{
    "info": {
        "nct_id": "NCT06776120",
        "official_title": "The Performance of Fecal Immunochemical Test (FIT) in Diagnosing Colorectal Cancer Among Vietnamese Patients with Lower Gastrointestinal Symptoms",
        "inclusion_criteria": "In order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Aged 40 - 75 years.\n* Informed consent available.\n* Patients with lower GI symptoms (patients who experience at least one month of any lower GI symptoms: lower abdominal pain, constipation, diarrhea, changes in stool caliber, and abdominal bloating) who are scheduled for a first-time screening colonoscopy.\nHealthy volunteers allowed\nMust have minimum age of 40 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "Individuals meeting any of the following exclusion criteria will be excluded from the study:\n\n1. History of chronic inflammatory bowel disease, diverticular disease of the colon, colorectal surgery, polypectomy, colorectal cancer, artificial heart valves, or vascular graft surgery.\n2. Previous colorectal diagnostic imaging, including colonoscopy, sigmoidoscopy, computed tomography (CT) colonography, or barium enema.\n3. Presence of alarm symptoms, including lower gastrointestinal bleeding (hematochezia or melena), an abdominal mass, or unexplained clinically significant weight loss (loss of more than 5 kg or 5-10% of body weight over the past 6 months).\n4. Symptoms or signs of anorectal tumors or anal ulcers.\n5. Acute diarrhea lasting ≤14 days.\n6. Current use of aspirin, antiplatelet agents, anticoagulants, or nonsteroidal anti-inflammatory drugs (NSAIDs), as these may cause false-positive FIT results.\n7. Diagnosis of hereditary colorectal cancer syndromes (e.g., Lynch syndrome or familial adenomatous polyposis).\n8. Pregnancy, breastfeeding, or menstruation at the time of the study.\n9. Contraindications to colonoscopy.\n10. Incomplete colonoscopy due to failure to advance the scope to the cecum or inadequate bowel preparation (Boston Bowel Preparation Scale [BBPS] score <6 or a segment score <2).",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Aged 40 - 75 years.",
            "criterions": [
                {
                    "exact_snippets": "Aged 40 - 75 years.",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 40,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Informed consent available.",
            "criterions": [
                {
                    "exact_snippets": "Informed consent available.",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with lower GI symptoms (patients who experience at least one month of any lower GI symptoms: lower abdominal pain, constipation, diarrhea, changes in stool caliber, and abdominal bloating) who are scheduled for a first-time screening colonoscopy.",
            "criterions": [
                {
                    "exact_snippets": "lower GI symptoms (patients who experience at least one month of any lower GI symptoms: lower abdominal pain, constipation, diarrhea, changes in stool caliber, and abdominal bloating)",
                    "criterion": "lower GI symptoms",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "month"
                            }
                        },
                        {
                            "requirement_type": "symptoms",
                            "expected_value": [
                                "lower abdominal pain",
                                "constipation",
                                "diarrhea",
                                "changes in stool caliber",
                                "abdominal bloating"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "scheduled for a first-time screening colonoscopy",
                    "criterion": "first-time screening colonoscopy",
                    "requirements": [
                        {
                            "requirement_type": "scheduled",
                            "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 40 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 40 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 40,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 75 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 75 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. History of chronic inflammatory bowel disease, diverticular disease of the colon, colorectal surgery, polypectomy, colorectal cancer, artificial heart valves, or vascular graft surgery.",
            "criterions": [
                {
                    "exact_snippets": "History of chronic inflammatory bowel disease",
                    "criterion": "chronic inflammatory bowel disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of ... diverticular disease of the colon",
                    "criterion": "diverticular disease of the colon",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of ... colorectal surgery",
                    "criterion": "colorectal surgery",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of ... polypectomy",
                    "criterion": "polypectomy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of ... colorectal cancer",
                    "criterion": "colorectal cancer",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of ... artificial heart valves",
                    "criterion": "artificial heart valves",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of ... vascular graft surgery",
                    "criterion": "vascular graft surgery",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Previous colorectal diagnostic imaging, including colonoscopy, sigmoidoscopy, computed tomography (CT) colonography, or barium enema.",
            "criterions": [
                {
                    "exact_snippets": "Previous colorectal diagnostic imaging, including colonoscopy, sigmoidoscopy, computed tomography (CT) colonography, or barium enema.",
