Intestinal Flora Differences Between Colorectal Cancer Patients and Healthy Individuals

NCT06875648 | Completed

• 1 other identifier: GDMEC-2024-028
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

This observational case-control study aims to compare the composition of intestinal microbiota between colorectal cancer (CRC) patients and healthy individuals. Fecal samples from 36 CRC patients and 25 healthy controls were analyzed for bacterial abundance. Results indicate significant differences in beneficial, neutral, and harmful bacterial populations between groups, with CRC patients showing reduced beneficial flora (e.g., Lactobacillus) and increased harmful/neutral flora (e.g., Staphylococcus). Further stratification by cancer stage (I-III) revealed progressive dysbiosis with disease progression.

Conditions

Colorectal Cancer; Gut Microbiota Dysbiosis

Keywords

Colorectal Neoplasms (MeSH); Gastrointestinal Microbiome (MeSH); Dysbiosis (MeSH); Microbial Biomarkers

Outcome Measures

Primary Outcomes (1)

• Comparison of Mean Relative Abundance of Intestinal Bacterial Genera between CRC Patients and Healthy Controls

  The primary metric is the mean relative abundance of specific intestinal bacterial genera (e.g., Lactobacillus, Bifidobacterium, Staphylococcus). Quantitative comparison will be performed between CRC patients and healthy controls using data obtained from fecal samples via 16S rRNA sequencing or qPCR. This is a retrospective analysis of samples collected between January 2021 and March 2025.

  Retrospective analysis of fecal samples collected between January 2021 and March 2025

Study Arms (2)

CRC Patients

Participants: 36 individuals with histopathologically confirmed colorectal cancer. Data Source: Archived fecal samples and medical records from patients diagnosed between January 2022 and October 2023. Inclusion Criteria: Adults (≥18 years). Newly diagnosed CRC without prior chemotherapy/radiotherapy. Availability of fecal samples collected at diagnosis. Exclusion Criteria: Antibiotic/probiotic use within 3 months before sample collection. Concurrent gastrointestinal infections or inflammatory bowel disease. Subgroups: Stratified by clinical stage (I, II, III) based on TNM classification from medical records.

Other: Not applicable (observational study)

Healthy Controls

Participants: 25 age- and gender-matched individuals without gastrointestinal diseases or cancer history. Data Source: Archived fecal samples and health screening records from routine check-ups during the same period. Inclusion Criteria: Adults (≥18 years). No history of colorectal polyps, cancer, or chronic gastrointestinal disorders. Normal colonoscopy or fecal occult blood test results. Exclusion Criteria: Antibiotic/probiotic use within 3 months before sample collection. Recent acute gastrointestinal symptoms (e.g., diarrhea, constipation).

Other: Not applicable (observational study)

Interventions

Not applicable (observational study) OTHER

Retrospective analysis of gut microbiota in CRC patients vs. healthy controls. No interventions were administered; data were collected from archived samples and medical records.

CRC Patients; Healthy Controls

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Retrospective case-control study of 36 CRC patients (stages I-III, diagnosed 2022-2023) and 25 healthy controls from Central Hospital, Zhanjiang, China. CRC group: pre-treatment fecal samples, TNM staging. Control group: age/gender-matched, no GI diseases, normal colonoscopy/fecal tests. Exclusions: antibiotic/probiotic use (past 3 months), inflammatory bowel disease, incomplete records.

You may qualify if:

• Adults (≥18 years) with histopathologically confirmed colorectal cancer (CRC group)
• Archived fecal sample available from time of CRC diagnosis (prior to treatment)
• Complete clinical records including TNM staging (I-III) for CRC patients
• Age- and gender-matched adults without CRC history (control group)
• Archived fecal sample available from routine health check-ups (control group)

You may not qualify if:

• Recent antibiotic or probiotic use (within 3 months)
• History of inflammatory bowel disease
• Incomplete medical records
• For controls: history of colorectal cancer, polyps, or chronic gastrointestinal diseases
• For controls: abnormal colonoscopy or fecal occult blood test within the past year

Sponsors & Collaborators

• Hansung University: lead

Study Sites (1)

Central Hospital of Guangdong Provincial Nongken

Zhanjiang, Guangdong, 524002, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Biospecimen Type: Fecal samples (preserved for microbial DNA analysis). Collection: Collected retrospectively from colorectal cancer (CRC) patients at diagnosis and healthy controls during routine check-ups. Storage: Archived at -80°C in hospital biobanks prior to DNA extraction. Processing: DNA extracted from fecal samples using standardized kits (e.g., QIAamp DNA Stool Mini Kit). Focus on bacterial genomic DNA (e.g., 16S rRNA gene sequencing targeting V3-V4 regions or whole-genome shotgun metagenomics). Quality Control: DNA concentration and purity verified via spectrophotometry (e.g., NanoDrop) and gel electrophoresis. Purpose: To characterize gut microbiota composition (bacterial taxa abundance) and compare CRC patients vs. healthy controls.

MeSH Terms

Conditions

Colorectal Neoplasms; Dysbiosis

Interventions

Observation

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 13, 2025
• Study Start: January 1, 2021
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)