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

• Sponsor: Zhujiang Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05998915
• Collaborator: (none)
• Enrollment: 5
• Location: 1
• Anticipated Duration (Months): 34
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Human Microecology；Colorectal Disease；Auxiliary Diagnosis	Other: observe only

Detailed Description

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

Study Design

• Study Type: Observational
• Anticipated Enrollment: 5 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: A Multi-center Study on Human Microecology Assisted Diagnosis of Colorectal Cancer
• Actual Study Start Date: Mar 1, 2023
• Anticipated Primary Completion Date: Dec 30, 2025
• Anticipated Study Completion Date: Dec 31, 2025

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. collect specimen before colonscope [Baseline (before colonscope)]

   collect fecal，saliva，urine，blood

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhujiang Hospital of Southern Medical University	Guangzhou	Guangdong	China	510000

Sponsors and Collaborators

• Zhujiang Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zhujiang Hospital
• ClinicalTrials.gov Identifier: NCT05998915
• Other Study ID Numbers: CALM2102
• First Posted: Aug 21, 2023
• Last Update Posted: Aug 21, 2023
• Last Verified: Mar 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Disease

Study Results

No Results Posted as of Aug 21, 2023