title: Multicenter Trial Estimating the Persistence of Molecular Remission in Chronic Myeloid Leukemia After Stopping TKI

acronym: EURO-SKI

summary:
The EURO-SKI is a multicenter open label, uncontrolled trial estimating the persistence of molecular remission in Chronic Myeloid Leukemia (CML) patients after stopping Tyrosine Kinase Inhibitor (TKI). Main goal is the assessment of the duration of major molecular response (MMR) or better after stopping TKI therapy.

Secondary goals include:

Identification of clinical and biological factors affecting the persistence of complete molecular remission after stopping TKI (e.g. level of Complete molecular remission (CMR), risk score, duration of TKI treatment, type of TKI pretreatment)
Evaluation of quality of life (QoL) in patients stopping TKI
Evaluation of medico-economic impact of stopping TKI
Estimating the number of patients in CMR who are eligible for stopping TKI therapy by setting up a screening log
Time to recovery of CMR There will be no randomised comparison. Based on the experience of the STIM trial (Mahon et al., Lancet Onc 2010) we expect an overall six-month molecular-relapse-free survival probability of at least 40%. An interim analysis will be performed after a pilot phase where 200 patients have been observed for at least six months. Formally, it is planned to test the null hypothesis H0: Six-month molecular relapse-free survival probability P ≤ 40% against the alternative hypothesis H1: Six-month molecular-relapse-free survival probability P > 40%. Eligible are adult CML patients in chronic phase on TKI treatment in CMR for at least one year (> 4 log reduction of BCR-ABL transcripts on IS, TKI treatment for at least 3 years, confirmed by a PCR within a standardized CMR laboratory). Clinical and biological monitoring will be performed during 3 years: Associated scientific projects are performed. Recruitment period: 2 years; follow up: 3 years. Planned patient recruitment in main phase: n=500

ReferenceType: background

ReferenceCitation: Richter J, Lubking A, Soderlund S, Lotfi K, Markevarn B, Sjalander A, Stenke L, Deneberg S, Ahlstrand E, Myhr-Eriksson K, Panayiotidis P, Gedde-Dahl T, Zackova D, Mayer J, Olsson-Stromberg U, Mahon FX, Saussele S, Hjorth-Hansen H, Koskenvesa P. Molecular status 36 months after TKI discontinuation in CML is highly predictive for subsequent loss of MMR-final report from AFTER-SKI. Leukemia. 2021 Aug;35(8):2416-2418. doi: 10.1038/s41375-021-01173-w. Epub 2021 Feb 15. No abstract available.

ReferenceCitation: Soderlund S, Persson I, Ilander M, Guilhot J, Hjorth-Hansen H, Koskenvesa P, Richter J, Saussele S, Mustjoki S, Olsson-Stromberg U. Plasma proteomics of biomarkers for inflammation or cancer cannot predict relapse in chronic myeloid leukaemia patients stopping tyrosine kinase inhibitor therapy. Leuk Res. 2020 Mar;90:106310. doi: 10.1016/j.leukres.2020.106310. Epub 2020 Jan 23.

ReferenceCitation: Bouillon AS, Ventura Ferreira MS, Awad SA, Richter J, Hochhaus A, Kunzmann V, Dengler J, Janssen J, Ossenkoppele G, Westerweel PE, Te Boekhorst PAW, Mahon FX, Hjorth-Hansen H, Isfort S, Fioretos T, Hummel S, Schemionek M, Wilop S, Koschmieder S, Saussele S, Mustjoki S, Beier F, Brummendorf TH. Telomere shortening correlates with leukemic stem cell burden at diagnosis of chronic myeloid leukemia. Blood Adv. 2018 Jul 10;2(13):1572-1579. doi: 10.1182/bloodadvances.2018017772.

ReferenceCitation: Schutz C, Inselmann S, Saussele S, Dietz CT, Mu Ller MC, Eigendorff E, Brendel CA, Metzelder SK, Bru Mmendorf TH, Waller C, Dengler J, Goebeler ME, Herbst R, Freunek G, Hanzel S, Illmer T, Wang Y, Lange T, Finkernagel F, Hehlmann R, Huber M, Neubauer A, Hochhaus A, Guilhot J, Xavier Mahon F, Pfirrmann M, Burchert A. Expression of the CTLA-4 ligand CD86 on plasmacytoid dendritic cells (pDC) predicts risk of disease recurrence after treatment discontinuation in CML. Leukemia. 2017 Apr;31(4):829-836. doi: 10.1038/leu.2017.9. Epub 2017 Jan 11. Erratum In: Leukemia. 2018 Jan 30;:

ReferenceType: result

ReferenceCitation: Saussele S, Richter J, Guilhot J, Gruber FX, Hjorth-Hansen H, Almeida A, Janssen JJWM, Mayer J, Koskenvesa P, Panayiotidis P, Olsson-Stromberg U, Martinez-Lopez J, Rousselot P, Vestergaard H, Ehrencrona H, Kairisto V, Machova Polakova K, Muller MC, Mustjoki S, Berger MG, Fabarius A, Hofmann WK, Hochhaus A, Pfirrmann M, Mahon FX; EURO-SKI investigators. Discontinuation of tyrosine kinase inhibitor therapy in chronic myeloid leukaemia (EURO-SKI): a prespecified interim analysis of a prospective, multicentre, non-randomised, trial. Lancet Oncol. 2018 Jun;19(6):747-757. doi: 10.1016/S1470-2045(18)30192-X. Epub 2018 May 4.

repositories_concat: closed

publisher_dissemination: Elsevier

ReferenceCitation: Ilander M, Olsson-Stromberg U, Schlums H, Guilhot J, Bruck O, Lahteenmaki H, Kasanen T, Koskenvesa P, Soderlund S, Hoglund M, Markevarn B, Sjalander A, Lotfi K, Dreimane A, Lubking A, Holm E, Bjoreman M, Lehmann S, Stenke L, Ohm L, Gedde-Dahl T, Majeed W, Ehrencrona H, Koskela S, Saussele S, Mahon FX, Porkka K, Hjorth-Hansen H, Bryceson YT, Richter J, Mustjoki S. Increased proportion of mature NK cells is associated with successful imatinib discontinuation in chronic myeloid leukemia. Leukemia. 2017 May;31(5):1108-1116. doi: 10.1038/leu.2016.360. Epub 2016 Nov 28.

repository_institution: Umeå University - DiVA at Umeå University

repository_institution: KTH Royal Institute of Technology - KTH Publication Database DiVA

version: submittedVersion

repositories_concat: DiVA.org;PubMed Central

publisher_dissemination: Springer-Nature

ReferenceCitation: Rinaldetti S, Pfirrmann M, Manz K, Guilhot J, Dietz C, Panagiotidis P, Spiess B, Seifarth W, Fabarius A, Muller M, Pagoni M, Dimou M, Dengler J, Waller CF, Brummendorf TH, Herbst R, Burchert A, Janbetaen C, Goebeler ME, Jost PJ, Hanzel S, Schafhausen P, Prange-Krex G, Illmer T, Janzen V, Klausmann M, Eckert R, Buschel G, Kiani A, Hofmann WK, Mahon FX, Saussele S. Effect of ABCG2, OCT1, and ABCB1 (MDR1) Gene Expression on Treatment-Free Remission in a EURO-SKI Subtrial. Clin Lymphoma Myeloma Leuk. 2018 Apr;18(4):266-271. doi: 10.1016/j.clml.2018.02.004. Epub 2018 Feb 8.

evidence: open (via crossref license)

repository_institution: Technical University Munich - mediaTUM – the media and publications repository of the Technical University Munich

repository_institution: Würzburg University - Online Publication Service of Würzburg University

lead_sponsor: European LeukemiaNet

location_country: Germany Finland Portugal Norway Denmark Sweden Netherlands Greece Czechia France

location_facility: Universitätsmedizin Mannheim, Universität Heidelberg

location_facility: University of Athens, Society of Hematology

location_facility: Oslo universitetssykehus HF Rikshospitalet

location_facility: Universitätsklinikum Giessen und Marburg GmbH

location_facility: Norwegian University of Science and Technology

location_facility: Hopital de la Milétrie, Centre Hospitalier Universitaire (CHU) de Poitiers

location_facility: Centre Hospitalier Universitaire (CHU) de Nantes

location_facility: Instituto Português de Oncologia Francisco Gentil

intervention_type: Other


title: (Apex) Multicenter, Randomized, Active-Controlled Efficacy And Safety Study Comparing Extended Duration Betrixaban With Standard Of Care Enoxaparin For The Prevention Of Venous Thromboembolism In Acute Medically Ill Patients

acronym: APEX

summary: The purpose of this study is to evaluate whether extended prophylaxis with oral betrixaban can prevent blood clots in the leg and lung that sometime occur in patients hospitalized for an acute medical illness and to compare these results with standard of care enoxaparin. The safety of betrixaban will also be studied.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Jamil A, Jamil U, Singh K, Khan F, Chi G. Extended Thromboprophylaxis With Betrixaban or Rivaroxaban for Acutely Ill Hospitalized Medical Patients: Meta-Analysis of Prespecified Subgroups. Crit Pathw Cardiol. 2021 Mar 1;20(1):16-24. doi: 10.1097/HPC.0000000000000232.

oa_host_type: closed

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Yee MK, Gibson CM, Nafee T, Kerneis M, Daaboul Y, Korjian S, Chi G, AlKhalfan F, Hernandez AF, Hull RD, Cohen AT, Goldhaber SZ. Characterization of Major and Clinically Relevant Non-Major Bleeds in the APEX Trial. TH Open. 2019 Apr 17;3(2):e103-e108. doi: 10.1055/s-0039-1685496. eCollection 2019 Apr.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

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: Georg Thieme

ReferenceCitation: Guy H, Laskier V, Fisher M, Bucior I, Deitelzweig S, Cohen AT. Budget impact analysis of betrixaban for venous thromboembolism prophylaxis in nonsurgical patients with acute medical illness in the United Kingdom. Expert Rev Pharmacoecon Outcomes Res. 2020 Jun;20(3):259-267. doi: 10.1080/14737167.2019.1629905. Epub 2019 Jun 19.

publisher_dissemination: Informa

ReferenceCitation: Chi G, Gibson CM, Kalayci A, Cohen AT, Hernandez AF, Hull RD, Kahe F, Jafarizade M, Sharfaei S, Liu Y, Harrington RA, Goldhaber SZ. Extended-duration betrixaban versus shorter-duration enoxaparin for venous thromboembolism prophylaxis in critically ill medical patients: an APEX trial substudy. Intensive Care Med. 2019 Apr;45(4):477-487. doi: 10.1007/s00134-019-05565-6. Epub 2019 Feb 18.

ReferenceCitation: Kalayci A, Gibson CM, Chi G, Yee MK, Korjian S, Datta S, Nafee T, Gurin M, Haroian N, Qamar I, Hull RD, Hernandez AF, Cohen AT, Harrington RA, Goldhaber SZ. Asymptomatic Deep Vein Thrombosis is Associated with an Increased Risk of Death: Insights from the APEX Trial. Thromb Haemost. 2018 Dec;118(12):2046-2052. doi: 10.1055/s-0038-1675606. Epub 2018 Nov 12.

ReferenceCitation: Chi G, Gibson CM, Liu Y, Hernandez AF, Hull RD, Cohen AT, Harrington RA, Goldhaber SZ. Inverse relationship of serum albumin to the risk of venous thromboembolism among acutely ill hospitalized patients: Analysis from the APEX trial. Am J Hematol. 2019 Jan;94(1):21-28. doi: 10.1002/ajh.25296. Epub 2018 Oct 17.

oa_host_type: publisher

evidence: open (via free article)

unpaywall_oa_status: bronze

publisher_dissemination: Wiley

ReferenceCitation: Chi G, Goldhaber SZ, Hull RD, Hernandez AF, Kerneis M, Al Khalfan F, Cohen AT, Harrington RA, Gibson CM. Thrombus Burden of Deep Vein Thrombosis and Its Association with Thromboprophylaxis and D-Dimer Measurement: Insights from the APEX Trial. Thromb Haemost. 2017 Dec;117(12):2389-2395. doi: 10.1160/TH17-08-0538. Epub 2017 Dec 6.

