A Multi-center Study on Human Microecology Assisted Diagnosis of Colorectal Cancer (2102)

November 23, 2023 updated by: Zhujiang Hospital
As for this research，we want to find whether the intestinal microecology (flora, peptidoglycan fragments) have certain distribution characteristics in colorectal diseases; whether it can predict the development of disease/as a prognostic indicator.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

We even want to find whether it can predict the development of disease/as a prognostic indicator.

Study Type

Observational

Enrollment (Estimated)

5

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

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Zhujiang Hospital of Southern Medical University
        • 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

2500

Description

Inclusion Criteria:

  • people who is going to get the colonoscopy examination

Exclusion Criteria:

  • people who was diagnosed as one cancer，expect for CRC; who has had the antibiotics or the medicine that treats for colorectal disease, except for medical probiotics, in one month; who has had the laxative and the colonscopy in one week; who had a operation in three month.

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
Intervention / Treatment
Colorectal Cancer(CRC)
People who is diagnosed with CRC by colonoscopy and pathological biopsy
Other: observe only
observe only
Inflammatory Bowel Disease
People who is diagnosed with IBD by colonoscopy and pathological biopsy
Other: observe only
observe only
Colorectal adenoma(CRA)/adenomatous polyposis
People who is diagnosed with CRA by colonoscopy and pathological biopsy
Other: observe only
observe only
Non-adenomatous polyps
People who is diagnosed with non-adenomatous polyps by colonoscopy and pathological biopsy
Other: observe only
observe only
Irritable bowel syndrome
People who is diagnosed with IBS by colonoscopy and pathological biopsy
Other: observe only
observe only
normal
People who has no obvious abnormality in the whole colon
Other: observe only
observe only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
collect specimen before colonscope
Time Frame: Baseline (before colonscope)
collect fecal，saliva，urine，blood to assess the level of the activation of NOD2，cytokines
Baseline (before colonscope)

Collaborators and Investigators

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

Sponsor

Zhujiang 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)

March 1, 2023

Primary Completion (Estimated)

December 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

August 11, 2023

First Submitted That Met QC Criteria

August 17, 2023

First Posted (Actual)

August 21, 2023

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 23, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CALM2102

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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