{
    "info": {
        "nct_id": "NCT05487248",
        "official_title": "A Study of On-treatment CtDNA Changes in Chemo-refractory Colorectal Cancer Patients",
        "inclusion_criteria": "1. Age ≥ 18 years old\n2. Male or female\n3. ECOG performance status ≤2\n4. Must have histologically or cytologically verified colorectal cancer adenocarcinoma\n5. Inoperable locally advanced or metastatic disease\n6. Presence of measurable disease (by RECIST criteria version 1.1) on baseline CT scan of the thorax/abdomen/pelvis or CT scan of the thorax and MRI of the abdomen/pelvis\n7. At least two prior systemic treatments for advanced/metastatic colorectal cancer including oxaliplatin and irinotecan-based therapy (adjuvant or neoadjuvant systemic chemotherapy will be considered if tumour progression was documented within 6 month of the last chemotherapy dose)\n8. Candidate for standard third-line or subsequent lines of therapy as per decision of the treating physician\n9. Life expectancy of at least 3 months\n10. Women of childbearing potential must have a negative serum pregnancy test done within 28 days prior to enrolment.\n11. Effective contraception is in place for women of childbearing potential.\n12. Completion of all necessary screening procedures within 28 days prior to enrolment.\n13. Availability of archived tumour tissue\n14. Signed Informed Consent form (ICF) obtained prior to any study related procedure.\n\n    Inclusion criterion applicable to FRANCE only\n15. Affiliated to the French Social Security System\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Tumours other than colorectal cancer\n2. Histologies other than adenocarcinoma\n3. Any baseline medical condition that would contraindicate the use of systemic chemotherapy or may preclude the regular administration of the same\n4. Any psychiatric condition that would prohibit the understanding or rendering of informed consent\n5. Other invasive malignancy within 3 years except for non-invasive malignancies such as cervical carcinoma in situ, non-melanomatous carcinoma of the skin or ductal carcinoma in situ of the breast that has/have been surgically cured\n6. Subject with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator's opinion, may interfere with completion of the study.\n7. Pregnant and/ or lactating women\n\n   Exclusion criterion applicable to FRANCE only\n8. Vulnerable persons according to the article L.1121-6 of the Public Health Code, adults who are the subject of a measure of legal protection or unable to express their consent according to article L.1121-8 of the Public Health Code.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Age ≥ 18 years old",
            "criterions": [
                {
                    "exact_snippets": "Age ≥ 18 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Male or female",
            "criterions": [
                {
                    "exact_snippets": "Male or female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "allowed_values",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. ECOG performance status ≤2",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status ≤2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Must have histologically or cytologically verified colorectal cancer adenocarcinoma",
            "criterions": [
                {
                    "exact_snippets": "histologically or cytologically verified colorectal cancer adenocarcinoma",
                    "criterion": "colorectal cancer adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "verification method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Inoperable locally advanced or metastatic disease",
            "criterions": [
                {
                    "exact_snippets": "Inoperable locally advanced or metastatic disease",
                    "criterion": "disease operability",
                    "requirements": [
                        {
                            "requirement_type": "operability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Inoperable locally advanced or metastatic disease",
                    "criterion": "disease stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "metastatic"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Presence of measurable disease (by RECIST criteria version 1.1) on baseline CT scan of the thorax/abdomen/pelvis or CT scan of the thorax and MRI of the abdomen/pelvis",
            "criterions": [
                {
                    "exact_snippets": "Presence of measurable disease (by RECIST criteria version 1.1)",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "measurement criteria",
                            "expected_value": "RECIST criteria version 1.1"
                        }
                    ]
                },
                {
                    "exact_snippets": "baseline CT scan of the thorax/abdomen/pelvis or CT scan of the thorax and MRI of the abdomen/pelvis",
                    "criterion": "imaging requirement",
                    "requirements": [
                        {
                            "requirement_type": "imaging type",
                            "expected_value": [
                                "CT scan of the thorax/abdomen/pelvis",
                                "CT scan of the thorax and MRI of the abdomen/pelvis"
                            ]
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "baseline"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. At least two prior systemic treatments for advanced/metastatic colorectal cancer including oxaliplatin and irinotecan-based therapy (adjuvant or neoadjuvant systemic chemotherapy will be considered if tumour progression was documented within 6 month of the last chemotherapy dose)",
            "criterions": [
                {
                    "exact_snippets": "At least two prior systemic treatments for advanced/metastatic colorectal cancer",
                    "criterion": "prior systemic treatments",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "treatments"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "including oxaliplatin and irinotecan-based therapy",
                    "criterion": "prior systemic treatments",
                    "requirements": [
                        {
                            "requirement_type": "inclusion",
                            "expected_value": [
                                "oxaliplatin",
                                "irinotecan-based therapy"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "adjuvant or neoadjuvant systemic chemotherapy will be considered if tumour progression was documented within 6 month of the last chemotherapy dose",
                    "criterion": "tumour progression",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": "within 6 months of the last chemotherapy dose"
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Candidate for standard third-line or subsequent lines of therapy as per decision of the treating physician",
            "criterions": [
                {
                    "exact_snippets": "Candidate for standard third-line or subsequent lines of therapy",
                    "criterion": "therapy line",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": "third-line or subsequent lines"
                        }
                    ]
                },
                {
                    "exact_snippets": "as per decision of the treating physician",
                    "criterion": "physician decision",
                    "requirements": [
                        {
                            "requirement_type": "approval",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Life expectancy of at least 3 months",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy of at least 3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Women of childbearing potential must have a negative serum pregnancy test done within 28 days prior to enrolment.",
            "criterions": [
                {
                    "exact_snippets": "Women of childbearing potential",
                    "criterion": "childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "negative serum pregnancy test",
                    "criterion": "serum pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "done within 28 days prior to enrolment",
                    "criterion": "serum pregnancy test timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 28 days prior to enrolment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Effective contraception is in place for women of childbearing potential.",
            "criterions": [
                {
                    "exact_snippets": "Effective contraception is in place for women of childbearing potential.",
