Diagnostic Accuracy of a Panel of Bacterial Gene Markers (M3) for Colorectal Advanced Neoplasia

Launched by CHINESE UNIVERSITY OF HONG KONG · Jun 1, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at how well a new test, called the M3 panel, can detect advanced colorectal neoplasia, which includes conditions like colorectal cancer and polyps. The M3 panel checks for specific bacterial gene markers in addition to a commonly used test called FIT (Fecal Immunochemical Test). Researchers want to see if this new test can improve the accuracy of diagnosing these serious conditions during routine colonoscopies.

To participate in this study, you need to be at least 18 years old and scheduled for a colonoscopy either for cancer screening, monitoring polyps, or checking symptoms like abdominal pain. However, certain conditions may prevent you from joining, such as having a history of colorectal cancer or other significant health issues. If you decide to participate, you will be asked to provide consent and undergo the usual procedures during your colonoscopy, with the added benefit of helping researchers learn more about colorectal health. This study is currently recruiting participants of all genders.

Gender

ALL

Eligibility criteria

• 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);