{
"info": {
"nct_id": "NCT06142760",
"official_title": "Daily AI-based Treatment Adaptation Under Weekly Offline MR-guidance in Chemoradiotherapy for Cervical Cancer 1 AIM-C1",
"inclusion_criteria": "* biopsy-proven cervical cancer including squamous-cell carcinoma, adenocarcinoma or adeno-squamous cell carcinoma\n* FIGO stage IB, IIA, IIB, IIIA, IIIB, IIIC1\n* indication and eligibility for definitive chemoradiotherapy including brachytherapy discussed in an interdisciplinary tumor board\n* Karnofsky performance score ≥ 70%\n* 18-80 years of age\n* Capacity of the patient to consent to participation in the study\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* FIGO stage IIIC2 and IV\n* Paraaortic lymphatic node metastases\n* small cell neuroendocrine cancer, melanoma and other rare cancers of the cervix\n* previous radiotherapy of the pelvic region\n* previous total or partial hysterectomy\n* neoadjuvant chemotherapy\n* contraindications against performing contrast-enhanced MRI scans (pacemakers, other implants making MRI impossible, allergy to gadolinium (GD)-based contrast agent)\n* claustrophobia\n* pregnant or lactating women\n* other primary malignancies within 5 years before except carcinoma in situ of the cervix and basal cell carcinoma of the skin\n* patient is enrolled in another study, that could influence the outcome of the presented study",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* biopsy-proven cervical cancer including squamous-cell carcinoma, adenocarcinoma or adeno-squamous cell carcinoma",
"criterions": [
{
"exact_snippets": "biopsy-proven cervical cancer",
"criterion": "cervical cancer",
"requirement": {
"requirement_type": "diagnosis method",
"expected_value": "biopsy-proven"
}
},
{
"exact_snippets": "squamous-cell carcinoma",
"criterion": "cervical cancer subtype",
"requirement": {
"requirement_type": "subtype",
"expected_value": "squamous-cell carcinoma"
}
},
{
"exact_snippets": "adenocarcinoma",
"criterion": "cervical cancer subtype",
"requirement": {
"requirement_type": "subtype",
"expected_value": "adenocarcinoma"
}
},
{
"exact_snippets": "adeno-squamous cell carcinoma",
"criterion": "cervical cancer subtype",
"requirement": {
"requirement_type": "subtype",
"expected_value": "adeno-squamous cell carcinoma"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "biopsy-proven cervical cancer",
"criterion": "cervical cancer",
"requirement": {
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"expected_value": "biopsy-proven"
}
},
{
"or_criteria": [
{
"exact_snippets": "squamous-cell carcinoma",
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"expected_value": "squamous-cell carcinoma"
}
},
{
"exact_snippets": "adenocarcinoma",
"criterion": "cervical cancer subtype",
"requirement": {
"requirement_type": "subtype",
"expected_value": "adenocarcinoma"
}
},
{
"exact_snippets": "adeno-squamous cell carcinoma",
"criterion": "cervical cancer subtype",
"requirement": {
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"expected_value": "adeno-squamous cell carcinoma"
}
}
]
}
]
}
]
}
},
{
"identified_line": {
"line": "* indication and eligibility for definitive chemoradiotherapy including brachytherapy discussed in an interdisciplinary tumor board",
"criterions": [
{
"exact_snippets": "indication and eligibility for definitive chemoradiotherapy including brachytherapy",
"criterion": "indication and eligibility for definitive chemoradiotherapy including brachytherapy",
"requirement": {
"requirement_type": "discussion",
"expected_value": "interdisciplinary tumor board"
}
}
]
},
"logical_structure": {
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"requirement": {
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}
}
]
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},
{
"identified_line": {
"line": "* Karnofsky performance score ≥ 70%",
"criterions": [
{
"exact_snippets": "Karnofsky performance score ≥ 70%",
"criterion": "Karnofsky performance score",
"requirement": {
"requirement_type": "score",
"expected_value": {
"operator": ">=",
"value": 70,
"unit": "%"
}
}
}
]
},
"logical_structure": {
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{
"exact_snippets": "Karnofsky performance score ≥ 70%",
"criterion": "Karnofsky performance score",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 70,
"unit": "%"
}
}
}
]
}
},
{
"identified_line": {
"line": "* 18-80 years of age",
"criterions": [
{
"exact_snippets": "18-80 years of age",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
},
{
"operator": "<=",
"value": 80,
"unit": "years"
}
]
}
}
}
]
},
"logical_structure": {
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"exact_snippets": "18-80 years of age",
"criterion": "age",
"requirement": {
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"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
},
{
"operator": "<=",
"value": 80,
"unit": "years"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* Capacity of the patient to consent to participation in the study",
"criterions": [
{
"exact_snippets": "Capacity of the patient to consent",
"criterion": "capacity to consent",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Capacity of the patient to consent",
"criterion": "capacity to consent",
"requirement": {
"requirement_type": "ability",
"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": {
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"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": "* FIGO stage IIIC2 and IV",
"criterions": [
{
"exact_snippets": "FIGO stage IIIC2",
"criterion": "FIGO stage",
"requirement": {
"requirement_type": "stage",
"expected_value": "IIIC2"
}
},
{
"exact_snippets": "FIGO stage ... IV",
"criterion": "FIGO stage",
"requirement": {
"requirement_type": "stage",
"expected_value": "IV"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "FIGO stage IIIC2",
"criterion": "FIGO stage",
"requirement": {
"requirement_type": "stage",
"expected_value": "IIIC2"
}
},
{
"exact_snippets": "FIGO stage ... IV",
"criterion": "FIGO stage",
"requirement": {
"requirement_type": "stage",
"expected_value": "IV"
}
}
]
}
},
{
"identified_line": {
"line": "* Paraaortic lymphatic node metastases",
"criterions": [
{
"exact_snippets": "Paraaortic lymphatic node metastases",
"criterion": "paraaortic lymphatic node metastases",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Paraaortic lymphatic node metastases",
"criterion": "paraaortic lymphatic node metastases",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* small cell neuroendocrine cancer, melanoma and other rare cancers of the cervix",
"criterions": [
{
"exact_snippets": "small cell neuroendocrine cancer",
"criterion": "small cell neuroendocrine cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "melanoma",
"criterion": "melanoma",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "other rare cancers of the cervix",
"criterion": "rare cancers of the cervix",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "small cell neuroendocrine cancer",
"criterion": "small cell neuroendocrine cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "melanoma",
"criterion": "melanoma",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "other rare cancers of the cervix",
"criterion": "rare cancers of the cervix",
"requirement": {
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"expected_value": true
}
}
]
}
},
{
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{
"exact_snippets": "previous radiotherapy of the pelvic region",
"criterion": "radiotherapy",
"requirement": {
"requirement_type": "location",
"expected_value": "pelvic region"
}
},
{
"exact_snippets": "previous radiotherapy of the pelvic region",
"criterion": "radiotherapy",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
"logical_structure": {
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{
"exact_snippets": "previous radiotherapy of the pelvic region",
"criterion": "radiotherapy",
"requirement": {
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"expected_value": "pelvic region"
}
},
{
"exact_snippets": "previous radiotherapy of the pelvic region",
"criterion": "radiotherapy",
"requirement": {
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"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* previous total or partial hysterectomy",
"criterions": [
{
"exact_snippets": "previous total or partial hysterectomy",
"criterion": "hysterectomy",
"requirement": {
"requirement_type": "type",
"expected_value": [
"total",
"partial"
]
}
},
{
"exact_snippets": "previous total or partial hysterectomy",
"criterion": "hysterectomy",
"requirement": {
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"expected_value": true
}
}
]
},
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"and_criteria": [
{
"and_criteria": [
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"criterion": "hysterectomy",
"requirement": {
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"expected_value": [
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"partial"
]
}
},
{
"exact_snippets": "previous total or partial hysterectomy",
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"requirement": {
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"expected_value": true
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* neoadjuvant chemotherapy",
"criterions": [
{
"exact_snippets": "neoadjuvant chemotherapy",
"criterion": "neoadjuvant chemotherapy",
"requirement": {
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"expected_value": true
}
}
]
},
"logical_structure": {
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"exact_snippets": "neoadjuvant chemotherapy",
"criterion": "neoadjuvant chemotherapy",
"requirement": {
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"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* claustrophobia",
"criterions": [
{
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"criterion": "claustrophobia",
"requirement": {
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"expected_value": false
}
}
]
},
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"requirement": {
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"expected_value": false
}
}
}
},
{
"identified_line": {
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{
"exact_snippets": "pregnant",
"criterion": "pregnancy",
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"expected_value": false
}
},
{
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"criterion": "lactation",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
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{
"exact_snippets": "pregnant",
"criterion": "pregnancy",
"requirement": {
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"expected_value": false
}
},
{
"exact_snippets": "lactating women",
"criterion": "lactation",
"requirement": {
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"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* other primary malignancies within 5 years before except carcinoma in situ of the cervix and basal cell carcinoma of the skin",
"criterions": [
{
"exact_snippets": "other primary malignancies within 5 years before",
"criterion": "other primary malignancies",
"requirement": {
"requirement_type": "time since diagnosis",
"expected_value": {
"operator": "<",
"value": 5,
"unit": "years"
}
}
},
{
"exact_snippets": "except carcinoma in situ of the cervix",
"criterion": "carcinoma in situ of the cervix",
"requirement": {
"requirement_type": "exclusion",
"expected_value": true
}
},
{
"exact_snippets": "except ... basal cell carcinoma of the skin",
"criterion": "basal cell carcinoma of the skin",
"requirement": {
"requirement_type": "exclusion",
"expected_value": true
}
}
]
},
"logical_structure": {
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"exact_snippets": "other primary malignancies within 5 years before",
"criterion": "other primary malignancies",
"requirement": {
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"expected_value": {
"operator": "<",
"value": 5,
"unit": "years"
}
}
},
{
"not_criteria": {
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"criterion": "carcinoma in situ of the cervix",
"requirement": {
"requirement_type": "exclusion",
"expected_value": true
}
}
},
{
"not_criteria": {
"exact_snippets": "except ... basal cell carcinoma of the skin",
"criterion": "basal cell carcinoma of the skin",
"requirement": {
"requirement_type": "exclusion",
"expected_value": true
}
}
}
]
}
}
]
}
},
{
"identified_line": {
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"criterions": [
{
"exact_snippets": "patient is enrolled in another study",
"criterion": "enrollment in another study",
"requirement": {
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"expected_value": true
}
}
]
},
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"criterion": "enrollment in another study",
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"expected_value": true
}
}
]
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}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"line": "* FIGO stage IB, IIA, IIB, IIIA, IIIB, IIIC1",
"criterions": [
{
"exact_snippets": "FIGO stage IB, IIA, IIB, IIIA, IIIB, IIIC1",
"criterion": "FIGO stage",
"requirement": {
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"expected_value": [
"IB",
"IIA",
"IIB",
"IIIA",
"IIIB",
"IIIC1"
]
}
}
]
},
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"criterion": "FIGO stage",
"requirement": {
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"expected_value": "IB"
}
},
{
"exact_snippets": "FIGO stage IB, IIA, IIB, IIIA, IIIB, IIIC1",
"criterion": "FIGO stage",
"requirement": {
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"expected_value": "IIA"
}
},
{
"exact_snippets": "FIGO stage IB, IIA, IIB, IIIA, IIIB, IIIC1",
"criterion": "FIGO stage",
"requirement": {
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"expected_value": "IIB"
}
},
{
"exact_snippets": "FIGO stage IB, IIA, IIB, IIIA, IIIB, IIIC1",
"criterion": "FIGO stage",
"requirement": {
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"expected_value": "IIIA"
}
},
{
"exact_snippets": "FIGO stage IB, IIA, IIB, IIIA, IIIB, IIIC1",
"criterion": "FIGO stage",
"requirement": {
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"expected_value": "IIIB"
}
},
{
"exact_snippets": "FIGO stage IB, IIA, IIB, IIIA, IIIB, IIIC1",
"criterion": "FIGO stage",
"requirement": {
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"expected_value": "IIIC1"
}
}
]
}
}
],
"failed_exclusion": [
{
"identified_line": {
"line": "* contraindications against performing contrast-enhanced MRI scans (pacemakers, other implants making MRI impossible, allergy to gadolinium (GD)-based contrast agent)",
"criterions": [
{
"exact_snippets": "contraindications against performing contrast-enhanced MRI scans (pacemakers, other implants making MRI impossible",
"criterion": "contraindications for MRI",
"requirement": {
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"expected_value": false
}
},
{
"exact_snippets": "allergy to gadolinium (GD)-based contrast agent",
"criterion": "allergy to gadolinium-based contrast agent",
"requirement": {
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"expected_value": false
}
}
]
},
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{
"exact_snippets": "contraindications against performing contrast-enhanced MRI scans (pacemakers, other implants making MRI impossible",
"criterion": "contraindications for MRI",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
{
"exact_snippets": "allergy to gadolinium (GD)-based contrast agent",
"criterion": "allergy to gadolinium-based contrast agent",
"requirement": {
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"expected_value": true
}
}
]
}
}
],
"failed_miscellaneous": []
}