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BMS_PD-L1_onco : Assessment of the PD-L1 Protein as a Biomarker in Oncology and Hematology

CompletedN/A

Sponsor: Rennes University Hospital

Conditions: Diffuse Large B-cell Lymphoma, Hodgkin Lymphoma, Metastatic Breastcancer, Non-small Cell Lung Cancer

Countries: France

Diffuse large B-cell lymphomas (DLBCLs) represent 25 to 30% of adult non-Hodgkin lymphomas in western countries. DLBCLs are aggressive cancer but potentially curable with multi-agent chemotherapy. Whereas R-CHOP regimen has led to a marked improvement in survival, this disease remains a biologically heterogeneous entity. New therapeutic strategies are required including identification of patients' subgroups with different prognostic. This project is based on BMS\_LyTrans and Goelams 075 clinical trial. A study of whole blood transcriptome in 75 DLBCL patients and in 87 controls showed that PD-L1 (CD274) gene was overexpressed in DLBCL patients. Preliminary results demonstrated that PD-L1 is detected in plasma of DLBCL patients with a significantly higher concentration than in controls. This protein was selected as a potential biomarker because of its established role in anti-tumoral immunity. Interaction between PD-L1 and its receptor PD-1 is known to inhibit activation of immune responses by inducing T-lymphocytes anergy and/or apoptosis. Moreover, a direct involvement of PD-L1 in the protection of cancer cells from lysis by activated T lymphocytes has been demonstrated. PD-L1 expression has been described in several solid tumours, including ovary cancer, breast cancer, colon cancer, renal cell carcinoma, non-small cell lung carcinoma and in hematological malignancies such as T-NHL, MM and Hodgkin's lymphoma. Furthermore the expression of PD-L1 by tumour cells is associated with poor prognosis. The blockade of PD-L1/PD-1 axis may represent a novel therapeutic approach in aggressive cancers. These first results incite to identify the cells releasing soluble PD-L1 and to investigate its role in the anti-tumoral immunity in DLBCL patients. The aim of this study is to identify cells producing soluble PD-L1 in DLBCL patients at diagnosis in comparison to others tumours known to express PD-L1 (metastatic breast cancer, Hodgkin's lymphoma, non-small cell lung cancer).

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: Yes

Study type: OBSERVATIONAL

Eligibility 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

Locations (4)

Rennes, Brittanny, France
Rennes, Brittanny, France
Marseille, France
Montpellier, France