{
"info": {
"nct_id": "NCT02714920",
"official_title": "DNA Repair Enzyme Signature Associated With Response to Chemo- and Radio-therapy in Head and Neck Cancer: ChemRadAssay",
"inclusion_criteria": "* Age over 18 years old;\n* HNSCC proven on a biopsy, located in the oral cavity or the oropharynx (the tumor must be accessible to a biopsy during an outpatient visit);\n* Tumor accessible to a biopsy under local anesthesia;\n* TNM classification: any stage except M1;\n* Eligible for radiotherapy as a curative treatment;\n* No surgery planned as exclusive treatment;\n* Able to comply with the scheduled visits;\n* Affiliated to or beneficiary of a social security system (or equivalent) ;\n* Having given written informed consent prior to any procedure related to the study.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Recurrence or second cancer in a previously irradiated area;\n* Nasopharyngeal carcinoma;\n* Tumor requiring general anesthesia to perform the biopsy;\n* Radiotherapy planned to be provided outside of the investigation center;\n* Pregnant or lactating woman;\n* Adult ward of court (under guardianship or trusteeship).",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Age over 18 years old;",
"criterions": [
{
"exact_snippets": "Age over 18 years old",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 18,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Age over 18 years old",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 18,
"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Tumor accessible to a biopsy under local anesthesia;",
"criterions": [
{
"exact_snippets": "Tumor accessible to a biopsy",
"criterion": "tumor accessibility",
"requirement": {
"requirement_type": "accessibility",
"expected_value": true
}
},
{
"exact_snippets": "under local anesthesia",
"criterion": "biopsy anesthesia type",
"requirement": {
"requirement_type": "type",
"expected_value": "local"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Tumor accessible to a biopsy",
"criterion": "tumor accessibility",
"requirement": {
"requirement_type": "accessibility",
"expected_value": true
}
},
{
"exact_snippets": "under local anesthesia",
"criterion": "biopsy anesthesia type",
"requirement": {
"requirement_type": "type",
"expected_value": "local"
}
}
]
}
},
{
"identified_line": {
"line": "* Eligible for radiotherapy as a curative treatment;",
"criterions": [
{
"exact_snippets": "Eligible for radiotherapy as a curative treatment",
"criterion": "radiotherapy eligibility",
"requirement": {
"requirement_type": "purpose",
"expected_value": "curative treatment"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Eligible for radiotherapy as a curative treatment",
"criterion": "radiotherapy eligibility",
"requirement": {
"requirement_type": "purpose",
"expected_value": "curative treatment"
}
}
]
}
},
{
"identified_line": {
"line": "* No surgery planned as exclusive treatment;",
"criterions": [
{
"exact_snippets": "No surgery planned as exclusive treatment",
"criterion": "surgery as exclusive treatment",
"requirement": {
"requirement_type": "planned",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "No surgery planned as exclusive treatment",
"criterion": "surgery as exclusive treatment",
"requirement": {
"requirement_type": "planned",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Able to comply with the scheduled visits;",
"criterions": [
{
"exact_snippets": "Able to comply with the scheduled visits",
"criterion": "compliance with scheduled visits",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Able to comply with the scheduled visits",
"criterion": "compliance with scheduled visits",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Affiliated to or beneficiary of a social security system (or equivalent) ;",
"criterions": [
{
"exact_snippets": "Affiliated to or beneficiary of a social security system (or equivalent)",
"criterion": "social security system affiliation",
"requirement": {
"requirement_type": "affiliation",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Affiliated to or beneficiary of a social security system (or equivalent)",
"criterion": "social security system affiliation",
"requirement": {
"requirement_type": "affiliation",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Having given written informed consent prior to any procedure related to the study.",
"criterions": [
{
"exact_snippets": "given written informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "given written informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Recurrence or second cancer in a previously irradiated area;",
"criterions": [
{
"exact_snippets": "Recurrence ... in a previously irradiated area",
"criterion": "recurrence",
"requirement": {
"requirement_type": "location",
"expected_value": "previously irradiated area"
}
},
{
"exact_snippets": "second cancer in a previously irradiated area",
"criterion": "second cancer",
"requirement": {
"requirement_type": "location",
