{
"info": {
"nct_id": "NCT01660776",
"official_title": "BMS_PD-L1_onco : Assessment of the PD-L1 Protein as a Biomarker in Oncology and Hematology",
"inclusion_criteria": "General inclusion criteria :\n\n* Age ≥ 18 years and ≤ 75 years,\n* Life expectancy more than 4 months\n* Signed informed consent obtained\n* Social security affiliation is mandatory\n* Non previously treated (even by corticotherapy),\n* HIV negative, HBs negative, HCV negative\n\nInclusion criteria for DLBCL patients :\n\n* A biopsy proven diagnosis of de novo DLBCL according to the current WHO criteria,\n* Immunohistochemistry for GCB/nonGC classification according to Hans' algorithm\n* Patients with advanced-stage disease defined as Ann Arbor stages III or IV, or stages I or II with bulky disease (>7cm)\n\nInclusion criteria for non-small cell lung cancer patients :\n\n* A biopsy proven diagnosis of de novo non-small cell lung cancer (all stages) according to the current WHO criteria\n\nInclusion criteria for Hodgkin's lymphoma patients :\n\n* A biopsy proven diagnosis of Hodgkin's lymphoma according to the current WHO criteria\n\nInclusion criteria for metastatic breast cancer or with lymph node involvement :\n\n* A biopsy proven diagnosis infiltrating lobular or ductal breast carcinoma\n* with lymph node involvement or metastasis\n\nInclusion criteria for patients with immune thrombocytopenia (ITP) :\n\n* 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.\n* Bone marrow examination excluding a central aetiology of thrombocytopenia\n\nInclusion criteria for healthy volunteers :\n\n- Inclusion criteria for blood donation according to the Etablissement Français du Sang (EFS) criteria\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
"exclusion_criteria": "General non-inclusion criteria :\n\n* Age < 18 years et > 75 years,\n* Pregnant women,\n* Person legally involved in a case\n* No social security affiliation\n* Signed informed consent not obtained,\n* Preliminary treatment (even corticoid treatment).\n* HIV positive, HBs positive, HCV positive\n\nNon-inclusion criteria for DLBCL patients :\n\n* Lymphoma other than DLBCL,\n* Transformation of a low grade lymphoma to a high grade lymphoma (DLBCL),\n* Extranodal marginal zone lymphoma of MALT lymphoma,\n* Post-transplant lymphoproliferative disorders,\n* Lymphoblastic lymphoma,\n* Burkitt's lymphoma,\n* Carcinoma or history of carcinoma except in situ cervical carcinoma.\n\nNon-inclusion criteria for non-small cell lung cancer patients : None\n\nNon-inclusion criteria for Hodgkin patients :\n\n- Non Hodgkin's lymphoma\n\nNon-inclusion criteria for metastatic breast cancer or with lymph node involvement :\n\n* Carcinoma other than infiltrating lobular or ductal breast carcinoma\n* Chemotherapy in 30 days preceding the inclusion\n* Hormonotherapy in 7 days preceding the inclusion\n* Carcinoma or history of carcinoma except in situ cervical carcinoma.\n* Hemoglobin level < 10g/dl\n\nNon-inclusion criteria for patients with immune thrombocytopenia (ITP) :\n\n- Central aetiology of the thrombocytopenia\n\nNon-inclusion criteria for healthy volunteers :\n\n- Exclusion criteria for blood donation according to the Etablissement Français du Sang (EFS) criteria",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Age ≥ 18 years and ≤ 75 years,",
"criterions": [
{
"exact_snippets": "Age ≥ 18 years and ≤ 75 years",
"criterion": "age",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
},
{
"operator": "<=",
"value": 75,
"unit": "years"
}
]
}
}
]
}
]
},
{
"line": "* Life expectancy more than 4 months",
"criterions": [
{
"exact_snippets": "Life expectancy more than 4 months",
"criterion": "life expectancy",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": ">",
"value": 4,
"unit": "months"
}
}
]
}
]
},
{
"line": "* Signed informed consent obtained",
"criterions": [
{
"exact_snippets": "Signed informed consent obtained",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "signed",
