summary:
Phase II study, randomized, open-label, multicentric, willing to establish the benefit of pursuing chemotherapy beyond 6 weeks for non progressive patients. The study will proceed in two successive phases :

non randomized phase in which all patients will undergo chemotherapy
second phase in which only non progressive patients are going to be randomized ("discontinuation design"). Patients that will show progression in their disease during the first 6 weeks will be released of the study

location_facility: Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie

title: Phase II Randomized Study Measuring the Interest of Pursuing or Not the CT for Non-progressive Patients With Metastatic Esophageal Squamous-cell Cancer After 6 Weeks of LV5FU2-paclitaxel Given After a 1st Line Fluoropyrimidine/Pt Salt CT


type: Other Identifier

title: Analysis of Volatile Organic Compounds in Exhaled Air as a Diagnostic Tool for Thoracic Cancers

acronym: CATOCOV

summary: Determination of volatile organic compounds to discriminate patients with lung cancer from healthy smokers and non-smokers healthy subjects.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Diagnostic

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: University Hospital, Lille

collaborators: Institut National de Recherche en Informatique et en Automatique

location_facility: Institut Pasteur - Centre de Prévention et d'Education à la Santé (CPES)

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Ongoing

appel_a_projets: PHRCI

region: Hauts-de-France

nom_etablissement: CHR LILLE

type_etablissement: CH

acronyme: CATOCOV

titre: Analyse des Composés Organiques Volatiles dans l'Air Exhalé comme outil diagnostique des Cancers Thoraciques

discipline_principale: cancers broncho-pulmonaires, composés organiques volatiles, analyse de l'air exhalé, méthode séparative par chromatographie (gc-ms), diagnostic précoce

nom_porteur: HULO

prenom_porteur: Sébastien


title: Effectiveness and Safety of Early Intramuscular Botulinum Toxin Injections to Prevent Shoulder Deformity in Babies With Obstetrical Brachial Plexus Palsy

acronym: POPB-TOX

summary:
In children population with obstetrical brachial plexus palsy (OBPP), shoulder musculoskeletal deformity is the main cause of morbidity, with a loss of range of shoulder motion, pain and a reduction in social participation. Some uncontrolled studies shows that early injections of botulinum toxin (BTI) in the internal shoulder rotator muscles (which cause the deformity) are one of the most promising treatment for the prevention of bony deformity.

The main objective of this study will be the evaluation of the effectiveness of BTI in the internal shoulder rotator muscles at the age of 12 months in preventing an increase in posterior subluxation of the glenohumeral joint in babies with OBPP (evaluated at the ages of 11 months and 18 months), compared to the Sham group.

design_allocation: Randomized

primary_purpose: Treatment

ReferenceType: derived

ReferenceCitation: Pons C, Eddi D, Le Gal G, Garetier M, Ben Salem D, Houx L, Fitoussi F, Quintero N, Brochard S; POPB-TOX Group. Effectiveness and safety of early intramuscular botulinum toxin injections to prevent shoulder deformity in babies with brachial plexus birth injury (POPB-TOX), a randomised controlled trial: study protocol. BMJ Open. 2019 Sep 30;9(9):e032901. doi: 10.1136/bmjopen-2019-032901.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: British Medical Journal

lead_sponsor: University Hospital, Brest

location_facility: Institut Régionnal de Réadaptation Centre de Réadaptation pour enfant

location_facility: ESEAN (Etablissement de Santé pour Enfants et Adolescents de la région Nantaise)

intervention_type: Drug

appel_a_projets: PHRCN

region: Bretagne

nom_etablissement: CHRU BREST

type_etablissement: CHUR

acronyme: POPB Tox

titre: Efficacité et sécurité des injections intramusculaires de toxine botulinique précoces dans la prévention de la déformation de l'épaule des nourrissons atteints de paralysie obstétricale du plexus brachial: un essai multicentrique contrôlé randomisé en double aveugle contre placebo

discipline_principale: médecine physique et réadaptation

nom_porteur: BROCHARD

prenom_porteur: Sylvain


title: Clinical and Molecular Description of PKD1 and PKD2 Mutation Negative Carriers in Autosomal Dominant Polycystic Kidney Disease (ADPKD): The GeneQuest Study

acronym: GeneQuest

summary:
The aim of this study is to identify families with ADPKD , characterize the phenotype and screen for mutations in known genes (PKD1 and PKD2, and then HNF1b and UMOD in PKD1 PKD2 negative carriers).

Genome wide analysis will be performed in families without mutations identified.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

ReferenceCitation: Lefevre S, Audrezet MP, Halimi JM, Longuet H, Bridoux F, Ecotiere L, Augusto JF, Duveau A, Renaudineau E, Vigneau C, Frouget T, Charasse C, Gueguen L, Perrichot R, Couvrat G, Seret G, Le Meur Y, Cornec-Le Gall E; Genkyst Study Group. Diagnosis and risk factors for intracranial aneurysms in autosomal polycystic kidney disease: a cross-sectional study from the Genkyst cohort. Nephrol Dial Transplant. 2022 Oct 19;37(11):2223-2233. doi: 10.1093/ndt/gfac027.

oa_host_type: repository

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

repository_normalized: HAL

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

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

repositories_concat: HAL

unpaywall_oa_status: green

publisher_dissemination: Oxford University Press

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

location_facility: Centre de néphrologie et de dialyse d'Armorique

intervention_type: Other

status_simplified: Completed


title: Pilot Study to Assess Efficacy and Safety of a Quadruple Therapy With Asunaprevir, Daclatasvir, Ribavirin and Pegylated Interferon Alpha-2a in HCV Genotype 4-infected Patients Non-responders to Pegylated Interferon-Ribavirin Regimen

summary:
Success rates, after retreatment with Peg-Interferon/Ribavirin bitherapy, in patients infected with HCV (hepatitis C virus) genotype 4 and non-responders to a first standard treatment, are disappointing. The association of Asunaprevir and Daclatasvir in combination with the standard-of-care bitherapy has been shown to increase the efficacy of the treatment in non-responders genotype 1-infected patients.

Given the absence of current solutions and urgent therapeutic needs for HCV genotype 4-infected patients previously treated with pegylated Interferon/Ribavirin, this pilot study aims to evaluate the efficacy and safety of a quadritherapy associating Asunaprevir, Daclatasvir, pegylated Interferon alpha-2a and Ribavirin, in this very difficult to treat population.

60 subjects will be enrolled.

The primary endpoint will be the rate of sustained virological response (SVR), defined by an undetectable HCV RNA, at Week 36 (12 weeks after the end of a 24 weeks quadritherapy).

lead_sponsor: ANRS, Emerging Infectious Diseases

sponsor_collaborators:
ANRS, Emerging Infectious Diseases
Bristol-Myers Squibb

location_facility:
Hôpital Purpan
Hôpital Jean Verdier
Hôpital AVICENNE
Hôpital Tenon
Hôpital de Haut Lévêque
Hôpital de l'Hôtel Dieu
Hôpital Pitié Salpêtrière
Hôpital Saint Eloi
Centre Hospitalier Intercommunal
Hôpital de Brabois
Institut Arnault Tzank
Hôpital Charles Nicolle
Hôpital Paul Brousse
Hôpital Cochin
Hôpital Pontchaillou
Hôpital de l'Archet
Hôpital de La Source
Fondation Hôpital Saint Joseph
Hôpital Saint Antoine
Hôpital Henri Mondor
Hôpital de la Croix Rousse
Hôpital Dupuytren
Hôpital Albert Michallon
Hôpital Beaujon
Hôpital Claude Huriez


title: Evaluation of the Non-inferiority of TulleGras M.S.® Versus Urgotul® in Pain Associated With Removal of Wound Dressing During Care of Venous Leg Ulcer. An Open-label, Multicenter, Randomized, Controlled, Crossover Study With Blinded Reading of Healing Criteria.

summary: Evaluation of the non-inferiority of TulleGras M.S.® versus Urgotul® in pain associated with removal of wound dressing during care of venous leg ulcer

lead_sponsor: Mylan Inc.

sponsor_collaborators:
Mylan Inc.
CEN Biotech

location_facility:
Research Facility ID ORG-000857
Research facility ID ORG-001081
Research facility ORG-001362
Research facility ID ORG-001083
Research Facility ID ORG-000830
Research facility ID ORG-000831
Research facility ID ORG-000865
Research facility ID ORG-000845
Research Facility ID ORG-000859
Research Facility ID ORG-000862
Research facility ORG-001361
Research facility ID ORG-000836
Research Facility ID ORG-000850
Research facility ID ORG-001216
Research Facility ID ORG-001182
Research facility ID ORG-000981
Research facility ID ORG-000855
Research Facility ID ORG-000844
Research facility ID ORG-001082
Research facility ID ORG-000856
Research facility ID ORG-000853
Research facility ID ORG-000835
Research Facility ID ORG-001183
Research Facility ID ORG-001181
Research Facility ID ORG-000832
Research Facility ID ORG-000869
Research facility ID ORG-001215

lead_sponsor_type: industriel


title: Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing

summary: A randomized clinical trial to investigate the use of the temporary Diaphragm Pacing Therapy System (DPTS) to rehabilitate the diaphragm in mechanically ventilated patients who have failed at least two weaning attempts. The goal is to strengthen and rehabilitate the diaphragm to liberate the patient more quickly from mechanical ventilation.

ReferenceType: background

ReferenceCitation: Evans D, Shure D, Clark L, Criner GJ, Dres M, de Abreu MG, Laghi F, McDonagh D, Petrof B, Nelson T, Similowski T. Temporary transvenous diaphragm pacing vs. standard of care for weaning from mechanical ventilation: study protocol for a randomized trial. Trials. 2019 Jan 17;20(1):60. doi: 10.1186/s13063-018-3171-9.

ReferenceType: result

ReferenceCitation: Dres M, de Abreu MG, Merdji H, Muller-Redetzky H, Dellweg D, Randerath WJ, Mortaza S, Jung B, Bruells C, Moerer O, Scharffenberg M, Jaber S, Besset S, Bitter T, Geise A, Heine A, Malfertheiner MV, Kortgen A, Benzaquen J, Nelson T, Uhrig A, Moenig O, Meziani F, Demoule A, Similowski T; RESCUE-2 Study Group Investigators. Randomized Clinical Study of Temporary Transvenous Phrenic Nerve Stimulation in Difficult-to-Wean Patients. Am J Respir Crit Care Med. 2022 May 15;205(10):1169-1178. doi: 10.1164/rccm.202107-1709OC.

oa_colors: green hybrid

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

version: submittedVersion

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

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: American Thoracic Society

ipd_sharing: Undecided

ipd_sharing_description: Only investigators participating in this clinical trial will be able to see final de-identified participant data at the completion of the study and it will be available through the clinical research organization (CRO).

lead_sponsor: Lungpacer Medical Inc.

sponsor_collaborators:
Lungpacer Medical Inc.
Syntactx

location_country: Germany France

location_facility: Charite Universitatsmedizin Berlin - Mitte campus

location_facility: Wissenschaftliches Institut Bethanien fur Pneumologie e.V.

location_facility: Asklepios Kliniken Hamburg GmbH - Asklepios Klinikum Harburg

location_facility: Centre Hospitalier Universitaire de Nice (CHU Nice)

location_facility: Heart and Diabetes Center Bad Oeynhausen


title: Phase 3 Study Randomized Against Placebo, Evaluating the Efficacy of Auriculotherapy in Patients With Musculoskeletal Pain by Aromatase Inhibitors in Adjuvant Treatment of Breast Cancer (TRIPLE-A)

acronym: TRIPLE-A

summary: Auriculotherapy is a complementary medicine, with few side effects, without contraindication, inexpensive and not very restrictive.Its efficacy has been found in several tests especially for the treatment of intraoperative pain. It remains more controversial in other indications. Evaluation of the value of auriculotherapy is often difficult because of the methodological limitations of the trials conducted. In the daily practice, the auriculotherapy is proposed to improve the articular pains of patients treated by AA. This Phase III study aims at validate this approach.

primary_purpose: Supportive Care

lead_sponsor: Centre Francois Baclesse

location_facility:
CHU Grenoble
Hôpital Privé Paul d'Egine
Centre Oscar Lambret
Groupe Hospitalier Paris St Joseph
IGR
Centre François Baclesse
Hôpital Cognac-Jay - Forcilles


acronym: MYELAXAT

lead_sponsor: University Hospital, Grenoble

summary:
To evaluate:

the incidence of venous thromboembolic event (VTE)
the incidence of hemorrhagic complications, In a population of patients with myeloma who are treated with IMiDs and require thromboprophylaxis for 6 months, using an oral anti-Xa anticoagulant, Apixaban, in a preventive scheme, 2.5 mg x2/day

ReferenceCitation: Agnelli G, Buller HR, Cohen A, Curto M, Gallus AS, Johnson M, Porcari A, Raskob GE, Weitz JI; AMPLIFY-EXT Investigators. Apixaban for extended treatment of venous thromboembolism. N Engl J Med. 2013 Feb 21;368(8):699-708. doi: 10.1056/NEJMoa1207541. Epub 2012 Dec 8.

oa_colors: green other

evidence: open (via free article)

license: public-domain

license_normalized: public-domain

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

repositories_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Anagnostopoulos A, Weber D, Rankin K, Delasalle K, Alexanian R. Thalidomide and dexamethasone for resistant multiple myeloma. Br J Haematol. 2003 Jun;121(5):768-71. doi: 10.1046/j.1365-2141.2003.04345.x.

