Colorectal Cancer Associated Host and Microbiome Study

Recruiting

• Conditions: Colorectal Neoplasms

• Registration Number: NCT03998644
• Lead Sponsor: Shanghai 10th People's Hospital

Brief Summary

Recruit of healthy, precancer and colorectal cancer patients and record necessary information of demographic and also other messages. All the volunteers were asked to provide samples including stool, blood, urine and tissues. This protocol is performed with the permission of the ethics committee and all the participants were provided with informed consent.

Detailed Description

Healthy subjects, precancer patients identified by colonoscopy or colonoscopy history and colorectal cancer patients identified by two independent pathologists will be enrolled. The demographic message including age, weight, height, drug history, family history of all participants will be recorded. Blood, stool and urine samples will be collected of all subjects. Tumor and adjacent tissue samples of colorectal cancer and precancer patients were collected, as well as normal tissue of healthy subjects.

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2016-12-26
• Status Verified: 2019-06
• Study First Submitted QC: 2019-06-25
• Study First Posted: 2019-06-26
• Last Update Submitted: 2019-06-30
• Last Update Posted: 2019-07-02
• Primary Completion: 2020-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

Not provided

Exclusion Criteria

1. Any one who can not provide accurate information.
2. Any one who denies the study.
3. Younger than 18.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gut microbiota structure and function difference between colorectal cancer, precancer and healthy controls	average of 5 years	The results were based on the 16S rRNA metagenomic sequencing.

Secondary Outcome Measures

Name	Time	Method
Metabolic difference of blood samples between colorectal cancer, precancer and healthy controls	average of 5 years	The metabolites of the blood samples by LC-MS will be detected.

Trial Locations

Locations (1)

Shanghai 10th People's Hospital; 🇨🇳 Shanghai, Shanghai, China