                    "criterion": "colorectal diagnostic imaging",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Presence of alarm symptoms, including lower gastrointestinal bleeding (hematochezia or melena), an abdominal mass, or unexplained clinically significant weight loss (loss of more than 5 kg or 5-10% of body weight over the past 6 months).",
            "criterions": [
                {
                    "exact_snippets": "Presence of alarm symptoms, including lower gastrointestinal bleeding (hematochezia or melena)",
                    "criterion": "lower gastrointestinal bleeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Presence of alarm symptoms, including ... an abdominal mass",
                    "criterion": "abdominal mass",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Presence of alarm symptoms, including ... unexplained clinically significant weight loss (loss of more than 5 kg or 5-10% of body weight over the past 6 months)",
                    "criterion": "weight loss",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 5,
                                        "unit": "kg"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 5,
                                        "unit": "%"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 10,
                                        "unit": "%"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Symptoms or signs of anorectal tumors or anal ulcers.",
            "criterions": [
                {
                    "exact_snippets": "Symptoms or signs of anorectal tumors",
                    "criterion": "anorectal tumors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Symptoms or signs of ... anal ulcers",
                    "criterion": "anal ulcers",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Acute diarrhea lasting ≤14 days.",
            "criterions": [
                {
                    "exact_snippets": "Acute diarrhea lasting ≤14 days",
                    "criterion": "acute diarrhea",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Current use of aspirin, antiplatelet agents, anticoagulants, or nonsteroidal anti-inflammatory drugs (NSAIDs), as these may cause false-positive FIT results.",
            "criterions": [
                {
                    "exact_snippets": "Current use of aspirin",
                    "criterion": "aspirin use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Current use of ... antiplatelet agents",
                    "criterion": "antiplatelet agents use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Current use of ... anticoagulants",
                    "criterion": "anticoagulants use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Current use of ... nonsteroidal anti-inflammatory drugs (NSAIDs)",
                    "criterion": "NSAIDs use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Diagnosis of hereditary colorectal cancer syndromes (e.g., Lynch syndrome or familial adenomatous polyposis).",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of hereditary colorectal cancer syndromes",
                    "criterion": "hereditary colorectal cancer syndromes",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Lynch syndrome",
                    "criterion": "Lynch syndrome",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "familial adenomatous polyposis",
                    "criterion": "familial adenomatous polyposis",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Pregnancy, breastfeeding, or menstruation at the time of the study.",
            "criterions": [
                {
                    "exact_snippets": "Pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "menstruation",
                    "criterion": "menstruation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Contraindications to colonoscopy.",
            "criterions": [
                {
                    "exact_snippets": "Contraindications to colonoscopy",
                    "criterion": "colonoscopy",
                    "requirements": [
                        {
                            "requirement_type": "contraindications",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Incomplete colonoscopy due to failure to advance the scope to the cecum or inadequate bowel preparation (Boston Bowel Preparation Scale [BBPS] score <6 or a segment score <2).",
            "criterions": [
                {
                    "exact_snippets": "Incomplete colonoscopy due to failure to advance the scope to the cecum",
                    "criterion": "colonoscopy completion",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "inadequate bowel preparation (Boston Bowel Preparation Scale [BBPS] score <6",
                    "criterion": "bowel preparation quality",
                    "requirements": [
                        {
                            "requirement_type": "BBPS score",
                            "expected_value": {
                                "operator": "<",
                                "value": 6,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "a segment score <2",
                    "criterion": "bowel preparation segment score",
                    "requirements": [
                        {
                            "requirement_type": "segment score",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "In order to be eligible to participate in this study, an individual must meet all of the following criteria:",
            "criterions": []
        }
    ],
    "failed_exclusion": [
        {
            "line": "Individuals meeting any of the following exclusion criteria will be excluded from the study:",
            "criterions": []
        }
    ],
    "failed_miscellaneous": []
}