Colorectal Cancer Associated Host and Microbiome Study

Colorectal Neoplasms Clinical Trial

Official title:

A Study Focused on the Host and Microbiome of Colorectal Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03998644
• Other study ID #: CCAHMS
• Status: Recruiting
• Start date: December 2015
• Est. completion date: December 2025

Study information

• Verified date: June 2019
• Source: Shanghai 10th People's Hospital
• Contact: Huanlong Qin, Ph.D
• Phone: 86-021-66301161
• Email: huanlqin[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 2025
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

1. individuals who were clear and signed the informed consent.

2. Male and female.

3. Age >18

Exclusion Criteria:

1. Any one who can not provide accurate information.

2. Any one who denies the study.

3. Younger than 18.

Related Conditions & MeSH terms

• Colorectal Neoplasms

Locations

Country	Name	City	State
China	Shanghai 10th People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gut microbiota structure and function difference between colorectal cancer, precancer and healthy controls	The results were based on the 16S rRNA metagenomic sequencing.	average of 5 years
Secondary	Metabolic difference of blood samples between colorectal cancer, precancer and healthy controls	The metabolites of the blood samples by LC-MS will be detected.	average of 5 years