"expected_value": true
}
]
}
]
},
{
"line": "* Social security affiliation is mandatory",
"criterions": [
{
"exact_snippets": "Social security affiliation is mandatory",
"criterion": "social security affiliation",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Non previously treated (even by corticotherapy),",
"criterions": [
{
"exact_snippets": "Non previously treated",
"criterion": "previous treatment",
"requirements": [
{
"requirement_type": "status",
"expected_value": false
}
]
}
]
},
{
"line": "* HIV negative, HBs negative, HCV negative",
"criterions": [
{
"exact_snippets": "HIV negative",
"criterion": "HIV status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "negative"
}
]
},
{
"exact_snippets": "HBs negative",
"criterion": "Hepatitis B surface antigen status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "negative"
}
]
},
{
"exact_snippets": "HCV negative",
"criterion": "Hepatitis C virus status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "negative"
}
]
}
]
},
{
"line": "Inclusion criteria for DLBCL patients :",
"criterions": [
{
"exact_snippets": "DLBCL patients",
"criterion": "DLBCL diagnosis",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* A biopsy proven diagnosis of de novo DLBCL according to the current WHO criteria,",
"criterions": [
{
"exact_snippets": "biopsy proven diagnosis of de novo DLBCL",
"criterion": "de novo DLBCL diagnosis",
"requirements": [
{
"requirement_type": "method of diagnosis",
"expected_value": "biopsy proven"
}
]
},
{
"exact_snippets": "according to the current WHO criteria",
"criterion": "diagnosis criteria",
"requirements": [
{
"requirement_type": "standard",
"expected_value": "current WHO criteria"
}
]
}
]
},
{
"line": "* Immunohistochemistry for GCB/nonGC classification according to Hans' algorithm",
"criterions": [
{
"exact_snippets": "Immunohistochemistry for GCB/nonGC classification according to Hans' algorithm",
"criterion": "GCB/nonGC classification",
"requirements": [
{
"requirement_type": "method",
"expected_value": "Immunohistochemistry"
},
{
"requirement_type": "algorithm",
"expected_value": "Hans' algorithm"
}
]
}
]
},
{
"line": "* Patients with advanced-stage disease defined as Ann Arbor stages III or IV, or stages I or II with bulky disease (>7cm)",
"criterions": [
{
"exact_snippets": "advanced-stage disease defined as Ann Arbor stages III or IV",
"criterion": "disease stage",
"requirements": [
{
"requirement_type": "stage",
"expected_value": [
"III",
"IV"
]
}
]
},
{
"exact_snippets": "stages I or II with bulky disease (>7cm)",
"criterion": "disease stage",
"requirements": [
{
"requirement_type": "stage",
"expected_value": [
"I",
"II"
]
},
{
"requirement_type": "bulky disease",
"expected_value": {
"operator": ">",
"value": 7,
"unit": "cm"
}
}
]
}
]
},
{
"line": "Inclusion criteria for non-small cell lung cancer patients :",
"criterions": [
{
"exact_snippets": "non-small cell lung cancer",
"criterion": "non-small cell lung cancer",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* A biopsy proven diagnosis of de novo non-small cell lung cancer (all stages) according to the current WHO criteria",
"criterions": [
{
"exact_snippets": "biopsy proven diagnosis",
"criterion": "diagnosis method",
"requirements": [
{
"requirement_type": "method",
"expected_value": "biopsy"
}
]
},
{
"exact_snippets": "de novo non-small cell lung cancer",
"criterion": "cancer type",
"requirements": [
{
"requirement_type": "type",
"expected_value": "de novo non-small cell lung cancer"
}
]
},
{
"exact_snippets": "all stages",
"criterion": "cancer stage",
"requirements": [
{
"requirement_type": "stage",
"expected_value": "all stages"
}
]
},
{
"exact_snippets": "according to the current WHO criteria",
"criterion": "diagnosis criteria",
"requirements": [
{
"requirement_type": "criteria",
"expected_value": "current WHO criteria"
}
]
}
]
},
{
"line": "Inclusion criteria for Hodgkin's lymphoma patients :",
"criterions": [
{