ReferenceCitation: Attal M, Lauwers-Cances V, Marit G, Caillot D, Moreau P, Facon T, Stoppa AM, Hulin C, Benboubker L, Garderet L, Decaux O, Leyvraz S, Vekemans MC, Voillat L, Michallet M, Pegourie B, Dumontet C, Roussel M, Leleu X, Mathiot C, Payen C, Avet-Loiseau H, Harousseau JL; IFM Investigators. Lenalidomide maintenance after stem-cell transplantation for multiple myeloma. N Engl J Med. 2012 May 10;366(19):1782-91. doi: 10.1056/NEJMoa1114138.

ReferenceCitation: Barlogie B, Desikan R, Eddlemon P, Spencer T, Zeldis J, Munshi N, Badros A, Zangari M, Anaissie E, Epstein J, Shaughnessy J, Ayers D, Spoon D, Tricot G. Extended survival in advanced and refractory multiple myeloma after single-agent thalidomide: identification of prognostic factors in a phase 2 study of 169 patients. Blood. 2001 Jul 15;98(2):492-4. doi: 10.1182/blood.v98.2.492.

ReferenceCitation: Baz R, Li L, Kottke-Marchant K, Srkalovic G, McGowan B, Yiannaki E, Karam MA, Faiman B, Jawde RA, Andresen S, Zeldis J, Hussein MA. The role of aspirin in the prevention of thrombotic complications of thalidomide and anthracycline-based chemotherapy for multiple myeloma. Mayo Clin Proc. 2005 Dec;80(12):1568-74. doi: 10.4065/80.12.1568.

ReferenceCitation: Blom JW, Doggen CJ, Osanto S, Rosendaal FR. Malignancies, prothrombotic mutations, and the risk of venous thrombosis. JAMA. 2005 Feb 9;293(6):715-22. doi: 10.1001/jama.293.6.715.

ReferenceCitation: Carrier M, Le Gal G, Tay J, Wu C, Lee AY. Rates of venous thromboembolism in multiple myeloma patients undergoing immunomodulatory therapy with thalidomide or lenalidomide: a systematic review and meta-analysis. J Thromb Haemost. 2011 Apr;9(4):653-63. doi: 10.1111/j.1538-7836.2011.04215.x.

ReferenceCitation: Cavo M, Zamagni E, Tosi P, Cellini C, Cangini D, Tacchetti P, Testoni N, Tonelli M, de Vivo A, Palareti G, Tura S, Baccarani M. First-line therapy with thalidomide and dexamethasone in preparation for autologous stem cell transplantation for multiple myeloma. Haematologica. 2004 Jul;89(7):826-31.

ReferenceCitation: Chen C, Reece DE, Siegel D, Niesvizky R, Boccia RV, Stadtmauer EA, Abonour R, Richardson P, Matous J, Kumar S, Bahlis NJ, Alsina M, Vescio R, Coutre SE, Pietronigro D, Knight RD, Zeldis JB, Rajkumar V. Expanded safety experience with lenalidomide plus dexamethasone in relapsed or refractory multiple myeloma. Br J Haematol. 2009 Jul;146(2):164-70. doi: 10.1111/j.1365-2141.2009.07728.x. Epub 2009 May 26.

ReferenceCitation: Cohen AT, Davidson BL, Gallus AS, Lassen MR, Prins MH, Tomkowski W, Turpie AG, Egberts JF, Lensing AW; ARTEMIS Investigators. Efficacy and safety of fondaparinux for the prevention of venous thromboembolism in older acute medical patients: randomised placebo controlled trial. BMJ. 2006 Feb 11;332(7537):325-9. doi: 10.1136/bmj.38733.466748.7C. Epub 2006 Jan 26.

ReferenceCitation: Cohen AT, Spiro TE, Buller HR, Haskell L, Hu D, Hull R, Mebazaa A, Merli G, Schellong S, Spyropoulos AC, Tapson V; MAGELLAN Investigators. Rivaroxaban for thromboprophylaxis in acutely ill medical patients. N Engl J Med. 2013 Feb 7;368(6):513-23. doi: 10.1056/NEJMoa1111096.

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

repository_institution: Nova Science Publishers, Inc. - Nova Science Publishers

repositories_institution: Nova Science Publishers, Inc. - Nova Science Publishers

ReferenceCitation: Connolly SJ, Eikelboom J, Joyner C, Diener HC, Hart R, Golitsyn S, Flaker G, Avezum A, Hohnloser SH, Diaz R, Talajic M, Zhu J, Pais P, Budaj A, Parkhomenko A, Jansky P, Commerford P, Tan RS, Sim KH, Lewis BS, Van Mieghem W, Lip GY, Kim JH, Lanas-Zanetti F, Gonzalez-Hermosillo A, Dans AL, Munawar M, O'Donnell M, Lawrence J, Lewis G, Afzal R, Yusuf S; AVERROES Steering Committee and Investigators. Apixaban in patients with atrial fibrillation. N Engl J Med. 2011 Mar 3;364(9):806-17. doi: 10.1056/NEJMoa1007432. Epub 2011 Feb 10.

ReferenceCitation: Dimopoulos M, Spencer A, Attal M, Prince HM, Harousseau JL, Dmoszynska A, San Miguel J, Hellmann A, Facon T, Foa R, Corso A, Masliak Z, Olesnyckyj M, Yu Z, Patin J, Zeldis JB, Knight RD; Multiple Myeloma (010) Study Investigators. Lenalidomide plus dexamethasone for relapsed or refractory multiple myeloma. N Engl J Med. 2007 Nov 22;357(21):2123-32. doi: 10.1056/NEJMoa070594. Erratum In: N Engl J Med. 2009 Jul 30;361(5):544.

ReferenceCitation: Facon T, Mary JY, Hulin C, Benboubker L, Attal M, Pegourie B, Renaud M, Harousseau JL, Guillerm G, Chaleteix C, Dib M, Voillat L, Maisonneuve H, Troncy J, Dorvaux V, Monconduit M, Martin C, Casassus P, Jaubert J, Jardel H, Doyen C, Kolb B, Anglaret B, Grosbois B, Yakoub-Agha I, Mathiot C, Avet-Loiseau H; Intergroupe Francophone du Myelome. Melphalan and prednisone plus thalidomide versus melphalan and prednisone alone or reduced-intensity autologous stem cell transplantation in elderly patients with multiple myeloma (IFM 99-06): a randomised trial. Lancet. 2007 Oct 6;370(9594):1209-18. doi: 10.1016/S0140-6736(07)61537-2.

ReferenceCitation: Goldhaber SZ, Leizorovicz A, Kakkar AK, Haas SK, Merli G, Knabb RM, Weitz JI; ADOPT Trial Investigators. Apixaban versus enoxaparin for thromboprophylaxis in medically ill patients. N Engl J Med. 2011 Dec 8;365(23):2167-77. doi: 10.1056/NEJMoa1110899. Epub 2011 Nov 13.

ReferenceCitation: Heit JA, Silverstein MD, Mohr DN, Petterson TM, O'Fallon WM, Melton LJ 3rd. Risk factors for deep vein thrombosis and pulmonary embolism: a population-based case-control study. Arch Intern Med. 2000 Mar 27;160(6):809-15. doi: 10.1001/archinte.160.6.809.

ReferenceCitation: Hussein MA. Thromboembolism risk reduction in multiple myeloma patients treated with immunomodulatory drug combinations. Thromb Haemost. 2006 Jun;95(6):924-30. doi: 10.1160/TH06-02-0080.

ReferenceCitation: Johnson DC, Corthals S, Ramos C, Hoering A, Cocks K, Dickens NJ, Haessler J, Goldschmidt H, Child JA, Bell SE, Jackson G, Baris D, Rajkumar SV, Davies FE, Durie BG, Crowley J, Sonneveld P, Van Ness B, Morgan GJ. Genetic associations with thalidomide mediated venous thrombotic events in myeloma identified using targeted genotyping. Blood. 2008 Dec 15;112(13):4924-34. doi: 10.1182/blood-2008-02-140434. Epub 2008 Sep 19.

ReferenceCitation: Kristinsson SY, Pfeiffer RM, Bjorkholm M, Goldin LR, Schulman S, Blimark C, Mellqvist UH, Wahlin A, Turesson I, Landgren O. Arterial and venous thrombosis in monoclonal gammopathy of undetermined significance and multiple myeloma: a population-based study. Blood. 2010 Jun 17;115(24):4991-8. doi: 10.1182/blood-2009-11-252072. Epub 2010 Mar 18. Erratum In: Blood. 2011 Apr 7;117(14):3938.

ReferenceCitation: Larocca A, Cavallo F, Bringhen S, Di Raimondo F, Falanga A, Evangelista A, Cavalli M, Stanevsky A, Corradini P, Pezzatti S, Patriarca F, Cavo M, Peccatori J, Catalano L, Carella AM, Cafro AM, Siniscalchi A, Crippa C, Petrucci MT, Yehuda DB, Beggiato E, Di Toritto TC, Boccadoro M, Nagler A, Palumbo A. Aspirin or enoxaparin thromboprophylaxis for patients with newly diagnosed multiple myeloma treated with lenalidomide. Blood. 2012 Jan 26;119(4):933-9; quiz 1093. doi: 10.1182/blood-2011-03-344333. Epub 2011 Aug 11.

ReferenceCitation: Lassen MR, Raskob GE, Gallus A, Pineo G, Chen D, Hornick P; ADVANCE-2 investigators. Apixaban versus enoxaparin for thromboprophylaxis after knee replacement (ADVANCE-2): a randomised double-blind trial. Lancet. 2010 Mar 6;375(9717):807-15. doi: 10.1016/S0140-6736(09)62125-5.

ReferenceCitation: Leizorovicz A, Cohen AT, Turpie AG, Olsson CG, Vaitkus PT, Goldhaber SZ; PREVENT Medical Thromboprophylaxis Study Group. Randomized, placebo-controlled trial of dalteparin for the prevention of venous thromboembolism in acutely ill medical patients. Circulation. 2004 Aug 17;110(7):874-9. doi: 10.1161/01.CIR.0000138928.83266.24. Epub 2004 Aug 2.

ReferenceCitation: Leleu X, Daley L, Rodon P et al. MELISSE : Etude Multicentrique Prospective Observationelle pour definir les Facteurs de Risques de Thrombose dans le Myelome traite par les IMiDs. Congrès SFH, Paris, Mars 2011.

ReferenceCitation: Levine MN, Gu C, Liebman HA, Escalante CP, Solymoss S, Deitchman D, Ramirez L, Julian J. A randomized phase II trial of apixaban for the prevention of thromboembolism in patients with metastatic cancer. J Thromb Haemost. 2012 May;10(5):807-14. doi: 10.1111/j.1538-7836.2012.04693.x.

ReferenceCitation: Libourel EJ, Sonneveld P, van der Holt B, de Maat MP, Leebeek FW. High incidence of arterial thrombosis in young patients treated for multiple myeloma: results of a prospective cohort study. Blood. 2010 Jul 8;116(1):22-6. doi: 10.1182/blood-2009-12-257519. Epub 2010 Mar 25.

ReferenceCitation: Lyman GH, Khorana AA, Falanga A, Clarke-Pearson D, Flowers C, Jahanzeb M, Kakkar A, Kuderer NM, Levine MN, Liebman H, Mendelson D, Raskob G, Somerfield MR, Thodiyil P, Trent D, Francis CW; American Society of Clinical Oncology. American Society of Clinical Oncology guideline: recommendations for venous thromboembolism prophylaxis and treatment in patients with cancer. J Clin Oncol. 2007 Dec 1;25(34):5490-505. doi: 10.1200/JCO.2007.14.1283. Epub 2007 Oct 29.

ReferenceCitation: Mileshkin L, Biagi JJ, Mitchell P, Underhill C, Grigg A, Bell R, McKendrick J, Briggs P, Seymour JF, Lillie K, Smith JG, Zeldis JB, Prince HM. Multicenter phase 2 trial of thalidomide in relapsed/refractory multiple myeloma: adverse prognostic impact of advanced age. Blood. 2003 Jul 1;102(1):69-77. doi: 10.1182/blood-2002-09-2846. Epub 2003 Mar 13.

