colorectal cancer
Conditions
Interventions
None listed
Sponsors
St. Marianna University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with a confirmed diagnosis of colorectal cancer who are scheduled to undergo colonoscopy as part of routine clinical care at the time of diagnosis or thereafter. * If the patient has already undergone colonoscopy, the diagnosis is definitive, and no further examinations are required, only the results from that prior colonoscopy will be used. * If a repeat colonoscopy is performed (e.g., for pre-operative assessment), the findings from the repeat examination will be used as study data. 2. Genetically Japanese individuals. 3. Age: 40 - 65 years at the time of enrollment. 4. Performance Status (ECOG): 0, 1, or 2. 5. **Written informed consent** obtained from the patient after adequate explanation of the study.
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding individuals. 2. Subjects who have difficulty with spontaneous defecation and require laxatives, enemas, or similar interventions. 3. Patients with severe dysfunction or failure of a major organ (heart, lung, liver, kidney, or bone marrow). 4. Patients with inflammatory bowel disease (IBD) or familial adenomatous polyposis. 5. Patients with a history of colorectal surgery, excluding appendectomy. 6. Individuals who have used antibiotics within the past three months. 7. Individuals judged by the principal or sub-investigator to be unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic accuracy of the gut-microbiome assay for colorectal cancer (including early lesions): sensitivity and specificity | — |
Countries
Japan
Contacts
Public ContactTADATERU MAEHATA
St. Marianna University School of Medicine Department of Gastroenterology
Outcome results
None listed