{
"info": {
"nct_id": "NCT05675982",
"official_title": "Real-Time Monitoring of Circulating Tumor DNA and Study of Prognostic Factors in Patients Treated With Anti-CD19 CAR-T Cells for Relapsed or Refractory Diffuse Large B-cell Lymphoma",
"inclusion_criteria": "* Patients aged 18 or over\n* Carriers of relapsed or refractory diffuse large cell B-cell lymphoma (LBDGC R/R), relapsed or refractory primary mediastinum B-cell lymphoma or follicular lymphoma transformed into LBDGC R/R\n* Patients with an indication for treatment with CAR-T anti CD19\n* PET-CT pre-injection of CAR-T performed\n* Signed informed consent\n* Patients affiliated or beneficiaries of a health insurance scheme\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Pregnant or breastfeeding women\n* Absence or insufficiency of tumor material (patient's most recent diagnostic biopsy) fixed in FFPE paraffin of insufficient quality/quantity for next-generation sequencing (NGS) analysis\n* Lack of patient consent\n* Patient treated with CAR-T as part of a therapeutic clinical trial\n* Patient whose weight is less than 30 kg\n* Protected adult or deprived of liberty (under guardianship or curatorship)\n* Patient unable to understand the study for any reason whatsoever or to comply with the constraints of the trial (language, psychological, geographic problem, etc.).",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Patients aged 18 or over",
"criterions": [
{
"exact_snippets": "Patients aged 18 or over",
"criterion": "age",
"requirement": {
"requirement_type": "minimum age",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Patients aged 18 or over",
"criterion": "age",
"requirement": {
"requirement_type": "minimum age",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Carriers of relapsed or refractory diffuse large cell B-cell lymphoma (LBDGC R/R), relapsed or refractory primary mediastinum B-cell lymphoma or follicular lymphoma transformed into LBDGC R/R",
"criterions": [
{
"exact_snippets": "Carriers of relapsed or refractory diffuse large cell B-cell lymphoma (LBDGC R/R)",
"criterion": "diffuse large cell B-cell lymphoma",
"requirement": {
"requirement_type": "condition",
"expected_value": "relapsed or refractory"
}
},
{
"exact_snippets": "relapsed or refractory primary mediastinum B-cell lymphoma",
"criterion": "primary mediastinum B-cell lymphoma",
"requirement": {
"requirement_type": "condition",
"expected_value": "relapsed or refractory"
}
},
{
"exact_snippets": "follicular lymphoma transformed into LBDGC R/R",
"criterion": "follicular lymphoma",
"requirement": {
"requirement_type": "transformation",
"expected_value": "transformed into LBDGC R/R"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Carriers of relapsed or refractory diffuse large cell B-cell lymphoma (LBDGC R/R)",
"criterion": "diffuse large cell B-cell lymphoma",
"requirement": {
"requirement_type": "condition",
"expected_value": "relapsed or refractory"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "relapsed or refractory primary mediastinum B-cell lymphoma",
"criterion": "primary mediastinum B-cell lymphoma",
"requirement": {
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"expected_value": "relapsed or refractory"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "follicular lymphoma transformed into LBDGC R/R",
"criterion": "follicular lymphoma",
"requirement": {
"requirement_type": "transformation",
"expected_value": "transformed into LBDGC R/R"
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Patients with an indication for treatment with CAR-T anti CD19",
"criterions": [
{
"exact_snippets": "indication for treatment with CAR-T anti CD19",
"criterion": "indication for CAR-T anti CD19 treatment",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "indication for treatment with CAR-T anti CD19",
"criterion": "indication for CAR-T anti CD19 treatment",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* PET-CT pre-injection of CAR-T performed",
"criterions": [
{
"exact_snippets": "PET-CT pre-injection of CAR-T performed",
"criterion": "PET-CT",
"requirement": {
"requirement_type": "timing",
"expected_value": "pre-injection of CAR-T"
}
},
{
"exact_snippets": "PET-CT pre-injection of CAR-T performed",
"criterion": "PET-CT",
"requirement": {
"requirement_type": "completion",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "PET-CT pre-injection of CAR-T performed",
"criterion": "PET-CT",
"requirement": {
"requirement_type": "timing",
"expected_value": "pre-injection of CAR-T"
}
},
{
"exact_snippets": "PET-CT pre-injection of CAR-T performed",
"criterion": "PET-CT",
"requirement": {
"requirement_type": "completion",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Signed informed consent",
"criterions": [
{
"exact_snippets": "Signed informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "signed",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Signed informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "signed",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Patients affiliated or beneficiaries of a health insurance scheme",
"criterions": [
{
"exact_snippets": "affiliated or beneficiaries of a health insurance scheme",
"criterion": "health insurance scheme",
"requirement": {
"requirement_type": "affiliation",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
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"exact_snippets": "affiliated or beneficiaries of a health insurance scheme",
"criterion": "health insurance scheme",
"requirement": {
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"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"
}
}
]
},
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"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
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"expected_value": "healthy"
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},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
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"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
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"operator": ">=",
"value": 18,
"unit": "Years"
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}
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],
"exclusion_lines": [
{
"identified_line": {
"line": "* Pregnant or breastfeeding women",
"criterions": [
{
"exact_snippets": "Pregnant",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "breastfeeding women",
"criterion": "breastfeeding",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
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{
"exact_snippets": "Pregnant",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "breastfeeding women",
"criterion": "breastfeeding",
"requirement": {
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"expected_value": false
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]
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},
{
"identified_line": {
"line": "* Absence or insufficiency of tumor material (patient's most recent diagnostic biopsy) fixed in FFPE paraffin of insufficient quality/quantity for next-generation sequencing (NGS) analysis",
"criterions": [
{
"exact_snippets": "Absence or insufficiency of tumor material ... fixed in FFPE paraffin of insufficient quality/quantity for next-generation sequencing (NGS) analysis",
"criterion": "tumor material",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Absence or insufficiency of tumor material ... fixed in FFPE paraffin of insufficient quality/quantity for next-generation sequencing (NGS) analysis",
"criterion": "tumor material",
"requirement": {
"requirement_type": "quality",
"expected_value": "sufficient for NGS analysis"
}
},
{
"exact_snippets": "Absence or insufficiency of tumor material ... fixed in FFPE paraffin of insufficient quality/quantity for next-generation sequencing (NGS) analysis",
"criterion": "tumor material",
"requirement": {
"requirement_type": "quantity",
"expected_value": "sufficient for NGS analysis"
}
}
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},
"logical_structure": {
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"not_criteria": {
"exact_snippets": "Absence or insufficiency of tumor material ... fixed in FFPE paraffin of insufficient quality/quantity for next-generation sequencing (NGS) analysis",
"criterion": "tumor material",
"requirement": {
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"expected_value": true
}
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"expected_value": "sufficient for NGS analysis"
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"criterion": "tumor material",
"requirement": {
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}
}
}
]
}
},
{
"identified_line": {
"line": "* Lack of patient consent",
"criterions": [
{
"exact_snippets": "Lack of patient consent",
"criterion": "patient consent",
"requirement": {
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"expected_value": true
}
}
]
},
"logical_structure": {
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"exact_snippets": "Lack of patient consent",
"criterion": "patient consent",
"requirement": {
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"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* Patient treated with CAR-T as part of a therapeutic clinical trial",
"criterions": [
{
"exact_snippets": "Patient treated with CAR-T as part of a therapeutic clinical trial",
"criterion": "CAR-T treatment",
"requirement": {
"requirement_type": "context",
"expected_value": "therapeutic clinical trial"
}
}
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"logical_structure": {
"and_criteria": [
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"exact_snippets": "Patient treated with CAR-T as part of a therapeutic clinical trial",
"criterion": "CAR-T treatment",
"requirement": {
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"expected_value": "therapeutic clinical trial"
}
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{
"identified_line": {
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"criterions": [
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"exact_snippets": "weight is less than 30 kg",
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"requirement": {
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"value": 30,
"unit": "kg"
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}
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"value": 30,
"unit": "kg"
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"identified_line": {
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"criterion": "protected adult",
"requirement": {
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{
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{
"exact_snippets": "psychological ... problem",
"criterion": "psychological condition",
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},
{
"exact_snippets": "geographic problem",
"criterion": "geographic location",
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}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}