) will be compared to the history of clinical thrombosis (venous or arterial thrombosis and/or obstetrical complications such as defined by the Saporro criteria updated with Sydney criteria in 2006) for each patient.

lead_sponsor: Hospices Civils de Lyon

location_facility:
CHU de Clermont-Ferrand
Centre Hospitalier Lyon Sud
Hôpital Cardiologique Louis Pradel
Hôpital Edouard Herriot


title: Measuring Endoscopic ACTIvity in Patients Treated With VEDOlizumab for Ulcerative Colitis

acronym: ACTIVEDO

summary: Describe the proportion of patients with ulcerative colitis (UC) treated with vedolizumab (VDZ) who achieve mucosal healing at week 54 of treatment.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility:
CHU de Nantes
CHI de Haute-Saône
CHU de Montpellier
CHU de Besançon


title: Safety, Tolerability and Efficacy of Regorafenib in Combination With FOLFIRINOX in Patients With RAS-mutated Metastatic Colorectal Cancer: a Dose-escalation, Phase I/II Trial

acronym: FOLFIRINOX-R

summary: Safety, tolerability and efficacy of regorafenib in combination with FOLFIRINOX in patients with RAS-mutated metastatic colorectal cancer: a dose-escalation, phase I/II trial

ReferenceCitation: Van Cutsem E, Cervantes A, Adam R, Sobrero A, Van Krieken JH, Aderka D, Aranda Aguilar E, Bardelli A, Benson A, Bodoky G, Ciardiello F, D'Hoore A, Diaz-Rubio E, Douillard JY, Ducreux M, Falcone A, Grothey A, Gruenberger T, Haustermans K, Heinemann V, Hoff P, Köhne CH, Labianca R, Laurent-Puig P, Ma B, Maughan T, Muro K, Normanno N, Österlund P, Oyen WJ, Papamichael D, Pentheroudakis G, Pfeiffer P, Price TJ, Punt C, Ricke J, Roth A, Salazar R, Scheithauer W, Schmoll HJ, Tabernero J, Taïeb J, Tejpar S, Wasan H, Yoshino T, Zaanan A, Arnold D. ESMO consensus guidelines for the management of patients with metastatic colorectal cancer. Ann Oncol. 2016 Aug;27(8):1386-422. doi: 10.1093/annonc/mdw235. Epub 2016 Jul 5.

ReferenceCitation: Modest DP, Ricard I, Heinemann V, Hegewisch-Becker S, Schmiegel W, Porschen R, Stintzing S, Graeven U, Arnold D, von Weikersthal LF, Giessen-Jung C, Stahler A, Schmoll HJ, Jung A, Kirchner T, Tannapfel A, Reinacher-Schick A. Outcome according to KRAS-, NRAS- and BRAF-mutation as well as KRAS mutation variants: pooled analysis of five randomized trials in metastatic colorectal cancer by the AIO colorectal cancer study group. Ann Oncol. 2016 Sep;27(9):1746-53. doi: 10.1093/annonc/mdw261. Epub 2016 Jun 29.

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: Mross K, Frost A, Steinbild S, Hedbom S, Büchert M, Fasol U, Unger C, Krätzschmar J, Heinig R, Boix O, Christensen O. A phase I dose-escalation study of regorafenib (BAY 73-4506), an inhibitor of oncogenic, angiogenic, and stromal kinases, in patients with advanced solid tumors. Clin Cancer Res. 2012 May 1;18(9):2658-67. doi: 10.1158/1078-0432.CCR-11-1900. Epub 2012 Mar 15.

ReferenceCitation: Schmieder R, Hoffmann J, Becker M, Bhargava A, Müller T, Kahmann N, Ellinghaus P, Adams R, Rosenthal A, Thierauch KH, Scholz A, Wilhelm SM, Zopf D. Regorafenib (BAY 73-4506): antitumor and antimetastatic activities in preclinical models of colorectal cancer. Int J Cancer. 2014 Sep 15;135(6):1487-96. doi: 10.1002/ijc.28669. Epub 2014 Apr 17.

