Colorectal CancerNCT07321548
Investigating the Gut Microbiota of Individuals With Adenoma, Advanced Adenoma and Colorectal Cancer
An observational study of Colorectal Cancer and Colorectal Adenoma, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
This observational study aims to help establish the first molecular test for non-invasive prediction of recurrent adenoma, which will help identify patients at high risk of recurrent adenoma for further colonoscopy examination, and validate the microbial test for CRC screening in different populations. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Colorectal Adenoma, Colorectal Neoplasms
- What is being tested?
- Fecal immunochemical test
- How many people
- 1,757 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 Mar 2021to 30 Sep 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Population scheduled for colonoscopy of participating country/city will be invited and recruited in wards, clinics or endoscopy centres.
Who may be able to join
- History of polypectomy or surgical removal of adenoma or CRC within the past 10 years
- Will undergo a scheduled standard colonoscopy examination
Who cannot join
- History of inflammatory bowel disease
Trial locations and contacts
1 site in 1 country.
About this study
This observational study aims to help establish the first molecular test for non-invasive prediction of recurrent adenoma, which will help identify patients at high risk of recurrent adenoma for further colonoscopy examination, and validate the microbial test for CRC screening in different populations.
Read the detailed description
Colorectal cancer (CRC) is one of the most common malignancies worldwide. CRC is now the commonest cancer and the second cause of cancer death in Hong Kong. Most CRCs begin as small polyps. Some polyps in particular adenomas may gradually develop into cancer. Early detection of cancer can facilitate successful treatment, and early detection of adenomas can prevent and decrease CRC incidence. Therefore, many efforts are being made to screening of colorectal adenoma and cancer, which will benefit public health greatly in Hong Kong and worldwide.
Abnormality in the composition of the gut microbiota has been implicated as a potentially important etiological factor in the initiation and progression of CRC. With the widespread application of metagenomic analyses in the investigation of intestinal microbiota, an increasing number of bacteria have been identified to be positively associated with CRC. Recent basic research has established a critical function for the intestinal microbiota and specific bacterial species, in promoting colorectal tumorigenesis.
Based on the previously identified microbial markers, the investigators have recently proven that fecal microbial markers can also serve in non-invasive diagnosis of recurrent adenoma in post polypectomy patients. The results have shown that, the panel of microbial markers composing of Fusobacterium nucleatum (Fn), Bacteroides clarus (Bc), Clostridium hathewayi (Ch), and the Lachnoclostridium marker m3 shows good diagnostic performance for colorectal adenoma and CRC. Microbial markers can be used to predict risk of adenoma recurrence during follow-up surveillance, with different scoring algorithms and cutoff values as compared to those used for colorectal neoplasm screening. However, only retrospective samples were used in the previous study, and sample size was limited. A prospective study is warranted to verify the accuracy of the microbial test for predicting recurrent adenoma.
- Conditions
- Colorectal Cancer, Colorectal Adenoma, Colorectal Neoplasms
- Being tested
- Fecal immunochemical test
- Keywords
- Gut Microbiome, Non-invasive Test
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal immunochemical testDiagnostic test
This diagnosis test is commonly used for screening CRC, which can act as an indicator to compare the performance of our new molecular test
| Study group | Role | What they receive |
|---|---|---|
| N | Healthy control Receives: Diagnostic Test: Fecal immunochemical test | |
| nAA | Subject diagnosed with non-advanced adenoma Receives: Diagnostic Test: Fecal immunochemical test | |
| AA | Subject diagnosed with advanced adenoma Receives: Diagnostic Test: Fecal immunochemical test | |
| CRC | Subject diagnosed with colorectal cancer Receives: Diagnostic Test: Fecal immunochemical test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the performance of microbial markers in predicting adenoma and CRC
Measured: 3 months after stool sample submission
Secondary outcomes (2)
Compare microbiome composition between healthy subjects and populations with adenoma, advanced adenoma, and colorectal cancer
Measured: Approximately 1 year after completed subject recruitment of the study
Delineate the gut microbial community profiles of the population with adenoma, advanced adenoma, and colorectal cancer residing in different geographical locations with different lifestyles
Measured: Approximately 1 year after completed subject recruitment of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start15 Mar 2021
- Primary completion30 Nov 2024
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 1,757 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Gastroenterology and Hepatology, Vietnam, Mahidol University, National University of Malaysia, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Responsible party
- Principal investigator, Jessie Qiaoyi Liang, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07321548
- Sponsor's protocol ID
- CREC 2021.036
- Status last verified
- Oct 2025
- First submitted
- 18 Dec 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Gut Microbiota of Individuals With Adenoma, Advanced Adenoma and Colorectal Cancer
- ClinicalTrials.gov ID
- NCT07321548
- Acronym / sponsor ID
- CREC 2021.036
- Conditions
- Colorectal Cancer, Colorectal Adenoma, Colorectal Neoplasms
- Keywords
- Gut Microbiome, Non-invasive Test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,757 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Institute of Gastroenterology and Hepatology, Vietnam, Mahidol University, National University of Malaysia, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 7 Jan 2026 (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 study aims to help establish the first molecular test for non-invasive prediction of recurrent adenoma, which will help identify patients at high risk of recurrent adenoma for further colonoscopy examination, and validate the microbial test for CRC screening in different populations.
