NCT06379412

Brief Summary

The goal of this observational study is to explore the association of peptidoglycan fragments derived from gut microbiota with colorectal cancer (CRC). The main question it aims to answer is: Are peptidoglycan fragments from the gut microbiota associated with the progression of colorectal cancer? Participants will provide biological specimens (blood, feces, colon tissue obtained during surgery)

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 23, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

April 26, 2024

Status Verified

April 1, 2024

Enrollment Period

1.4 years

First QC Date

April 18, 2024

Last Update Submit

April 25, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • HPLC-MS/MS was used to detect peptidoglycan fragment content in biological specimens of 200 participants

    The content of peptidoglycan fragments was detected by HPLC-MS/MS

    baseline (before treatment)

Study Arms (4)

Colorectal Cancer(CRC)

People who are diagnosed with CRC by colonoscopy and pathological biopsy

Other: observational study, no intervention

Colorectal adenoma(CRA)

People who are diagnosed with CRA by colonoscopy and pathological biopsy

Other: observational study, no intervention

Colorectal polyp(CRP)

People who are diagnosed with CRP by colonoscopy and pathological biopsy

Other: observational study, no intervention

Healthy

People who have no obvious abnormality in the whole colon

Other: observational study, no intervention

Interventions

observational study, no intervention

Colorectal Cancer(CRC)Colorectal adenoma(CRA)Colorectal polyp(CRP)Healthy

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Meet eligibility criteria

You may qualify if:

  • People who underwent total colonoscopy in gastroenteroscopy room.
  • People who agree to participate in this study and are willing to sign informed consent.

You may not qualify if:

  • Previous diagnosis of malignant tumors other than colorectal cancer.
  • Received any of the following drug treatments within 1 month before sample collection: ① Drugs used for the treatment of colorectal diseases; ② Antibiotics; ③probiotics; ④ Laxatives.
  • Patients with a family history of colorectal cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Observation

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • He Xiaolong, Professor

    Southern Medical University, China

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2024

First Posted

April 23, 2024

Study Start

July 1, 2023

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

April 26, 2024

Record last verified: 2024-04

Locations