Colorectal Cancer Associated Host and Microbiome Study

June 30, 2019 updated by: Huanlong Qin, Shanghai 10th People's Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Huanlong Qin, Ph.D
  • Phone Number: 86-021-66301161
  • Email: huanlqin@126.com

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200072
        • Recruiting
        • Shanghai 10th People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Three different groups were created by healthy volunteers, precancerous and colorectal cancer patients. The information of these individuals will be analyzed and some conclusions will be drawn.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
healthy
Subjects without colorectal disorders.
precancerous
Subjects with risk factors that may contribute to the carcinogenesis.
colorectal cancer
Patients who were identified by standard procedures to suffer with colorectal cancer.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai 10th People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2015

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

December 26, 2016

First Submitted That Met QC Criteria

June 25, 2019

First Posted (Actual)

June 26, 2019

Study Record Updates

Last Update Posted (Actual)

July 2, 2019

Last Update Submitted That Met QC Criteria

June 30, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCAHMS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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