Detailed description
Colorectal cancer (CRC) is one of the most common malignancies worldwide. CRC is now the commonest cancer and the second cause of cancer death in Hong Kong. Most CRCs begin as small polyps. Some polyps in particular adenomas may gradually develop into cancer. Early detection of cancer can facilitate successful treatment, and early detection of adenomas can prevent and decrease CRC incidence. Therefore, many efforts are being made to screening of colorectal adenoma and cancer, which will benefit public health greatly in Hong Kong and worldwide.
Abnormality in the composition of the gut microbiota has been implicated as a potentially important etiological factor in the initiation and progression of CRC. With the widespread application of metagenomic analyses in the investigation of intestinal microbiota, an increasing number of bacteria have been identified to be positively associated with CRC. Recent basic research has established a critical function for the intestinal microbiota and specific bacterial species, in promoting colorectal tumorigenesis.
Based on the previously identified microbial markers, the investigators have recently proven that fecal microbial markers can also serve in non-invasive diagnosis of recurrent adenoma in post polypectomy patients. The results have shown that, the panel of microbial markers composing of Fusobacterium nucleatum (Fn), Bacteroides clarus (Bc), Clostridium hathewayi (Ch), and the Lachnoclostridium marker m3 shows good diagnostic performance for colorectal adenoma and CRC. Microbial markers can be used to predict risk of adenoma recurrence during follow-up surveillance, with different scoring algorithms and cutoff values as compared to those used for colorectal neoplasm screening. However, only retrospective samples were used in the previous study, and sample size was limited. A prospective study is warranted to verify the accuracy of the microbial test for predicting recurrent adenoma.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| N | – | Diagnostic Test: Fecal immunochemical testHealthy control |
| nAA | – | Diagnostic Test: Fecal immunochemical testSubject diagnosed with non-advanced adenoma |
| AA | – | Diagnostic Test: Fecal immunochemical testSubject diagnosed with advanced adenoma |
| CRC | – | Diagnostic Test: Fecal immunochemical testSubject diagnosed with colorectal cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Population scheduled for colonoscopy of participating country/city will be invited and recruited in wards, clinics or endoscopy centres.
Key inclusion criteria (2 listed)
- History of polypectomy or surgical removal of adenoma or CRC within the past 10 years
- Will undergo a scheduled standard colonoscopy examination
Key exclusion criteria (1 listed)
- History of inflammatory bowel disease
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 |
|---|---|---|
| Fecal immunochemical testThis diagnosis test is commonly used for screening CRC, which can act as an indicator to compare the performance of our new molecular test | Diagnostic test | AA, CRC, N, nAA |
Primary outcome
Determine the performance of microbial markers in predicting adenoma and CRC
Time frame: 3 months after stool sample submission
2 secondary outcomes
Compare microbiome composition between healthy subjects and populations with adenoma, advanced adenoma, and colorectal cancer
Time frame: Approximately 1 year after completed subject recruitment of the study
Delineate the gut microbial community profiles of the population with adenoma, advanced adenoma, and colorectal cancer residing in different geographical locations with different lifestyles
Time frame: Approximately 1 year after completed subject recruitment of the study
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 7 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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 and Colorectal Adenoma, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 2 inclusion and 1 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 7 Jan 2026. 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 Hong Kong. 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?
Determine the performance of microbial markers in predicting adenoma and CRC (time frame: 3 months after stool sample submission). 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 7 Jan 2026.