{
    "info": {
        "nct_id": "NCT06294873",
        "official_title": "Stool Sample Collection Study for Colorectal Cancer Test Research and Development",
        "inclusion_criteria": "1. Participant is a person ≥18 years of age.\n2. Participant has a diagnosis of CRC, at any stage, or ≥1 cm colorectal polyp/adenoma/mass found during pre-enrollment colonoscopy that is of sufficient size to require surgical excision or complex colonoscopic polypectomy.\n3. Participant understands the study procedures and can provide informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Participant has actively bleeding hemorrhoids.\n2. Participant has active synchronous extra-colonic aerodigestive tract cancers (e.g., lung, esophagus, stomach, or pancreatic cancer).\n3. Participant has a prior history of extra-colonic aerodigestive tract malignancy within the past 5 years.\n4. Participant has a history of any inflammatory bowel disease.\n5. Participant has familial adenomatous polyposis, hereditary non-polyposis colorectal cancer (Lynch) syndrome, or other hereditary cancer syndromes.\n6. Participant has benign (non-pre-cancerous) polyps such as inflammatory polyps or hamartoma polyps.\n7. Individual has a condition the Investigator believes would interfere with their ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.\n\n   -",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Participant is a person ≥18 years of age.",
            "criterions": [
                {
                    "exact_snippets": "Participant is a person ≥18 years of age.",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Participant has a diagnosis of CRC, at any stage, or ≥1 cm colorectal polyp/adenoma/mass found during pre-enrollment colonoscopy that is of sufficient size to require surgical excision or complex colonoscopic polypectomy.",
            "criterions": [
                {
                    "exact_snippets": "diagnosis of CRC",
                    "criterion": "CRC diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "at any stage",
                    "criterion": "CRC stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "any"
                        }
                    ]
                },
                {
                    "exact_snippets": "≥1 cm colorectal polyp/adenoma/mass",
                    "criterion": "colorectal polyp/adenoma/mass size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "cm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "sufficient size to require surgical excision or complex colonoscopic polypectomy",
                    "criterion": "colorectal polyp/adenoma/mass treatment requirement",
                    "requirements": [
                        {
                            "requirement_type": "treatment requirement",
                            "expected_value": [
                                "surgical excision",
                                "complex colonoscopic polypectomy"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Participant understands the study procedures and can provide informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.",
            "criterions": [
                {
                    "exact_snippets": "Participant understands the study procedures",
                    "criterion": "understanding of study procedures",
                    "requirements": [
                        {
                            "requirement_type": "understanding",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "can provide informed consent",
                    "criterion": "ability to provide informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "authorization for release of relevant protected health information",
                    "criterion": "authorization for release of protected health information",
                    "requirements": [
                        {
                            "requirement_type": "authorization",
                            "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. Participant has actively bleeding hemorrhoids.",
            "criterions": [
                {
                    "exact_snippets": "actively bleeding hemorrhoids",
                    "criterion": "hemorrhoids",
                    "requirements": [
                        {
                            "requirement_type": "bleeding",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Participant has active synchronous extra-colonic aerodigestive tract cancers (e.g., lung, esophagus, stomach, or pancreatic cancer).",
            "criterions": [
                {
                    "exact_snippets": "active synchronous extra-colonic aerodigestive tract cancers",
                    "criterion": "synchronous extra-colonic aerodigestive tract cancers",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "lung",
                    "criterion": "lung cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "esophagus",
                    "criterion": "esophageal cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "stomach",
                    "criterion": "stomach cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pancreatic cancer",
                    "criterion": "pancreatic cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Participant has a prior history of extra-colonic aerodigestive tract malignancy within the past 5 years.",
            "criterions": [
                {
                    "exact_snippets": "prior history of extra-colonic aerodigestive tract malignancy within the past 5 years",
                    "criterion": "extra-colonic aerodigestive tract malignancy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Participant has a history of any inflammatory bowel disease.",
            "criterions": [
                {
                    "exact_snippets": "history of any inflammatory bowel disease",
                    "criterion": "inflammatory bowel disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Participant has familial adenomatous polyposis, hereditary non-polyposis colorectal cancer (Lynch) syndrome, or other hereditary cancer syndromes.",
            "criterions": [
                {
                    "exact_snippets": "Participant has familial adenomatous polyposis",
                    "criterion": "familial adenomatous polyposis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hereditary non-polyposis colorectal cancer (Lynch) syndrome",
                    "criterion": "hereditary non-polyposis colorectal cancer (Lynch) syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "other hereditary cancer syndromes",
                    "criterion": "hereditary cancer syndromes",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Participant has benign (non-pre-cancerous) polyps such as inflammatory polyps or hamartoma polyps.",
            "criterions": [
                {
                    "exact_snippets": "Participant has benign (non-pre-cancerous) polyps",
                    "criterion": "benign polyps",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "inflammatory polyps",
                    "criterion": "inflammatory polyps",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hamartoma polyps",
                    "criterion": "hamartoma polyps",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Individual has a condition the Investigator believes would interfere with their ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.",
            "criterions": [
                {
                    "exact_snippets": "condition the Investigator believes would interfere with their ability to provide informed consent",
                    "criterion": "condition affecting informed consent",
                    "requirements": [
                        {
                            "requirement_type": "interference",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "condition the Investigator believes would ... comply with the study protocol",
                    "criterion": "condition affecting compliance with study protocol",
                    "requirements": [
                        {
                            "requirement_type": "interference",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "condition the Investigator believes would ... confound the interpretation of the study results",
                    "criterion": "condition confounding study results",
                    "requirements": [
                        {
                            "requirement_type": "interference",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "condition the Investigator believes would ... put the person at undue risk",
                    "criterion": "condition putting person at undue risk",
                    "requirements": [
                        {
                            "requirement_type": "risk",
                            "expected_value": "undue"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "-",
            "criterions": []
        }
    ],
    "failed_miscellaneous": []
}