BMS_PD-L1BMS_PD-L1_onco : Assessment of the PD-L1 Protein as a Biomarker in Oncology and Hematology
Data Collection
Collected from today forward - ProspectiveBreast Diseases+22
+ Bronchial Neoplasms
+ Carcinoma, Bronchogenic
Case-Crossover
Comparing exposures during disease occurrence and non-occurrence in order to assess the short-term effects of triggers.Summary
Study start date: June 7, 2012
Actual date on which the first participant was enrolled.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
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.105 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Case-Crossover
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.6 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 4 locations
Rennes University Hospital
Rennes, FranceInstitut Paoli Calmette
Marseille, FranceMontpellier University Hospital
Montpellier, France