ReferenceCitation: Yee MK, Nafee T, Daaboul Y, Korjian S, AlKhalfan F, Kerneis M, Wiest C, Goldhaber SZ, Hernandez AF, Hull RD, Cohen AT, Harrington RA, Gibson CM. Increased benefit of betrixaban among patients with a history of venous thromboembolism: a post-hoc analysis of the APEX trial. J Thromb Thrombolysis. 2018 Jan;45(1):1-8. doi: 10.1007/s11239-017-1583-0.

ReferenceCitation: Chi G, Januzzi JL, Korjian S, Daaboul Y, Goldhaber SZ, Hernandez AF, Hull RD, Gold A, Cohen AT, Harrington RA, Gibson CM. N-terminal pro-B-type natriuretic peptide and the risk of stroke among patients hospitalized with acute heart failure: an APEX trial substudy. J Thromb Thrombolysis. 2017 Nov;44(4):457-465. doi: 10.1007/s11239-017-1552-7.

ReferenceCitation: Arbetter DF, Jain P, Yee MK, Michalak N, Hernandez AF, Hull RD, Goldhaber SZ, Harrington RA, Gold A, Cohen AT, Gibson CM. Competing risk analysis in a large cardiovascular clinical trial: An APEX substudy. Pharm Stat. 2017 Nov;16(6):445-450. doi: 10.1002/pst.1823. Epub 2017 Aug 24.

ReferenceCitation: Chi G, Goldhaber SZ, Kittelson JM, Turpie AGG, Hernandez AF, Hull RD, Gold A, Curnutte JT, Cohen AT, Harrington RA, Gibson CM. Effect of extended-duration thromboprophylaxis on venous thromboembolism and major bleeding among acutely ill hospitalized medical patients: a bivariate analysis. J Thromb Haemost. 2017 Oct;15(10):1913-1922. doi: 10.1111/jth.13783. Epub 2017 Sep 4.

license: publisher-specific-oa

license_normalized: publisher-specific

unpaywall_oa_status: hybrid

ReferenceCitation: Gibson CM, Korjian S, Chi G, Daaboul Y, Jain P, Arbetter D, Goldhaber SZ, Hull R, Hernandez AF, Lopes RD, Gold A, Cohen AT, Harrington RA; APEX Investigators. Comparison of Fatal or Irreversible Events With Extended-Duration Betrixaban Versus Standard Dose Enoxaparin in Acutely Ill Medical Patients: An APEX Trial Substudy. J Am Heart Assoc. 2017 Jul 11;6(7):e006015. doi: 10.1161/JAHA.117.006015.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: Harvard University - Digital Access to Scholarship at Harvard (DASH)

repository_institution: Università Cattolica del Sacro Cuore - PubliCatt

repositories_concat: LIRIAS (KU Leuven);PubMed Central;dash.harvard.edu;pdfs.semanticscholar.org;publicatt.unicatt.it

ReferenceCitation: Gibson CM, Goldhaber SZ, Cohen AT, Nafee T, Hernandez AF, Hull R, Korjian S, Daaboul Y, Chi G, Yee M, Harrington RA. When academic research organizations and clinical research organizations disagree: Processes to minimize discrepancies prior to unblinding of randomized trials. Am Heart J. 2017 Jul;189:1-8. doi: 10.1016/j.ahj.2017.03.018. Epub 2017 Mar 31. No abstract available.

ReferenceCitation: Marszalek J, Mehrsefat S, Chi G. The risk of stroke among acutely ill hospitalized medical patients: lessons from recent trials on extended-duration thromboprophylaxis. Expert Rev Hematol. 2017 Aug;10(8):679-684. doi: 10.1080/17474086.2017.1343662. Epub 2017 Jun 21.

ReferenceCitation: Gibson CM, Chi G, Halaby R, Korjian S, Daaboul Y, Jain P, Arbetter D, Goldhaber SZ, Hull R, Hernandez AF, Gold A, Bandman O, Harrington RA, Cohen AT; APEX Investigators. Extended-Duration Betrixaban Reduces the Risk of Stroke Versus Standard-Dose Enoxaparin Among Hospitalized Medically Ill Patients: An APEX Trial Substudy (Acute Medically Ill Venous Thromboembolism Prevention With Extended Duration Betrixaban). Circulation. 2017 Feb 14;135(7):648-655. doi: 10.1161/CIRCULATIONAHA.116.025427. Epub 2016 Nov 14.

ReferenceCitation: Cohen AT, Harrington RA, Goldhaber SZ, Hull RD, Wiens BL, Gold A, Hernandez AF, Gibson CM; APEX Investigators. Extended Thromboprophylaxis with Betrixaban in Acutely Ill Medical Patients. N Engl J Med. 2016 Aug 11;375(6):534-44. doi: 10.1056/NEJMoa1601747. Epub 2016 May 27.

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

repository_institution: St George's University of London - St George's Online Research Archive

ReferenceCitation: Cohen AT, Harrington R, Goldhaber SZ, Hull R, Gibson CM, Hernandez AF, Kitt MM, Lorenz TJ. The design and rationale for the Acute Medically Ill Venous Thromboembolism Prevention with Extended Duration Betrixaban (APEX) study. Am Heart J. 2014 Mar;167(3):335-41. doi: 10.1016/j.ahj.2013.11.006. Epub 2013 Dec 10.

location_country:
Finland
Germany
Poland
Argentina
Australia
Brazil
Croatia
Chile
Czechia
Canada
Serbia
France
Lithuania
Slovakia
Hungary
Denmark
United States
Latvia
Ukraine
Montserrat
Romania
Belgium
Peru
Estonia
Italy
United Kingdom
Singapore
Austria
Spain
South Africa
Bulgaria
Georgia
Russian Federation
Israel


study_start_date_type: Actual

intervention_type: Drug

acronym: GALEN

lead_sponsor: The Lymphoma Academic Research Organisation

summary:
This study is to determine first the appropriate dose of lenalidomide to administer in combination with fixed doses of obinutuzumab in relapsed/refractory follicular lymphoma patients.

In a second step, this study aims to determine the efficacy of this combination in 3 separate populations: relapsed/refractory aggressive lymphoma (diffuse large B-cell lymphoma and mantle cell lymphoma: cohort 1), relapsed/refractory follicular lymphoma (cohort 2) and previously untreated follicular lymphoma (cohorts 3 and 4).

ReferenceCitation: Bachy E, Houot R, Feugier P, Bouabdallah K, Bouabdallah R, Virelizier EN, Maerevoet M, Fruchart C, Snauwaert S, Le Gouill S, Marolleau JP, Molina L, Molucon-Chabrot C, Thieblemont C, Tilly H, Bijou F, Haioun C, Van den Neste E, Fabiani B, Meignan M, Cartron G, Salles G, Casasnovas O, Morschhauser F. Obinutuzumab plus lenalidomide in advanced, previously untreated follicular lymphoma in need of systemic therapy: a LYSA study. Blood. 2022 Apr 14;139(15):2338-2346. doi: 10.1182/blood.2021013526.

oa_colors: green other

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

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon

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

repositories_concat: HAL

publisher_dissemination: American Society of Hematology

ReferenceCitation: Morschhauser F, Le Gouill S, Feugier P, Bailly S, Nicolas-Virelizier E, Bijou F, Salles GA, Tilly H, Fruchart C, Van Eygen K, Snauwaert S, Bonnet C, Haioun C, Thieblemont C, Bouabdallah R, Wu KL, Canioni D, Meignin V, Cartron G, Houot R. Obinutuzumab combined with lenalidomide for relapsed or refractory follicular B-cell lymphoma (GALEN): a multicentre, single-arm, phase 2 study. Lancet Haematol. 2019 Aug;6(8):e429-e437. doi: 10.1016/S2352-3026(19)30089-4. Epub 2019 Jul 8.

evidence: open (via crossref license, author manuscript)

version: acceptedVersion

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - IRD - Institut de recherche pour le développement

repository_institution: University of Liège - ORBi - Open Repository and Bibliography of the University of Liège

ReferenceCitation: Morschhauser F, Salles G, Le Gouill S, Tilly H, Thieblemont C, Bouabdallah K, Fabiani B, Menard C, Tarte K, Cartron G, Houot R. An open-label phase 1b study of obinutuzumab plus lenalidomide in relapsed/refractory follicular B-cell lymphoma. Blood. 2018 Oct 4;132(14):1486-1494. doi: 10.1182/blood-2018-05-853499. Epub 2018 Aug 1.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - UFC - Université de Franche-Comté

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

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

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

location_facility: Université Catholique de Louvain Saint Luc

location_facility: AZ Groeninge - Campus Maria's Voorzienigheid

location_facility: Institut d'Hématologie de Basse Normandie

location_facility: Université Catholique de Louvain Mont Godinne

title: A Phase Ib/II Study of OBINUTUZUMAB Combined to LENALIDOMIDE for the Treatment of Follicular and Relapsed/Refractory Aggressive (DLBCL and MCL) B-cell Lymphoma

primary_purpose: Treatment

source: euctr


title: ABILITY Diabetes Global

acronym: ABILITY

summary: To compare in diabetic patients eligible for percutaneous coronary intervention (PCI) with minimal exclusion criteria, the efficacy and safety of Abluminus DES+ sirolimus- eluting stents (SES) versus XIENCE Everolimus-Eluting Stents (EES). At least 40% of patients are expected to be affected by multivessel coronary artery disease and 30% with acute coronary syndrome

status: Active, not recruiting

study_completion_date_type: Anticipated

primary_purpose: Other

ReferenceCitation: International Diabetes Federation 2015. IDF DIABETES ATLAS Seventh Edition. 2015; ISBN: 978-2-930229-81-2

ReferenceCitation: Thiele H, Zeymer U. Chapter: Cardiogenic shock in patients with acute coronary syndromes (p. 441), The ESC Textbook of Intensive and Acute Cardiovascular Care (2 ed.) [IACC]. Edited by Marco Tubaro, Pascal Vranckx, Susanna Price, and Christiaan Vrints. Updated on 22 February 2018 DOI: 10.1093/med/9780199687039.003.0049_update_003

doi: thiele

ReferenceCitation: Kereiakes DJ, Cutlip DE, Applegate RJ, Wang J, Yaqub M, Sood P, Su X, Su G, Farhat N, Rizvi A, Simonton CA, Sudhir K, Stone GW. Outcomes in diabetic and nondiabetic patients treated with everolimus- or paclitaxel-eluting stents: results from the SPIRIT IV clinical trial (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System). J Am Coll Cardiol. 2010 Dec 14;56(25):2084-9. doi: 10.1016/j.jacc.2010.10.006.

ReferenceCitation: Kufner S, Byrne RA, Dommasch M, Massberg S, Schoemig A, Kastrati A. Comparison of "limus"-eluting stents with permanent-vs biodegradable polymer in patients with diabetes mellitus with coronary artery disease. Eur Heart J 2012; 33: 558-9

ReferenceCitation: Stone GW, Kedhi E, Kereiakes DJ, Parise H, Fahy M, Serruys PW, Smits PC. Differential clinical responses to everolimus-eluting and Paclitaxel-eluting coronary stents in patients with and without diabetes mellitus. Circulation. 2011 Aug 23;124(8):893-900. doi: 10.1161/CIRCULATIONAHA.111.031070. Epub 2011 Aug 8.

ReferenceCitation: Cutlip DE, Chhabra AG, Baim DS, Chauhan MS, Marulkar S, Massaro J, Bakhai A, Cohen DJ, Kuntz RE, Ho KK. Beyond restenosis: five-year clinical outcomes from second-generation coronary stent trials. Circulation. 2004 Sep 7;110(10):1226-30. doi: 10.1161/01.CIR.0000140721.27004.4B. Epub 2004 Aug 30.

ReferenceCitation: Lee TT, Feinberg L, Baim DS, Holmes DR, Aroesty JM, Carrozza JP Jr, Cohen DJ, Ho KK, Cutlip DE. Effect of diabetes mellitus on five-year clinical outcomes after single-vessel coronary stenting (a pooled analysis of coronary stent clinical trials). Am J Cardiol. 2006 Sep 15;98(6):718-21. doi: 10.1016/j.amjcard.2006.03.059. Epub 2006 Jul 13.