"exact_snippets": "Hodgkin's lymphoma patients",
"criterion": "Hodgkin's lymphoma",
"requirements": [
{
"requirement_type": "diagnosis",
"expected_value": true
}
]
}
]
},
{
"line": "* A biopsy proven diagnosis of Hodgkin's lymphoma according to the current WHO criteria",
"criterions": [
{
"exact_snippets": "A biopsy proven diagnosis of Hodgkin's lymphoma",
"criterion": "Hodgkin's lymphoma diagnosis",
"requirements": [
{
"requirement_type": "method",
"expected_value": "biopsy proven"
}
]
},
{
"exact_snippets": "according to the current WHO criteria",
"criterion": "diagnosis criteria",
"requirements": [
{
"requirement_type": "standard",
"expected_value": "current WHO criteria"
}
]
}
]
},
{
"line": "Inclusion criteria for metastatic breast cancer or with lymph node involvement :",
"criterions": [
{
"exact_snippets": "metastatic breast cancer",
"criterion": "breast cancer",
"requirements": [
{
"requirement_type": "stage",
"expected_value": "metastatic"
}
]
},
{
"exact_snippets": "lymph node involvement",
"criterion": "lymph node involvement",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* A biopsy proven diagnosis infiltrating lobular or ductal breast carcinoma",
"criterions": [
{
"exact_snippets": "biopsy proven diagnosis",
"criterion": "diagnosis",
"requirements": [
{
"requirement_type": "method",
"expected_value": "biopsy proven"
}
]
},
{
"exact_snippets": "infiltrating lobular or ductal breast carcinoma",
"criterion": "breast carcinoma type",
"requirements": [
{
"requirement_type": "type",
"expected_value": [
"infiltrating lobular",
"ductal"
]
}
]
}
]
},
{
"line": "* with lymph node involvement or metastasis",
"criterions": [
{
"exact_snippets": "lymph node involvement",
"criterion": "lymph node involvement",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "metastasis",
"criterion": "metastasis",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "Inclusion criteria for patients with immune thrombocytopenia (ITP) :",
"criterions": [
{
"exact_snippets": "patients with immune thrombocytopenia (ITP)",
"criterion": "immune thrombocytopenia (ITP)",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* 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.",
"criterions": [
{
"exact_snippets": "platelet count less than 100 G/L",
"criterion": "platelet count",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": "<",
"value": 100,
"unit": "G/L"
}
}
]
},
{
"exact_snippets": "absence of other causes or disorders that may be associated with thrombocytopenia",
"criterion": "other causes or disorders associated with thrombocytopenia",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Bone marrow examination excluding a central aetiology of thrombocytopenia",
"criterions": [
{
"exact_snippets": "Bone marrow examination",
"criterion": "bone marrow examination",
"requirements": [
{
"requirement_type": "purpose",
"expected_value": "excluding a central aetiology of thrombocytopenia"
}
]
}
]
},
{
"line": "Inclusion criteria for healthy volunteers :",
"criterions": [
{
"exact_snippets": "healthy volunteers",
"criterion": "health status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "healthy"
}
]
}
]
},
{
"line": "- Inclusion criteria for blood donation according to the Etablissement Français du Sang (EFS) criteria",
"criterions": [
{
"exact_snippets": "Inclusion criteria for blood donation according to the Etablissement Français du Sang (EFS) criteria",
"criterion": "blood donation eligibility",
"requirements": [
{
"requirement_type": "guideline",
"expected_value": "Etablissement Français du Sang (EFS) criteria"
}
]
}
]
},
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "healthy"
}
]
}
]
},
{
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
]
}
]
},
{
"line": "Must have maximum age of 75 Years",
"criterions": [
{
"exact_snippets": "maximum age of 75 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 75,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "* Age < 18 years et > 75 years,",