ReferenceCitation: Grothey A, Van Cutsem E, Sobrero A, Siena S, Falcone A, Ychou M, Humblet Y, Bouché O, Mineur L, Barone C, Adenis A, Tabernero J, Yoshino T, Lenz HJ, Goldberg RM, Sargent DJ, Cihon F, Cupit L, Wagner A, Laurent D; CORRECT Study Group. Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet. 2013 Jan 26;381(9863):303-12. doi: 10.1016/S0140-6736(12)61900-X. Epub 2012 Nov 22.

ReferenceCitation: Li J, Qin S, Xu R, Yau TC, Ma B, Pan H, Xu J, Bai Y, Chi Y, Wang L, Yeh KH, Bi F, Cheng Y, Le AT, Lin JK, Liu T, Ma D, Kappeler C, Kalmus J, Kim TW; CONCUR Investigators. Regorafenib plus best supportive care versus placebo plus best supportive care in Asian patients with previously treated metastatic colorectal cancer (CONCUR): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2015 Jun;16(6):619-29. doi: 10.1016/S1470-2045(15)70156-7. Epub 2015 May 13.

ReferenceCitation: Schultheis B, Folprecht G, Kuhlmann J, Ehrenberg R, Hacker UT, Köhne CH, Kornacker M, Boix O, Lettieri J, Krauss J, Fischer R, Hamann S, Strumberg D, Mross KB. Regorafenib in combination with FOLFOX or FOLFIRI as first- or second-line treatment of colorectal cancer: results of a multicenter, phase Ib study. Ann Oncol. 2013 Jun;24(6):1560-7. doi: 10.1093/annonc/mdt056. Epub 2013 Mar 13.

ReferenceCitation: Leitinger B. Discoidin domain receptor functions in physiological and pathological conditions. Int Rev Cell Mol Biol. 2014;310:39-87. doi: 10.1016/B978-0-12-800180-6.00002-5. Review.

ReferenceCitation: Rammal H, Saby C, Magnien K, Van-Gulick L, Garnotel R, Buache E, El Btaouri H, Jeannesson P, Morjani H. Corrigendum: Discoidin Domain Receptors: Potential Actors and Targets in Cancer. Front Pharmacol. 2016 Sep 30;7:346. eCollection 2016.

ReferenceCitation: Gao H, Chakraborty G, Zhang Z, Akalay I, Gadiya M, Gao Y, Sinha S, Hu J, Jiang C, Akram M, Brogi E, Leitinger B, Giancotti FG. Multi-organ Site Metastatic Reactivation Mediated by Non-canonical Discoidin Domain Receptor 1 Signaling. Cell. 2016 Jun 30;166(1):47-62. doi: 10.1016/j.cell.2016.06.009.

ReferenceCitation: Jeitany M, Leroy C, Tosti P, Lafitte M, Le Guet J, Simon V, Bonenfant D, Robert B, Grillet F, Mollevi C, El Messaoudi S, Otandault A, Canterel-Thouennon L, Busson M, Thierry AR, Martineau P, Pannequin J, Roche S, Sirvent A. Inhibition of DDR1-BCR signalling by nilotinib as a new therapeutic strategy for metastatic colorectal cancer. EMBO Mol Med. 2018 Apr;10(4). pii: e7918. doi: 10.15252/emmm.201707918.

ReferenceCitation: Zopf D, Fichtner I, Bhargava A, Steinke W, Thierauch KH, Diefenbach K, Wilhelm S, Hafner FT, Gerisch M. Pharmacologic activity and pharmacokinetics of metabolites of regorafenib in preclinical models. Cancer Med. 2016 Nov;5(11):3176-3185. doi: 10.1002/cam4.883. Epub 2016 Oct 13.