ReferenceCitation: Morgan KP, Kapur A, Beatt KJ. Anatomy of coronary disease in diabetic patients: an explanation for poorer outcomes after percutaneous coronary intervention and potential target for intervention. Heart. 2004 Jul;90(7):732-8. doi: 10.1136/hrt.2003.021014.

ReferenceCitation: Hadi HA, Suwaidi JA. Endothelial dysfunction in diabetes mellitus. Vasc Health Risk Manag. 2007;3(6):853-76.

ReferenceCitation: Schalkwijk CG, Stehouwer CD. Vascular complications in diabetes mellitus: the role of endothelial dysfunction. Clin Sci (Lond). 2005 Aug;109(2):143-59. doi: 10.1042/CS20050025.

ReferenceCitation: Dangas GD, Claessen BE, Caixeta A, Sanidas EA, Mintz GS, Mehran R. In-stent restenosis in the drug-eluting stent era. J Am Coll Cardiol. 2010 Nov 30;56(23):1897-907. doi: 10.1016/j.jacc.2010.07.028.

ReferenceCitation: Lightell DJ Jr, Woods TC. Relative resistance to Mammalian target of rapamycin inhibition in vascular smooth muscle cells of diabetic donors. Ochsner J. 2013 Spring;13(1):56-60.

ReferenceCitation: Denardo SJ, Carpinone PL, Vock DM, Batich CD, Pepine CJ. Changes to polymer surface of drug-eluting stents during balloon expansion. JAMA. 2012 May 23;307(20):2148-50. doi: 10.1001/jama.2012.4111. No abstract available.

ReferenceCitation: Popma JJ, Leon MB, Moses JW, Holmes DR Jr, Cox N, Fitzpatrick M, Douglas J, Lambert C, Mooney M, Yakubov S, Kuntz RE; SIRIUS Investigators. Quantitative assessment of angiographic restenosis after sirolimus-eluting stent implantation in native coronary arteries. Circulation. 2004 Dec 21;110(25):3773-80. doi: 10.1161/01.CIR.0000150331.14687.4B. Epub 2004 Dec 13.

ReferenceCitation: Mulukutla SR, Vlachos HA, Marroquin OC, Selzer F, Holper EM, Abbott JD, Laskey WK, Williams DO, Smith C, Anderson WD, Lee JS, Srinivas V, Kelsey SF, Kip KE. Impact of drug-eluting stents among insulin-treated diabetic patients: a report from the National Heart, Lung, and Blood Institute Dynamic Registry. JACC Cardiovasc Interv. 2008 Apr;1(2):139-47. doi: 10.1016/j.jcin.2008.02.005.

ReferenceCitation: Stenestrand U, James SK, Lindback J, Frobert O, Carlsson J, Schersten F, Nilsson T, Lagerqvist B; SCAAR/SWEDEHEART study group. Safety and efficacy of drug-eluting vs. bare metal stents in patients with diabetes mellitus: long-term follow-up in the Swedish Coronary Angiography and Angioplasty Registry (SCAAR). Eur Heart J. 2010 Jan;31(2):177-86. doi: 10.1093/eurheartj/ehp424. Epub 2009 Nov 10.

ReferenceCitation: Maeng M, Jensen LO, Galloe AM, Thayssen P, Christiansen EH, Hansen KN, Helqvist S, Botker HE, Lassen JF, Thuesen L. Comparison of the sirolimus-eluting versus paclitaxel-eluting coronary stent in patients with diabetes mellitus: the diabetes and drug-eluting stent (DiabeDES) randomized angiography trial. Am J Cardiol. 2009 Feb 1;103(3):345-9. doi: 10.1016/j.amjcard.2008.09.084. Epub 2008 Nov 12.

ReferenceCitation: Dibra A, Kastrati A, Mehilli J, Pache J, Schuhlen H, von Beckerath N, Ulm K, Wessely R, Dirschinger J, Schomig A; ISAR-DIABETES Study Investigators. Paclitaxel-eluting or sirolimus-eluting stents to prevent restenosis in diabetic patients. N Engl J Med. 2005 Aug 18;353(7):663-70. doi: 10.1056/NEJMoa044372. Epub 2005 Aug 16.

ReferenceCitation: Stone GW, Midei M, Newman W, Sanz M, Hermiller JB, Williams J, Farhat N, Mahaffey KW, Cutlip DE, Fitzgerald PJ, Sood P, Su X, Lansky AJ; SPIRIT III Investigators. Comparison of an everolimus-eluting stent and a paclitaxel-eluting stent in patients with coronary artery disease: a randomized trial. JAMA. 2008 Apr 23;299(16):1903-13. doi: 10.1001/jama.299.16.1903.

ReferenceCitation: Mahmud E, Ormiston JA, Turco MA, Popma JJ, Weissman NJ, O'Shaughnessy CD, Mann T, Hall JJ, McGarry TF, Cannon LA, Webster MW, Mandinov L, Baim DS. TAXUS Liberte attenuates the risk of restenosis in patients with medically treated diabetes mellitus: results from the TAXUS ATLAS program. JACC Cardiovasc Interv. 2009 Mar;2(3):240-52. doi: 10.1016/j.jcin.2008.12.009.

ReferenceCitation: Serruys PW, Ruygrok P, Neuzner J, Piek JJ, Seth A, Schofer JJ, Richardt G, Wiemer M, Carrie D, Thuesen L, Boone E, Miquel-Herbert K, Daemen J. A randomised comparison of an everolimus-eluting coronary stent with a paclitaxel-eluting coronary stent:the SPIRIT II trial. EuroIntervention. 2006 Nov;2(3):286-94.

ReferenceCitation: Grube E, Chevalier B, Guagliumi G, Smits PC, Stuteville M, Dorange C, Papeleu P, Kaul U, Dzavik V. The SPIRIT V diabetic study: a randomized clinical evaluation of the XIENCE V everolimus-eluting stent vs the TAXUS Liberte paclitaxel-eluting stent in diabetic patients with de novo coronary artery lesions. Am Heart J. 2012 May;163(5):867-875.e1. doi: 10.1016/j.ahj.2012.02.006. Epub 2012 Apr 11.

ReferenceCitation: Garcia-Garcia HM, McFadden EP, Farb A, Mehran R, Stone GW, Spertus J, Onuma Y, Morel MA, van Es GA, Zuckerman B, Fearon WF, Taggart D, Kappetein AP, Krucoff MW, Vranckx P, Windecker S, Cutlip D, Serruys PW; Academic Research Consortium. Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document. Eur Heart J. 2018 Jun 14;39(23):2192-2207. doi: 10.1093/eurheartj/ehy223.

repository_institution: University of Bern - Bern Open Repository and Information System

publisher_dissemination: Oxford University Press

ReferenceCitation: Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; Executive Group on behalf of the Joint European Society of Cardiology (ESC)/American College of Cardiology (ACC)/American Heart Association (AHA)/World Heart Federation (WHF) Task Force for the Universal Definition of Myocardial Infarction. Fourth Universal Definition of Myocardial Infarction (2018). J Am Coll Cardiol. 2018 Oct 30;72(18):2231-2264. doi: 10.1016/j.jacc.2018.08.1038. Epub 2018 Aug 25. No abstract available.

oa_colors: green hybrid

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

repository_institution: Imperial College London - Spiral

ReferenceCitation: Lansky AJ, Messe SR, Brickman AM, Dwyer M, van der Worp HB, Lazar RM, Pietras CG, Abrams KJ, McFadden E, Petersen NH, Browndyke J, Prendergast B, Ng VG, Cutlip DE, Kapadia S, Krucoff MW, Linke A, Moy CS, Schofer J, van Es GA, Virmani R, Popma J, Parides MK, Kodali S, Bilello M, Zivadinov R, Akar J, Furie KL, Gress D, Voros S, Moses J, Greer D, Forrest JK, Holmes D, Kappetein AP, Mack M, Baumbach A. Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials: An Academic Research Consortium Initiative. J Am Coll Cardiol. 2017 Feb 14;69(6):679-691. doi: 10.1016/j.jacc.2016.11.045.

ReferenceCitation: Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. No abstract available.

ipd_sharing: No

lead_sponsor: Concept Medical Inc.

location_country:
Germany
Ireland
Poland
Australia
Brazil
Czechia
France
Switzerland
India
Belgium
Malaysia
Italy
United Kingdom
Singapore
Netherlands
Austria
Mexico
Korea, Republic of
Bangladesh
Taiwan
Sweden

location_facility: Szpital Kliniczny Przemienienia Pańskiego

location_facility: Oddział Kardiologii Szpitale Polskie Sztum

location_facility: University Hospital Královské Vinohrady, Department of Medecine Cardiology

location_facility: XII Oddział Kardiologiczny PAKS w Bełchatowie

location_facility: X Department of Invasive Cardiology, Tychy American Heart of Poland SA

location_facility: INSTITUTO DO CORAÇÃO - InCor University of São Paulo Medical School

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Policlinico Umberto I, "Sapienza" University of Rome Dept.of Cardiovascular, Respiratory, Nephrologic & Anesthesiologic Sciences

location_facility: Kerckhoff-Klinik GmbH Abteilung Kardiologie/Herzchirurgie

location_facility: National Heart Foundation Hospital & Research Institute

location_facility: Brighton & Sussex University NHS Hospitals Trust

location_facility: Department of Interventional Cardiology Med-Pro American Heart of Poland

location_facility: Instituto Dante Pazzanese de Cardiologia

location_facility: Schwarzwald Baar Klinikum Villingen-Schwenningen GmbH

location_facility: Charite Berlin, Department of Cardiology, Campus Benjamin Franklin

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Örebro Univ. Hospital, Dpt. of cardiology

location_facility: National University of Ireland, Galway Galway University Hospital

location_facility: Instituto nacional de cardiologia ignacio chavez

location_facility: Zgierskie Centrum Kardiologii Med-Pro Polsko-Amerykańskie Kliniki Serca

location_facility: Worcestershire Acute NHS Trust, Worcestershire Royal Hospital

location_facility: Polsko-Amerykańskie Kliniki Serca III Oddział Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii

location_facility: Division of Cardiology, University of Campania "Luigi Vanvitelli"

location_facility: Grupo Intervención San Luis - Hospital de Especialidades de la Salud - San Luis Potosí City

location_facility: Groupe Hospitalier Mutualiste de Grenoble

location_facility: Nyskie Centrum Kardiologiczne Polsko-Amerykańskich Klinik Serca w Nysie

location_facility: Helios Amper-Klinikum Dachau, Dept. of Cardiology & Pneumology

location_facility: UKSH, Campus Kiel, Department of Cardiology

location_facility: Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii w Pińczowie

location_facility: Antwerp Cardiovascular Center Middelheim

location_facility: Klinik für Kardiologie und Angiologie II, Herz-Zentrum Bad Krozingen

location_facility: University Hospital Brno, Department of Medecine Cardiology

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Multicenter International Observational Study to Identify eGFR Trajectories and Their Determinants, and to Build a Multidimensional Prediction System to Predict the Probabilities of Belonging to eGFR Trajectories

acronym: TRAJAKT

summary:
The gold standard for characterizing chronic kidney disease (CKD) is the glomerular filtration rate (GFR), which is commonly estimated in both native and transplanted kidneys for patient monitoring and therapeutic management and ultimately guides decision-making about whether a patient needs renal replacement therapy. In particular, the National Kidney Foundation has defined CKD stages according to estimated GFR (eGFR) values and in several studies, the eGFR slope or change has been found to be strongly associated with end stage renal disease (ESRD).

However, little is known about the heterogeneity of eGFR evolution in time - i.e. eGFR trajectories - and the related progression to ESRD and death. To date, no studies have investigated eGFR trajectories in diversified cohorts and populations worldwide, although this approach could provide a better understanding of CKD evolution and hence improve risk stratification. In addition, determinants of eGFR trajectories remain poorly described.