ReferenceCitation: Minnema MC, Breitkreutz I, Auwerda JJ, van der Holt B, Cremer FW, van Marion AM, Westveer PH, Sonneveld P, Goldschmidt H, Lokhorst HM. Prevention of venous thromboembolism with low molecular-weight heparin in patients with multiple myeloma treated with thalidomide and chemotherapy. Leukemia. 2004 Dec;18(12):2044-6. doi: 10.1038/sj.leu.2403533. No abstract available.

ReferenceCitation: Neben K, Moehler T, Benner A, Kraemer A, Egerer G, Ho AD, Goldschmidt H. Dose-dependent effect of thalidomide on overall survival in relapsed multiple myeloma. Clin Cancer Res. 2002 Nov;8(11):3377-82.

ReferenceCitation: Osman K, Comenzo R, Rajkumar SV. Deep venous thrombosis and thalidomide therapy for multiple myeloma. N Engl J Med. 2001 Jun 21;344(25):1951-2. doi: 10.1056/NEJM200106213442516. No abstract available.

ReferenceCitation: Palumbo A, Bertola A, Falco P, Rosato R, Cavallo F, Giaccone L, Bringhen S, Musto P, Pregno P, Caravita T, Ciccone G, Boccadoro M. Efficacy of low-dose thalidomide and dexamethasone as first salvage regimen in multiple myeloma. Hematol J. 2004;5(4):318-24. doi: 10.1038/sj.thj.6200403.

ReferenceCitation: Palumbo A, Bringhen S, Caravita T, Merla E, Capparella V, Callea V, Cangialosi C, Grasso M, Rossini F, Galli M, Catalano L, Zamagni E, Petrucci MT, De Stefano V, Ceccarelli M, Ambrosini MT, Avonto I, Falco P, Ciccone G, Liberati AM, Musto P, Boccadoro M; Italian Multiple Myeloma Network, GIMEMA. Oral melphalan and prednisone chemotherapy plus thalidomide compared with melphalan and prednisone alone in elderly patients with multiple myeloma: randomised controlled trial. Lancet. 2006 Mar 11;367(9513):825-31. doi: 10.1016/S0140-6736(06)68338-4.

ReferenceCitation: Palumbo A, Rus C, Zeldis JB, Rodeghiero F, Boccadoro M; Italian Multiple Myeloma Network, Gimema. Enoxaparin or aspirin for the prevention of recurrent thromboembolism in newly diagnosed myeloma patients treated with melphalan and prednisone plus thalidomide or lenalidomide. J Thromb Haemost. 2006 Aug;4(8):1842-5. doi: 10.1111/j.1538-7836.2006.02059.x. No abstract available.

ReferenceCitation: Palumbo A, Rajkumar SV, Dimopoulos MA, Richardson PG, San Miguel J, Barlogie B, Harousseau J, Zonder JA, Cavo M, Zangari M, Attal M, Belch A, Knop S, Joshua D, Sezer O, Ludwig H, Vesole D, Blade J, Kyle R, Westin J, Weber D, Bringhen S, Niesvizky R, Waage A, von Lilienfeld-Toal M, Lonial S, Morgan GJ, Orlowski RZ, Shimizu K, Anderson KC, Boccadoro M, Durie BG, Sonneveld P, Hussein MA; International Myeloma Working Group. Prevention of thalidomide- and lenalidomide-associated thrombosis in myeloma. Leukemia. 2008 Feb;22(2):414-23. doi: 10.1038/sj.leu.2405062. Epub 2007 Dec 20.

ReferenceCitation: Palumbo A, Bringhen S, Liberati AM, Caravita T, Falcone A, Callea V, Montanaro M, Ria R, Capaldi A, Zambello R, Benevolo G, Derudas D, Dore F, Cavallo F, Gay F, Falco P, Ciccone G, Musto P, Cavo M, Boccadoro M. Oral melphalan, prednisone, and thalidomide in elderly patients with multiple myeloma: updated results of a randomized controlled trial. Blood. 2008 Oct 15;112(8):3107-14. doi: 10.1182/blood-2008-04-149427. Epub 2008 May 27.

ReferenceCitation: Palumbo A, Davies F, Kropff M, Blade J, Delforge M, Leal da Costa F, Garcia Sanz R, Schey S, Facon T, Morgan G, Moreau P. Consensus guidelines for the optimal management of adverse events in newly diagnosed, transplant-ineligible patients receiving melphalan and prednisone in combination with thalidomide (MPT) for the treatment of multiple myeloma. Ann Hematol. 2010 Aug;89(8):803-11. doi: 10.1007/s00277-010-0925-1. Epub 2010 Mar 16.

ReferenceCitation: Palumbo A, Cavo M, Bringhen S, Zamagni E, Romano A, Patriarca F, Rossi D, Gentilini F, Crippa C, Galli M, Nozzoli C, Ria R, Marasca R, Montefusco V, Baldini L, Elice F, Callea V, Pulini S, Carella AM, Zambello R, Benevolo G, Magarotto V, Tacchetti P, Pescosta N, Cellini C, Polloni C, Evangelista A, Caravita T, Morabito F, Offidani M, Tosi P, Boccadoro M. Aspirin, warfarin, or enoxaparin thromboprophylaxis in patients with multiple myeloma treated with thalidomide: a phase III, open-label, randomized trial. J Clin Oncol. 2011 Mar 10;29(8):986-93. doi: 10.1200/JCO.2010.31.6844. Epub 2011 Jan 31.

ReferenceCitation: Pernod G, Albaladejo P, Godier A, Samama CM, Susen S, Gruel Y, Blais N, Fontana P, Cohen A, Llau JV, Rosencher N, Schved JF, de Maistre E, Samama MM, Mismetti P, Sie P; Working Group on Perioperative Haemostasis. Management of major bleeding complications and emergency surgery in patients on long-term treatment with direct oral anticoagulants, thrombin or factor-Xa inhibitors: proposals of the working group on perioperative haemostasis (GIHP) - March 2013. Arch Cardiovasc Dis. 2013 Jun-Jul;106(6-7):382-93. doi: 10.1016/j.acvd.2013.04.009. Epub 2013 Jun 25.

ReferenceCitation: Rajkumar SV, Hayman S, Gertz MA, Dispenzieri A, Lacy MQ, Greipp PR, Geyer S, Iturria N, Fonseca R, Lust JA, Kyle RA, Witzig TE. Combination therapy with thalidomide plus dexamethasone for newly diagnosed myeloma. J Clin Oncol. 2002 Nov 1;20(21):4319-23. doi: 10.1200/JCO.2002.02.116.

ReferenceCitation: Rajkumar SV, Gertz MA, Lacy MQ, Dispenzieri A, Fonseca R, Geyer SM, Iturria N, Kumar S, Lust JA, Kyle RA, Greipp PR, Witzig TE. Thalidomide as initial therapy for early-stage myeloma. Leukemia. 2003 Apr;17(4):775-9. doi: 10.1038/sj.leu.2402866.

ReferenceCitation: Rajkumar SV, Hayman SR, Lacy MQ, Dispenzieri A, Geyer SM, Kabat B, Zeldenrust SR, Kumar S, Greipp PR, Fonseca R, Lust JA, Russell SJ, Kyle RA, Witzig TE, Gertz MA. Combination therapy with lenalidomide plus dexamethasone (Rev/Dex) for newly diagnosed myeloma. Blood. 2005 Dec 15;106(13):4050-3. doi: 10.1182/blood-2005-07-2817. Epub 2005 Aug 23.

ReferenceCitation: Rajkumar SV, Blood E, Vesole D, Fonseca R, Greipp PR; Eastern Cooperative Oncology Group. Phase III clinical trial of thalidomide plus dexamethasone compared with dexamethasone alone in newly diagnosed multiple myeloma: a clinical trial coordinated by the Eastern Cooperative Oncology Group. J Clin Oncol. 2006 Jan 20;24(3):431-6. doi: 10.1200/JCO.2005.03.0221. Epub 2005 Dec 19.

ReferenceCitation: Rajkumar SV, Jacobus S, Callander NS, Fonseca R, Vesole DH, Williams ME, Abonour R, Siegel DS, Katz M, Greipp PR; Eastern Cooperative Oncology Group. Lenalidomide plus high-dose dexamethasone versus lenalidomide plus low-dose dexamethasone as initial therapy for newly diagnosed multiple myeloma: an open-label randomised controlled trial. Lancet Oncol. 2010 Jan;11(1):29-37. doi: 10.1016/S1470-2045(09)70284-0. Epub 2009 Oct 21. Erratum In: Lancet Oncol. 2010 Jan;11(1):14.

ReferenceCitation: Samama MM, Cohen AT, Darmon JY, Desjardins L, Eldor A, Janbon C, Leizorovicz A, Nguyen H, Olsson CG, Turpie AG, Weisslinger N. A comparison of enoxaparin with placebo for the prevention of venous thromboembolism in acutely ill medical patients. Prophylaxis in Medical Patients with Enoxaparin Study Group. N Engl J Med. 1999 Sep 9;341(11):793-800. doi: 10.1056/NEJM199909093411103.

ReferenceCitation: Samama CM. [Perioperative venous thromboembolism prophylaxis: short review and recommendations]. Ann Fr Anesth Reanim. 2008 Dec;27 Suppl 3:S2-8. doi: 10.1016/S0750-7658(08)75140-2. French.

ReferenceCitation: Schey SA, Cavenagh J, Johnson R, Child JA, Oakervee H, Jones RW. An UK myeloma forum phase II study of thalidomide; long term follow-up and recommendations for treatment. Leuk Res. 2003 Oct;27(10):909-14. doi: 10.1016/s0145-2126(03)00027-4.

ReferenceCitation: Schulman S, Kearon C; Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost. 2005 Apr;3(4):692-4. doi: 10.1111/j.1538-7836.2005.01204.x.

ReferenceCitation: Schutt P, Ebeling P, Buttkereit U, Brandhorst D, Opalka B, Hoiczyk M, Flasshove M, Hense J, Bojko P, Metz K, Moritz T, Seeber S, Nowrousian MR. Thalidomide in combination with vincristine, epirubicin and dexamethasone (VED) for previously untreated patients with multiple myeloma. Eur J Haematol. 2005 Jan;74(1):40-6. doi: 10.1111/j.1600-0609.2004.00349.x.

ReferenceCitation: Sidra G, Williams CD, Russell NH, Zaman S, Myers B, Byrne JL. Combination chemotherapy with cyclophosphamide, thalidomide and dexamethasone for patients with refractory, newly diagnosed or relapsed myeloma. Haematologica. 2006 Jun;91(6):862-3.

ReferenceCitation: Sie P, Samama CM, Godier A, Rosencher N, Steib A, Llau JV, Van der Linden P, Pernod G, Lecompte T, Gouin-Thibault I, Albaladejo P; Working Group on Perioperative Haemostasis; French Study Group on Thrombosis and Haemostasis. Surgery and invasive procedures in patients on long-term treatment with direct oral anticoagulants: thrombin or factor-Xa inhibitors. Recommendations of the Working Group on Perioperative Haemostasis and the French Study Group on Thrombosis and Haemostasis. Arch Cardiovasc Dis. 2011 Dec;104(12):669-76. doi: 10.1016/j.acvd.2011.09.001. Epub 2011 Oct 29.

ReferenceCitation: Singhal S, Mehta J, Desikan R, Ayers D, Roberson P, Eddlemon P, Munshi N, Anaissie E, Wilson C, Dhodapkar M, Zeddis J, Barlogie B. Antitumor activity of thalidomide in refractory multiple myeloma. N Engl J Med. 1999 Nov 18;341(21):1565-71. doi: 10.1056/NEJM199911183412102. Erratum In: N Engl J Med 2000 Feb 3;342(5):364.

ReferenceCitation: Sjalander A, Jansson JH, Bergqvist D, Eriksson H, Carlberg B, Svensson P. Efficacy and safety of anticoagulant prophylaxis to prevent venous thromboembolism in acutely ill medical inpatients: a meta-analysis. J Intern Med. 2008 Jan;263(1):52-60. doi: 10.1111/j.1365-2796.2007.01878.x.

ReferenceCitation: Srkalovic G, Cameron MG, Rybicki L, Deitcher SR, Kattke-Marchant K, Hussein MA. Monoclonal gammopathy of undetermined significance and multiple myeloma are associated with an increased incidence of venothromboembolic disease. Cancer. 2004 Aug 1;101(3):558-66. doi: 10.1002/cncr.20405.

ReferenceCitation: Turpie AG, Lassen MR, Eriksson BI, Gent M, Berkowitz SD, Misselwitz F, Bandel TJ, Homering M, Westermeier T, Kakkar AK. Rivaroxaban for the prevention of venous thromboembolism after hip or knee arthroplasty. Pooled analysis of four studies. Thromb Haemost. 2011 Mar;105(3):444-53. doi: 10.1160/TH10-09-0601. Epub 2010 Dec 6.

