{
    "info": {
        "nct_id": "NCT05495672",
        "official_title": "Circulating Tumor DNA Guided Therapeutic Strategies for Colorectal Cancer Patients With Small Pulmonary Nodules Suspected to be Metastases: an Open-Label, Prospective, Phase II Cohort Study",
        "inclusion_criteria": "1. Age ≥ 18 and ≤80 years old, regardless of gender;\n2. Pathologically confirmed as adenocarcinoma of advanced colorectal cancer;\n3. Lung lesions only, which was considered as metastatic by imaging consultation, and clinically diagnosed as lung metastasis of colorectal cancer;\n4. Multiple lung lesions are allowed, but the maximum lesion diameter should be less than or equal to 2 cm;\n5. For lesions larger than 1 cm, local treatment is planned, such as radical surgical resection or local radiotherapy, radio frequency ablation or interventional therapy (absolute alcohol treatment or cryotherapy);\n6. Eastern Cooperative Oncology Group (ECOG) score 1 ~ 2;\n7. The subjects (or their legal representative / Guardian) must sign the informed consent form, indicating that they understand the purpose of the study, understand the necessary procedures of the study, and are willing to participate in the study;\n8. Surgical specimens or puncture specimens containing tumor tissue are available;\n9. 20 mL of peripheral blood are available (10 mL per tube, two tubes in total);\n10. Agreed to follow up for at least 2 years.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 80 Years",
        "exclusion_criteria": "1. The pathology was not confirmed by enteroscopic biopsy or biopsy of metastatic lesions;\n2. Patients with stage I-III colorectal cancer;\n3. Primary lung cancer, GGO, tuberculosis and other non metastatic conditions were excluded after diagnosis by imaging consultation;\n4. Presence of metastasis other than lung;\n5. Insufficient organ function, such as severe abnormal hemogram, abnormal liver and kidney function;\n6. Any signs of severe or uncontrolled systemic diseases that the researcher believes may have a significant patient risk/benefit balance, including uncontrolled hypertension, severe infection, hepatitis B, hepatitis C and human immunodeficiency virus;\n7. History of alcoholism or drug abuse;\n8. Pregnant or lactating patients.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Age ≥ 18 and ≤80 years old, regardless of gender;",
            "criterions": [
                {
                    "exact_snippets": "Age ≥ 18 and ≤80 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 80,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "regardless of gender",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "inclusion",
                            "expected_value": "all"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Pathologically confirmed as adenocarcinoma of advanced colorectal cancer;",
            "criterions": [
                {
                    "exact_snippets": "Pathologically confirmed as adenocarcinoma",
                    "criterion": "adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "pathologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "advanced colorectal cancer",
                    "criterion": "colorectal cancer",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "advanced"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Lung lesions only, which was considered as metastatic by imaging consultation, and clinically diagnosed as lung metastasis of colorectal cancer;",
            "criterions": [
                {
                    "exact_snippets": "Lung lesions only",
                    "criterion": "lung lesions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "considered as metastatic by imaging consultation",
                    "criterion": "metastatic status by imaging",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "metastatic"
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically diagnosed as lung metastasis of colorectal cancer",
                    "criterion": "lung metastasis of colorectal cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Multiple lung lesions are allowed, but the maximum lesion diameter should be less than or equal to 2 cm;",
            "criterions": [
                {
                    "exact_snippets": "Multiple lung lesions are allowed",
                    "criterion": "lung lesions",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": "multiple"
                        }
                    ]
                },
                {
                    "exact_snippets": "maximum lesion diameter should be less than or equal to 2 cm",
                    "criterion": "lesion diameter",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. For lesions larger than 1 cm, local treatment is planned, such as radical surgical resection or local radiotherapy, radio frequency ablation or interventional therapy (absolute alcohol treatment or cryotherapy);",
            "criterions": [
                {
                    "exact_snippets": "lesions larger than 1 cm",
                    "criterion": "lesion size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "cm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "local treatment is planned",
                    "criterion": "local treatment plan",
                    "requirements": [
                        {
                            "requirement_type": "planned",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Eastern Cooperative Oncology Group (ECOG) score 1 ~ 2;",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) score 1 ~ 2",
                    "criterion": "ECOG score",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. The subjects (or their legal representative / Guardian) must sign the informed consent form, indicating that they understand the purpose of the study, understand the necessary procedures of the study, and are willing to participate in the study;",
            "criterions": [
                {
                    "exact_snippets": "The subjects (or their legal representative / Guardian) must sign the informed consent form",
                    "criterion": "informed consent form",
                    "requirements": [
                        {
                            "requirement_type": "signature",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "indicating that they understand the purpose of the study",
                    "criterion": "understanding of the study purpose",
                    "requirements": [
                        {