An unsupervised approach could allow examining eGFR trajectories over time and could lead to the identification of patient groups according to the probability of the progression of their kidney disease.

Therefore, this study aims:

To identify the long-term eGFR trajectories after kidney transplantation using latent class mixed models;
To identify the clinical, immunological, histological and functional determinants of the eGFR trajectories using multinomial regressions;
To investigate the associations of the eGFR trajectories with the progression to ESRD and death.

Based on the results, the investigators will provide an easily accessible tool to calculate personalized probabilities of belonging to eGFR trajectories after kidney transplantation, by using datasets from prospective cohorts and post hoc analysis of randomized control trial datasets.

status: Unknown status

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: Paris Translational Research Center for Organ Transplantation

location_country:
United States
Croatia
Belgium
France

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Department of Transplantation, Nephrology and Clinical Immunology, Hôpital Foch

location_facility: Nephrology Dialysis Transplantation Department, University of Lorraine, Centre Hospitalier Universitaire de Nancy

location_facility: Department of Nephrology and Organ Transplantation, Centre Hospitalier Universitaire Rangueil

location_facility: Department of Surgery, Johns Hopkins University School of Medicine

location_facility: Albert Einstein College of Medicine, Renal Division Montefiore Medical Center, Kidney Transplantation Program

location_facility: Department of Nephrology, Arterial Hypertension, Dialysis and Transplantation, University Hospital Centre Zagreb, School od Medicine University of Zagreb

location_facility: Virginia Commonwealth University School of Medicine

location_facility: Bretonneau Hospital, Nephrology and Immunology Department

location_facility: Department of Nephrology and Renal Transplantation, University Hospitals Leuven

location_facility: Kidney Transplant Department, Necker Hospital, Assistance Publique - Hôpitaux de Paris

location_facility: Department of Nephrology, Centre Hospitalier Universitaire de Montpellier

location_facility: William J. von Liebig Center for Transplantation and Clinical Regeneration, Mayo Clinic

location_facility: Department of Medicine, Division of Nephrology, Comprehensive Transplant Center, Cedars Sinai Medical Center

location_facility: Kidney Transplant Department, Saint-Louis Hospital, Assistance Publique - Hôpitaux de Paris

status_simplified: Unknown


title: Treatment of Symptoms Associated With Vulvovaginal Atrophy in Postmenopausal Women by Hyaluronic Acid Injection Into the Vaginal Mucosa

acronym: SYLIVA

summary: DESIRIAL® is a CE-marketed hyaluronic acid gel intented to rehydrate vaginal and vestibular mucous membranes by mucosal injections. In this study, 121 postmenopausal women of minimum age 45 with symptoms associated with vulvovaginal atrophy, refusing estrogen therapies for treatment of symptoms or with contraindications for such therapies, with at least one moderate to severe vulvovaginal symptom among dryness sensation, dyspareunia, itching / irritation and pain, who have given her informed consent and met all the eligibility criteria, will be enrolled. Patients will randomly receive 1 injection of DESIRIAL® or placebo (ratio 2:1) in the vaginal mucosa at Day 0. If still eligible 12 weeks after, patients receiving placebo at Day 0 will be treated with DESIRIAL®. Patients will come to a total of 6 to 8 visits depending on the product injected at Day 0 over a period of 11 up to 12 months. Phone interview will be performed between 3 and 5 days after injection. Variation of vulvovaginal symptomatology, sexual function, vaginal pH and safety will be assessed.

lead_sponsor: Laboratoires Vivacy

location_country: Belgium France

location_facility:
Clinique Georges V
Cabinet Dr Ali Bennani
Gynaecologisch Centrum
Cabinet de Gynécologie
Cabinet Gynécologie Obstétrique
Cabinet de gynécologie
Gynecology private office
CHRU Jeanne de Flandres
Polyclinique de l'Atlantique
Gynaecologie Dr Deniz Gulcan
MIRHA

status_simplified: Completed


title: A Phase III Clinical Trial of Intra-arterial TheraSphere® in the Treatment of Patients With Unresectable Hepatocellular Carcinoma (HCC)

acronym: STOP-HCC

summary: The safety and effectiveness of TheraSphere will be evaluated in patients with unresectable hepatocellular carcinoma in whom treatment with standard-of-care sorafenib is planned. All patients receive the standard-of-care sorafenib with or without the addition of TheraSphere.

ReferenceCitation: Chauhan N, Bukovcan J, Boucher E, Cosgrove D, Edeline J, Hamilton B, Kulik L, Master F, Salem R. Intra-Arterial TheraSphere Yttrium-90 Glass Microspheres in the Treatment of Patients With Unresectable Hepatocellular Carcinoma: Protocol for the STOP-HCC Phase 3 Randomized Controlled Trial. JMIR Res Protoc. 2018 Aug 15;7(8):e11234. doi: 10.2196/11234.

evidence: oa repository (semantic scholar lookup)

repositories_concat: PubMed Central;pdfs.semanticscholar.org

publisher_dissemination: JMIR Publications

lead_sponsor: Boston Scientific Corporation

sponsor_collaborators:
Boston Scientific Corporation
Biocompatibles UK Ltd

location_country:
Germany
Italy
United Kingdom
Singapore
Netherlands
Belgium
United States
Korea, Republic of
Spain
Canada
France

location_facility: Servicio de Radiología, Hospital Universitario Virgen de la Arrixaca.

location_facility: McGill University Health Centre / Royal Victoria Hospital

location_facility: Banner - University Medical Center Phoenix

location_facility: Universitätsklinikum Tübingen, Diagnostische und Interventionelle Radiologie

location_facility: Keimyung University Dongsan Medical Center

location_facility: University College London Cancer Institute

location_facility: Hospital Universitario y Politecnico La Fe

location_facility: Seattle Cancer Care Alliance/University of Washington Medical Center

location_facility: Azienda Ospedaliero -Universitaria di Bologna

location_facility: Universitätsklinikum Leipzig, Klinik für Diagnostische und Interventionelle Radiologie

location_facility: Hosptal Universitario Central de Asturias (nuevo HUCA)

location_facility: Hospital Clínico Universitario Lozano Blesa

location_facility: Hospital Clínico Universitario de Valladolid


acronym: CONSIGN

lead_sponsor: Bayer

summary:
This is a phase III B, prospective, interventional, open-label, single-arm, multicenter study to provide regorafenib to subjects diagnosed with metastatic colorectal cancer who have failed after standard therapy and for whom no therapy alternatives exist, in the time between positive results and approval / availability on the market, and to collect safety data for regorafenib until market access.

Regorafenib is an oral (i.e. taken by mouth) multi-targeted kinase inhibitor. A kinase inhibitor targets certain key proteins that are essential for the survival of the cancer cell. By specifically targeting these proteins, regorafenib may stop cancer growth. The growth of the tumor may be decreased by preventing these specific proteins from functioning.

The primary endpoint of this study will be safety.

ReferenceCitation: Van Cutsem E, Martinelli E, Cascinu S, Sobrero A, Banzi M, Seitz JF, Barone C, Ychou M, Peeters M, Brenner B, Hofheinz RD, Maiello E, Andre T, Spallanzani A, Garcia-Carbonero R, Arriaga YE, Verma U, Grothey A, Kappeler C, Miriyala A, Kalmus J, Falcone A, Zaniboni A. Regorafenib for Patients with Metastatic Colorectal Cancer Who Progressed After Standard Therapy: Results of the Large, Single-Arm, Open-Label Phase IIIb CONSIGN Study. Oncologist. 2019 Feb;24(2):185-192. doi: 10.1634/theoncologist.2018-0072. Epub 2018 Sep 6.

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

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

repositories:
HAL
PubMed Central
www.repositoriosalud.es

status: No longer available

title: An Open-label Phase IIIb Study of Regorafenib in Patients With Metastatic Colorectal Cancer (CRC) Who Have Progressed After Standard Therapy

type: EudraCT Number

location_country:
Finland
Germany
Ireland
Poland
Australia
Czechia
Canada
France
Portugal
Hungary
Denmark
Switzerland
United States
Belgium
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Mexico
Spain
Greece
Russian Federation
Israel

study_type: Expanded Access


lead_sponsor: UNICANCER

summary: This is a multicentric randomized phase III trial comparing adjuvant chemotherapy with gemcitabine versus 5-fluorouracil, leucovorin, irinotecan and oxaliplatin (mFolfirinox) in patients with resected pancreatic adenocarcinoma.

ReferenceCitation: Conroy T, Castan F, Lopez A, Turpin A, Ben Abdelghani M, Wei AC, Mitry E, Biagi JJ, Evesque L, Artru P, Lecomte T, Assenat E, Bauguion L, Ychou M, Bouche O, Monard L, Lambert A, Hammel P; Canadian Cancer Trials Group and the Unicancer-GI-PRODIGE Group. Five-Year Outcomes of FOLFIRINOX vs Gemcitabine as Adjuvant Therapy for Pancreatic Cancer: A Randomized Clinical Trial. JAMA Oncol. 2022 Nov 1;8(11):1571-1578. doi: 10.1001/jamaoncol.2022.3829. Erratum In: JAMA Oncol. 2023 Jan 1;9(1):151.

oa_host_type: repository

unpaywall_oa_status: green

publisher_dissemination: American Medical Association

ReferenceCitation: Conroy T, Hammel P, Hebbar M, Ben Abdelghani M, Wei AC, Raoul JL, Chone L, Francois E, Artru P, Biagi JJ, Lecomte T, Assenat E, Faroux R, Ychou M, Volet J, Sauvanet A, Breysacher G, Di Fiore F, Cripps C, Kavan P, Texereau P, Bouhier-Leporrier K, Khemissa-Akouz F, Legoux JL, Juzyna B, Gourgou S, O'Callaghan CJ, Jouffroy-Zeller C, Rat P, Malka D, Castan F, Bachet JB; Canadian Cancer Trials Group and the Unicancer-GI-PRODIGE Group. FOLFIRINOX or Gemcitabine as Adjuvant Therapy for Pancreatic Cancer. N Engl J Med. 2018 Dec 20;379(25):2395-2406. doi: 10.1056/NEJMoa1809775.

publisher_dissemination: Massachusetts Medical Society

sponsor_collaborators:
UNICANCER
Canadian Cancer Trials Group

location_facility: The Royal Victoria Hospital - Cancer Care Program

location_facility: Centre Hospitalier Universitaire de Sherbrooke

location_facility: Juravinski Cancer centre at Hamilton Health Sciences

location_facility: Saskatoon Cancer Centre, University of Saskatchewan

location_facility: Fondation Ambroise Paré / Hôpital Européen

location_facility: General Surgery - TGH Site, Univ. Health Network

location_facility: Algoma District Cancer Program, Sault Area Hospital

location_facility: CancerCare Manitoba, St. Boniface General Hospital

location_facility: Department of Medical Oncology Health Sciences North

location_facility: Cancer Centre of Southeastern Ontario at Kingston General Hospital

location_facility: McGill University (Department of Oncology)

title: Multicentric Randomized Phase III Trial Comparing Adjuvant Chemotherapy With Gemcitabine Versus 5-fluorouracil, Leucovorin, Irinotecan and Oxaliplatin (mFolfirinox) in Patients With Resected Pancreatic Adenocarcinoma

type: Other Identifier

location_country: Canada France


title: Medtronic Product Surveillance Registry

acronym: PSR

summary: The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products. The Registry data is intended to benefit and support interests of patients, hospitals, clinicians, regulatory bodies, payers, and industry by streamlining the clinical surveillance process and facilitating leading edge performance assessment via the least burdensome approach.

status: Recruiting

ReferenceCitation: Qin D, Filippaios A, Murphy J, Berg M, Lampert R, Schloss EJ, Noone M, Mela T. Short- and Long-Term Risk of Lead Dislodgement Events: Real-World Experience From Product Surveillance Registry. Circ Arrhythm Electrophysiol. 2022 Aug;15(8):e011029. doi: 10.1161/CIRCEP.122.011029. Epub 2022 Aug 4.

evidence: open (via free pdf)

ReferenceCitation: Garg A, Koneru JN, Fagan DH, Stromberg K, Padala SK, El-Chami MF, Roberts PR, Piccini JP, Cheng A, Ellenbogen KA. Morbidity and mortality in patients precluded for transvenous pacemaker implantation: Experience with a leadless pacemaker. Heart Rhythm. 2020 Dec;17(12):2056-2063. doi: 10.1016/j.hrthm.2020.07.035. Epub 2020 Aug 4.

