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A Study Protocol on the Fecal Metagenomics and Metabolomics Features of Colorectal Adenomas and Colorectal Cancer

A Study Protocol on the Fecal Metagenomics and Metabolomics Features of Colorectal Adenomas and Colorectal Cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400093924
Enrollment
Unknown
Registered
2024-12-13
Start date
2025-01-01
Completion date
Unknown
Last updated
2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal cancer

Interventions

Non-high-risk colorectal adenoma group:N/A
High-risk colorectal adenoma group:N/A

Sponsors

The First Medical Center of the General Hospital of the People's Liberation Army
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18–75 years; 2.No history of other malignant tumors; 3.No antibiotic treatment within three months prior to the start of treatment; 4. Must sign an informed consent form and agree to undergo relevant examinations and follow-up; 5. Must have a moderate to good physical condition to complete the study procedures; 6. Must agree to provide external hospital endoscopy reports. High-risk colorectal adenoma group: Diagnosis requires meeting at least one of the following criteria: Adenoma diameter = 10 mm; Pathological diagnosis of villous or tubulovillous adenoma; Pathology indicating high-grade dysplasia; Number of adenomas = 3. Non-high-risk colorectal adenoma group: Pathological diagnosis of adenoma but without the characteristics of high-risk colorectal adenomas mentioned above. Colorectal cancer group: Diagnosed with colorectal cancer via colonoscopy, with no prior radiotherapy, chemotherapy, or surgical treatment. Healthy control group: Healthy individuals aged 18–75 years were selected as controls.

Exclusion criteria

Exclusion criteria: 1. Patients with hereditary colorectal cancer; 2. Presence of severe systemic diseases such as cardiovascular, respiratory, or urinary system disorders; 3. Autoimmune diseases such as systemic lupus erythematosus or rheumatoid arthritis; 4. Recent history of acute infectious diseases or gastrointestinal infections; 5. Underwent surgery causing significant intestinal changes within the past year; 6. Long-term use of hormones, immunosuppressants, or other medications affecting the gut microbiota within the past three months; 7. Pregnant or breastfeeding women; 8. Coagulation disorders, contraindications to discontinuing anticoagulant medication, or related hematological disorders.

Design outcomes

Primary

MeasureTime frame
Fecal metagenomic sequencing results;Fecal metabolomics results;

Secondary

MeasureTime frame
Complete blood count ;Serological laboratory tests;The results of HE staining of intestinal tissues;Gene expression analysis of intestinal tissues;Dietary tolerance;Gastrointestinal symptoms;Bowel movement status;Exhaust situation;Incidence of newly developed polyps on endoscopy (if any);

Countries

China

Contacts

Public ContactGang Sun

The First Medical Center of the General Hospital of the People's Liberation Ar

sunok301@126.com+86 135 0107 8679

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026