{
    "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": [
        {
            "line": "* Patients aged 18 or over",
            "criterions": [
                {
                    "exact_snippets": "Patients aged 18 or over",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "relapsed or refractory"
                        }
                    ]
                },
                {
                    "exact_snippets": "relapsed or refractory primary mediastinum B-cell lymphoma",
                    "criterion": "primary mediastinum B-cell lymphoma",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "relapsed or refractory"
                        }
                    ]
                },
                {
                    "exact_snippets": "follicular lymphoma transformed into LBDGC R/R",
                    "criterion": "follicular lymphoma",
                    "requirements": [
                        {
                            "requirement_type": "transformation",
                            "expected_value": "transformed into LBDGC R/R"
                        }
                    ]
                }
            ]
        },
        {
            "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",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* PET-CT pre-injection of CAR-T performed",
            "criterions": [
                {
                    "exact_snippets": "PET-CT pre-injection of CAR-T performed",
                    "criterion": "PET-CT",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "pre-injection of CAR-T"
                        },
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Signed informed consent",
            "criterions": [
                {
                    "exact_snippets": "Signed informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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",
                    "requirements": [
                        {
                            "requirement_type": "affiliation",
                            "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": "* Pregnant or breastfeeding women",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding women",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "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",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "quality",
                            "expected_value": "sufficient for NGS analysis"
                        },
                        {
                            "requirement_type": "quantity",
                            "expected_value": "sufficient for NGS analysis"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Lack of patient consent",
            "criterions": [
                {
                    "exact_snippets": "Lack of patient consent",
                    "criterion": "patient consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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",
                    "requirements": [
                        {
                            "requirement_type": "context",
                            "expected_value": "therapeutic clinical trial"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient whose weight is less than 30 kg",
            "criterions": [
                {
                    "exact_snippets": "weight is less than 30 kg",
                    "criterion": "weight",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 30,
                                "unit": "kg"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Protected adult or deprived of liberty (under guardianship or curatorship)",
            "criterions": [
                {
                    "exact_snippets": "Protected adult or deprived of liberty (under guardianship or curatorship)",
                    "criterion": "protected adult",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "deprived of liberty (under guardianship or curatorship)",
                    "criterion": "deprived of liberty",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient unable to understand the study for any reason whatsoever or to comply with the constraints of the trial (language, psychological, geographic problem, etc.).",
            "criterions": [
                {
                    "exact_snippets": "Patient unable to understand the study",
                    "criterion": "ability to understand the study",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unable ... to comply with the constraints of the trial",
                    "criterion": "ability to comply with trial constraints",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "language ... problem",
                    "criterion": "language proficiency",
                    "requirements": [
                        {
                            "requirement_type": "proficiency",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "psychological ... problem",
                    "criterion": "psychological condition",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "no problem"
                        }
                    ]
                },
                {
                    "exact_snippets": "geographic problem",
                    "criterion": "geographic location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "no problem"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}