ReferenceCitation: Singh JP, Cha YM, Lunati M, Chung ES, Li S, Smeets P, O'Donnell D. Real-world behavior of CRT pacing using the AdaptivCRT algorithm on patient outcomes: Effect on mortality and atrial fibrillation incidence. J Cardiovasc Electrophysiol. 2020 Apr;31(4):825-833. doi: 10.1111/jce.14376. Epub 2020 Feb 28.

repository_institution: PubMed Central - Europe PMC

ReferenceCitation: Stearns LM, Abd-Elsayed A, Perruchoud C, Spencer R, Hammond K, Stromberg K, Weaver T. Intrathecal Drug Delivery Systems for Cancer Pain: An Analysis of a Prospective, Multicenter Product Surveillance Registry. Anesth Analg. 2020 Feb;130(2):289-297. doi: 10.1213/ANE.0000000000004425.

evidence: open (via page says license)

lead_sponsor: Medtronic

location_country:
Finland
Germany
Ireland
Poland
Argentina
Australia
Brazil
Japan
Czechia
Canada
Serbia
France
Colombia
Portugal
Slovakia
Hungary
Hong Kong
Denmark
Switzerland
United States
India
Belgium
China
Malaysia
Puerto Rico
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
Israel


title: LUX-Lung 8: A Randomized, Open-label Phase III Trial of Afatinib Versus Erlotinib in Patients With Advanced Squamous Cell Carcinoma of the Lung as Second-line Therapy Following First-line Platinum-based Chemotherapy

summary: This randomised, open-label phase III trial will be performed in patients with advanced squamous cell carcinoma of the lung requiring second-line treatment after receiving first-line platinum-based chemotherapy. The primary objective of this trial is to compare the efficacy of BIBW 2992 to erlotinib as second-line treatment in this group of patients.

ReferenceCitation: Lu S, Li W, Zhou C, Hu CP, Qin S, Cheng G, Feng J, Wang J, Cseh A, Peil B, Gibson N, Ehrnrooth E, Zhang L. Afatinib vs erlotinib for second-line treatment of Chinese patients with advanced squamous cell carcinoma of the lung. Onco Targets Ther. 2018 Nov 30;11:8565-8573. doi: 10.2147/OTT.S161506. eCollection 2018.

ReferenceCitation: Goss GD, Felip E, Cobo M, Lu S, Syrigos K, Lee KH, Goker E, Georgoulias V, Li W, Guclu S, Isla D, Min YJ, Morabito A, Ardizzoni A, Gadgeel SM, Fulop A, Buhnemann C, Gibson N, Kramer N, Solca F, Cseh A, Ehrnrooth E, Soria JC. Association of ERBB Mutations With Clinical Outcomes of Afatinib- or Erlotinib-Treated Patients With Lung Squamous Cell Carcinoma: Secondary Analysis of the LUX-Lung 8 Randomized Clinical Trial. JAMA Oncol. 2018 Sep 1;4(9):1189-1197. doi: 10.1001/jamaoncol.2018.0775.

repositories_concat: PubMed Central;www.repositoriosalud.es

ReferenceCitation: Gadgeel S, Goss G, Soria JC, Felip E, Georgoulias V, Lu S, Cobo M, Syrigos K, Lee KH, Goker E, Guclu SZ, Isla D, Morabito A, Dupuis N, Buhnemann C, Kramer N, Solca F, Ehrnrooth E, Ardizzoni A. Evaluation of the VeriStrat(R) serum protein test in patients with advanced squamous cell carcinoma of the lung treated with second-line afatinib or erlotinib in the phase III LUX-Lung 8 study. Lung Cancer. 2017 Jul;109:101-108. doi: 10.1016/j.lungcan.2017.05.010. Epub 2017 May 11.

repository_institution: INFN Catania - INFM-OAR

repository_normalized: Zenodo

repositories_concat: Zenodo

ReferenceCitation: Soria JC, Felip E, Cobo M, Lu S, Syrigos K, Lee KH, Goker E, Georgoulias V, Li W, Isla D, Guclu SZ, Morabito A, Min YJ, Ardizzoni A, Gadgeel SM, Wang B, Chand VK, Goss GD; LUX-Lung 8 Investigators. Afatinib versus erlotinib as second-line treatment of patients with advanced squamous cell carcinoma of the lung (LUX-Lung 8): an open-label randomised controlled phase 3 trial. Lancet Oncol. 2015 Aug;16(8):897-907. doi: 10.1016/S1470-2045(15)00006-6. Epub 2015 Jul 5.

lead_sponsor: Boehringer Ingelheim

location_country:
Germany
Ireland
Argentina
Turkey
Chile
Canada
France
Portugal
Hungary
Denmark
United States
India
China
Italy
United Kingdom
Singapore
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan

location_facility: The Catholic University of Korea, St.Vincent's Hospital

location_facility: General Hospital of Chest Diseases Sotiria

location_facility: The Ohio State University Wexner Medical Center

location_facility: Ege Universitesi Tip Fakultesi Tibbi Onkoloji Bilim Dali

location_facility: Ospedale Molinette, AO Città della Salute e della

location_facility: Xiangya Hospital, Central South University

location_facility: SMZ Baumgartner Hoehe Otto Wagner Spital

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: West Jefferson General Hospital and Cancer Clinic

location_facility: CHUC - Centro Hospitalar e Universitário de Coimbra, EPE

location_facility: "Hippokratio" Hospital of Athens, 2nd Internal Medicine Clin

location_facility: University Hospital of Larisa, Oncology Clinic

location_facility: The Catholic University of Korea, Seoul St.Mary's Hospital

location_facility: Pulmonology Institute of Veszprem County, Farkasgyepu

location_facility: Institute of Chest Diseases Csongrad County,Dpt. Pulmonology

location_facility: Lung Hospital of Matra, Dept. Pulmonology

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: Johns Hopkins Singapore International Medical Centre

location_facility: Gaziantep Univ. Tip Fakultesi Tibbi Onkoloji Bilim Dali

location_facility: Aladar Petz County Teaching Hospital, Dept. Pulmonology

location_facility: National Koranyi TBC and Pulm. Internal Med. Clinic

location_facility: Centro Hemato-Oncologico Privado de Toluca S.A. de C.V.

location_facility: Pest County Lung Hospital, Department No. 3

location_facility: Oncology Hematology Associates of Norhtern Pennsylvania, PC

location_facility: Centro Internacional de Estudios Clinicos - CIEC

location_facility: P.O. Bellaria IRCCS Istituto delle scienze Neurologiche di Bologna

location_facility: Washington University School of Medicine

location_facility: Seoul National University Bundang Hospital

location_facility: Hospital Regional Universitario de Málaga

location_facility: B. P .Poddar Hospital & Medical Research Ltd.

location_facility: University of Pecs, 1st internal Med. Dept., Pulmonology

location_facility: Instituto de Terapias Oncologicas Providencia

location_facility: Koo Foundation Sun Yet-Sen Cancer Center

location_facility: St. Antonius ziekenhuis, locatie Nieuwegein

location_facility: Montreal General Hospital - McGill University Health Centre

location_facility: Maidstone Hospital, Kent Oncology Centre

location_facility: Sri Ramachandra Medical College & Research Institute

location_facility: University General Hospital of Heraklion

location_facility: Paris Cancer Center (PCC), Texas Oncology

location_facility: Cancer Center of Cookeville Regional Medical Center

location_facility: Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

location_facility: METC Academisch Ziekenhuis Maastricht/Universiteit van Maastricht

location_facility: Boca Raton Reginl Hospital-Lynn Cancer Institute

location_facility: Uludag Universitesi Tip Fakultesi, Bursa

location_facility: Istituto Nazionale Tumori Fondazione Pascale


title: An Observational, Non-Interventional, Multi-Center, Multi-National Study of Patients With Atypical Hemolytic-Uremic Syndrome (aHUS Registry)

summary: Post-marketing safety data on patients treated and untreated with eculizumab or ravulizumab.

time_perspective: Other

ReferenceCitation: Halimi JM, Al-Dakkak I, Anokhina K, Ardissino G, Licht C, Lim WH, Massart A, Schaefer F, Walle JV, Rondeau E. Clinical characteristics and outcomes of a patient population with atypical hemolytic uremic syndrome and malignant hypertension: analysis from the Global aHUS registry. J Nephrol. 2023 Apr;36(3):817-828. doi: 10.1007/s40620-022-01465-z. Epub 2022 Sep 24.

repository_institution: Ghent University - Ghent University Academic Bibliography

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

repository_normalized: irua

repositories:
PubMed Central
archive.ugent.be
irua

repositories_concat: PubMed Central;archive.ugent.be;irua

ReferenceCitation: Woodward L, Johnson S, Walle JV, Beck J, Gasteyger C, Licht C, Ariceta G; aHUS Registry SAB. An innovative and collaborative partnership between patients with rare disease and industry-supported registries: the Global aHUS Registry. Orphanet J Rare Dis. 2016 Nov 21;11(1):154. doi: 10.1186/s13023-016-0537-5.

repositories_concat: PubMed Central;archive.ugent.be

ReferenceCitation: Licht C, Ardissino G, Ariceta G, Cohen D, Cole JA, Gasteyger C, Greenbaum LA, Johnson S, Ogawa M, Schaefer F, Vande Walle J, Fremeaux-Bacchi V. The global aHUS registry: methodology and initial patient characteristics. BMC Nephrol. 2015 Dec 10;16:207. doi: 10.1186/s12882-015-0195-1.

repository_institution: Heidelberg University - heiDOK - The Heidelberg Document Repository

repository_institution: Newcastle Univesity - Newcastle University ePrints

ReferenceCitation: Belingheri M, Possenti I, Tel F, Paglialonga F, Testa S, Salardi S, Ardissino G. Cryptic activity of atypical hemolytic uremic syndrome and eculizumab treatment. Pediatrics. 2014 Jun;133(6):e1769-71. doi: 10.1542/peds.2013-2921. Epub 2014 May 19.