ReferenceCitation: Mouliere F, El Messaoudi S, Gongora C, Guedj AS, Robert B, Del Rio M, Molina F, Lamy PJ, Lopez-Crapez E, Mathonnet M, Ychou M, Pezet D, Thierry AR. Circulating Cell-Free DNA from Colorectal Cancer Patients May Reveal High KRAS or BRAF Mutation Load. Transl Oncol. 2013 Jun 1;6(3):319-28. Print 2013 Jun.

ReferenceCitation: Mouliere F, El Messaoudi S, Pang D, Dritschilo A, Thierry AR. Multi-marker analysis of circulating cell-free DNA toward personalized medicine for colorectal cancer. Mol Oncol. 2014 Jul;8(5):927-41. doi: 10.1016/j.molonc.2014.02.005. Epub 2014 Mar 24.

ReferenceCitation: Thierry AR, Mouliere F, El Messaoudi S, Mollevi C, Lopez-Crapez E, Rolet F, Gillet B, Gongora C, Dechelotte P, Robert B, Del Rio M, Lamy PJ, Bibeau F, Nouaille M, Loriot V, Jarrousse AS, Molina F, Mathonnet M, Pezet D, Ychou M. Clinical validation of the detection of KRAS and BRAF mutations from circulating tumor DNA. Nat Med. 2014 Apr;20(4):430-5. doi: 10.1038/nm.3511. Epub 2014 Mar 23.

ReferenceCitation: Thierry AR, El Messaoudi S, Mollevi C, Raoul JL, Guimbaud R, Pezet D, Artru P, Assenat E, Borg C, Mathonnet M, De La Fouchardière C, Bouché O, Gavoille C, Fiess C, Auzemery B, Meddeb R, Lopez-Crapez E, Sanchez C, Pastor B, Ychou M. Clinical utility of circulating DNA analysis for rapid detection of actionable mutations to select metastatic colorectal patients for anti-EGFR treatment. Ann Oncol. 2017 Sep 1;28(9):2149-2159. doi: 10.1093/annonc/mdx330.

ReferenceCitation: Tie J, Kinde I, Wang Y, Wong HL, Roebert J, Christie M, Tacey M, Wong R, Singh M, Karapetis CS, Desai J, Tran B, Strausberg RL, Diaz LA Jr, Papadopoulos N, Kinzler KW, Vogelstein B, Gibbs P. Circulating tumor DNA as an early marker of therapeutic response in patients with metastatic colorectal cancer. Ann Oncol. 2015 Aug;26(8):1715-22. doi: 10.1093/annonc/mdv177. Epub 2015 Apr 7.

ReferenceCitation: Vidal J, Muinelo L, Dalmases A, Jones F, Edelstein D, Iglesias M, Orrillo M, Abalo A, Rodríguez C, Brozos E, Vidal Y, Candamio S, Vázquez F, Ruiz J, Guix M, Visa L, Sikri V, Albanell J, Bellosillo B, López R, Montagut C. Plasma ctDNA RAS mutation analysis for the diagnosis and treatment monitoring of metastatic colorectal cancer patients. Ann Oncol. 2017 Jun 1;28(6):1325-1332. doi: 10.1093/annonc/mdx125.

ReferenceCitation: Thierry AR, Pastor B, Jiang ZQ, Katsiampoura AD, Parseghian C, Loree JM, Overman MJ, Sanchez C, Messaoudi SE, Ychou M, Kopetz S. Circulating DNA Demonstrates Convergent Evolution and Common Resistance Mechanisms during Treatment of Colorectal Cancer. Clin Cancer Res. 2017 Aug 15;23(16):4578-4591. doi: 10.1158/1078-0432.CCR-17-0232. Epub 2017 Apr 11.