ReferenceCitation: Weber D, Rankin K, Gavino M, Delasalle K, Alexanian R. Thalidomide alone or with dexamethasone for previously untreated multiple myeloma. J Clin Oncol. 2003 Jan 1;21(1):16-9. doi: 10.1200/JCO.2003.03.139.

ReferenceCitation: Wu P, Davies FE, Horton C, Jenner MW, Krishnan B, Alvares CL, Saso R, McCormack R, Dines S, Treleaven JG, Potter MN, Ethell ME, Morgan GJ. The combination of cyclophosphomide, thalidomide and dexamethasone is an effective alternative to cyclophosphamide - vincristine - doxorubicin - methylprednisolone as induction chemotherapy prior to autologous transplantation for multiple myeloma: a case-matched analysis. Leuk Lymphoma. 2006 Nov;47(11):2335-8. doi: 10.1080/10428190600821955.

ReferenceCitation: Zangari M, Anaissie E, Barlogie B, Badros A, Desikan R, Gopal AV, Morris C, Toor A, Siegel E, Fink L, Tricot G. Increased risk of deep-vein thrombosis in patients with multiple myeloma receiving thalidomide and chemotherapy. Blood. 2001 Sep 1;98(5):1614-5. doi: 10.1182/blood.v98.5.1614.

ReferenceCitation: Zangari M, Siegel E, Barlogie B, Anaissie E, Saghafifar F, Fassas A, Morris C, Fink L, Tricot G. Thrombogenic activity of doxorubicin in myeloma patients receiving thalidomide: implications for therapy. Blood. 2002 Aug 15;100(4):1168-71. doi: 10.1182/blood-2002-01-0335.

ReferenceCitation: Zangari M, Barlogie B, Anaissie E, Saghafifar F, Eddlemon P, Jacobson J, Lee CK, Thertulien R, Talamo G, Thomas T, Van Rhee F, Fassas A, Fink L, Tricot G. Deep vein thrombosis in patients with multiple myeloma treated with thalidomide and chemotherapy: effects of prophylactic and therapeutic anticoagulation. Br J Haematol. 2004 Sep;126(5):715-21. doi: 10.1111/j.1365-2141.2004.05078.x.

ReferenceCitation: Zervas K, Dimopoulos MA, Hatzicharissi E, Anagnostopoulos A, Papaioannou M, Mitsouli Ch, Panagiotidis P, Korantzis J, Tzilianos M, Maniatis A; Greek Myeloma Study Group. Primary treatment of multiple myeloma with thalidomide, vincristine, liposomal doxorubicin and dexamethasone (T-VAD doxil): a phase II multicenter study. Ann Oncol. 2004 Jan;15(1):134-8. doi: 10.1093/annonc/mdh026.

ReferenceCitation: Zonder JA, Barlogie B, Durie BG, McCoy J, Crowley J, Hussein MA. Thrombotic complications in patients with newly diagnosed multiple myeloma treated with lenalidomide and dexamethasone: benefit of aspirin prophylaxis. Blood. 2006 Jul 1;108(1):403; author reply 404. doi: 10.1182/blood-2006-01-0154. No abstract available.

ReferenceCitation: Zonder JA, Crowley J, Hussein MA, Bolejack V, Moore DF Sr, Whittenberger BF, Abidi MH, Durie BG, Barlogie B. Lenalidomide and high-dose dexamethasone compared with dexamethasone as initial therapy for multiple myeloma: a randomized Southwest Oncology Group trial (S0232). Blood. 2010 Dec 23;116(26):5838-41. doi: 10.1182/blood-2010-08-303487. Epub 2010 Sep 27.

ReferenceCitation: Zufferey P, Laporte S, Quenet S, Molliex S, Auboyer C, Decousus H, Mismetti P. Optimal low-molecular-weight heparin regimen in major orthopaedic surgery. A meta-analysis of randomised trials. Thromb Haemost. 2003 Oct;90(4):654-61. doi: 10.1160/TH03-02-0086.

sponsor_collaborators:
University Hospital, Grenoble
Celgene Corporation

location_facility:
Chru Hopital Huriez
Chu Hopital Henri Mondor
Hia Percy
Groupe Hospitalier Du Havre
Centre Leon Berard
Ch de Perigueux
Chu Bordeaux
Chru de Tours
Chd Vendee
Centre Hospitalier
Hopital Pitie Salpetriere
Hopital St Vincent - Ghicl
Hopital de L'Archet
Ch Lyon Sud
Clinique Victor Hugo
CHRA
Chu Grenoble
Chu Poitiers
Ch La Cote Basque

status: Unknown status

title: Evaluation of the Use of an Oral Direct Anti-Xa Anticoagulant, Apixaban, in Prevention of Venous Thromboembolic Disease in Patients Treated With IMiDs During Myeloma : a Pilot Study

type: EudraCT Number

source: euctr

status_simplified: Unknown


summary: This observational study will evaluate patients' perception of treatment with erythropoiesis-stimulating agents in patients with chronic kidney disease not on dialysis. Eligible patients initiated on treatment with Mircera (methoxy polyethylene glycol-epoetin beta) will be followed for 6 months.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Hoffmann-La Roche


title: Risk Factors for Thromboembolic and Infectious Complications Related to Percutaneous Central Venous Catheters in Cancer - Prospective Multicenter Study

acronym: ONCOCIP

summary: The purpose of this study is to identify risk factors for thromboembolic and /or infectious complications in 3,000 patients with solid tumor and receiving a Percutaneous Central Venous Catheter (PCVC). A better understanding of the risk factors for these complications in this population would then allow interventional studies to be proposed to assess the benefit of prophylactic procedures in a sub-group of patients at most risk.

ReferenceCitation: Agnelli G, George DJ, Kakkar AK, Fisher W, Lassen MR, Mismetti P, Mouret P, Chaudhari U, Lawson F, Turpie AG; SAVE-ONCO Investigators. Semuloparin for thromboprophylaxis in patients receiving chemotherapy for cancer. N Engl J Med. 2012 Feb 16;366(7):601-9. doi: 10.1056/NEJMoa1108898.

ReferenceCitation: Debourdeau P, Farge D, Beckers M, Baglin C, Bauersachs RM, Brenner B, Brilhante D, Falanga A, Gerotzafias GT, Haim N, Kakkar AK, Khorana AA, Lecumberri R, Mandala M, Marty M, Monreal M, Mousa SA, Noble S, Pabinger I, Prandoni P, Prins MH, Qari MH, Streiff MB, Syrigos K, Buller HR, Bounameaux H. International clinical practice guidelines for the treatment and prophylaxis of thrombosis associated with central venous catheters in patients with cancer. J Thromb Haemost. 2013 Jan;11(1):71-80. doi: 10.1111/jth.12071.

ReferenceCitation: Saber W, Moua T, Williams EC, Verso M, Agnelli G, Couban S, Young A, De Cicco M, Biffi R, van Rooden CJ, Huisman MV, Fagnani D, Cimminiello C, Moia M, Magagnoli M, Povoski SP, Malak SF, Lee AY. Risk factors for catheter-related thrombosis (CRT) in cancer patients: a patient-level data (IPD) meta-analysis of clinical trials and prospective studies. J Thromb Haemost. 2011 Feb;9(2):312-9. doi: 10.1111/j.1538-7836.2010.04126.x.

ReferenceCitation: Akl EA, Kamath G, Yosuico V, Kim SY, Barba M, Sperati F, Cook DJ, Schunemann HJ. Thromboprophylaxis for patients with cancer and central venous catheters: a systematic review and a meta-analysis. Cancer. 2008 Jun;112(11):2483-92. doi: 10.1002/cncr.23479.

ReferenceCitation: Mollee P, Jones M, Stackelroth J, van Kuilenburg R, Joubert W, Faoagali J, Looke D, Harper J, Clements A. Catheter-associated bloodstream infection incidence and risk factors in adults with cancer: a prospective cohort study. J Hosp Infect. 2011 May;78(1):26-30. doi: 10.1016/j.jhin.2011.01.018. Epub 2011 Apr 2.

ReferenceCitation: Chaukiyal P, Nautiyal A, Radhakrishnan S, Singh S, Navaneethan SD. Thromboprophylaxis in cancer patients with central venous catheters. A systematic review and meta-analysis. Thromb Haemost. 2008 Jan;99(1):38-43. doi: 10.1160/TH07-07-0446.

ReferenceCitation: Khorana AA, Francis CW, Blumberg N, Culakova E, Refaai MA, Lyman GH. Blood transfusions, thrombosis, and mortality in hospitalized patients with cancer. Arch Intern Med. 2008 Nov 24;168(21):2377-81. doi: 10.1001/archinte.168.21.2377.

ReferenceCitation: Schwarz RE, Groeger JS, Coit DG. Subcutaneously implanted central venous access devices in cancer patients: a prospective analysis. Cancer. 1997 Apr 15;79(8):1635-40.

ReferenceCitation: Decousus H, Bourmaud A, Fournel P, Bertoletti L, Labruyere C, Presles E, Merah A, Laporte S, Stefani L, Piano FD, Jacquin JP, Meyer G, Chauvin F; ONCOCIP Investigators. Cancer-associated thrombosis in patients with implanted ports: a prospective multicenter French cohort study (ONCOCIP). Blood. 2018 Aug 16;132(7):707-716. doi: 10.1182/blood-2018-03-837153. Epub 2018 Jul 6.

oa_host_type: publisher

repositories_concat: closed

publisher_dissemination: American Society of Hematology

lead_sponsor: Institut de Cancérologie de la Loire

location_facility: CHU Saint-Etienne Service de Gastroentérologie

location_facility: CHU Saint-Etienne Service de Gynécologie


title: A Phase I/II Randomized Study to Determine the Maximum Tolerated Dose, Safety, Pharmacokinetics and Antitumor Activity of Debio 1143 Combined With Concurrent Chemo-Radiation Therapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck.

summary:
The use of multiple drugs in a single clinical trial or as a therapeutic strategy has become common, particularly in the treatment of cancer. Because traditional trials are designed to evaluate one agent at a time, the evaluation of therapies in combination requires specialized trial designs. In place of the traditional separate phase I and II trials, this trial uses a single phase I/II clinical trial to evaluate simultaneously the safety and efficacy of combination dose levels, and select the optimal combination dose.

Therefore, this is a two part trial of Debio 1143 combined with concurrent cisplatin and radiotherapy (CRT) in participants with previously untreated stage III, IVa or IVb head and neck cancer. The trial begins with an initial period of dose escalation (Phase I) to investigate the maximum tolerated dose (MTD) of Debio 1143 that can safely be given in combination with CRT.

Using the MTD determined in the Phase I portion, the randomized phase II trial in 94 participants compares Debio 1143 to placebo, both with concomitant CRT. The aim is to evaluate the efficacy and safety of Debio 1143.

ReferenceCitation: Sun XS, Tao Y, Le Tourneau C, Pointreau Y, Sire C, Kaminsky MC, Coutte A, Alfonsi M, Boisselier P, Martin L, Miroir J, Ramee JF, Delord JP, Clatot F, Rolland F, Villa J, Magne N, Elicin O, Gherga E, Nguyen F, Lafond C, Bera G, Calugaru V, Geoffrois L, Chauffert B, Zubel A, Zanna C, Brienza S, Crompton P, Rouits E, Gollmer K, Szyldergemajn S, Bourhis J. Debio 1143 and high-dose cisplatin chemoradiotherapy in high-risk locoregionally advanced squamous cell carcinoma of the head and neck: a double-blind, multicentre, randomised, phase 2 study. Lancet Oncol. 2020 Sep;21(9):1173-1187. doi: 10.1016/S1470-2045(20)30327-2. Epub 2020 Aug 3.

oa_host_type: closed

publisher_dissemination: Elsevier

lead_sponsor: Debiopharm International SA

location_country: Switzerland France

location_facility: Inselspital Bern, Universitätsklinik für Radio-Onkologie, Freiburgstrasse 4

location_facility: Centre Hospitalier de Bretagne Sud - HÔPITAL DU SCORFF

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

location_facility: Institut de Cancérologie Lucien Neuwirth (ICLN)

location_facility: L'Institut de Cancérologie de Lorraine (ICL) Alexis Vautrin

location_facility: Centre Hospitalier Universitaire Vaudois (CHUV)


title: Influence de l'ORientation de la réponse LYmphocytaire Sur la Survenue de Complications athéromateuses après Transplantation rénale (étude ORLY-EST 2)

acronym: ORLY-Est

summary:
The incidence of atherosclerotic complications is increased after kidney transplantation. Traditional risk factors do not fully explain this increased risk. Atherosclerosis is an inflammatory disease in which all players in the immune response are involved. The impact of these immune responses is not well known in immunocompromised patients, particularly among organ transplant. Nevertheless, the work of our group suggest that innate and acquired responses through different mechanisms influencing the evolution of atheromatous disease after transplantation.