ReferenceCitation: Ardissino G, Possenti I, Tel F, Testa S, Paglialonga F. Time to change the definition of hemolytic uremic syndrome. Eur J Intern Med. 2014 Feb;25(2):e29. doi: 10.1016/j.ejim.2013.12.002. Epub 2013 Dec 21. No abstract available.

sponsor_collaborators:
Alexion Pharmaceuticals, Inc.
Syneos Health

location_country:
Germany
Italy
Poland
Israel
United Kingdom
Denmark
Australia
Belgium
United States
Korea, Republic of
Spain
Taiwan
Canada
Russian Federation
France

location_facility:
Clinical Trial Site
Clinical Trial Site 4
Clinical Trial Site 5
Clinical Trial Site (Pediatric)
Clinical Trial Site 7
Clinical Trial Site 2
Clinical Trial Site (Adult)
Clinical Trial Site 1
Clinical Trial Site (pediatric)
Clinical Trial Site 6
Clinical Trial Site (adult)
Clinical Trial Site 3


title: An Observational, Multi-Center, Multi-National, Long Term Follow-Up Study of Atypical Hemolytic Uremic Syndrome (aHUS) Patients Treated With Eculizumab in a Prior Clinical Study

acronym: LTFU

summary: There is growing but limited information on the long term clinical status of aHUS patients who have previously received or are continuing to receive treatment with eculizumab. This study is designed to collect clinical data that will provide insight into the long-term outcomes of patients with aHUS.

status: Terminated

ReferenceCitation: Menne J, Delmas Y, Fakhouri F, Licht C, Lommele A, Minetti EE, Provot F, Rondeau E, Sheerin NS, Wang J, Weekers LE, Greenbaum LA. Outcomes in patients with atypical hemolytic uremic syndrome treated with eculizumab in a long-term observational study. BMC Nephrol. 2019 Apr 10;20(1):125. doi: 10.1186/s12882-019-1314-1.

repository_institution: Université de Lausanne - SERVAL

repositories_institution: Newcastle Univesity - Newcastle University ePrints

repositories_institution: University of Liège - ORBi - Open Repository and Bibliography of the University of Liège

lead_sponsor: Alexion Pharmaceuticals, Inc.

location_country:
Germany
Italy
United Kingdom
Australia
Sweden
Netherlands
Austria
Belgium
Switzerland
United States
Canada
France

location_facility: Providence Sacred Heart Medical Center & Children's Hospital

location_facility: Dunwoody Pediatrics & Children's Healthcare of Atlanta

location_facility: Le Centre Hospitalier Universitaire de Nice

location_facility: Hopital de la Timone Enfants, Unité de Néphrologie

location_facility: Fondazione IRCCS Ca Granda, Ospedale Maggiore Policlinico Maggiore Policlinico

location_facility: CHU-CH Charles Nicolle Pavillon de Pédiatrie

location_facility: Nephrology Clinic, Karolinska University Hospital

location_facility: Hopital Robert-Debré, Service de Néphrologie Pédiatrique

location_facility: Centre Hospitalier Universitaire Pellegrin, Service de Nephrologie Transplantation Dialyse

location_facility: Royal Devon & Exeter NHS Foundation Trust

location_facility: City Hospital, Nottingham University Hospitals, NHS Trust

location_facility: Centre Hospitalier Regional de la Source, Service de nephrologie/hemodialyse

location_facility: Fort Wayne Medical Oncology and Hematology

location_facility: Centre Hospitalier Inter-Communal de Cornouaille

location_facility: Le Kremlin Bicetre Hospital, Nephrology Unit

location_facility: Centre Hospitalier Universitaire (CHU) Sainte-Justine

location_facility: Universitatsklinik fur Innere Medizin Medizinische Universitat Graz

location_facility: INSELSPITAL Universitaetsklinik fuer Kinderheilkunde Kindernephrologie

location_facility: The Methodist Hospital Research Institute

location_facility: Radboud University Nijmegen Medical Centre Nijmegen

location_facility: Universitaetsklinikum Aachen Klinik fuer Nieren- und Hochdruckkrankheiten


title: A Multinational, Randomised, Open-labelled, Parallel Group Four Months Comparison of Twice Daily Biphasic Human Insulin 30 and Thrice Daily Biphasic Insulin Aspart 50 and 70 in Subjects With Type 1 or Type 2 Diabetes

summary: This trial is conducted in Europe. The aim of this trial is to compare the glycaemic control of biphasic insulin aspart (BIAsp) 70 and/or BIAsp 50 with biphasic human insulin (BHI) 30 treatment.

ReferenceCitation: Clements MR, Tits J, Kinsley BT, Rastam J, Friberg HH, Ligthelm RJ. Improved glycaemic control of thrice-daily biphasic insulin aspart compared with twice-daily biphasic human insulin; a randomized, open-label trial in patients with type 1 or type 2 diabetes. Diabetes Obes Metab. 2008 Mar;10(3):229-37. doi: 10.1111/j.1463-1326.2006.00687.x.

lead_sponsor: Novo Nordisk A/S

location_country:
Ireland
United Kingdom
Netherlands
Belgium
France


title: A Multi-National, Prospective, Observational Study in Patients With Unresectable or Metastatic Melanoma

acronym: IMAGE

summary: The purpose of this study is to examine the safety of Ipilimumab and patterns of use in the treatment of unresectable or metastatic melanoma in the post-approval setting

ReferenceCitation: Dalle S, Mortier L, Corrie P, Lotem M, Board R, Arance AM, Meiss F, Terheyden P, Gutzmer R, Buysse B, Oh K, Brokaw J, Le TK, Mathias SD, Scotto J, Lord-Bessen J, Moshyk A, Kotapati S, Middleton MR. Long-term real-world experience with ipilimumab and non-ipilimumab therapies in advanced melanoma: the IMAGE study. BMC Cancer. 2021 May 29;21(1):642. doi: 10.1186/s12885-021-08032-y.

repository_institution: Université de Lille (University Of Lille) - LillOA

repository_normalized: LillOA (Lille Open Archive)

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

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

repositories:
HAL
LillOA (Lille Open Archive)
PubMed Central
ora.ox.ac.uk

repositories_concat: HAL;LillOA (Lille Open Archive);PubMed Central;ora.ox.ac.uk

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

ReferenceCitation: Middleton MR, Dalle S, Claveau J, Mut P, Hallmeyer S, Plantin P, Highley M, Kotapati S, Le TK, Brokaw J, Abernethy AP. Real-world treatment practice in patients with advanced melanoma in the era before ipilimumab: results from the IMAGE study. Cancer Med. 2016 Jul;5(7):1436-43. doi: 10.1002/cam4.717. Epub 2016 Apr 26.

repository_institution: Conselleria de Salut i Consum del Govern de les Illes Balears - Docusalut

lead_sponsor: Bristol-Myers Squibb

location_country:
Germany
Ireland
Poland
Israel
Argentina
United Kingdom
Australia
Switzerland
Austria
Belgium
United States
Spain
Greece
Canada
France

location_facility:
Local Institutio
Local institution
Local Institution
Mid Ohio Onc/Hem, Inc


acronym: Zevalin in patients with Diffuse Large B-cell Lymphoma

lead_sponsor: Spectrum Pharmaceuticals, Inc

summary: The purpose of this study is to evaluate the efficacy and safety of Zevalin compared with observation alone in participants who are in PET-negative complete remission after first-line R-CHOP or R-CHOP like therapy.

location_facility: Oncology Research-Park Nicollet Institute

location_facility: Nuclear Medicine Physician, Jules Bordet Institute

location_facility: Hackensack UMC / John Theurer Cancer Center

location_facility: Department of Haematology Bristol Royal Infirmary

location_facility: The Christie NHS Foundation Trust, The Christie Hospital,

location_facility: Spaarne Ziekenhuis, Internal Medicine/Ocology

location_facility: CH de la Côte Basque, Service d'Hématologie

location_facility: Northwestern University Feinberg School of Medicine

location_facility: St. Luke's Mountain States Tumor Institute (MSTI)

location_facility: York Cancer Center / Cancer Care Associates of York

location_facility: Decatur Memorial Hospital Cancer Care Specialists of Central Illinois

location_facility: Policlinico S Orsola Malpighi, Istituto di Ematologia ''L.e A. Seragnoli''

location_facility: New Ematologia dell'Ospedale "Spedali Civili" di Brescia

location_facility: Azienda Ospedaliera San. Giovanni Battista di Torino, Dipartimento di Oncologia U.O.A Ematologia, Le Molinette,

location_facility: Service d'Hématologie Centre Henri Becquerel

location_facility: Thunder Bay Regional Health Sciences Centre-Regional Cancer Care

location_facility: Centre François Baclesse, Comite Hématologie

location_facility: University Medical Center Radboud Nijmegen

location_facility: The University of Texas M.D. Anderson Cancer Center

location_facility: University Medical Centre Groningen (UMCG)

location_facility: University of Iowa Hospitals and Clinics

title: A Phase 3, Open-label, Multicenter, Randomized Study of Sequential Zevalin (Ibritumomab Tiuxetan) Versus Observation in Patients at Least 60 Years of Age With Newly Diagnosed Diffuse Large B-cell Lymphoma in PET-negative Complete Remission After R-CHOP or R-CHOP-like Therapy

location_country:
Ireland
Italy
Israel
United Kingdom
Australia
Netherlands
Austria
Belgium
United States
Spain
Canada
Puerto Rico
France


title: A Multicenter, Multinational, Observational Study to Collect Information on Safety and to Document the Drug Utilization of Fampyra® When Used In Routine Medical Practice (LIBERATE)

acronym: LIBERATE

summary: The primary objective of the study is to collect additional safety data including the incidence rate of seizure and other specific Adverse Events (AEs) of interest from participants taking Fampyra in routine clinical practice. The secondary objectives of this study are to characterize utilization patterns of Fampyra in routine clinical practice, to assess the effectiveness of risk minimization measures as described in the risk management plan for Fampyra, to assess the change over time in participant self-reported evaluation of the physical and psychological impact of Multiple Sclerosis (MS) while taking Fampyra and to assess the change over time in physician assessment of walking ability in participants taking Fampyra (MS participants only).

ReferenceCitation: Castelnovo G, Gerlach O, Freedman MS, Bergmann A, Sinay V, Castillo-Trivino T, Kong G, Koster T, Williams H, Gafson AR, Killestein J. Safety, Patient-Reported Well-Being, and Physician-Reported Assessment of Walking Ability in Patients with Multiple Sclerosis for Prolonged-Release Fampridine Treatment in Routine Clinical Practice: Results of the LIBERATE Study. CNS Drugs. 2021 Sep;35(9):1009-1022. doi: 10.1007/s40263-021-00840-x. Epub 2021 Jul 28.

lead_sponsor: Biogen

location_country:
Germany
Ireland
Portugal
Israel
Argentina
Norway
Netherlands
Lebanon
United Arab Emirates
Spain
Czechia
Canada
France

location_facility:
Research Site
Site Research
Rsearch Site
Reasearch Center
Research site


acronym: BOOST

lead_sponsor: AGO Study Group

summary: The purpose of this study is to determine whether the early and continuous addition of bevacizumab for up to 30 months to the standard chemotherapy is more effective than the early and continuous addition of bevacizumab for up to 15 months.

ReferenceCitation: Pfisterer J, Joly F, Kristensen G, Rau J, Mahner S, Pautier P, El-Balat A, Kurtz JE, Canzler U, Sehouli J, Heubner ML, Hartkopf AD, Baumann K, Hasenburg A, Hanker LC, Belau A, Schmalfeldt B, Denschlag D, Park-Simon TW, Selle F, Jackisch C, Burges A, Luck HJ, Emons G, Meier W, Gropp-Meier M, Schroder W, de Gregorio N, Hilpert F, Harter P. Optimal Treatment Duration of Bevacizumab as Front-Line Therapy for Advanced Ovarian Cancer: AGO-OVAR 17 BOOST/GINECO OV118/ENGOT Ov-15 Open-Label Randomized Phase III Trial. J Clin Oncol. 2023 Feb 1;41(4):893-902. doi: 10.1200/JCO.22.01010. Epub 2022 Nov 4.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

sponsor_collaborators: Nordic Society of Gynaecological Oncology - Clinical Trials Unit

title: A Prospective Randomised Phase III Trial to Evaluate Optimal Treatment Duration of First-line Bevacizumab in Combination With Carboplatin and Paclitaxel in Patients With Primary Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer

location_country: Finland Germany Norway Denmark Sweden France


lead_sponsor: Janssen Sciences Ireland UC

summary: The purpose of this study is to establish the dose-response relationship for antiviral activity of 3 dose levels of JNJ-73763989+nucleos(t)ide analog (NA) and to evaluate the efficacy of combination regimens of JNJ-73763989+NA (with and without JNJ-56136379) and of JNJ-56136379+NA.

