BMS_PD-L1BMS_PD-L1_onco : Assessment of the PD-L1 Protein as a Biomarker in Oncology and Hematology
Collecte de données
Données recueillies dès le début de l'étude - ProspectiveMaladies du sein+22
+ Néoplasmes bronchiques
+ Carcinome bronchogénique
Cas croisé
Étude centrée sur les variations d'exposition chez un même individu, avec et sans symptômes, pour étudier les effets à court terme.Résumé
Date de début de l'étude : 7 juin 2012
Date à laquelle le premier participant a commencé l'étude.Secondary purposes are : To confirm the presence of plasma soluble form of PD-L1 in others malignancies To study surface expression of PD-L1 on circulating tumour cells with multiparameter fow cytometry and Veridex® technology in DLBCL and metastatic breast cancer patients To study surface expression of PD-L1 on circulating endothelial cells in DLBCL, Hodgkin lymphoma and metastatic breast cancer patients (subpart ended in late 2012) To study surface expression of PD-L1 on different types of leukocytes (monocytes, B and T lymphocytes) To separate circulating tumour cells expressing PD-L1 by immunomagnetic or Cell-sorting method To develop ELISPOT technique to study the release of soluble PD-L1 in culture supernatants of selected cells (subpart ended mid 2013) to evaluate the correlation between the expression of PD-L1 in the plasma and *) the expression of PD-L1 in the tumor, **) the expression of PD-L1 and other molecules in the bronchoalveolar liquid (whenever available from routine) in non-small cell lung cancer to evaluate the response to treatment according to plasma PD-L1 expression in non-small cell lung cancer to evaluate the susceptibility to develop a disease according to the single nucleotide polymorphisms of the PD-L1 gene in DLBCL and non-small cell lung cancer Constitution of the different cohorts and collection of samples Main cohort : de novo DLBCL at diagnosis Secondary cohorts: Hodgkin's lymphoma, metastatic breast cancer, non small cell lung cancer Control cohorts : healthy volunteers (blood donors), patients with immune thrombocytopenia (ITP) Quantification of plasma soluble PD-L1 in the different cohorts
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.105 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Cas croisé
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 18 à 75 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Inclusion Criteria: General inclusion criteria : Age ≥ 18 years and ≤ 75 years, Life expectancy more than 4 months Signed informed consent obtained Social security affiliation is mandatory Non previously treated (even by corticotherapy), HIV negative, HBs negative, HCV negative Inclusion criteria for DLBCL patients : A biopsy proven diagnosis of de novo DLBCL according to the current WHO criteria, Immunohistochemistry for GCB/nonGC classification according to Hans' algorithm Patients with advanced-stage disease defined as Ann Arbor stages III or IV, or stages I or II with bulky disease (>7cm) Inclusion criteria for non-small cell lung cancer patients : A biopsy proven diagnosis of de novo non-small cell lung cancer (all stages) according to the current WHO criteria Inclusion criteria for Hodgkin's lymphoma patients : A biopsy proven diagnosis of Hodgkin's lymphoma according to the current WHO criteria Inclusion criteria for metastatic breast cancer or with lymph node involvement : A biopsy proven diagnosis infiltrating lobular or ductal breast carcinoma with lymph node involvement or metastasis Inclusion criteria for patients with immune thrombocytopenia (ITP) : Primary ITP was defined by the IWG as a platelet count less than 100 G/L in the absence of other causes or disorders that may be associated with thrombocytopenia. Bone marrow examination excluding a central aetiology of thrombocytopenia Inclusion criteria for healthy volunteers : - Inclusion criteria for blood donation according to the Etablissement Français du Sang (EFS) criteria Exclusion Criteria: General non-inclusion criteria : Age < 18 years et > 75 years, Pregnant women, Person legally involved in a case No social security affiliation Signed informed consent not obtained, Preliminary treatment (even corticoid treatment). HIV positive, HBs positive, HCV positive Non-inclusion criteria for DLBCL patients : Lymphoma other than DLBCL, Transformation of a low grade lymphoma to a high grade lymphoma (DLBCL), Extranodal marginal zone lymphoma of MALT lymphoma, Post-transplant lymphoproliferative disorders, Lymphoblastic lymphoma, Burkitt's lymphoma, Carcinoma or history of carcinoma except in situ cervical carcinoma. Non-inclusion criteria for non-small cell lung cancer patients : None Non-inclusion criteria for Hodgkin patients : - Non Hodgkin's lymphoma Non-inclusion criteria for metastatic breast cancer or with lymph node involvement : Carcinoma other than infiltrating lobular or ductal breast carcinoma Chemotherapy in 30 days preceding the inclusion Hormonotherapy in 7 days preceding the inclusion Carcinoma or history of carcinoma except in situ cervical carcinoma. Hemoglobin level < 10g/dl Non-inclusion criteria for patients with immune thrombocytopenia (ITP) : - Central aetiology of the thrombocytopenia Non-inclusion criteria for healthy volunteers : - Exclusion criteria for blood donation according to the Etablissement Français du Sang (EFS) criteria
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.6 groupes d'intervention sont désignés dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Objectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 4 sites
Rennes University Hospital
Rennes, FranceInstitut Paoli Calmette
Marseille, FranceMontpellier University Hospital
Montpellier, France