Serial Gut Microbiome and Bacterial Gene Markers Changes After Endoscopic Resection of Colorectal Advanced Neoplasia

NCT05381792 | Recruiting

• 1 other identifier: 2022.127
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators hypothesize that gut microbiome composition and the four bacterial gene markers (M3) show dynamic changes after endoscopic resection of advanced neoplasia, some key bacteria are associated with restoration of gut microbiome after endoscopic resection.

Conditions

Colorectal Cancer; Colorectal Neoplasms; Colorectal Adenoma

Outcome Measures

Primary Outcomes (2)

• Serial bacterial gene markers changes (Fn, m3, Bc and Ch) after endoscopic resection of colorectal advanced neoplasia.

  Bacterial gene markers change tested by quantitative polymerase chain reaction (qPCR)

  6 months

• Serial gut microbiome changes after endoscopic resection of colorectal advanced neoplasia.

  Gut microbiome change tested by metagenomic sequencing

  6 months

Secondary Outcomes (3)

• The differences in the bacterial gene markers (Fn, m3, Bc and Ch) between different sites/sizes/pathology of advanced adenoma

  6 months

• The differences in the bacterial gene markers (Fn, m3, Bc and Ch) between different stages of CRC

  6 months

• The differences in the bacterial gene markers (Fn, m3, Bc and Ch) between advanced adenoma and CRC

  6 months

Study Arms (1)

Known colorectal advanced neoplasia group

Subjects with known colorectal advanced neoplasia and requiring endoscopic resection

Diagnostic Test: Bacterial gene markers test

Interventions

Bacterial gene markers test DIAGNOSTIC_TEST

Bacterial gene markers test using qPCR

Known colorectal advanced neoplasia group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with known colorectal advanced neoplasia

You may qualify if:

• Subjects require endoscopic resection (e.g. endoscopic mucosal resection or endoscopic submucosal dissection) for advanced adenoma or early-stage colorectal cancer;
• Aged 18-90 years old;
• Written informed consent obtained.

You may not qualify if:

• Absolute contraindications to colonoscopy (e.g. perforation, intestinal obstruction, unstable cardiopulmonary status);
• Contraindications to endoscopic resection (e.g. active gastrointestinal bleeding, uninterrupted anticoagulation or dual antiplatelets);
• Known pregnancy or lactation;
• Advanced comorbid conditions (defined as American Society of Anesthesiologists grade 4 or above);

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Shatin, New Territories, Hong Kong

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Stool sample

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Min Dai

CONTACT

6049 0760; mindai@link.cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor (clinical)

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 19, 2022
• Study Start: September 1, 2022
• Primary Completion: December 15, 2024
• Study Completion: December 15, 2024
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)