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Universidade Federal da Bahia - Hospital Professor Edgard Santos

location_facility: Tokyo Medical and Dental University Hospital

location_facility: Vancouver ID Research and Care Centre Society

location_facility: CHU de Grenoble - Hopital Albert Michallon

location_facility: Sverdlovsk Regional Clinical Hospital #1

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Johns Hopkins Office of Capital Region Research - Sibley Memorial Hospital

location_facility: University of Alberta - Faculty of Medicine & Dentistry

location_facility: Fundacao de Medicina Tropical Doutor Heitor Vieira Dourado - FMT

location_facility: Neutrum Lekarze M.Hlebowicz i Partnerzy spolka partnerska

location_facility: St. Petersburg City Center for AIDS and Infectious Diseases Treatment and Prophylaxis

location_facility: Clinical Infectious Diseases Hospital n. a. S.P. Botkin

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: Ege University Medical of Faculty, Department of Gastroenterology

location_facility: The Hospital of Hyogo College of Medicine

location_facility: Azienda Ospedaliera Universitaria Policlinico G. Martino

location_facility: St George's, University of London and St George's University Hospitals NHS Foundation Trust

location_facility: Azienda Ospedaliero-Universitaria di Modena, Ospedale di Baggiovara

location_facility: Karadeniz Teknik University Medical Faculty

location_facility: Krasnoyarsk Regional Center For AIDS And Infectious Diseases Treatment And Prophylaxis

location_facility: National Hospital Organization Nagasaki Medical Center

location_facility: Universitätsklinikum Johann Wolfgang Goethe- Universität Frankfurt Medizinische Klinik 1

location_facility: Washington University School of Medicine

location_facility: Universita degli Studi di Roma 'La Sapienza' - Umberto I Policlinico di Roma

location_facility: NHS Greater Glasgow and Clyde - Gartnavel General Hospital

location_facility: Hospital Das Clinicas Da Faculdade De Medicina Da USP

location_facility: Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza w Bydgoszczy

location_facility: Azienda Ospedaliero Universitaria Pisana

title: A Phase 2b, Multicenter, Double-blind, Active-controlled, Randomized Study to Investigate the Efficacy and Safety of Different Combination Regimens Including JNJ-73763989 and/or JNJ-56136379 for the Treatment of Chronic Hepatitis B Virus Infection

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu

location_country:
Germany
Poland
Japan
Brazil
Thailand
Turkey
Czechia
Canada
France
Hong Kong
United States
Belgium
China
Malaysia
Italy
United Kingdom
Korea, Republic of
Spain
Russian Federation

ipd_sharing: Yes


type: Registry Identifier

title: A Phase 3, Multicenter, Randomized, Open-label Trial to Compare the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Lenvatinib (E7080/MK-7902) Versus Docetaxel in Previously Treated Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) and Progressive Disease (PD) After Platinum Doublet Chemotherapy and Immunotherapy (LEAP-008)

summary: This study will evaluate the efficacy and safety of pembrolizumab (MK-3475) with lenvatinib (E7080/MK-7902) vs. docetaxel in participants with metastatic non-small cell lung cancer (NSCLC) and progressive disease (PD) after platinum doublet chemotherapy and treatment with one prior anti-PD-1/PD-L1 monoclonal antibody (mAb). The primary hypotheses of this study are that pembrolizumab + lenvatinib (compared with docetaxel) prolongs: 1) overall survival (OS); and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review (BICR).

ReferenceCitation: Xing P, Wang M, Zhao J, Zhong W, Chi Y, Xu Z, Li J. Study protocol: A single-arm, multicenter, phase II trial of camrelizumab plus apatinib for advanced nonsquamous NSCLC previously treated with first-line immunotherapy. Thorac Cancer. 2021 Oct;12(20):2825-2828. doi: 10.1111/1759-7714.14113. Epub 2021 Aug 18.

ReferenceCitation: Taylor MH, Schmidt EV, Dutcus C, Pinheiro EM, Funahashi Y, Lubiniecki G, Rasco D. The LEAP program: lenvatinib plus pembrolizumab for the treatment of advanced solid tumors. Future Oncol. 2021 Feb;17(6):637-648. doi: 10.2217/fon-2020-0937. Epub 2020 Dec 10.

publisher_dissemination: Future Science Ltd

lead_sponsor: Merck Sharp & Dohme LLC

sponsor_collaborators:
Merck Sharp & Dohme LLC
Eisai Inc.

location_country:
Germany
Italy
Colombia
Portugal
Hungary
Argentina
Israel
Australia
Japan
United Kingdom
United States
Korea, Republic of
Spain
Greece
Canada
Puerto Rico
Russian Federation
France

location_facility: Hopital Europeen Georges Pompidou ( Site 0408)

location_facility: SPb SBHI City Clinical Oncological Dispensary ( Site 0901)

location_facility: Tudogyogyintezet Torokbalint ( Site 0602)

location_facility: Centro Medico Imbanaco de Cali S.A ( Site 1301)

location_facility: The Mass General Cancer Center at Newton-Wellesley ( Site 1692)

location_facility: Memorial Sloan-Kettering Cancer Center ( Site 1661)

location_facility: Ospedale San Gerardo - ASST Monza ( Site 0804)

location_facility: Harry & Jeanette Weinberg Cancer Institute ( Site 1626)

location_facility: GBUZ Republican Clinical Oncological Dispensary ( Site 0922)

location_facility: Veszprem Megyei Tudogyogyintezet ( Site 0607)

location_facility: IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 0808)

location_facility: National Cancer Center Hospital ( Site 0103)

location_facility: A.O. Ospedali Riuniti Villa Sofia - Cervello P.O. Villa Sofia ( Site 0810)

location_facility: Hospital Central de Asturias ( Site 1002)

location_facility: Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 0610)

location_facility: Hospital Universitario 12 de Octubre ( Site 1006)

location_facility: Orszagos Koranyi Pulmonologiai Intezet ( Site 0603)

location_facility: Metropolitan Hospital-4th Oncology Dept ( Site 1700)

location_facility: Comprehensive Blood & Cancer Center [Bakersfield, CA] ( Site 1604)

location_facility: European Interbalkan Medical Center ( Site 1704)

location_facility: Hospital Universitario Puerta de Hierro ( Site 1007)

location_facility: Istittuto Nazionale dei Tumori Regina Elena IRCCS - IFO ( Site 0807)

location_facility: Thompson Cancer Survival Center ( Site 1695)

location_facility: Severance Hospital Yonsei University Health System ( Site 0202)

location_facility: Pavlov First Saint Petersburg State Medical University ( Site 0917)

location_facility: Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 1304)

location_facility: Ad-Vance Medical Research LLC ( Site 2103)

location_facility: Puerto Rico Medical Research Center LLC ( Site 2101)

location_facility: Memorial Sloan-Kettering Cancer Center at Commack ( Site 1662)

location_facility: General Hospital of Chest Diseases "Sotiria" ( Site 1703)

location_facility: Sourasky Medical Center (Ichilov) - Oncology Clinic ( Site 0705)

location_facility: Medstar Good Samaritan Hospital ( Site 1625)

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz ( Site 0606)

location_facility: Chungbuk National University Hospital ( Site 0201)

location_facility: Birmingham Heartlands Hospital ( Site 1103)

location_facility: Kanagawa Cardiovascular and Respiratory Center ( Site 0105)

location_facility: University Hospital Coventry and Warwickshire NHS Trust ( Site 1112)

location_facility: Calvary Central Districts Hospital ( Site 0007)

location_facility: Petz Aladar Megyei Oktato Korhaz ( Site 0609)

location_facility: Policlinico San Matteo - Fondazione IRCCS ( Site 0812)

location_facility: AOU Policlinico Vittorio Emanuele ( Site 0811)

location_facility: Budgetary Healthcare Institution of Omsk Region Clinical Oncology Dispensary-Chemotherapy #1 ( Site

location_facility: Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház ( Site 0601)

location_facility: Hospital Universitario Fundacion Jimenez Diaz ( Site 1005)

location_facility: Evangelisches Krankenhaus Hamm gGmbH ( Site 0504)

location_facility: Orszagos Koranyi Pulmonologiai Intezet ( Site 0608)

location_facility: Seoul National University Bundang Hospital ( Site 0204)

location_facility: Niigata Cancer Center Hospital ( Site 0101)

location_facility: University of Massachusetts Medical School ( Site 1693)

location_facility: Memorial Sloan-Kettering Cancer Center at West Harrison ( Site 1666)

location_facility: University of Kentucky School of Medicine & Hospitals ( Site 1621)

location_facility: Kingston Health Sciences Centre ( Site 1503)

location_facility: Shaare Zedek Medical Center-Oncology ( Site 0706)

location_facility: Princess Alexandra Hospital - Division of Cancer Services ( Site 0002)

location_facility: Azienda Ospedaliera San Giuseppe Moscati ( Site 0809)

location_facility: Princess Margaret Cancer Centre ( Site 1502)

location_facility: Hospital Universitario Quiron Madrid ( Site 1012)

location_facility: Administradora Country SA - Clinica del Country ( Site 1307)

location_facility: Main Military Clinical Hospital n.a. N.N.Burdenko ( Site 0905)

location_facility: Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0918)

location_facility: New York Cancer and Blood Specialists ( Site 1696)

location_facility: Memorial Sloan-Kettering Cancer Center at Middletown ( Site 1665)

location_facility: Memorial Sloan-Kettering Cancer Center At Basking Ridge ( Site 1664)

location_facility: Thoraxklinik Heidelberg gGmbH am Universitaetsklinikum Heidelberg ( Site 0501)

location_facility: Hospital Britanico de Buenos Aires ( Site 2002)

location_facility: St James s University Hospital ( Site 1106)

location_facility: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0903)

location_facility: Kansai Medical University Hospital ( Site 0104)

location_facility: Instituto de Investigaciones Metabolicas ( Site 2004)

location_facility: Centro Hospitalar Lisboa Norte E.P.E. - Hospital Pulido Valente ( Site 1801)

location_facility: Kaiser Permanente Center for Health Research-Kaiser Permanente Medical Center ( Site 1644)

location_facility: Cancer Specialists of North Florida - Fleming Island ( Site 1675)

location_facility: Massachusetts General Hospital ( Site 1622)

location_facility: Hospital Universitari Vall d Hebron ( Site 1004)

location_facility: Southern Medical Day Care Centre ( Site 0001)

location_facility: Hematology and Oncology Institute ( Site 2105)

location_facility: Hospital Universitario Insular de Gran Canaria ( Site 1011)

location_facility: CHU Caen Service de Pneumologie ( Site 0401)

location_facility: Memorial Sloan Kettering Cancer Center - Nassau ( Site 1670)

location_facility: Hospital Universitario Marques de Valdecilla ( Site 1003)

location_facility: Nottingham City Hospital Campus ( Site 1105)

location_facility: Port Macquarie Base Hospital ( Site 0003)

location_facility: North Middlesex University Hospital NHS Trust ( Site 1109)

location_facility: Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 1305)

location_facility: Memorial Sloan-Kettering Cancer Center at Montvale ( Site 1667)

location_facility: Central Clinical Hospital of the Administration of the President ( Site 0910)

location_facility: The Cancer Institute Hospital of JFCR ( Site 0100)

location_facility: Istituto Nazionale dei Tumori ( Site 0806)

location_facility: Centre Hospitalier General - Avignon ( Site 0407)

location_facility: Hospital Clinico de Valencia ( Site 1010)

location_facility: Bozeman Health Deaconness Cancer Center ( Site 1632)

location_facility: Guy s and St Thomas Hospital NHS Foundation Trust ( Site 1102)

location_facility: SRH Wald-Klinikum Gera GmbH ( Site 0503)

location_facility: CHUQ-Univ Laval-Hotel Dieu de Quebec ( Site 1514)

location_facility: London Regional Cancer Program - London HSC ( Site 1505)

location_facility: Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 1800)

location_facility: MGH - North Shore Cancer Center ( Site 1668)

location_facility: University Hospital of Ioannina ( Site 1701)

location_facility: Consorci Hospitalari Mataro ( Site 1008)

location_facility: CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 1501)

location_facility: Azienda Ospedaliera di Perugia ( Site 0805)

location_facility: Hull & East Yorkshire NHS Trust. Castle Hill Hospital ( Site 1108)


lead_sponsor: AbbVie

summary: This study will evaluate the safety, tolerability, and efficacy of ABBV-3067 given alone and in combination with various doses of ABBV-2222 in adults with Cystic Fibrosis who are homozygous for the F508del mutation.

