{
"info": {
"nct_id": "NCT03017573",
"official_title": "Prospective Biobanking Study in Ovarian, Breast, Head and Neck and Cervical Cancer Patients Aiming at Better Understand the Link Between the Molecular Alterations of the Tumor Itself, Its Microenvironment and Immune Response (SCANDARE)",
"inclusion_criteria": "1. Tumor types :\n\n 1. Newly diagnosed treatment-naïve ovarian cancer patients eligible for surgery or neoadjuvant chemotherapy\n 2. Newly diagnosed treatment-naïve triple-negative breast cancer patients eligible for surgery or neoadjuvant chemotherapy\n 3. Newly diagnosed treatment-naïve head and neck cancer patients eligible for surgery\n 4. Newly diagnosed treatment-naïve cervical cancer patients (1) stage Ia - IIa1 with nodal metastasis, postoperative positive margin or parametrial-vaginal involvement, and (2) stage ≥IIa2).\n2. Male or female patients ≥ 18 years of age\n3. Signed informed consent\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "1. Male or female patients ≤18 years old\n2. Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule\n3. Individually deprived of liberty or placed under the authority of a tutor\n4. Patients not affiliated to the Social Security System",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "1. Tumor types :",
"criterions": [
{
"exact_snippets": "Tumor types",
"criterion": "tumor types",
"requirements": [
{
"requirement_type": "N/A",
"expected_value": "N/A"
}
]
}
]
},
{
"line": "1. Newly diagnosed treatment-naïve ovarian cancer patients eligible for surgery or neoadjuvant chemotherapy",
"criterions": [
{
"exact_snippets": "Newly diagnosed ... ovarian cancer",
"criterion": "ovarian cancer diagnosis",
"requirements": [
{
"requirement_type": "status",
"expected_value": "newly diagnosed"
}
]
},
{
"exact_snippets": "treatment-naïve",
"criterion": "treatment history",
"requirements": [
{
"requirement_type": "status",
"expected_value": "treatment-naïve"
}
]
},
{
"exact_snippets": "eligible for surgery",
"criterion": "surgery eligibility",
"requirements": [
{
"requirement_type": "eligibility",
"expected_value": true
}
]
},
{
"exact_snippets": "eligible for ... neoadjuvant chemotherapy",
"criterion": "neoadjuvant chemotherapy eligibility",
"requirements": [
{
"requirement_type": "eligibility",
"expected_value": true
}
]
}
]
},
{
"line": "2. Newly diagnosed treatment-naïve triple-negative breast cancer patients eligible for surgery or neoadjuvant chemotherapy",
"criterions": [
{
"exact_snippets": "Newly diagnosed",
"criterion": "diagnosis status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "newly diagnosed"
}
]
},
{
"exact_snippets": "treatment-naïve",
"criterion": "treatment history",
"requirements": [
{
"requirement_type": "status",
"expected_value": "treatment-naïve"
}
]
},
{
"exact_snippets": "triple-negative breast cancer",
"criterion": "cancer type",
"requirements": [
{
"requirement_type": "type",
"expected_value": "triple-negative breast cancer"
}
]
},
{
"exact_snippets": "eligible for surgery",
"criterion": "surgery eligibility",
"requirements": [
{
"requirement_type": "eligibility",
"expected_value": true
}
]
},
{
"exact_snippets": "eligible for ... neoadjuvant chemotherapy",
"criterion": "neoadjuvant chemotherapy eligibility",
"requirements": [
{
"requirement_type": "eligibility",
"expected_value": true
}
]
}
]
},
{
"line": "3. Newly diagnosed treatment-naïve head and neck cancer patients eligible for surgery",
"criterions": [
{
"exact_snippets": "Newly diagnosed",
"criterion": "diagnosis status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "newly diagnosed"
}
]
},
{
"exact_snippets": "treatment-naïve",
"criterion": "treatment history",
"requirements": [
{
"requirement_type": "status",
"expected_value": "treatment-naïve"
}
]
},
{
"exact_snippets": "head and neck cancer",
"criterion": "cancer type",
"requirements": [
{
"requirement_type": "type",
"expected_value": "head and neck cancer"
}
]
},
{
"exact_snippets": "eligible for surgery",
"criterion": "surgical eligibility",
"requirements": [
{
"requirement_type": "eligibility",
"expected_value": true
}
]
}
]
},
{
"line": "4. Newly diagnosed treatment-naïve cervical cancer patients (1) stage Ia - IIa1 with nodal metastasis, postoperative positive margin or parametrial-vaginal involvement, and (2) stage ≥IIa2).",
"criterions": [
{
"exact_snippets": "Newly diagnosed treatment-naïve cervical cancer patients",
"criterion": "cervical cancer diagnosis",
"requirements": [
{
"requirement_type": "status",
"expected_value": "newly diagnosed"
},
{
"requirement_type": "treatment history",
"expected_value": "treatment-naïve"
}
]
},
{
"exact_snippets": "stage Ia - IIa1",
"criterion": "cervical cancer stage",
"requirements": [
{
"requirement_type": "stage",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1,
"unit": "a"
},
{
"operator": "<=",
"value": 2,
"unit": "a1"
}
]
}
}
]
},
{
"exact_snippets": "nodal metastasis",
"criterion": "nodal metastasis",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "postoperative positive margin",
"criterion": "postoperative positive margin",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "parametrial-vaginal involvement",
"criterion": "parametrial-vaginal involvement",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "stage ≥IIa2",
"criterion": "cervical cancer stage",
"requirements": [
{
"requirement_type": "stage",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "a2"
}
}
]
}
]
},
{
"line": "2. Male or female patients ≥ 18 years of age",
"criterions": [
{
"exact_snippets": "Male or female patients",
"criterion": "gender",
"requirements": [
{
"requirement_type": "presence",
"expected_value": [
"male",
"female"
]
}
]
},
{
"exact_snippets": "≥ 18 years of age",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum age",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
]
}
]
},
{
"line": "3. Signed informed consent",
"criterions": [
{
"exact_snippets": "Signed informed consent",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "signed",
"expected_value": true
}
]
}
]
},
{
"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"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "1. Male or female patients ≤18 years old",
"criterions": [
{
"exact_snippets": "Male or female patients",
"criterion": "gender",
"requirements": [
{
"requirement_type": "presence",
"expected_value": [
"male",
"female"
]
}
]
},
{
"exact_snippets": "≤18 years old",
"criterion": "age",
"requirements": [
{
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 18,
"unit": "years"
}
}
]
}
]
},
{
"line": "2. Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule",
"criterions": [
{
"exact_snippets": "psychological, familial, sociological or geographical condition potentially hampering compliance",
"criterion": "condition hampering compliance",
"requirements": [
{
"requirement_type": "types",
"expected_value": [
"psychological",
"familial",
"sociological",
"geographical"
]
}
]
}
]
},
{
"line": "3. Individually deprived of liberty or placed under the authority of a tutor",
"criterions": [
{
"exact_snippets": "Individually deprived of liberty",
"criterion": "liberty status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "deprived"
}
]
},
{
"exact_snippets": "placed under the authority of a tutor",
"criterion": "authority status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "under authority of a tutor"
}
]
}
]
},
{
"line": "4. Patients not affiliated to the Social Security System",
"criterions": [
{
"exact_snippets": "Patients not affiliated to the Social Security System",
"criterion": "Social Security System affiliation",
"requirements": [
{
"requirement_type": "affiliation",
"expected_value": false
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}