The investigators therefore propose to study the impact of the expansion of regulatory T cells on the risk of atherosclerotic complications after transplantation.

Since November 2008, the investigators began a multicenter, prospective study whose purpose is to study in detail the immunological mechanisms of atherosclerosis after transplantation via immunomonitoring cohort of renal transplant patients in the Grand East Interregion. It was planned to include 500 patients and to date a little more than half have been included. After completion of the blood test, the tubes are routed over the Biomonitoring Platform (CIC-BT 506 Besançon) and the samples are stored in CRB Dijon.

The atherosclerotic events are recorded prospectively. The investigators hope to implement as part of ORLY IS, a second study to determine the impact of an expansion of regulatory T cells on the risk of atherosclerotic events.

Our hypothesis is that a cell rate regulatory T below the median results in an increase of 5% of atherosclerotic complications.

status: Active, not recruiting

ReferenceCitation: Ducloux D, Courivaud C, Bamoulid J, Crepin T, Gaiffe E, Laheurte C, Vauchy C, Rebibou JM, Saas P, Borot S. Immune phenotype predicts new onset diabetes after kidney transplantation. Hum Immunol. 2019 Nov;80(11):937-942. doi: 10.1016/j.humimm.2019.08.006. Epub 2019 Sep 10.

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

version: acceptedVersion

evidence: open (author manuscript)

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

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

ReferenceCitation: Ducloux D, Legendre M, Bamoulid J, Rebibou JM, Saas P, Courivaud C, Crepin T. ESRD-associated immune phenotype depends on dialysis modality and iron status: clinical implications. Immun Ageing. 2018 Jul 17;15:16. doi: 10.1186/s12979-018-0121-z. eCollection 2018.

license: cc-by

license_normalized: cc-by

publisher_dissemination: Springer-Nature

ipd_sharing_description: Identified individual participant data for all outcome measures will be made available within 6 monts of study completion

lead_sponsor: Centre Hospitalier Universitaire de Besancon

collaborators:
University of Franche-Comté
Etablissement Français du Sang

location_facility: Hôpital Civil- 1, place de l'hôpital BP426 ; 67091 Strasbourg Cedex

location_facility: Hôpital du Kremlin Bicêtre 78, rue du Général Leclerc, 94275 Le Kremlin-Bicêtre Cedex

location_facility: CHU Clermont-Ferrand, 58 rue Montalembert, 63003 Clermont-Ferrand

location_facility: CHU Reims, 45 rue Cognacq-Jay 51092 Reims Cedex

location_facility: CHU Dijon, Hôpital du Bocage, 2 Bd du Maréchal de Lattre de Tassigny, 21079 Dijon cedex


title: Comparison of Two Techniques of Renal Pre-transplant Infusion on the Evolution of Renal Function in the Recipient: Multicentre Randomized Trial

acronym: RENOMAP

summary: Comparison of two techniques of renal pre-transplant infusion on the evolution of renal function in the recipient: multicentre randomized trial

lead_sponsor: University Hospital, Tours

location_facility: Coordination des prélèvements d'organes et de Tissus,CHU-NANTES

location_facility: Chirurgien-Chirurgie de la transplantation et d'Urologie, Pavillon V, Hôpital Edouard HERRIOT

location_facility: Coordination des prélèvements d'organes et de Tissus- CHU-Limoges -CHU- DUPUYTREN

location_facility: Coordination des prélèvements d'organes et de Tissus Pôle Anesthésie-Réanimations,University Hospital

location_facility: Coordination Hospitalière de PMO-Anestésiste -réanimateur, CHU-Bordeaux -GROUPE HOSPITALIER PELLEGRIN DAR I

location_facility: Coordination Hospitalière de PMO , Pôle USSAR-Anestéthésie -Réa CHU-ANGERS

region: Centre-Val de Loire

nom_etablissement: CHU DE TOURS

acronyme: RenoMaP

titre: Comparaison de deux techniques de perfusion rénale pré-transplantation sur l'évolution de la fonction rénale chez le receveur : Essai randomisé multicentrique

discipline_principale: autre

nom_porteur: VENHARD

prenom_porteur: Jean-Christophe


title: Endoplasmic Reticulum Stress and Resistance to Treatments in Ph-negative Myeloproliferative Neoplasms

acronym: PhiNESS

summary: The aim of this study is to evaluate the endoplasmic reticulum stress markers as predictive for response to hydroxyurea in polycythemia vera (PV) and essential thrombocythemia (ET).

time_perspective: Retrospective

lead_sponsor: University Hospital, Bordeaux

location_facility:
Chu Angers
Ch de Libourne
Chu de Bordeaux
Ch de Dax
Crlcc Bergonie
Ch de La Cöte Basque
Chu de Brest

intervention_type: Biological


lead_sponsor: UNICANCER

summary:
The study consists of two distinct and sequential parts:

A Phase Ib aimed at determining the MTD (Maximum Tolerated Dose) of the combination (copanlisib/cetuximab) and the RP2D
A Phase II aimed at evaluating the efficacy of the combination at the RP2D (Recommended Phase 2 Dose)

All patients will be treated with the Copanlisib, a selective PI3KCA inhibitor, in association with Cetuximab.

ReferenceCitation: Marret G, Isambert N, Rezai K, Gal J, Saada-Bouzid E, Rolland F, Chausson M, Borcoman E, Alt M, Klijanienko J, Vansteene D, Guigay J, Kamal M, Bieche I, Le Tourneau C; UNICANCER Head, Neck Group. Phase I trial of copanlisib, a selective PI3K inhibitor, in combination with cetuximab in patients with recurrent and/or metastatic head and neck squamous cell carcinoma. Invest New Drugs. 2021 Dec;39(6):1641-1648. doi: 10.1007/s10637-021-01152-z. Epub 2021 Jul 28.

evidence: oa repository (via free pdf)

repository_normalized: Research Square

repositories_concat: Research Square

location_facility:
Institut de Cancérologie de Lorraine
Centre Léon Bérard
Centre Antoine Lacassagne
Institut de Cancérologie de l'Ouest
Centre Oscar Lambret
Centre Georges François Leclerc
Institut Curie

status: Terminated

title: Phase ib/II Trial of Copanlisib, a Selective PI3K Inhibitor, in Combination With Cetuximab in Patients With Recurrent and/or Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) Harboring a PI3KCA Mutation/Amplification and/or a PTEN Loss.

ipd_sharing_description: Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.


title: Phase 2 Gene Therapy Trial of Locally Advanced Pancreatic Adenocarcinoma Using Intratumoral Injection of CYL-02 in Combination With Gemcitabine

summary:
Pancreatic ductal adenocarcinoma (PDAC) is the fifth leading cause of cancer-related death in Western countries, and its incidence has increased over the last 40 years. Curative surgery to manage PDAC is possible in only a fraction of patients; indeed, a vast majority (85%) of patients is diagnosed with locally advanced tumors and/or metastases because they lack specific symptoms and early markers for this disease. For these patients, palliative armamentarium consists of conventional chemotherapeutic agents such as Gemcitabine and, more recently, FOLFIRINOX, which offer marginal survival benefits. Consequently, the prognosis for PDAC is still very poor and there is great need for new treatments that can change this poor outcome. In this context, the investigators have devised, in the past few years, a highly innovative approach based on therapeutic gene transfer, which does not rely on a specific genetic and/or cellular background to inhibit PDAC tumor growth. the investigators found that SSTR2 and DCK::UMK gene transfer demonstrated complementary therapeutic effects to inhibit tumor progression and dissemination, and reduced tumor burden, respectively. On the basis of these promising preclinical data, the investigators conducted past three years the first clinical study of non-viral vector-mediated therapeutic gene delivery, guided by endoscopy (EUS), and combined with standard Gemcitabine therapy in patients with locally advanced and metastatic PDAC. The phase 1 demonstrated that the gene-therapy product CYL-02 is expressed in PDAC tumors (with long-lasting expression within tumor tissues), is distributed within the bloodstream in some extent, when combined with Gemcitabine it can inhibit primary-tumor progression and dissemination. Our results tend to demonstrate therapeutic efficacy, especially in patients with locally advanced tumors. Based on these encouraging results, the investigators propose that patients with locally advanced PDAC at the time of diagnosis may clinically benefit from this approach.

This phase II study is designed to compare the efficacy of intra-tumoral gene delivery of CYL-02 plus Gemcitabine treatment or Gemcitabine alone in patient with locally advanced PDAC.

lead_sponsor: University Hospital, Toulouse

collaborators: BIOTHERAPY department of the clinical center of investigation- CIC 1436, Toulouse

location_facility:
Institut régional du Cancer
APHP Hôpital Beaujon
Hôpital privé Jean Mermoz
Rangueil Hospital
Institut Gustave Roussy
CHU de Marseille Hôpital Nord
Institut Paoli Calmettes


title: A Multi-Center Open-Label Study to Evaluate the Efficacy, Safety and Tolerability of Subcutaneous Tocilizumab in Tocilizumab-Naive Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-Biologic DMARD and/or Biologic Therapy

acronym: TOSCA

summary: This two part, multi-center, open-label, single-arm study will evaluate the efficacy and safety of tocilizumab as a monotherapy or in combination with methotrexate or other conventional synthetic disease modifying antirheumatic drugs (csDMARDs) in participants with moderate to severe active rheumatoid arthritis who have an inadequate response or are intolerant to non-biologic csDMARDs and/or biologic therapy.

ReferenceCitation: Choy E, Caporali R, Xavier R, Fautrel B, Sanmarti R, Bao M, Devenport J, Petho-Schramm A. Effects of concomitant glucocorticoids in TOZURA, a common-framework study programme of subcutaneous tocilizumab in rheumatoid arthritis. Rheumatology (Oxford). 2019 Jun 1;58(6):1056-1064. doi: 10.1093/rheumatology/key393.

evidence: open (via crossref license)

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

repository_institution: Cardiff University - ORCA Online Research @Cardiff

evidence: oa repository (semantic scholar lookup)

ReferenceCitation: Choy E, Caporali R, Xavier R, Fautrel B, Sanmarti R, Bao M, Bernasconi C, Petho-Schramm A. Subcutaneous tocilizumab in rheumatoid arthritis: findings from the common-framework phase 4 study programme TOZURA conducted in 22 countries. Rheumatology (Oxford). 2018 Mar 1;57(3):499-507. doi: 10.1093/rheumatology/kex443. Erratum In: Rheumatology (Oxford). 2018 Jun 1;57(6):1129.

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

repository_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia


title: Succinylcholine vs Rocuronium for Prehospital Emergency Intubation : a Randomized Trial

acronym: CURASMUR

summary: All adult patients with spontaneous cardiac activity and requiring tracheal intubation in the pre hospital emergency context will be included in order to compare the use of succinylcholine vs Rocuronium for prehospital emergency intubation.

ReferenceCitation: Guihard B, Chollet-Xemard C, Lakhnati P, Vivien B, Broche C, Savary D, Ricard-Hibon A, Marianne Dit Cassou PJ, Adnet F, Wiel E, Deutsch J, Tissier C, Loeb T, Bounes V, Rousseau E, Jabre P, Huiart L, Ferdynus C, Combes X. Effect of Rocuronium vs Succinylcholine on Endotracheal Intubation Success Rate Among Patients Undergoing Out-of-Hospital Rapid Sequence Intubation: A Randomized Clinical Trial. JAMA. 2019 Dec 17;322(23):2303-2312. doi: 10.1001/jama.2019.18254.

evidence: open (via free pdf)

publisher_dissemination: American Medical Association

lead_sponsor: Centre Hospitalier Universitaire de la Réunion

collaborators: Unité de Soutien Méthodologique (CHU de La Réunion)

collaborators: SAMU de Paris, Hôpital Necker - Enfants Malades

location_facility:
CHU Lariboisière
CHU Toulouse - Hôpital PURPAN
CH Marc Jacquet
CHU de Dijon
CHU Raymond Poincaré
CHU de Nîmes
CHU Hôtel-Dieu
CHRU de Lille
CH René Dubos
CHU Avicenne
CHU de La Réunion
CHU Henri Mondor
CHU de la Réunion
CH Annecy
CHU Necker
CH Gonesse
CHU Pitié-Salpêtrière


title: Dysfunctions of Human Muscle Stem Cells in Sepsis

acronym: DISCUSS

summary: Severe critical illness is often complicated by Intensive Care Unit - Acquired Weakness (ICU-AW), which is associated with increased in and post-ICU mortality, with delayed weaning from mechanical ventilation and with long-term functional. Several mechanisms have been incriminated in the pathophysiology of ICU-AW, but muscle regeneration has not been well investigated in this context, even though its involvement is suggested by the protracted functional consequences of ICU-AW. Recent data suggest that muscle regeneration could be impaired after sepsis, and that Mesenchymal Stem Cells (MSCs) treatment could improve the post-injury muscle recovery.

primary_purpose: Basic Science

ReferenceCitation: Rocheteau P, Chatre L, Briand D, Mebarki M, Jouvion G, Bardon J, Crochemore C, Serrani P, Lecci PP, Latil M, Matot B, Carlier PG, Latronico N, Huchet C, Lafoux A, Sharshar T, Ricchetti M, Chretien F. Sepsis induces long-term metabolic and mitochondrial muscle stem cell dysfunction amenable by mesenchymal stem cell therapy. Nat Commun. 2015 Dec 15;6:10145. doi: 10.1038/ncomms10145.