                    "criterion": "contraception",
                    "requirements": [
                        {
                            "requirement_type": "effectiveness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "women of childbearing potential",
                    "criterion": "childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Completion of all necessary screening procedures within 28 days prior to enrolment.",
            "criterions": [
                {
                    "exact_snippets": "Completion of all necessary screening procedures",
                    "criterion": "screening procedures",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within 28 days prior to enrolment",
                    "criterion": "screening procedures",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Availability of archived tumour tissue",
            "criterions": [
                {
                    "exact_snippets": "Availability of archived tumour tissue",
                    "criterion": "archived tumour tissue",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Signed Informed Consent form (ICF) obtained prior to any study related procedure.",
            "criterions": [
                {
                    "exact_snippets": "Signed Informed Consent form (ICF) obtained",
                    "criterion": "informed consent form",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "obtained",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Inclusion criterion applicable to FRANCE only",
            "criterions": [
                {
                    "exact_snippets": "applicable to FRANCE only",
                    "criterion": "geographic location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "FRANCE"
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. Affiliated to the French Social Security System",
            "criterions": [
                {
                    "exact_snippets": "Affiliated to the French Social Security System",
                    "criterion": "French Social Security System affiliation",
                    "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": "1. Tumours other than colorectal cancer",
            "criterions": [
                {
                    "exact_snippets": "Tumours other than colorectal cancer",
                    "criterion": "tumours",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": {
                                "operator": "!=",
                                "value": 1,
                                "unit": "colorectal cancer"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Histologies other than adenocarcinoma",
            "criterions": [
                {
                    "exact_snippets": "Histologies other than adenocarcinoma",
                    "criterion": "histology",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": {
                                "operator": "!=",
                                "value": 1,
                                "unit": "adenocarcinoma"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Any baseline medical condition that would contraindicate the use of systemic chemotherapy or may preclude the regular administration of the same",
            "criterions": [
                {
                    "exact_snippets": "baseline medical condition that would contraindicate the use of systemic chemotherapy",
                    "criterion": "baseline medical condition",
                    "requirements": [
                        {
                            "requirement_type": "contraindication",
                            "expected_value": "systemic chemotherapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "baseline medical condition that ... may preclude the regular administration of the same",
                    "criterion": "baseline medical condition",
                    "requirements": [
                        {
                            "requirement_type": "preclusion",
                            "expected_value": "regular administration of systemic chemotherapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Any psychiatric condition that would prohibit the understanding or rendering of informed consent",
            "criterions": [
                {
                    "exact_snippets": "psychiatric condition that would prohibit the understanding or rendering of informed consent",
                    "criterion": "psychiatric condition",
                    "requirements": [
                        {
                            "requirement_type": "impact on informed consent",
                            "expected_value": "prohibitive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Other invasive malignancy within 3 years except for non-invasive malignancies such as cervical carcinoma in situ, non-melanomatous carcinoma of the skin or ductal carcinoma in situ of the breast that has/have been surgically cured",
            "criterions": [
                {
                    "exact_snippets": "Other invasive malignancy within 3 years",
                    "criterion": "invasive malignancy",
                    "requirements": [
                        {
                            "requirement_type": "time since diagnosis",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "except for non-invasive malignancies such as cervical carcinoma in situ, non-melanomatous carcinoma of the skin or ductal carcinoma in situ of the breast",
                    "criterion": "non-invasive malignancies",
                    "requirements": [
                        {
                            "requirement_type": "types",
                            "expected_value": [
                                "cervical carcinoma in situ",
                                "non-melanomatous carcinoma of the skin",
                                "ductal carcinoma in situ of the breast"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "that has/have been surgically cured",
                    "criterion": "surgical cure",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "cured"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Subject with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator's opinion, may interfere with completion of the study.",
            "criterions": [
                {
                    "exact_snippets": "significant medical, neuro-psychiatric, or surgical condition",
                    "criterion": "medical, neuro-psychiatric, or surgical condition",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "currently uncontrolled by treatment",
                    "criterion": "condition control",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Pregnant and/ or lactating women",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating women",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Exclusion criterion applicable to FRANCE only",
            "criterions": [
                {
                    "exact_snippets": "Exclusion criterion applicable to FRANCE only",
                    "criterion": "geographic location",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": "FRANCE"
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Vulnerable persons according to the article L.1121-6 of the Public Health Code, adults who are the subject of a measure of legal protection or unable to express their consent according to article L.1121-8 of the Public Health Code.",
            "criterions": [
                {
                    "exact_snippets": "Vulnerable persons according to the article L.1121-6 of the Public Health Code",
                    "criterion": "vulnerable persons",
                    "requirements": [
                        {
                            "requirement_type": "legal definition",
                            "expected_value": "article L.1121-6 of the Public Health Code"
                        }
                    ]
                },
                {
                    "exact_snippets": "adults who are the subject of a measure of legal protection",
                    "criterion": "legal protection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "subject of a measure of legal protection"
                        }
                    ]
                },
                {
                    "exact_snippets": "unable to express their consent according to article L.1121-8 of the Public Health Code",
                    "criterion": "ability to express consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "legal definition",
                            "expected_value": "article L.1121-8 of the Public Health Code"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}