Clinical trial · Observational
Diagnostic Accuracy of a Panel of Bacterial Gene Markers (M3) for Colorectal Advanced Neoplasia
A Prospective Cross-sectional Multi-center Study to Assess the Diagnostic Accuracy of a Panel of Bacterial Gene Markers (M3) for Colorectal Advanced Neoplasia
NCT05405673CI-TRIAL-00080184M3-PROactive not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
The investigators aim to evaluate and compare the diagnostic accuracy of FIT and the novel panel of bacterial gene markers (Fn, m3, Ch and Bc) collectively named as M3, in detecting colorectal advanced neoplasia.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Adenoma | Colorectal Adenoma | ONTOLOGY_EXACT | 0.98 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fecal immunochemical test (FIT) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Colorectal neoplasia screening/surveillance cohort
- description
- Subjects with average risk of colorectal neoplasias requiring screening/surveillance colonoscopy
- interventionNames
- Diagnostic Test: Fecal immunochemical test (FIT)
Primary outcomes (2)
- measure
- Sensitivity of bacterial gene markers panel (M3)
- timeFrame
- 1 month
- description
- The proportion of subjects with true positive results of M3 among those with one of more advanced neoplasia detected in the index colonoscopy.
- measure
- Sensitivity of FIT/FOBT
- timeFrame
- 1 month
- description
- The proportion of subjects with true positive results of FIT among those with one of more advanced neoplasia detected in the index colonoscopy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. They require elective colonoscopy for colorectal cancer screening or polyp surveillance, or investigation of symptoms (e.g. anemia, change of bowel habit, abdominal pain); 2. Aged ≥18 years old; 3. Written informed consent obtained. Exclusion Criteria: 1. Contraindications to colonoscopy (e.g. perforation, intestinal obstruction, unstable cardiopulmonary status); 2. Contraindication to polyp resection (e.g. active gastrointestinal bleeding, uninterrupted anticoagulation or dual antiplatelets); 3. Known colorectal cancer or adenoma for staged procedure; 4. Previous colonic resection; 5. Personal history of colorectal cancer; 6. Personal history of polyposis syndrome; 7. Personal history of inflammatory bowel disease; 8. Known pregnancy or lactation; 9. Advanced comorbid conditions (defined as American Society of Anesthesiologists grade 4 or above);
References
Publications (0)
Data not yet available
No reference posted for this study.