Colorectal Neoplasia and Microbiota: Does Left Equal Right?

NCT03623152 | Unknown

• 1 other identifier: CRC MIC L&R
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Many studies, including our own, have shown that colorectal cancer (CRC) is related to changes in the microbiome of the colon. However, there are limitations in most studies and questions remained unanswered. Some early data showing that the microbiome in the left vs right colon are different. The aim of this study is to investigate the microbiome (including bacteriome, virome, and fungome) of adenoma/CRC comparing the left (distal to splenic flexure) vs right side (proximal to splenic flexure) of the colon.

Conditions

Colo-rectal Cancer

Outcome Measures

Primary Outcomes (1)

• Descriptive statistics will be used for demographics data

  Since the sample size is small, non-parametric chi-square test or Mann-Whitney tests will be used for the comparison of the clinical data between the cases with adenoma or CRC on the right and left side colon.

  All biological samples will be stored for a maximum of 10 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients have scheduled colonoscopy

You may qualify if:

• \>18 years of age, with the informed consent of the study-specific colonoscopy examination method and samples collection
• have an indication for a scheduled colonoscopy, either as an investigation of colorectal symptom or as part of a CRC screening
• for those who are known to have either adenoma or CRC, colonoscopy is arranged for endoscopic submucosal dissection (ESD) or endoscopic mucosectomy (EMR)

You may not qualify if:

• a. known history of coagulopathy b. recently on antithrombotics or antiplatelets c. recently on antibiotics, prebiotics, probiotics and symbiotics d. anticipated prolonged standard colonoscopy procedure at endoscopist's discretion e. consent cannot be obtained

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Endoscopy Center, Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Colonic biopsies from each site, stool and blood will be collected

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Joseph JY Sung

  Chinese Univeristy of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuet Ling Ching

CONTACT

35053524; jessicaching@cuhk.edu.hk

Ming Yeung Ho

CONTACT

26371398; andrewho@cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 7, 2018
• First Posted: August 9, 2018
• Study Start: August 7, 2018
• Primary Completion: September 6, 2019
• Study Completion: October 6, 2019
• Last Updated: July 24, 2019

Record last verified: 2019-07

Locations

HK (1)