"criterions": [
{
"exact_snippets": "Age < 18 years",
"criterion": "age",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": "<",
"value": 18,
"unit": "years"
}
}
]
},
{
"exact_snippets": "Age ... > 75 years",
"criterion": "age",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 75,
"unit": "years"
}
}
]
}
]
},
{
"line": "* Pregnant women,",
"criterions": [
{
"exact_snippets": "Pregnant women",
"criterion": "pregnancy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Person legally involved in a case",
"criterions": [
{
"exact_snippets": "Person legally involved in a case",
"criterion": "legal involvement",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* No social security affiliation",
"criterions": [
{
"exact_snippets": "No social security affiliation",
"criterion": "social security affiliation",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Signed informed consent not obtained,",
"criterions": [
{
"exact_snippets": "Signed informed consent not obtained",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "signed",
"expected_value": true
}
]
}
]
},
{
"line": "* Preliminary treatment (even corticoid treatment).",
"criterions": [
{
"exact_snippets": "Preliminary treatment (even corticoid treatment)",
"criterion": "preliminary treatment",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* HIV positive, HBs positive, HCV positive",
"criterions": [
{
"exact_snippets": "HIV positive",
"criterion": "HIV status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "positive"
}
]
},
{
"exact_snippets": "HBs positive",
"criterion": "HBs status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "positive"
}
]
},
{
"exact_snippets": "HCV positive",
"criterion": "HCV status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "positive"
}
]
}
]
},
{
"line": "Non-inclusion criteria for DLBCL patients :",
"criterions": [
{
"exact_snippets": "DLBCL patients",
"criterion": "DLBCL diagnosis",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Lymphoma other than DLBCL,",
"criterions": [
{
"exact_snippets": "Lymphoma other than DLBCL",
"criterion": "lymphoma type",
"requirements": [
{
"requirement_type": "exclusion",
"expected_value": "DLBCL"
}
]
}
]
},
{
"line": "* Transformation of a low grade lymphoma to a high grade lymphoma (DLBCL),",
"criterions": [
{
"exact_snippets": "Transformation of a low grade lymphoma to a high grade lymphoma (DLBCL)",
"criterion": "lymphoma transformation",
"requirements": [
{
"requirement_type": "transformation",
"expected_value": "low grade to high grade (DLBCL)"
}
]
}
]
},
{
"line": "* Extranodal marginal zone lymphoma of MALT lymphoma,",
"criterions": [
{
"exact_snippets": "Extranodal marginal zone lymphoma of MALT lymphoma",
"criterion": "extranodal marginal zone lymphoma",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "MALT lymphoma",
"criterion": "MALT lymphoma",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Post-transplant lymphoproliferative disorders,",
"criterions": [
{
"exact_snippets": "Post-transplant lymphoproliferative disorders",
"criterion": "post-transplant lymphoproliferative disorders",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Lymphoblastic lymphoma,",
"criterions": [
{
"exact_snippets": "Lymphoblastic lymphoma",
"criterion": "lymphoblastic lymphoma",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Burkitt's lymphoma,",
"criterions": [
{
"exact_snippets": "Burkitt's lymphoma",
"criterion": "Burkitt's lymphoma",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Carcinoma or history of carcinoma except in situ cervical carcinoma.",
"criterions": [
{
"exact_snippets": "Carcinoma",
"criterion": "carcinoma",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "history of carcinoma",
"criterion": "history of carcinoma",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "in situ cervical carcinoma",
"criterion": "in situ cervical carcinoma",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "Non-inclusion criteria for Hodgkin patients :",