ReferenceCitation: Adenis A, Mazard T, Fraisse J, Chalbos P, Pastor B, Evesque L, Ghiringhelli F, Mollevi C, Delaine S, Ychou M. FOLFIRINOX-R study design: a phase I/II trial of FOLFIRINOX plus regorafenib as first line therapy in patients with unresectable RAS-mutated metastatic colorectal cancer. BMC Cancer. 2021 May 17;21(1):564. doi: 10.1186/s12885-021-08312-7.

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

intervention_type: Combination Product


title: Evaluation of tDCS Efficacy in Enduring Anorexia Nervosa : a Randomized Controlled Clinical Trial

acronym: EVASTRAM

summary:
Approximately 20% of anorexia nervosa cases do not respond to conventional management strategies: cognitive behavioral therapy, weight gain contract, drug treatments, etc ... - whether they are applied outpatients or during very long hospitalizations. These situations of chronic evolution are characterized by a high rate of mortality. Brain stimulation could be an alternative therapy for these patients. tDCS (transcranial direct current stimulation) is a non-invasive stimulation technique that has demonstrated beneficial effects in other psychiatric conditions such as major depression or schizophrenia.

The objectives of the study will be to evaluate the efficacy of tDCS in anorexia nervosa resistant to conventional treatments on weight gain, eating behavior, psychological and nutritional behavioral scales, cognition, connectivity and brain activity.

location_facility:
CHU Grenoble
Hospices Civils de Lyon
CHU Saint-Etienne
CHU Clermont-Ferrand


title: Comparison of the Cumulative Number of Oocytes Obtained With 2 Controlled Ovarian Hyperstimulations (COH) Within the Same Cycle With FertistartKit® (DUOSTIM) Versus 2 Conventional COH in Poor Ovarian Responders Undergoing IVF. Bistim Study

summary: During ovarian stimulation, all the follicles grow under the action of FSH, only the selected follicles and with the faster growth are taken. However during this stimulation, other smaller follicles are also recruited and sensitized, which may increase the selection of follicles available on the follicular wave following. In patients with weak reserve this potentiation has a great interest, and the sequence of 2 stimulations on the same cycle could make it possible to obtain a larger number of oocytes and embryos, thus giving a better chance of delivery than on 2 distinct cycles of stimulation. However, this is preliminary data that needs to be confirmed with a randomized controlled trial. In this population of poor prognosis, the use of FSH-associated LH activity may optimize the ovarian response to stimulation, particularly the combination containing placental HCG (Fertistartkit®) that obtaining a slightly higher number of oocytes than highly purified HMG (Menopur®).

location_facility:
CHI Creteil
Polyclinique Saint Roch
Polyclinique Jean Villar
Cabinet Médical Carré Saint Giniez


title: Evaluation of the Bladder Stimulation, a Non-invasive Technique of Urine Collection, in Infant Less Than 6 Months to Diagnose Urinary Tract Infection: a Randomized Multicenter Study

acronym: EEStiVeN

summary: Urinary tract infection (UTI) is the most common serious bacterial infection among infants. Suprapubic aspiration and bladder catheterization are considered as the gold standard by the American Academy of Pediatrics for the diagnosis, yet it is painful and invasive. In contrast, the bladder stimulation technique has been shown to be a quick and non-invasive approach to collect urine in young infants. Actually, the investigators don't have data on bacterial contamination rates for clean-catch midstream urine collections using this technique

ReferenceCitation: Demonchy D, Ciais C, Fontas E, Berard E, Bréaud J, Rohrlich PS, Dubos F, Fortier C, Desmontils J, Hérisse AL, Donzeau D, Haas H, Tran A. Evaluation of bladder stimulation as a non-invasive technique for urine collection to diagnose urinary tract infection in infants under 6 months: a randomized multicenter study ("EE-Sti.Ve.N"). Trials. 2019 Dec 27;20(1):783. doi: 10.1186/s13063-019-3914-2.

lead_sponsor: Fondation Lenval

location_facility: Hôpitaux Pédiatriques de Nice CHU-Lenval