Colorectal CancerM3-PRONCT05405673
Diagnostic Accuracy of a Panel of Bacterial Gene Markers (M3) for Colorectal Advanced Neoplasia
An observational study of Colorectal Cancer and Colorectal Neoplasms, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
The investigators aim to evaluate and compare the diagnostic accuracy of FIT and the novel panel of bacterial gene markers (Fn, m3, Ch and Bc) collectively named as M3, in detecting colorectal advanced neoplasia. 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 Neoplasms, Colorectal Adenoma
- What is being tested?
- Fecal immunochemical test (FIT)
- How many people
- 2,500 participants
- Where
- 1 siteHong Kong
- Study dates
- 29 Jun 2022to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Subjects with average risk of colorectal neoplsia requring screening/surveillance colonoscopy
Who may be able to join
- They require elective colonoscopy for colorectal cancer screening or polyp surveillance, or investigation of symptoms (e.g. anemia, change of bowel habit, abdominal pain);
- Aged ≥18 years old;
- Written informed consent obtained.
Who cannot join
- Contraindications to colonoscopy (e.g. perforation, intestinal obstruction, unstable cardiopulmonary status);
- Contraindication to polyp resection (e.g. active gastrointestinal bleeding, uninterrupted anticoagulation or dual antiplatelets);
- Known colorectal cancer or adenoma for staged procedure;
- Previous colonic resection;
- Personal history of colorectal cancer;
- Personal history of polyposis syndrome;
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- Personal history of inflammatory bowel disease;
- Known pregnancy or lactation;
- Advanced comorbid conditions (defined as American Society of Anesthesiologists grade 4 or above);
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Cross-sectional Multi-center Study to Assess the Diagnostic Accuracy of a Panel of Bacterial Gene Markers (M3) for Colorectal Advanced Neoplasia
The investigators aim to evaluate and compare the diagnostic accuracy of FIT and the novel panel of bacterial gene markers (Fn, m3, Ch and Bc) collectively named as M3, in detecting colorectal advanced neoplasia.
Read the detailed description
Colorectal cancer (CRC) is the one of the most common cancers in Hong Kong with more than 5,500 new cases annually. There is prevailing evidence of increasing trend of young onset CRC globally. Early detection and resection of pre-malignant colorectal neoplasia has shown to reduce CRC-related mortality.
Non-invasive stool tests including guaiac-based faecal occult blood tests (gFOBT) and faecal immunochemical tests (FIT) are the cornerstones of population-based CRC screening programmes. The major limitation of this widely used strategy is its unsatisfactory sensitivities for CRC (79%) and advanced adenomas (AA; 40%). The sensitivity for non-advanced adenomas is even lower than 10%. A large proportion of advanced and non-advanced adenomas will be missed by FIT alone. Therefore, identification of alternative non-invasive test with better sensitivity to detect colorectal neoplasia is warranted.
Multitarget stool DNA test and faecal microbial DNA markers appear to be promising options for CRC screening. Several bacterial gene markers have been identified by metagenome sequencing and reported to be associated with CRC, including Fusobacterium nucleatum (Fn), Clostridium hathewayi (Ch) and Bacteroides clarus (Bc). However, these molecular markers had low accuracy in distinguishing adenomas from normal tissue. Recently, a new Lachnoclostridium gene marker (labelled as 'm3') has been shown to have high diagnostic yield for the detection of colorectal adenomas. In a case-control study of 1012 subjects, a linear increasing trend of m3 level was observed from fecal samples of healthy subjects to those with adenomas and cancers. The overall sensitivity of m3 was significantly higher than FIT in detecting all adenomas (48% vs 9.3%), AA (50.8% vs 16.1%) and non-advanced adenomas (44.2% vs 0%). The diagnostic accuracy of m3 could be further enhanced by combining with a panel of fecal microbial markers composing of Fusobacterium nucleatum (Fn), Bacteroides clarus (Bc), Clostridium hathewayi (Ch) for CRC (82.3%) and adenomas (64.2%). We hypothesized that the combination of these 4 bacterial gene markers (known as M3) is more sensitive than FIT in detecting colorectal advanced neoplasia.
- Conditions
- Colorectal Cancer, Colorectal Neoplasms, Colorectal Adenoma
- Being tested
- Fecal immunochemical test (FIT)
- Keywords
- FIT, Bacterial gene marker, Colonoscopy
- 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 test (FIT)Diagnostic test
Also called Bacterial gene marker test
A kind of stool test
| Study group | Role | What they receive |
|---|---|---|
| Colorectal neoplasia screening/surveillance cohort | Subjects with average risk of colorectal neoplasias requiring screening/surveillance colonoscopy Receives: Diagnostic Test: Fecal immunochemical test (FIT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of bacterial gene markers panel (M3)
The proportion of subjects with true positive results of M3 among those with one of more advanced neoplasia detected in the index colonoscopy.
Measured: 1 month
Sensitivity of FIT/FOBT
The proportion of subjects with true positive results of FIT among those with one of more advanced neoplasia detected in the index colonoscopy.