"criterions": [
{
"exact_snippets": "Hodgkin patients",
"criterion": "Hodgkin disease",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "- Non Hodgkin's lymphoma",
"criterions": [
{
"exact_snippets": "Non Hodgkin's lymphoma",
"criterion": "Non Hodgkin's lymphoma",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "Non-inclusion criteria for metastatic breast cancer or with lymph node involvement :",
"criterions": [
{
"exact_snippets": "metastatic breast cancer",
"criterion": "metastatic breast cancer",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "lymph node involvement",
"criterion": "lymph node involvement",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Carcinoma other than infiltrating lobular or ductal breast carcinoma",
"criterions": [
{
"exact_snippets": "Carcinoma other than infiltrating lobular or ductal breast carcinoma",
"criterion": "carcinoma type",
"requirements": [
{
"requirement_type": "exclusion",
"expected_value": [
"infiltrating lobular breast carcinoma",
"ductal breast carcinoma"
]
}
]
}
]
},
{
"line": "* Chemotherapy in 30 days preceding the inclusion",
"criterions": [
{
"exact_snippets": "Chemotherapy in 30 days preceding the inclusion",
"criterion": "chemotherapy",
"requirements": [
{
"requirement_type": "time since last treatment",
"expected_value": {
"operator": "<=",
"value": 30,
"unit": "days"
}
}
]
}
]
},
{
"line": "* Hormonotherapy in 7 days preceding the inclusion",
"criterions": [
{
"exact_snippets": "Hormonotherapy in 7 days preceding the inclusion",
"criterion": "hormonotherapy",
"requirements": [
{
"requirement_type": "time frame",
"expected_value": "7 days preceding the inclusion"
}
]
}
]
},
{
"line": "* Carcinoma or history of carcinoma except in situ cervical carcinoma.",
"criterions": [
{
"exact_snippets": "Carcinoma",
"criterion": "carcinoma",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "history of carcinoma",
"criterion": "history of carcinoma",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "in situ cervical carcinoma",
"criterion": "in situ cervical carcinoma",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Hemoglobin level < 10g/dl",
"criterions": [
{
"exact_snippets": "Hemoglobin level < 10g/dl",
"criterion": "hemoglobin level",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": "<",
"value": 10,
"unit": "g/dl"
}
}
]
}
]
},
{
"line": "Non-inclusion criteria for patients with immune thrombocytopenia (ITP) :",
"criterions": [
{
"exact_snippets": "immune thrombocytopenia (ITP)",
"criterion": "immune thrombocytopenia (ITP)",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "- Central aetiology of the thrombocytopenia",
"criterions": [
{
"exact_snippets": "Central aetiology of the thrombocytopenia",
"criterion": "thrombocytopenia",
"requirements": [
{
"requirement_type": "aetiology",
"expected_value": "central"
}
]
}
]
},
{
"line": "Non-inclusion criteria for healthy volunteers :",
"criterions": [
{
"exact_snippets": "healthy volunteers",
"criterion": "health status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "healthy"
}
]
}
]
},
{
"line": "- Exclusion criteria for blood donation according to the Etablissement Français du Sang (EFS) criteria",
"criterions": [
{
"exact_snippets": "Exclusion criteria for blood donation",
"criterion": "blood donation eligibility",
"requirements": [
{
"requirement_type": "eligibility",
"expected_value": false
}
]
},
{
"exact_snippets": "according to the Etablissement Français du Sang (EFS) criteria",
"criterion": "EFS criteria",
"requirements": [
{
"requirement_type": "compliance",
"expected_value": true
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"line": "General inclusion criteria :",
"criterions": []
}
],
"failed_exclusion": [
{
"line": "General non-inclusion criteria :",
"criterions": []
},
{
"line": "Non-inclusion criteria for non-small cell lung cancer patients : None",
"criterions": []
}
],
"failed_miscellaneous": []
}