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


N/A
18 Years
75 Years
Open (Enrolling)
Both
Hodgkin Lymphoma, Metastatic Breast Cancer.

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Trial Information

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


- Constitution of the different cohorts and collection of samples Main cohort: de novo
DLBCL at diagnosis Secondary cohorts: Hodgkin's lymphoma, metastatic breast carcinoma
Control cohorts : healthy volunteers (blood donors), patients with immune
thrombocytopenia (ITP)

- Quantification of plasma soluble PD-L1 in the different cohorts

- Study of membrane protein PD-L1 expression on circulating and bone marrow tumor cells
by multiparameter flow cytometry (DLBCL) and Veridex ® technology (breast cancer)

- Study of membrane protein PD-L1 expression on circulating endothelial cells with
Veridex ® technology

- Development of ELISPOT technique to detect extracellular PD-L1 releasing in
supernatants of human cell lines culture (breast carcinoma and hematopoietic cell
lines)

- Sorting circulating tumor cells by immunomagnetic technique and use of the ELISPOT
method to detect soluble PD-L1 in supernatants of culture


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

Inclusion criteria for DBCL patients :

- A biopsy proven diagnosis of 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)

- Not treated,

- HIV negative, HBs negative, HCV negative.

Inclusion criteria for Hodgkin's patients :

- A biopsy proven diagnosis of DLBCL according to the current WHO criteria

Inclusion criteria for metastatic breast cancer or with lymph node involvement :

- A biopsy proven infiltrating lobular or ductal breast carcinoma

- 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).

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,

- HIV positive, HBs positive, HCV positive

- Carcinoma or history of carcinoma except in situ cervical carcinoma.

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

Type of Study:

Observational

Study Design:

Observational Model: Case-Crossover, Time Perspective: Prospective

Outcome Measure:

Description of one or several cells producing soluble PD-L1 in DLBCL, metastatic breast cancer or Hodgkin's lymphoma patients

Outcome Description:

Description of one or several cells producing soluble PD-L1 in DLBCL, metastatic breast cancer or Hodgkin's lymphoma patients

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Thierry Fest, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Rennes University Hospital

Authority:

France: Committee for the Protection of Personnes

Study ID:

2011-A01163-38

NCT ID:

NCT01660776

Start Date:

June 2012

Completion Date:

June 2015

Related Keywords:

  • Hodgkin Lymphoma
  • Metastatic Breast Cancer.
  • DLBCL,
  • Hodgkin lymphoma
  • metastatic breast cancer.
  • Breast Neoplasms
  • Hodgkin Disease
  • Lymphoma

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