Colorectal Cancer; Gut Microbiota DysbiosisNCT06875648
Intestinal Flora Differences Between Colorectal Cancer Patients and Healthy Individuals
An observational study of Colorectal Cancer; Gut Microbiota Dysbiosis, run by Hansung University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer; Gut Microbiota Dysbiosis
- What is being tested?
- Not applicable (observational study)
- How many people
- 61 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 1 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Central Hospital of Guangdong Provincial Nongken
Zhanjiang, Guangdong, 524002
About this study
Official title: Intestinal Flora Differences Between Colorectal Cancer Patients and Healthy Individuals: A Case-Control Study
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.
Read the detailed description
This observational case-control study investigates the compositional differences in intestinal microbiota between individuals diagnosed with colorectal cancer (CRC) and healthy controls. The study enrolled 36 CRC patients confirmed by histopathology and 25 age- and gender-matched healthy volunteers without gastrointestinal diseases or antibiotic/probiotic use within the preceding three months. Fecal samples were collected from CRC patients at the time of diagnosis and from healthy participants during routine health screenings. Utilizing 16S rRNA sequencing or quantitative PCR, the relative abundance of specific bacterial taxa (e.g., Lactobacillus, Bifidobacterium, Staphylococcus) was quantified to assess dysbiosis patterns. Additionally, the analysis stratified CRC patients by clinical stage (I-III) to explore progressive shifts in microbial communities with disease advancement. The findings aim to elucidate the role of gut microbiota in CRC pathogenesis and provide insights into potential microbiome-based diagnostic or therapeutic strategies.
- Being tested
- Not applicable (observational study)
- Keywords
- Colorectal Neoplasms (MeSH), Gastrointestinal Microbiome (MeSH), Dysbiosis (MeSH), Microbial Biomarkers
- Medical subject headings
- Colorectal Neoplasms, Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Other: Not applicable (observational study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Retrospective analysis of fecal samples collected between January 2021 and March 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start1 Jan 2021
- Primary completion1 Mar 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer; Gut Microbiota DysbiosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hansung University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06875648
- Sponsor's protocol ID
- GDMEC-2024-028
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2025
- Last updated
- 18 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly due to restrictions imposed by the hospital ethics committee and Chinese data privacy laws.
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intestinal Flora Differences Between Colorectal Cancer Patients and Healthy Individuals: A Case-Control Study
- ClinicalTrials.gov ID
- NCT06875648
- Acronym / sponsor ID
- GDMEC-2024-028
- Keywords
- Colorectal Neoplasms (MeSH), Gastrointestinal Microbiome (MeSH), Dysbiosis (MeSH), Microbial Biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Hansung UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This observational case-control study investigates the compositional differences in intestinal microbiota between individuals diagnosed with colorectal cancer (CRC) and healthy controls. The study enrolled 36 CRC patients confirmed by histopathology and 25 age- and gender-matched healthy volunteers without gastrointestinal diseases or antibiotic/probiotic use within the preceding three months. Fecal samples were collected from CRC patients at the time of diagnosis and from healthy participants during routine health screenings. Utilizing 16S rRNA sequencing or quantitative PCR, the relative abundance of specific bacterial taxa (e.g., Lactobacillus, Bifidobacterium, Staphylococcus) was quantified to assess dysbiosis patterns. Additionally, the analysis stratified CRC patients by clinical stage (I-III) to explore progressive shifts in microbial communities with disease advancement. The findings aim to elucidate the role of gut microbiota in CRC pathogenesis and provide insights into potential microbiome-based diagnostic or therapeutic strategies.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRC Patients | – | Other: Not applicable (observational study)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. |
| Healthy Controls | – | Other: Not applicable (observational study)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). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not applicable (observational study)Retrospective analysis of gut microbiota in CRC patients vs. healthy controls. No interventions were administered; data were collected from archived samples and medical records. | Other | CRC Patients, Healthy Controls |
Primary outcome
Comparison of Mean Relative Abundance of Intestinal Bacterial Genera between CRC Patients and Healthy Controls
Time frame: Retrospective analysis of fecal samples collected between January 2021 and March 2025
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly due to restrictions imposed by the hospital ethics committee and Chinese data privacy laws.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer; Gut Microbiota Dysbiosis, run by Hansung University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Mean Relative Abundance of Intestinal Bacterial Genera between CRC Patients and Healthy Controls (time frame: Retrospective analysis of fecal samples collected between January 2021 and March 2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.