ReferenceCitation: Duceau B, Blatzer M, Bardon J, Chaze T, Giai Gianetto Q, Castelli F, Fenaille F, Duarte L, Lescot T, Tresallet C, Riou B, Matondo M, Langeron O, Rocheteau P, Chretien F, Bougle A. Using a multiomics approach to unravel a septic shock specific signature in skeletal muscle. Sci Rep. 2022 Nov 5;12(1):18776. doi: 10.1038/s41598-022-23544-8.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CEA - Commissariat à l’énergie atomique

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

lead_sponsor: Institut Pasteur

location_facility: Hôpital Pitié Salpétrière, Salle de surveillance post-interventionnelle, Accueil des Polytraumatisés

location_facility: Hôpital Saint-Antoine, Département d'Anesthésie-réanimation

location_facility: Hôpital Pitié Salpêtrière, Service de réanimation chirurgicale polyvalente

location_facility: Hôpital Pitié Salpêtrière, Anesthésie et Réanimation, Institut de Cardiologie

location_facility: Hôpital Pitié Salpêtrière, Service de Chirurgie Générale, Viscérale et Endocrinienne

location_facility: Hopital Henri Mondor, Service de Réanimation chirurgicale polyvalente

location_facility: Hôpital Pitié Salpêtrière, Service de Chirurgie Hépatobiliaire et de Transplantation Hépatique

intervention_type: Procedure


title: Thrombin Generation Capacity of Patients With Severe Haemophilia Receiving Prophylaxis

acronym: HOPE

summary:
Haemophilic arthropathy is one of the major complications of severe haemophilia. In order to maintain plasma clotting factor activity levels above 1% and avoid spontaneous joint bleeds and other serious bleeding events, prophylactic factor replacement therapy is used. Because of the high cost and limited availability of clotting factor concentrates, dosing is a crucial issue for prophylaxis therapy. Several studies reported a better correlation between clinical bleeding tendency of patients with haemophilia and thrombin generation assay results compared to FVIII/FIX levels. However there is no specific data showing that thrombin generation may be a better indicator of the clinical efficacy of prophylaxis compared to the conventional FVIII measurement.

The main objective of this open, multicentre, prospective study is to compare trough thrombin generation capacity and FVIII levels in severe haemophilia patients and compare these two laboratory results with:

the number of spontaneous haemarthroses and other spontaneous serious bleeds occurred in the last 6 months
the number of additional FVIII units used in the last 6 months

This project requires no change in term of type of treatment : During the study, each patient will be treated by his usual clotting factor at the usual regimen (frequency and dosage).

The clinical outcome with the usual prophylaxis regimen will be correlated to TGA results

primary_purpose: Other

lead_sponsor: Hospices Civils de Lyon

location_facility: CHU Dijon Bourgogne Hôpital François Mitterrand

location_facility: Unité d'Hémostase Clinique Centre Régional de Traitement des Hémophiles Centre de Référence de Maladies Hémorragiques Hôpital Cardiologique Louis Pradel


title: An Open Label Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Anetumab Ravtansine in Subjects With Mesothelin-expressing Advanced Solid Cancers and Different Stages of Concurrent Hepatic or Renal Impairment

summary: To characterize the safety, tolerability, pharmacokinetics and immunogenicity of anetumab ravtansine in subjects with advanced solid cancers and with different degrees of hepatic or renal impairment

lead_sponsor: Bayer

location_country:
Moldova, Republic of
France


title: Evaluation of the Implementation of a Clinical Pathway for Improving the Performance of Medical and Surgical Management of Hip Prosthesis Infections

acronym: OSCAR-PH

summary: The main objective is to determine the contribution of a clinical pathway to improve the effectiveness of medico-surgical management of hip prosthesis infections in terms of clinical cure. The hypothesis raised is that the implementation of a clinical pathway would improve the performance of the medical and surgical management of chronic infections of prosthetic hip.

location_facility: Groupe Hospitalier Mutualiste de Grenoble.


title: Study of the Performance of Acute Stroke Management in the Rhône Area After Implementation of a Multi-action Program

acronym: STROKE 69

summary:
Acute stroke management represents a true medical emergency that requires prompt diagnosis and urgent treatment. However, only a small percentage of patients access to thrombolysis on time. Various actions have been implemented since 2006 in the Rhone area as part of research projects and of the 2010-2014 national stroke action plan: training of health professionals involved in the stroke management, increase of public awareness through sensibilization campaigns, implementation of telemedicine and increase of the number of hospital beds dedicated to stroke (stroke units beds).

The main objective of the STROKE 69 study is to assess the impact of these actions on intra-hospital acute stroke management times in the Rhône area. The secondary objectives are to assess the impact of these actions on the rate and place of thrombolysis, the rate of post- thrombolysis hemorrhage, the rate of thrombectomies, mortality in the acute phase, at 3 and 12 months, the level of disability at 3 and 12 months, pre-hospital times, the number of calls to SAMU centre 15 (French mobile emergency medical services, equivalent to 911) and management channels.

The investigator will perform a prospective cohort study between 06/11/2015 and 06/06/2016 and data will be compared to data collected in a previous cohorts study, the AVC-69 cohort study (Porthault Chatard et al, Int J Stroke. 2012 Oct;7(7):E13), between 06/11/2006 and 06/06/2007, before the implementation of the actions in the Rhône area.

The cohort will be constituted of all consecutive patients treated for a stroke suspicion by the Rhône SAMU centre 15, or in one of the emergency unit or stroke unit of the Rhône area, and presenting a symptom-onset (the last time the patient was seen without deficit) less than 24 hours.

After collecting data in the acute phase, patients with a confirmed diagnosis of stroke or transient ischemic attack (TIA) will be followed for 12 months after their inclusion by telephone calls at 3 and 12 months to assess the level of disability and mortality.

AVC 69 study allowed us to include 1306 patients between 2006 to 2007, the investigator plan to include at least 1300 patients in the STROKE 69 cohort with approximately 1000 confirmed strokes or TIAs.

location_facility: Urgences et Réanimation Médicale et SAMU, Hôpital Edouard Herriot

location_facility: Department of stroke unit - Hospices Civils de Lyon


title: Determination of the Interest of HE4 as a Relapse Biomarker in Ovarian Cancers Stages IIIb, IIIc and IV After Neo-adjuvant Chemotherapy and Surgery.

summary: HE4 is a more sensitive marker than CA-125 in patients with ovarian cancers. The interest of serum HE4 before surgery has been demonstrated to predict overall survival and its interest has also been shown in combination with CA-125 (ROMA algorithm) to identify high risk patients. To date, no study shows clearly the predictive potential of serum HE4 as an early relapse biomarker in ovarian cancers.

lead_sponsor: Institut de Cancérologie de Lorraine

location_facility:
BENGRINE-LEVEVRE Leïla
KALBACHER Elsa
LONGO Raphaelle
GAVOILLE Céline
SAVOYE Aude-Marie
KURTZ Jean-Emmanuel
DEMARCHI Martin


title: Prospective, Sequential Multiple Assignment, Multicentric, Phase II Randomized Controlled Trial on Two Parallel Groups Comparing the Efficacy of Two Immunosuppressive Drugs (Methotrexate, Cyclophosphamide) in Large Granular Lymphocytes Leukemia

acronym: LGL

summary:
LGL leukemia represents a rare subtype of chronic T or NK lymphoproliferative disorders. It is an indolent disease, the main hematological or autoimmune complications lead to a treatment in more than 60% of patients.

Investigators set up at the University Hospital of Rennes, a database of more than 300 patients with LGL leukemia from major French services that support this disease, and published in 2010 the largest series of patients in the world (n = 229). However, the limited heterogeneity and retrospective data collected, as all previously released, makes it difficult the proposal of consensual treatment options. If first and second line treatments are based on the use of immunosuppression with methotrexate, cyclophosphamide, or cyclosporin A, no molecule has proven superiority over others. Methotrexate and cyclophosphamide are mainly used in the first line. Invetigators just have in the literature data on about 100 patients treated with either of these drugs. Combining the results of our series with those in the literature, invetigators estimate the respective overall response rate (RG) and complete response rate (CR) in 55% and 30% for methotrexate, and 60% and 50% for cyclophosphamide.

Thus, there are four objective in this study :

to compare the respective efficacies of methotrexate and cyclophosphamide when administered as first-line therapies in patients suffering from T/NK LGL leukemia with severe neutropenia or neutropenia associated with infections, and/or anemia requiring transfusions, and/or auto-immune associated disease
to evaluate the percentage of patients refractory to methotrexate or cyclophosphamide for which a second line treatment is efficacious
to explore, in case of non-response to the first-line therapy, the efficacy of ciclosporine A, the comparison being performed with the treatment which was not administered in the first-line therapy
to evaluate the response rate according to the phenotypic subtype of LGL leukemia.

lead_sponsor: Rennes University Hospital

location_facility: Hematology Unit - Institut Paoli-Calmettes

location_facility: Hôpital André Mignot Centre Hospitalier de Versailles

location_facility: Intern medecine Service - CH Antibes-Juan-les-Pins

location_facility: Hematology Service - CH Docteur Duchenne

location_facility: Hematology Service - Hopital La Pitié Salpetrière

location_facility: Hematology Unit CH Notre Dame Bon Secours

location_facility: Hematology Service - CH de la cote basque

location_facility: Oncology Unit - Institut de cancérologie de la Loire

location_facility: CHU Henri Mondor Lymphoid Hemopathy Unit

location_facility: Hematology Service - CH François Baclesse


title: Tissue Factor Pathway Inhibitor (TFPI) and Haemorrhagic Manifestations in Haemophilia A and B Patients

summary:
Haemophilia is a rare and serious congenital defect of blood coagulation due to a genetic mutation on a sexual chromosome. It affects quasi-essentially the men and it is responsible for bleeding. There are two types of haemophilia: Haemophilia A, (85 % of cases), due to a factor VIII (FVIII) deficiency and Haemophilia B (15 % of cases) due to factor IX (FIX) deficiency. According to the intensity of the defect, there are three forms of haemophilia: severe (FVIII or FIX lower than 1 %), moderate (factor level between 1 and 5 %), minor (factor level between 5 and 40 %). For a same level of factor VIII or IX, hemorrhagic manifestations are variable from one patient to the other. Moreover, several studies showed that haemophilic B patients bleed less and consume fewer anti-hemophilic concentrate that haemophilic A patients.

The main inhibitors of the coagulation are antithrombin, Protein C-Protein S-Thrombomodulin system, and tissue factor pathway inhibitor (TFPI). TFPI is the specific and exclusive inhibitor of tissue factor pathway that is the main way by which plasmatic coagulation starts. TFPI is a potent direct inhibitor of factor Xa and Xa-dependent inhibitor of the VIIa-Tissue Factor (TF) complex. In hemophilic patient, the production of Xa by the amplification pathway being strongly altered because of factor VIII or IX deficiency, thrombin generation (via Xa) comes exclusively from TFPI regulated tissue factor pathway. We can thus say that if haemophilic patients bleed, it is also because of the presence of TFPI that inhibits at the same time Xa and the complex TF-VIIa as soon as factor Xa is generated.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
HCL
Chu Tours
Chu Reims
Chu Nancy
CHRU Lille
CHU Saint-Etienne
AP-HM


title: Bergonie Institut Profiling : Fighting Cancer by Matching Molecular Alterations and Drugs in Early Phase Trials

acronym: BIP

summary:
This is a biology driven, monocentric study designed to identify actionable molecular alterations in cancer patients with advanced disease.

In this trial, high throughput analysis will be carried out using next generation sequencing, and immunological profiling.

Patients included in the BIP study and for whom a targetable genomic alteration had been identified might be subsequently included in an early phase trials running at Institut Bergonie or another French hospital.

lead_sponsor: Institut Bergonié

location_facility:
Centre Hospitalier de la Côte Basque
Institut Bergonie
Clinique Marzet
Clinique Tivoli-Ducos
Centre Hospitalier de Pau
Centre Eugène Marquis
Polyclinique Bordeaux Nord Aquitaine


lead_sponsor: Gilead Sciences

summary:
This study is to determine the antiviral efficacy of sofosbuvir (SOF)/ledipasvir (LDV) fixed-dose combination (FDC) with and without ribavirin (RBV), and to evaluate the safety and tolerability of each regimen as assessed by review of the accumulated safety data. Approximately 150 participants with genotype 1 HCV infection, who have previously received treatment for HCV, and who have a diagnosis for cirrhosis will be enrolled. Participants will be randomized to 1 of 2 groups.

Group 1: SOF/LDV FDC tablet plus placebo to match RBV for 24 weeks

Group 2: Delayed treatment group: placebo to match SOF/LDV FDC plus placebo to match RBV for 12 weeks, followed by SOF/LDV FDC once daily plus RBV in a divided daily dose for 12 weeks

Randomization will 1:1 to the two groups and will be stratified by HCV genotype (1a, 1b; mixed or other genotype 1 results will be stratified as genotype 1a), and prior HCV therapy treatment response (never achieved HCV RNA < the lower limit of quantitation (LLOQ), or achieved HCV RNA < LLOQ).

ReferenceCitation: Bourliere M, Bronowicki JP, de Ledinghen V, Hezode C, Zoulim F, Mathurin P, Tran A, Larrey DG, Ratziu V, Alric L, Hyland RH, Jiang D, Doehle B, Pang PS, Symonds WT, Subramanian GM, McHutchison JG, Marcellin P, Habersetzer F, Guyader D, Grange JD, Loustaud-Ratti V, Serfaty L, Metivier S, Leroy V, Abergel A, Pol S. Ledipasvir-sofosbuvir with or without ribavirin to treat patients with HCV genotype 1 infection and cirrhosis non-responsive to previous protease-inhibitor therapy: a randomised, double-blind, phase 2 trial (SIRIUS). Lancet Infect Dis. 2015 Apr;15(4):397-404. doi: 10.1016/S1473-3099(15)70050-2. Epub 2015 Mar 13. Erratum In: Lancet Infect Dis. 2015 Jul;15(7):761.

title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination for 12 Weeks With Ribavirin or for 24 Weeks Without Ribavirin in Treatment-Experienced Cirrhotic Subjects With Chronic Genotype 1 HCV Infection

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.


title: A Non-Inferiority, Multicentered, Controlled, Randomized, Double Blinded Study Investigating the Antibiotic Treatment Duration (3-day Versus 8-day) for Subjects Admitted to Emergency Services With Acute Non-severe Community Acquired Pneumonia (CAP)

acronym: PTC

summary: To investigate the non inferiority of a short lasting antibiotic treatment (3 days) when compared to a long lasting antibiotic treatment (8 days), at Day 15 after the beginning of treatment in terms of clinical efficacy, in adults admitted to emergency services for a non severe Community Acquired Pneumonia (PAC), who responded well to 3 days of beta-lactamin treatment (3GC or A/AC).

ReferenceCitation: Dinh A, Ropers J, Duran C, Davido B, Deconinck L, Matt M, Senard O, Lagrange A, Makhloufi S, Mellon G, de Lastours V, Bouchand F, Mathieu E, Kahn JE, Rouveix E, Grenet J, Dumoulin J, Chinet T, Pepin M, Delcey V, Diamantis S, Benhamou D, Vitrat V, Dombret MC, Renaud B, Perronne C, Claessens YE, Labarere J, Bedos JP, Aegerter P, Cremieux AC; Pneumonia Short Treatment (PTC) Study Group. Discontinuing beta-lactam treatment after 3 days for patients with community-acquired pneumonia in non-critical care wards (PTC): a double-blind, randomised, placebo-controlled, non-inferiority trial. Lancet. 2021 Mar 27;397(10280):1195-1203. doi: 10.1016/S0140-6736(21)00313-5. Erratum In: Lancet. 2021 Jun 5;397(10290):2150.

lead_sponsor: Versailles Hospital

location_facility:
CH Tenon
CHU Cochin
CHU Rennes Pontchaillou
Melun Hospital
CH Saint Denis
CHU Ambroise Paré
CH Bicêtre
CH Beaujon
CHU Bichat
CHU Rouen
CHI Creteil
Central Hospital Raymon Poincaré
CH Pontoise
CH Argenteuil
CH Versailles
CHU de Grenoble
Foch Hospital
CHU Saint Antoine
CH Lariboisière
CH d'Annecy Genevois


title: Phase 3 Study Comparing Preventive Reversal of Vitamine K Antagonist Versus Reversion Only in Case of Intracranial Bleeding in Patients Receiving Vitamine K Antagonist Treatment

acronym: PREVACT

summary:
The occurence of a minor craniocerebral trauma in patients receiving vitamine K antagonist treatment leads to a high risk of bleeding.

Current guidelines recommend to perform a CT scan, and, in case of intracranial bleeding, to reverse anticoagulation with concomitant administration of prothrombin complex concentrates (PCCs) and vitamin K.

However, even if a reversion is performed, the prognostic of post-traumatic intracranial bleeding remain bad.

The investigators hypothesize that, for patients admitted in an emergency department after a minor head trauma and receiving anticoagulant treatment, a systematic preventive reversion with PCCs can lead to a significant reduction of intracranial haemorrhage and can also improve the neurological prognostic of patients versus the current strategy.

PREVACT will test this hypothesis, in an open label, randomized, multicentre, clinical trial involving 400 patients.

lead_sponsor: University Hospital, Angers

location_facility:
HCL Edouard Herriot
CHU Nice
Chu Tenon
CHG du Mans
Chu Saint Brieuc
Chu Nantes
Ch Longjumeau
Ch Saint Malo
Ch Annecy
Ch Les Sables D'Olonne
CHU Angers
Ch Versailles
Chu Toulouse
CHU Pitié Salpétrière
CH Agen
CHU Clermont Ferrand
CHU METZ
CHU Chateauroux
Chu Poitiers
Chu Tours
Chg Montauban


title: McGrath Mac Videolaryngoscope Versus Macintosh Laryngoscope for Orotracheal Intubation in Critical Care Unit

acronym: MACMAN

summary: The aim of this study is to demonstrate that the rate of successful orotracheal intubation at first laryngoscopy will be higher in patients intubated with McGrath Mac videolaryngoscope compared to patients intubated with classical Macintosh laryngoscope in patients requiring an orotracheal intubation in ICU.

ReferenceCitation: Bailly A, Lascarrou JB, Le Thuaut A, Boisrame-Helms J, Kamel T, Mercier E, Ricard JD, Lemiale V, Champigneulle B, Reignier J; Clinical Research in Intensive Care and Sepsis Group. McGRATH MAC videolaryngoscope versus Macintosh laryngoscope for orotracheal intubation in intensive care patients: the randomised multicentre MACMAN trial study protocol. BMJ Open. 2015 Dec 23;5(12):e009855. doi: 10.1136/bmjopen-2015-009855.

ReferenceCitation: Lascarrou JB, Boisrame-Helms J, Bailly A, Le Thuaut A, Kamel T, Mercier E, Ricard JD, Lemiale V, Colin G, Mira JP, Meziani F, Messika J, Dequin PF, Boulain T, Azoulay E, Champigneulle B, Reignier J; Clinical Research in Intensive Care and Sepsis (CRICS) Group. Video Laryngoscopy vs Direct Laryngoscopy on Successful First-Pass Orotracheal Intubation Among ICU Patients: A Randomized Clinical Trial. JAMA. 2017 Feb 7;317(5):483-493. doi: 10.1001/jama.2016.20603.

lead_sponsor: Centre Hospitalier Departemental Vendee

sponsor_collaborators:
Centre Hospitalier Departemental Vendee
Nantes University Hospital

location_facility:
CHD Vendee
CHU Louis Mourier
CHU Orleans
CHU Strasbourg Nouvel Hôpital Civil
CHU Paris Cochin
CHU Tours
CHU Saint Louis


title: Evaluation of Risk Factors Associated With Intracranial Aneurysm Recanalization After Endovascular Treatment

acronym: ARETA

summary:
Endovascular treatment is now the first line treatment for the management of intracranial aneurysms. However aneurysm recanalization is an important limitation to this treatment. Several factors seems to be associated with aneurysm recanalization including medical history of the patient, aneurysm status (ruptured or unruptured), aneurysm size and location, modalities of treatment, immediate post-operative occlusion of the aneurysm.

A precise knowledge of factors increasing the risk of aneurysm recanalization is quite important to optimize strategy of treatment and reduce the recanalization rate. No large, prospective, multicenter trial dealing with this question has been published in the literature.

ReferenceCitation: Pierot L, Barbe C, Thierry A, Bala F, Eugene F, Cognard C, Herbreteau D, Velasco S, Chabert E, Desal H, Aggour M, Rodriguez-Regent C, Gallas S, Sedat J, Marnat G, Sourour N, Consoli A, Papagiannaki C, Spelle L, White P. Patient and aneurysm factors associated with aneurysm recanalization after coiling. J Neurointerv Surg. 2022 Nov;14(11):1096-1101. doi: 10.1136/neurintsurg-2021-017972. Epub 2021 Nov 5.

ReferenceCitation: Pierot L, Barbe C, Herbreteau D, Gauvrit JY, Januel AC, Bala F, Ricolfi F, Desal H, Velasco S, Aggour M, Chabert E, Sedat J, Trystram D, Marnat G, Gallas S, Rodesch G, Clarencon F, Papagiannaki C, White P, Spelle L; From the Departments of Neuroradiology, Research, and Public Health. Immediate post-operative aneurysm occlusion after endovascular treatment of intracranial aneurysms with coiling or balloon-assisted coiling in a prospective multicenter cohort of 1189 patients: Analysis of Recanalization after Endovascular Treatment of intracranial Aneurysm (ARETA) Study. J Neurointerv Surg. 2021 Oct;13(10):918-923. doi: 10.1136/neurintsurg-2020-017012. Epub 2020 Dec 21.

ReferenceCitation: Pierot L, Barbe C, Herbreteau D, Gauvrit JY, Januel AC, Bala F, Ricolfi F, Desal H, Velasco S, Aggour M, Chabert E, Sedat J, Trystram D, Marnat G, Gallas S, Rodesch G, Clarencon F, Papagiannaki C, White P, Spelle L. Delayed thromboembolic events after coiling of unruptured intracranial aneurysms in a prospective cohort of 335 patients. J Neurointerv Surg. 2021 Jun;13(6):534-540. doi: 10.1136/neurintsurg-2020-016654. Epub 2020 Sep 7.

ReferenceCitation: Pierot L, Barbe C, Herbreteau D, Gauvrit JY, Januel AC, Bala F, Ricolfi F, Desal H, Velasco S, Aggour M, Chabert E, Sedat J, Trystram D, Marnat G, Gallas S, Rodesch G, Clarencon F, Papagiannaki C, White P, Spelle L. Rebleeding and bleeding in the year following intracranial aneurysm coiling: analysis of a large prospective multicenter cohort of 1140 patients-Analysis of Recanalization after Endovascular Treatment of Intracranial Aneurysm (ARETA) Study. J Neurointerv Surg. 2020 Dec;12(12):1219-1225. doi: 10.1136/neurintsurg-2020-015971. Epub 2020 Jun 16.

ReferenceCitation: Pierot L, Barbe C, Ferre JC, Cognard C, Soize S, White P, Spelle L. Patient and aneurysm factors associated with aneurysm rupture in the population of the ARETA study. J Neuroradiol. 2020 Jun;47(4):292-300. doi: 10.1016/j.neurad.2019.07.007. Epub 2019 Sep 17.

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

lead_sponsor: CHU de Reims

location_facility: Centre Hospitalier Universitaire de Besançon

location_facility: Centre Hospitalier Universitaire de Reims

location_facility: Centre Hospitalier Universitaire de Poitiers


title: A PHASE II TRIAL EVALUATING THE COMBINATION OF ERIBULIN (HALAVEN®) + BEVACIZUMAB (AVASTIN®) AS A FIRST LINE TREATMENT IN PATIENTS WITH METASTATIC HER2- BREAST CANCER

acronym: ESMERALDA

summary:
The efficacy of eribulin is now well known in metastatic breast cancer. Furthermore, a phase III combine study ( chemo + bev)in metastatic first line shown a gain in PFS with no extra toxicities.

It could be interesting to explore the combination of bev + eribulin in first line metastatic breast cancer.

lead_sponsor: ARCAGY/ GINECO GROUP

location_facility: Hôpital Morvan - Centre Hospitalier Universitaire

location_facility: Hôpital Privé Drôme Ardèche - Clinique Pasteur

location_facility: Centre Hospitalier Privé de Saint-Grégoire

location_facility: Centre Hospitalier de la Région d'Annecy

location_facility: Institut Curie - Hopital Claudius Régaud

location_facility: Centre de Radiothérapie - Clinique Sainte-Anne


title: A Cohort of Outpatients From French Research Memory Centers in Order to Improve Knowledge on Alzheimer's Disease and Related Disorders

acronym: MEMENTO

summary: A Multicenter national prospective cohort study including at least 2300 individuals consecutively recruited from French Research Memory Centers and followed-up over 5 years.