Measured: 1 month
Secondary outcomes (13)
Sensitivity of M3 for early-stage (stage 1) or invasive (stage 2-4) colorectal cancers
The proportion of subjects with true positive results of M3 among those with early-stage (stage 1) or invasive (stage 2-4) colorectal cancers detected in the index colonoscopy.
Measured: 1 month
Sensitivity of FIT/FOBT for early-stage (stage 1) or invasive (stage 2-4) colorectal cancers
The proportion of subjects with true positive results of FIT among those with early-stage (stage 1) or invasive (stage 2-4) colorectal cancers detected in the index colonoscopy.
Measured: 1 month
Sensitivity of FIT/FOBT for advanced adenomas
The proportion of subjects with true positive results of FIT among those with one or more advanced adenomas detected in the index colonoscopy.
Measured: 1 month
Sensitivity of M3 for advanced adenomas
The proportion of subjects with true positive results of M3 among those with one or more advanced adenomas detected in the index colonoscopy.
Measured: 1 month
Sensitivity of FIT/FOBT for all adenomas
The proportion of subjects with true positive results of FIT among those with all advanced adenomas detected in the index colonoscopy.
Measured: 1 month
Sensitivity of M3 for all adenomas
The proportion of subjects with true positive results of M3 among those with all advanced adenomas detected in the index colonoscopy.
Measured: 1 month
Sensitivity of FIT/FOBT for sessile serrated lesions (SSL)
The proportion of subjects with true positive results of FIT among those with SSLs detected in the index colonoscopy.
Measured: 1 month
Sensitivity of M3 for sessile serrated lesions (SSL)
The proportion of subjects with true positive results of M3 among those with SSLs detected in the index colonoscopy.
Measured: 1 month
Specificity
The proportion of true negative results of M3/FOBT/FIT among those with no adenoma detected in colonoscopy
Measured: 1 month
Positive predictive value (PPV)
The ratio of subjects truly diagnosed as positive to all those who had positive test results
Measured: 1 month
Negative predictive value (NPV)
The ratio of subjects truly diagnosed as negative to all those who had negative test results
Measured: 1 month
Overall diagnostic accuracy
The proportion of correctly classified subjects among all subjects
Measured: 1 month
Microbiota changes in subjects with adenomas or normal findings after polypectomy
Microbiota change measured by qPCR or metagenomic sequencing
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start29 Jun 2022
- Primary completion7 May 2025
- Study completion31 Dec 2030 (estimated)
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 only
- Time perspective
- Cross-sectional
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Dr Cipto Mangunkusumo General Hospital, Aster CMI Hospital, Osaka International Cancer Institute, Sano hospital, Thingangyun Sanpya General Hospital, Changi General Hospital, National Taiwan University Hospital, Phramongkutklao College of Medicine and Hospital, St. Mark's Hospital, Oxford University Hospitals NHS Trust
- Responsible party
- Principal investigator, Louis Ho Shing Lau, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05405673
- Sponsor's protocol ID
- 2022.170
- Acronym
- M3-PRO
- Status last verified
- Sep 2026
- First submitted
- 1 Jun 2022
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cross-sectional Multi-center Study to Assess the Diagnostic Accuracy of a Panel of Bacterial Gene Markers (M3) for Colorectal Advanced Neoplasia
- ClinicalTrials.gov ID
- NCT05405673
- Acronym / sponsor ID
- M3-PRO / 2022.170
- Conditions
- Colorectal Cancer, Colorectal Neoplasms, Colorectal Adenoma
- Keywords
- FIT, Bacterial gene marker, Colonoscopy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Dr Cipto Mangunkusumo General Hospital, Aster CMI Hospital, Osaka International Cancer Institute, Sano hospital, Thingangyun Sanpya General Hospital, Changi General Hospital, National Taiwan University Hospital, Phramongkutklao College of Medicine and Hospital, St. Mark's Hospital, Oxford University Hospitals NHS Trust
- Study start
- 29 Jun 2022 (actual)
- Primary completion
- 7 May 2025 (actual)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 6 Jun 2022 (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.
The investigators aim to evaluate and compare the diagnostic accuracy of FIT and the novel panel of bacterial gene markers (Fn, m3, Ch and Bc) collectively named as M3, in detecting colorectal advanced neoplasia.
Detailed description
Colorectal cancer (CRC) is the one of the most common cancers in Hong Kong with more than 5,500 new cases annually. There is prevailing evidence of increasing trend of young onset CRC globally. Early detection and resection of pre-malignant colorectal neoplasia has shown to reduce CRC-related mortality.
Non-invasive stool tests including guaiac-based faecal occult blood tests (gFOBT) and faecal immunochemical tests (FIT) are the cornerstones of population-based CRC screening programmes. The major limitation of this widely used strategy is its unsatisfactory sensitivities for CRC (79%) and advanced adenomas (AA; 40%). The sensitivity for non-advanced adenomas is even lower than 10%. A large proportion of advanced and non-advanced adenomas will be missed by FIT alone. Therefore, identification of alternative non-invasive test with better sensitivity to detect colorectal neoplasia is warranted.
Multitarget stool DNA test and faecal microbial DNA markers appear to be promising options for CRC screening. Several bacterial gene markers have been identified by metagenome sequencing and reported to be associated with CRC, including Fusobacterium nucleatum (Fn), