Fecal Metagenomics and Metabolomics Analyses to Identify Potential Screening Biomarkers for Colorectal Polyps and Cancer in Chinese Population

NCT04947930 | Unknown

• 1 other identifier: 2021SYSUMMS
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

Many previous studies had revealed that gastrointestinal microbiome is changed compositionally and ecologically in patients with colorectal cancer comparing with healthy population. These finding provide us with a new sight to take advantage of gut microbiota. The current study aims to explore new potential biomarkers for early screening and prognostic prediction of colorectal cancer and colorectal polyps by analyzing metagenomics and metabolomics of gut microbiota.

Conditions

Colorectal Cancer; Colorectal Polyp; Mass Screening; Gastrointestinal Microbiome

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity of the screening tool generated from fecal metagenomics and metabolomics data.

  12months

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be enrolled in the Six Affiliated Hospital, Sun Yat-sen University (Guangzhou, China)，which is one of the largest gastrointestinal specialized medical centers in South China.

You may qualify if:

• Participants aged 18 to 80 years old.
• Participants who had been diagnosed with colorectal cancer or advanced colorectal polyps for the first time according to pathology results.
• Participants who had signed informed consent.
• Participants must have the ability to complete the questionnaires of the study.

You may not qualify if:

• Participants who had a positive personal history of colorectal polyps.
• Participants who had a positive personal history of colorectal cancer.
• Participants who had a positive personal history of other gastrointestinal diseases, such as inflammatory bowel disease， intestinal tuberculosis, or irritable bowel syndrome.
• Participants who had undergone a colonoscopy or other procedure requiring bowel preparation in the last two months.
• Participants who had been hospitalized for any reason in the last two months.
• Participants who had consumed antibiotics for any reason in the last three months.
• Participants who had consumed prebiotic supplements regularly in the last year.
• Participants who had other physical conditions that didn't suitable to participate in the study, such as severe cardiovascular diseases, serious mental illness, or pregnant status.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

The Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

Location

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

Study Officials

• Ping Lan, MD

  The Sixth Affiliated Hospital, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ping Lan, MD

CONTACT

+86-13710316769; lanping@mail.sysu.edu.cn

Xiaosheng He, PhD

CONTACT

+86-13543490940; hexsheng@mail.sysu.edu.cn

Study Design

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

Study Record Dates

• First Submitted: June 29, 2021
• First Posted: July 1, 2021
• Study Start: July 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2023
• Last Updated: July 1, 2021

Record last verified: 2021-06

Locations

CN (1)