ReferenceCitation: Blanc F, Bouteloup V, Paquet C, Chupin M, Pasquier F, Gabelle A, Ceccaldi M, de Sousa PL, Krolak-Salmon P, David R, Fischer C, Dartigues JF, Wallon D, Moreaud O, Sauvee M, Belin C, Harston S, Botzung A, Albasser T, Demuynck C, Namer I, Habert MO, Kremer S, Bousiges O, Verny M, Muller C, Philippi N, Chene G, Cretin B, Mangin JF, Dufouil C. Prodromal characteristics of dementia with Lewy bodies: baseline results of the MEMENTO memory clinics nationwide cohort. Alzheimers Res Ther. 2022 Jul 19;14(1):96. doi: 10.1186/s13195-022-01037-0.

repository_institution: Universite de Bordeaux - Oskar-Bordeaux

repositories_concat: PubMed Central;oskar-bordeaux.fr

ReferenceCitation: Dufouil C, Dubois B, Vellas B, Pasquier F, Blanc F, Hugon J, Hanon O, Dartigues JF, Harston S, Gabelle A, Ceccaldi M, Beauchet O, Krolak-Salmon P, David R, Rouaud O, Godefroy O, Belin C, Rouch I, Auguste N, Wallon D, Benetos A, Pariente J, Paccalin M, Moreaud O, Hommet C, Sellal F, Boutoleau-Bretonniere C, Jalenques I, Gentric A, Vandel P, Azouani C, Fillon L, Fischer C, Savarieau H, Operto G, Bertin H, Chupin M, Bouteloup V, Habert MO, Mangin JF, Chene G; MEMENTO cohort Study Group. Cognitive and imaging markers in non-demented subjects attending a memory clinic: study design and baseline findings of the MEMENTO cohort. Alzheimers Res Ther. 2017 Aug 29;9(1):67. doi: 10.1186/s13195-017-0288-0.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - UJM - Université Jean Monnet

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Francois Rabelais - Tours

endpoint_id: HAL

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - CEA - Commissariat à l’énergie atomique

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

sponsor_collaborators:
University Hospital, Bordeaux
Fondation Plan Alzheimer

location_facility: CHU de Bordeaux - Hôpital Xavier-Arnozan

location_facility: CHU de Saint-Etienne - Hôpital de la charité


title: Chemoembolisation of Hepatocellular Carcinomas Not Subject to Interventive Care by Idarubicin-loaded Beads - IDASPHERE II

acronym: IDASPHERE II

summary:
The most frequently used products in CHE are doxorubicin (36%), cisplatin (31%), and epirubicin (12%). But until recently, there were no obvious reasons to use one product over another. In fact, systemic chemotherapy is considered ineffective in HCC [hepatocellular carcinoma], which does not allow any argument in favour of the product. Moreover, 2 randomised trials comparing the molecules (doxorubicin vs. epirubicin) proved to be negative in terms of survival.

Cytotoxicity of different anticancer agents on HCC cell lines have been compared in order to select the best candidate for CHE. Eleven chemotherapy molecules have been tested, including those more frequently used in CHE. Among them, idarubicin (an anthracycline) proved to be the most effective in vitro by far. The superiority of idarubicin (as opposed to doxorubicin) was noted especially on the SNU-449 line, which is known for its resistance to several chemotherapy agents. The best cytotoxicity of idarubicin can be explained by 2 mechanisms: 1) idarubicin has a better intracellular penetration than the other anthracyclines. This is probably due to its more considerable lipophily, facilitating thus its passage through the membrane made up of a double lipid layer, 2) idarubicin is resistant to the multidrug resistance system (MDR). The MDR mechanism, which is often noted in HCC, consists of membrane pumps transporting the molecule outside the cell. These two particularities could explain a more significant accumulation of idarubicin in the HCC cells, and thus better efficacy. It is interesting to note that orally administered idarubicin (5 mg/day for 21 days) has proved to be less toxic and is effective in HCC. Currently, idarubicin is used to treat leukaemia. Its toxicity profile (especially, haematological and cardiac) is known.

On these grounds, A pilot study has been conducted in order to assess the tolerance and efficacy of lipiodol-based CHE using a 10 mg dose of idarubicin in 21 patients with unresectable HCC. These preliminary data reveal that CHE with idarubicin is effective and less toxic.

Idarubicin can be loaded in microbeads. A phase I study (IDASPHERE) has been conducted on DC Beads® microbeads (300-500µm) loaded with idarubicin (dose increased from 5 to 25 mg). The DLT [dose-limiting toxicity] and MTD [maximum tolerated dose] have been determined in 21 patients using a CRM. The MTD of idarubicin was assessed at 10 mg. In our study, the idarubicin-loaded beads did not give rise to any specific toxicity-related problem. The 10 mg dose is compatible with the known toxicity profile of idarubicin: cumulative cardiotoxicity of doxorubicin is noted from 550 mg/m², whereas that of idarubicin is noted from 93 mg/m². There is thus a 5.9:1 ratio between their cumulative toxicities. The most frequently used dose (and also the weakest one) for the doxorubicin-based CHE is 50 mg. The equivalent of the idarubicin dose would thus be: 50 mg (doxorubicin) / 5.9 (doxorubicin/idarubicin ratio) = approx. 10 mg of idarubicin.

It has been already demonstrated that hepatic extraction of idarubicin is better than those of doxorubicin and daunorubicin in an animal sarcoma model. In this study, AUC 0-48h and AUC 0-72h were 1.35 times higher with idarubicin, proving that its intra-hepatic penetration was 35% higher.

The randomised phase II PRECISION V study compared conventional CHE (cCHE) with CHE by doxorubicin beads (DC Bead®) in patients with HCC. It is currently the largest randomised trial on CHE published. The PRECISION V data can be thus used to compare the other studies in terms of efficacy and tolerance.

To continue our preliminary study and the phase I IDASPHERE study, investigators wish to assess thus the efficacy and confirm the tolerance of idarubicin-loaded beads for the CHE of HCC according to a protocol similar to PRECISION V, as part of a single-arm phase II study.

ReferenceCitation: Guiu B, Chevallier P, Assenat E, Barbier E, Merle P, Bouvier A, Dumortier J, Nguyen-Khac E, Gugenheim J, Rode A, Oberti F, Valette PJ, Yzet T, Chevallier O, Barbare JC, Latournerie M, Boulin M. Idarubicin-loaded Beads for Chemoembolization of Hepatocellular Carcinoma: The IDASPHERE II Single-Arm Phase II Trial. Radiology. 2019 Jun;291(3):801-808. doi: 10.1148/radiol.2019182399. Epub 2019 Apr 30.

publisher_dissemination: Radiological Society of North America (RSNA)

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_facility:
Hôpital de l'Archet II
CHU - Hôpital François Mitterand
Hôpital Edouard Herriot
Hôpital La Croix Rousse
CHU d'ANGERS
CHU St Eloi
CHU Amiens


title: Health Economics Evaluation of Percutaneous Vertebroplasty Compared to Radiation Therapy in Patients With Painful Spine Metastases.

acronym: Radiointer

summary:
The purpose of this study is to evaluate cost-utility analysis in order to provide recommendations to French decision-makers between vertebroplasty and radiation therapy in Bone spine metastases. Indeed, radiation therapy is often advocated a systematic way. The object of this study would be to expand the use of vertebroplasty.

Moreover, this study assess to the strategy impact on the pain control reduction and functional preservation. In fact, analgesic effect is achieved differently depending on the procedure used.Eligible patients will be recruited and registered consecutively. Patients will be randomly,

This is a health-economic multicenter, prospective, randomized with stratification according to number of vertebrae to treat (1-3 vertebrae vs 4-6 vertebrae) and center :

Arm A: Percutaneous vertebroplasty
Arm B: External radiotherapy

This is an open-label study. The expected total study period is 2.5 years (enrolment: 2 years, patient follow-up: 6 months). A total number of 304 patients with spine metastases will be recruited (152 patients/arm).

lead_sponsor: Centre Leon Berard

location_facility:
Institut Bergonié
Centre Antoine Lacassagne
HCL- Hopital Edouard Herriot
Centre Leon Berard
Institut Gustave Roussy
Centre Paul Strauss
Institut Curie

appel_a_projets: PRMEK

region: Auvergne-Rhône-Alpes

nom_etablissement: CENTRE LEON BERARD

type_etablissement: CLCC

titre: Evaluation médico-économique de la vertébroplastie percutanée comparée à la radiothérapie chez les patients atteints de métastases osseuses douloureuses.

discipline_principale: spine metastasis

nom_porteur: RICHIOUD

prenom_porteur: Bertrand


title: A Prospective, Multicenter and Observational Trial to Evaluate Evolution of Quality of Life (SF-36) After Total Thyroidectomy.

acronym: ThyrQol

summary: The purpose of this study is to evaluate the evolution of quality of life and voice function with different questionnaires (VIH, SF36) before and after total thyroidectomy.

lead_sponsor: Nantes University Hospital

location_facility:
La Pitié-Salpétrière - AP-HP
CHD La Roche sur Yon
Nancy University Hospital
Lyon University Hospital
Limoges University Hospital
Nantes University Hospital
Angers University Hospital


title: IMAGE (Metabolic Risk During Gestation) : Prospective Study of Women With Gestational Diabetes

acronym: IMAGE

summary: Gestational diabetes (GDM) is defined by abnormal glucose tolerance during gestation. This complication occurs in 4-10% and is associated with fetal complications and macrosomia. In addition, women with GDM have an increased risk to develop type 2 diabetes after delivery. Despite recommendations, it is difficult to follow-up all women with GDM during the postpartum period due to high numbers of subjects that exceed usual healthcare resources. It is therefore necessary to focus clinical attention toward women at high risk of type 2 diabetes in order to set adequate preventive strategies.

primary_purpose: Screening

location_facility: Centre Hospitalier de Givors - Hôpital de Montgelas - Service de médicine 8

location_facility: Groupement Hospitalier des Portes du Sud - Service d'Endocrinologie Diabétologie Nutrition

location_facility: CHU Grenoble - Clinique d'Endocrinologie Diabétologie Nutrition

location_facility: Hospices Civils de Lyon - Hôpital Femme-Mère-Enfant - Service de gynécologie obstétrique

location_facility: Hospices Civils de Lyon - Groupement Hospitalier Sud - Service d'Endocrinologie, Diabète, Nutrition

location_facility: CHU Saint Etienne - Hôpital Nord - Service d'endocrinologie, diabètes, nutrition

location_facility: CHU Clermont-Ferrand - Hôpital Gabriel Montpied - Service d'endocrinologie


title: Evaluation of the Video Capsule Colonoscopy for the Detection and the Control of Colon Lesions in Children Presenting Confirmed or Suspected Inflammatory Bowel Disease

acronym: VICCOINBODI

summary:
The incidence of Inflammatory Bowel Diseases (IBD) is in a continuous progression both in adults as in children. The colonoscopy is considered as the gold standard exam for the diagnosis and the follow-up of the patients presenting or suspected to have an IBD. The follow-up and financial management of this kind of pathology is very much dependent on the quality of the endoscopic images. Because colonoscopy is an expensive and invasive technique which assumes a general sedation, many efforts have been done to develop new less expensive and less invasive techniques in order to offer alternatives to the classic colon endoscopy. One of these new techniques is the colon videocapsule (CVC) endoscopy (PillCam® colon 2 - Given Imaging, Yoqneam, Israel). This is a new promising semi-invasive endoscopic technique which has been successfully validated with adults. We hypothesize that the CVC can be used in children with similar results in terms of efficacy, as is the case for adults.

This prospective simple blind multicenter study, will investigate the diagnostic value of the CVC compared to the conventional colonoscopy under general sedation for the detection and the control of colon lesions in children presenting IBD.

If the feasibility and the efficacy of the colon video capsule technique are also proven for use with children, then this new technique might become a very interesting alternative for the endoscopic examination of the colon because of being less expensive and less invasive.

Moreover, this technique would be very useful as a means of lesions detection all along the digestive tract and not limited to the colon only.

primary_purpose: Prevention

location_facility: Service d'Hépatologie, gastroentérologie et nutrition pédiatrique, Hôpital Femme Mère Enfant, Hospices Civils de Lyon

location_facility: Service de Gastroentérologie, Hépatologie, Nutrition et Diabétologie, Hôpital des Enfants, CHU de Toulouse

location_facility: Service de Gastroentérologie, Mucoviscidose et Nutrition, Hôpital Robert Debré, AP-HP

location_facility: Service de Pédiatrie, Hôpital Sud, CHU de Rennes

location_facility: Clinique de Pédiatrie, Hôpital Jeanne de Flandre, CHU de Lille

location_facility: Service de Hépato Gastroentérologie et Nutrition, Hôpital Necker Enfants Malades, AP-HP

location_facility: Service de Pédiatrie Médicale, Hôpital Pellegrin, CHU de Bordeaux