                            "requirement_type": "understanding",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "understand the necessary procedures of the study",
                    "criterion": "understanding of study procedures",
                    "requirements": [
                        {
                            "requirement_type": "understanding",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "are willing to participate in the study",
                    "criterion": "willingness to participate",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Surgical specimens or puncture specimens containing tumor tissue are available;",
            "criterions": [
                {
                    "exact_snippets": "Surgical specimens or puncture specimens containing tumor tissue are available;",
                    "criterion": "tumor tissue",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. 20 mL of peripheral blood are available (10 mL per tube, two tubes in total);",
            "criterions": [
                {
                    "exact_snippets": "20 mL of peripheral blood are available",
                    "criterion": "peripheral blood",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "=",
                                "value": 20,
                                "unit": "mL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Agreed to follow up for at least 2 years.",
            "criterions": [
                {
                    "exact_snippets": "Agreed to follow up for at least 2 years.",
                    "criterion": "follow-up period",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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 80 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 80 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 80,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. The pathology was not confirmed by enteroscopic biopsy or biopsy of metastatic lesions;",
            "criterions": [
                {
                    "exact_snippets": "The pathology was not confirmed by enteroscopic biopsy",
                    "criterion": "pathology confirmation by enteroscopic biopsy",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "The pathology was not confirmed by ... biopsy of metastatic lesions",
                    "criterion": "pathology confirmation by biopsy of metastatic lesions",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Patients with stage I-III colorectal cancer;",
            "criterions": [
                {
                    "exact_snippets": "stage I-III colorectal cancer",
                    "criterion": "colorectal cancer",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "stage"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "stage"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Primary lung cancer, GGO, tuberculosis and other non metastatic conditions were excluded after diagnosis by imaging consultation;",
            "criterions": [
                {
                    "exact_snippets": "Primary lung cancer ... were excluded after diagnosis by imaging consultation",
                    "criterion": "primary lung cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "GGO ... were excluded after diagnosis by imaging consultation",
                    "criterion": "GGO",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "tuberculosis ... were excluded after diagnosis by imaging consultation",
                    "criterion": "tuberculosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "other non metastatic conditions were excluded after diagnosis by imaging consultation",
                    "criterion": "non metastatic conditions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Presence of metastasis other than lung;",
            "criterions": [
                {
                    "exact_snippets": "Presence of metastasis other than lung",
                    "criterion": "metastasis",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "other than lung"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Insufficient organ function, such as severe abnormal hemogram, abnormal liver and kidney function;",
            "criterions": [
                {
                    "exact_snippets": "Insufficient organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "sufficiency",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "severe abnormal hemogram",
                    "criterion": "hemogram",
                    "requirements": [
                        {
                            "requirement_type": "normality",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "abnormal liver ... function",
                    "criterion": "liver function",
                    "requirements": [
                        {
                            "requirement_type": "normality",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "abnormal ... kidney function",
                    "criterion": "kidney function",
                    "requirements": [
                        {
                            "requirement_type": "normality",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Any signs of severe or uncontrolled systemic diseases that the researcher believes may have a significant patient risk/benefit balance, including uncontrolled hypertension, severe infection, hepatitis B, hepatitis C and human immunodeficiency virus;",
            "criterions": [
                {
                    "exact_snippets": "severe or uncontrolled systemic diseases",
                    "criterion": "systemic diseases",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe or uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "severe infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "hepatitis B",
                    "criterion": "hepatitis B",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hepatitis C",
                    "criterion": "hepatitis C",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "human immunodeficiency virus",
                    "criterion": "human immunodeficiency virus",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. History of alcoholism or drug abuse;",
            "criterions": [
                {
                    "exact_snippets": "History of alcoholism",
                    "criterion": "alcoholism",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of ... drug abuse",
                    "criterion": "drug abuse",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Pregnant or lactating patients.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}