location_facility: Medical University of South Carolina /ID# 212187

location_facility: Unity Health Toronto - St. Michael's Hospital /ID# 212552

location_facility: Institut za zdravstvenu zastitu majke i deteta Srbije Dr Vukan Cupic /ID# 212820

location_facility: Institut universitaire de cardiologie et de pneumologie de Québec - Université L /ID# 212655

location_facility: CHU Nantes - Hopital Laennec /ID# 212897

location_facility: CHU Montpellier - Hôpital Saint Eloi /ID# 212856

location_facility: Nottingham University Hospitals NHS Trust /ID# 212531

location_facility: Universitair Ziekenhuis Leuven /ID# 213050

location_facility: QEII - Health Sciences Centre /ID# 212656

location_facility: Univerzitna nemocnica Bratislava Nemocnica Ruzinov /ID# 213596

location_facility: Nationwide Children's Hospital /ID# 213158

location_facility: University of Iowa Hospitals and Clinics /ID# 212351

location_facility: Chu de Nice-Hopital L'Archet Ii /Id# 212862

location_facility: Cliniques Universitaires de Bruxelles Hopital Erasme /ID# 213413

location_facility: McGill University Health Center Research Institute /ID# 212553

location_facility: Cardiff & Vale University Health Board /ID# 212504

location_facility: Cardinal Glennon Children's Hospital /ID# 212349

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 212665

location_facility: Vanderbilt University Medical Center /ID# 212353

location_facility: Liverpool Heart and Chest Hospital NHS Foundation Trust /ID# 212291

location_facility: Royal Brompton and Harefield Hospitals /ID# 212490

location_facility: Washington University-School of Medicine /ID# 212352

location_facility: CHUM - Centre hospitalier de l'Universite de Montréal /ID# 227815

location_facility: CHU Bordeaux - Hopital Haut Leveque /ID# 212898

location_facility: Universitair Medisch Centrum Utrecht /ID# 212935

location_facility: Univerzitna nemocnica Bratislava Nemocnica Ruzinov /ID# 213146

location_facility: Orszagos Koranyi Pulmonologiai Intezet /ID# 213494

location_facility: CHU de Reims - Hôpital Maison Blanche /ID# 212910

location_facility: Royal Papworth Hospital NHS Foundation Trust /ID# 212507

location_facility: Leeds Teaching Hospitals NHS Trust /ID# 212491

title: A Phase 2 Study of ABBV-3067 Alone and in Combination With ABBV-2222 in Cystic Fibrosis Subjects Who Are Homozygous for the F508del Mutation

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

location_country:
Poland
New Zealand
Slovakia
Hungary
United Kingdom
Netherlands
Belgium
United States
Czechia
Canada
Serbia
France


title: Electronic Assessment of Quality of Life in Patients With Symptomatic Chemotherapy-induced Anaemia: An International Prospective Observational Study (eAQUA)

summary:
This is a multicenter, international, prospective, observational study of patients who are receiving systemic chemotherapy for solid tumour cancers (breast, colorectal, ovarian, prostate, lung, bladder, endometrial, renal, pancreatic, esophageal or gastric) and who are receiving darbepoetin alfa (Aranesp®) or other erythropoiesis-stimulating agent (ESA) to treat symptomatic anaemia.

Quality of Life will be assessed electronically with the aim of estimating improvement in quality of life for those patients receiving darbepoetin alfa (Aranesp®) who also have an increase in haemoglobin (Hb) of ≥1 g/dL

ReferenceCitation: Mouysset JL, Freier B, van den Bosch J, Levache CB, Bols A, Tessen HW, Belton L, Bohac GC, Terwey JH, Tonini G. Hemoglobin levels and quality of life in patients with symptomatic chemotherapy-induced anemia: the eAQUA study. Cancer Manag Res. 2016 Jan 21;8:1-10. doi: 10.2147/CMAR.S88110. eCollection 2016.

lead_sponsor: Amgen

location_country: Germany Italy Poland Romania Netherlands Austria Belgium Greece France


title: An Open-Label Re-Treatment Study With PegInterferon Alfa-2a, Ribavirin and BMS-790052 With or Without BMS-650032 for Subjects With Chronic Hepatitis C

summary: The purpose of this study is to provide anti-hepatitis C virus drugs to patients who received placebo + peginterferon alfa-2a + ribavirin in prior Bristol-Myers Squibb (BMS) studies and determine whether addition of these drugs results in higher cure rates in patients who previously failed therapy. Approximately 100 genotype 1b patients who received placebo in BMS study NCT01428063 (AI447-028) will receive active drugs in this study.

design_allocation: Non-Randomized

location_country:
Germany
Ireland
Poland
New Zealand
Argentina
Australia
Canada
France
Denmark
United States
Italy
United Kingdom
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Sweden

location_facility: North Shore Long Island Jewish Health System

location_facility: Scpmg/ Kaiser Permanente Los Angeles Medical Center

location_facility: University Of Colorado Denver And Hospital

location_facility: Washington University School Of Medicine


title: A Phase III Randomized, Multicenter, Two Arm, Open-label Trial to Evaluate the Efficacy of Trastuzumab Emtansine Compared With Treatment of Physician's Choice in Patients With HER2-positive Metastatic Breast Cancer Who Have Received at Least Two Prior Regimens of HER2 Directed Therapy

summary: This randomized, multicenter, 2-arm, open-label study (TH3RESA) will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) in comparison with treatment of the physician's choice in participants with metastatic or unresectable locally advanced/recurrent human epidermal growth factor receptor 2 (HER2)-positive breast cancer. Eligible participants will be randomized to receive either trastuzumab emtansine 3.6 mg/kg intravenously every 21 days or treatment of the physician's choice. Participants continue to receive study treatment until disease progression or unacceptable toxicity occurs. This study is also known under Roche study protocol number BO25734.

ReferenceCitation: Chen SC, Quartino A, Polhamus D, Riggs M, French J, Wang X, Vadhavkar S, Smitt M, Hoersch S, Strasak A, Jin JY, Girish S, Li C. Population pharmacokinetics and exposure-response of trastuzumab emtansine in advanced breast cancer previously treated with >/=2 HER2-targeted regimens. Br J Clin Pharmacol. 2017 Dec;83(12):2767-2777. doi: 10.1111/bcp.13381. Epub 2017 Sep 3.

ReferenceCitation: Krop IE, Kim SB, Martin AG, LoRusso PM, Ferrero JM, Badovinac-Crnjevic T, Hoersch S, Smitt M, Wildiers H. Trastuzumab emtansine versus treatment of physician's choice in patients with previously treated HER2-positive metastatic breast cancer (TH3RESA): final overall survival results from a randomised open-label phase 3 trial. Lancet Oncol. 2017 Jun;18(6):743-754. doi: 10.1016/S1470-2045(17)30313-3. Epub 2017 May 16.

ReferenceCitation: Krop IE, Kim SB, Gonzalez-Martin A, LoRusso PM, Ferrero JM, Smitt M, Yu R, Leung AC, Wildiers H; TH3RESA study collaborators. Trastuzumab emtansine versus treatment of physician's choice for pretreated HER2-positive advanced breast cancer (TH3RESA): a randomised, open-label, phase 3 trial. Lancet Oncol. 2014 Jun;15(7):689-99. doi: 10.1016/S1470-2045(14)70178-0. Epub 2014 May 2.

lead_sponsor: Hoffmann-La Roche

location_country:
Germany
Poland
Australia
Brazil
Thailand
Canada
France
Czech Republic
Slovakia
Hungary
Switzerland
United States
India
Belgium
Italy
Norway
United Kingdom
Sweden
Korea, Republic of
Spain
Russian Federation
Israel


acronym: ISIS-ICD

summary: ISIS- ICD study has been designed to evaluate the impact of PARAD+ algorithm on inappropriate shocks, in a general population implanted for primary or secondary prevention with a dual or tri chamber device at one year follow-up

ReferenceCitation: Ruiz-Granell R, Dovellini EV, Dompnier A, Khalighi K, Garcia-Campo E, Olivier A, Barcelo A, Ritter P. Algorithm-based reduction of inappropriate defibrillator shock: Results of the Inappropriate Shock Reduction wIth PARAD+ Rhythm DiScrimination-Implantable Cardioverter Defibrillator Study. Heart Rhythm. 2019 Sep;16(9):1429-1435. doi: 10.1016/j.hrthm.2019.03.016. Epub 2019 Mar 22.

lead_sponsor: MicroPort CRM

location_country:
Germany
Italy
United Kingdom
Japan
United States
Spain
France

location_facility: Tokyo Medical and Dental University Hospital

location_facility: Southern California Electrophysiology Associates

location_facility: CHRU du Morvan Hôpital la Cavale Blanche

location_facility: CHU Groupe Hospitalo-universitaire Caremeau

location_facility: Centre Hospitalier Universitaire de La Timone

location_facility: Kardiologische Praxis Dr. med Taggeselle

location_facility: Centre Hospitalier Universitaire D'Amiens

location_facility: Universitatsklinikum Schleswig-Holstein Campus Lübeck

location_facility: Policlinico Consorziale di Bari U.O Cardiologia Universitaria

location_facility: Pitt Memeorial Hospital Heart Rhythm Associates

location_facility: Klinik für Kardiologie Städtisches Klinikum Lüneburg gGmbH


title: A Phase IIB/III Randomized, Double-blind, Placebo Controlled Study Comparing First Line Therapy With or Without TG4010 Immunotherapy Product in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC)

acronym: TIME

summary:
This is a Phase IIb/III randomized, double-blind, placebo-controlled study to compare the efficacy and safety of first-line therapy combined with TG4010 or placebo in stage IV non-small cell lung cancer (NSCLC).

TG4010 is a suspension of recombinant Modified Vaccinia virus strain Ankara (MVA strain) carrying coding sequences for human MUC1 antigen and human interleukin-2 (IL2). TG4010 has been developed for use as an immunotherapy in cancer patients whose tumors express the MUC1 antigen.

TG4010 is intended to induce a MUC1-specific cellular immune response and to produce a non-specific activation of several components of the immune system.

ReferenceCitation: Tosch C, Bastien B, Barraud L, Grellier B, Nourtier V, Gantzer M, Limacher JM, Quemeneur E, Bendjama K, Preville X. Viral based vaccine TG4010 induces broadening of specific immune response and improves outcome in advanced NSCLC. J Immunother Cancer. 2017 Sep 19;5(1):70. doi: 10.1186/s40425-017-0274-x.

publisher_dissemination: British Medical Journal

ReferenceCitation: Quoix E, Lena H, Losonczy G, Forget F, Chouaid C, Papai Z, Gervais R, Ottensmeier C, Szczesna A, Kazarnowicz A, Beck JT, Westeel V, Felip E, Debieuvre D, Madroszyk A, Adam J, Lacoste G, Tavernaro A, Bastien B, Halluard C, Palanche T, Limacher JM. TG4010 immunotherapy and first-line chemotherapy for advanced non-small-cell lung cancer (TIME): results from the phase 2b part of a randomised, double-blind, placebo-controlled, phase 2b/3 trial. Lancet Oncol. 2016 Feb;17(2):212-223. doi: 10.1016/S1470-2045(15)00483-0. Epub 2015 Dec 23.

lead_sponsor: Transgene

location_country:
Germany
Italy
Poland
Hungary
Israel
United Kingdom
Belgium
United States
Spain
France

location_facility: CHU de Clermont-Ferrand, Hopital Gabriel Montpied

location_facility: Kenezy Korhaz-Rendelointezet Eu Szolgaltato Nonprofit Kft

location_facility: Komarom-Esztergom Megyei Onkorm. Szent Borbala Korhaza

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: Abington Hematology Oncology Associates Inc

location_facility: Centre Hospitalier Intercommunal de la Haute Saone

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie

location_facility: Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

location_facility: Institut Paoli-Calmettes, Service d'oncologie médicale

location_facility: Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego

location_facility: Southampton University Hospitals NHS Trust

location_facility: START Madrid. Centro Integral Oncologico Clara Campal

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Orszagos Koranyi TBC es Pulmonologiai Intezet

location_facility: Tolna Megyei Onkormanyzat Balassa Janos Korhaza

location_facility: A.O.U. Senese Policlinico Santa Maria alle Scotte

location_facility: CH Mulhouse Hopital Emile Muller Moenchsberg

location_facility: Centrum Onkologii-Instytut im. M. Sklodowskiej Curie

location_facility: Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza

location_facility: Hôpital Pasteur - Service de médecine F- Pavillon 43

location_facility: Azienda Ospedaliera di Perugia Ospedale S.Maria della Miseri

location_facility: SP Zespol Gruzlicy i Chorob Pluc w Olsztynie