{
"info": {
"nct_id": "NCT04528420",
"official_title": "Evaluation of Optimised Early Management in the Context of Radiochemotherapy for Curatively Treated Squamous Cell Carcinoma of the Head and Neck",
"inclusion_criteria": "* Male or female, over 18 and under 75 years of age,\n* Worl Health Organisation score < 2,\n* Treatment for a localized squamous cell carcinoma of the head and neck for which a curative treatment by concomitant post-operative radiochemotherapy based on cisplatin is retained,\n* Having signed the informed consent,\n* Affiliate or beneficiary of a social protection scheme.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
"exclusion_criteria": "* History of other neoplastic disease less than 2 years old or progressive,\n* History of radiotherapy for head and neck cancer,\n* Contraindications to cisplatin,\n* Pregnant or breastfeeding woman,\n* Protected major (under guardianship or curatorship),\n* Patient participating in a therapeutic study\n* Patient unable to understand the study for any reason or to comply with the constraints of the trial",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Male or female, over 18 and under 75 years of age,",
"criterions": [
{
"exact_snippets": "Male or female",
"criterion": "gender",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "over 18 and under 75 years of age",
"criterion": "age",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">",
"value": 18,
"unit": "years"
},
{
"operator": "<",
"value": 75,
"unit": "years"
}
]
}
}
]
}
]
},
{
"line": "* Worl Health Organisation score < 2,",
"criterions": [
{
"exact_snippets": "Worl Health Organisation score < 2",
"criterion": "World Health Organisation score",
"requirements": [
{
"requirement_type": "score",
"expected_value": {
"operator": "<",
"value": 2,
"unit": "N/A"
}
}
]
}
]
},
{
"line": "* Treatment for a localized squamous cell carcinoma of the head and neck for which a curative treatment by concomitant post-operative radiochemotherapy based on cisplatin is retained,",
"criterions": [
{
"exact_snippets": "localized squamous cell carcinoma of the head and neck",
"criterion": "squamous cell carcinoma of the head and neck",
"requirements": [
{
"requirement_type": "localization",
"expected_value": "localized"
}
]
},
{
"exact_snippets": "curative treatment by concomitant post-operative radiochemotherapy based on cisplatin is retained",
"criterion": "treatment plan",
"requirements": [
{
"requirement_type": "treatment type",
"expected_value": "curative"
},
{
"requirement_type": "treatment method",
"expected_value": [
"concomitant",
"post-operative",
"radiochemotherapy",
"cisplatin"
]
}
]
}
]
},
{
"line": "* Having signed the informed consent,",
"criterions": [
{
"exact_snippets": "Having signed the informed consent",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "signed",
"expected_value": true
}
]
}
]
},
{
"line": "* Affiliate or beneficiary of a social protection scheme.",
"criterions": [
{
"exact_snippets": "Affiliate or beneficiary of a social protection scheme.",
"criterion": "social protection scheme",
"requirements": [
{
"requirement_type": "affiliation or beneficiary status",
"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"
}
}
]
}
]
},
{
"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": "* History of other neoplastic disease less than 2 years old or progressive,",
"criterions": [
{
"exact_snippets": "History of other neoplastic disease less than 2 years old",
"criterion": "history of other neoplastic disease",
"requirements": [
{
"requirement_type": "age",
"expected_value": {
"operator": "<",
"value": 2,
"unit": "years"
}
}
]
},
{
"exact_snippets": "progressive",
"criterion": "progressive neoplastic disease",
"requirements": [
{
"requirement_type": "progression",
"expected_value": true
}
]
}
]
},
{
"line": "* History of radiotherapy for head and neck cancer,",
"criterions": [
{
"exact_snippets": "History of radiotherapy for head and neck cancer",
"criterion": "radiotherapy history",
"requirements": [
{
"requirement_type": "condition",
"expected_value": "head and neck cancer"
}
]
}
]
},
{
"line": "* Contraindications to cisplatin,",
"criterions": [
{
"exact_snippets": "Contraindications to cisplatin",
"criterion": "cisplatin",
"requirements": [
{
"requirement_type": "contraindications",
"expected_value": true
}
]
}
]
},
{
"line": "* Pregnant or breastfeeding woman,",
"criterions": [
{
"exact_snippets": "Pregnant",
"criterion": "pregnancy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "breastfeeding",
"criterion": "breastfeeding",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Protected major (under guardianship or curatorship),",
"criterions": [
{
"exact_snippets": "Protected major (under guardianship or curatorship)",
"criterion": "legal status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "protected major"
}
]
}
]
},
{
"line": "* Patient participating in a therapeutic study",
"criterions": [
{
"exact_snippets": "Patient participating in a therapeutic study",
"criterion": "participation in a therapeutic study",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Patient unable to understand the study for any reason or to comply with the constraints of the trial",
"criterions": [
{
"exact_snippets": "Patient unable to understand the study",
"criterion": "understanding of the study",
"requirements": [
{
"requirement_type": "ability",
"expected_value": true
}
]
},
{
"exact_snippets": "unable ... to comply with the constraints of the trial",
"criterion": "compliance with trial constraints",
"requirements": [
{
"requirement_type": "ability",
"expected_value": true
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}