Onkoloji ve Hematolojide Biyobelirteç Olarak PD-L1 Proteininin Değerlendirilmesi

Sade dilde özet

Bu çalışma, çeşitli kanser ve kan hastalıklarında PD-L1 proteininin bir biyobelirteç (hastalıkla ilişkili işaret) olarak değerini araştırıyor. Diffüz büyük B hücreli lenfoma gibi doğrulanmış, daha önce tedavi görmemiş 18-75 yaş arası hastalar dahil edilmiştir. Faz uygulanmayan gözlemsel bir çalışmadır ve tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

N/A

Durum

Tamamlandı

Sponsor

Rennes University Hospital

Başlangıç

07.06.2012

Tahmini bitiş

02.10.2019

Ülkeler

France

İlgili genler

Merkezler

• Rennes, France
• Rennes, France
• Marseille, France
• Montpellier, France

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

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