"expected_value": "previously irradiated area"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Recurrence ... in a previously irradiated area",
"criterion": "recurrence",
"requirement": {
"requirement_type": "location",
"expected_value": "previously irradiated area"
}
},
{
"exact_snippets": "second cancer in a previously irradiated area",
"criterion": "second cancer",
"requirement": {
"requirement_type": "location",
"expected_value": "previously irradiated area"
}
}
]
}
},
{
"identified_line": {
"line": "* Nasopharyngeal carcinoma;",
"criterions": [
{
"exact_snippets": "Nasopharyngeal carcinoma",
"criterion": "nasopharyngeal carcinoma",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Nasopharyngeal carcinoma",
"criterion": "nasopharyngeal carcinoma",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* Tumor requiring general anesthesia to perform the biopsy;",
"criterions": [
{
"exact_snippets": "Tumor requiring general anesthesia to perform the biopsy",
"criterion": "tumor biopsy",
"requirement": {
"requirement_type": "anesthesia requirement",
"expected_value": "general anesthesia"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Tumor requiring general anesthesia to perform the biopsy",
"criterion": "tumor biopsy",
"requirement": {
"requirement_type": "anesthesia requirement",
"expected_value": "general anesthesia"
}
}
]
}
},
{
"identified_line": {
"line": "* Radiotherapy planned to be provided outside of the investigation center;",
"criterions": [
{
"exact_snippets": "Radiotherapy planned to be provided outside of the investigation center",
"criterion": "radiotherapy location",
"requirement": {
"requirement_type": "location",
"expected_value": "outside of the investigation center"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Radiotherapy planned to be provided outside of the investigation center",
"criterion": "radiotherapy location",
"requirement": {
"requirement_type": "location",
"expected_value": "outside of the investigation center"
}
}
]
}
},
{
"identified_line": {
"line": "* Pregnant or lactating woman;",
"criterions": [
{
"exact_snippets": "Pregnant",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "lactating",
"criterion": "lactation",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Pregnant",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "lactating",
"criterion": "lactation",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Adult ward of court (under guardianship or trusteeship).",
"criterions": [
{
"exact_snippets": "Adult ward of court (under guardianship or trusteeship)",
"criterion": "ward of court status",
"requirement": {
"requirement_type": "status",
"expected_value": "under guardianship or trusteeship"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Adult ward of court (under guardianship or trusteeship)",
"criterion": "ward of court status",
"requirement": {
"requirement_type": "status",
"expected_value": "under guardianship or trusteeship"
}
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"line": "* HNSCC proven on a biopsy, located in the oral cavity or the oropharynx (the tumor must be accessible to a biopsy during an outpatient visit);",
"criterions": [
{
"exact_snippets": "HNSCC proven on a biopsy",
"criterion": "HNSCC",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "located in the oral cavity or the oropharynx",
"criterion": "tumor location",
"requirement": {
"requirement_type": "location",
"expected_value": [
"oral cavity",
"oropharynx"
]
}
},
{
"exact_snippets": "the tumor must be accessible to a biopsy during an outpatient visit",
"criterion": "tumor accessibility",
"requirement": {
"requirement_type": "accessibility",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "HNSCC proven on a biopsy",
"criterion": "HNSCC",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"or_criteria": [
{
"exact_snippets": "located in the oral cavity or the oropharynx",
"criterion": "tumor location",
"requirement": {
"requirement_type": "location",
"expected_value": "oral cavity"
}
},
{
"exact_snippets": "located in the oral cavity or the oropharynx",
"criterion": "tumor location",
"requirement": {
"requirement_type": "location",
"expected_value": "oropharynx"
}
}
]
}
]
},
{
"exact_snippets": "the tumor must be accessible to a biopsy during an outpatient visit",
"criterion": "tumor accessibility",
"requirement": {
"requirement_type": "accessibility",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* TNM classification: any stage except M1;",
"criterions": [
{
"exact_snippets": "TNM classification: any stage except M1",
"criterion": "TNM classification",
"requirement": {
"requirement_type": "stage",
"expected_value": "any stage except M1"
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "TNM classification: any stage except M1",
"criterion": "TNM classification",
"requirement": {
"requirement_type": "stage",
"expected_value": "M1"
}
}
}
}
],
"failed_exclusion": [],
"failed_miscellaneous": []
}