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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04947930
• Other study ID #: 2021SYSUMMS
• Status: Not yet recruiting
• Start date: July 2021
• Est. completion date: July 2023

Study information

• Verified date: June 2021
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: Ping Lan, MD
• Phone: +86-13710316769
• Email: lanping[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Patients who come to the Sixth Affiliated Hospital, Sun Yat-sen University for medical purposes will be invited to participate in the study. Participants will be asked to collect two stool samples. One stool sample will be used for metagenomic sequencing and the other will be used to extract metabolomics data. Meanwhile, participants will be asked to complete a questionnaire about lifestyle and diet habits with the assistance of a well-trained nurse. We will delineate the community and metabolites differences in the gut microbiota between colorectal cancer patients and healthy populations by comparing cases with controls. Considering the different gut microbiota profiles among different populations caused by varied diet habits and lifestyles, the current study will try to describe the microbiota profiles in the Chinese population. Besides, we will explore new potential biomarkers for early screening and prognostic prediction which is suitable to Chinese populations. Moreover, we will attempt to find out the interactions between diet and microbiota through a comprehensive analysis of the questionnaire and the collected results.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: July 2023
• Est. primary completion date: July 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Participants aged 18 to 80 years old.

2. Participants who had been diagnosed with colorectal cancer or advanced colorectal polyps for the first time according to pathology results.

3. Participants who had signed informed consent.

4. Participants must have the ability to complete the questionnaires of the study.

Exclusion Criteria:

1. Participants who had a positive personal history of colorectal polyps.

2. Participants who had a positive personal history of colorectal cancer.

3. Participants who had a positive personal history of other gastrointestinal diseases, such as inflammatory bowel disease, intestinal tuberculosis, or irritable bowel syndrome.

4. Participants who had undergone a colonoscopy or other procedure requiring bowel preparation in the last two months.

5. Participants who had been hospitalized for any reason in the last two months.

6. Participants who had consumed antibiotics for any reason in the last three months.

7. Participants who had consumed prebiotic supplements regularly in the last year.

8. 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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Polyp
• Gastrointestinal Microbiome
• Mass Screening
• Polyps

Locations

Country	Name	City	State
China	The Sixth Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of the screening tool generated from fecal metagenomics and metabolomics data.		12months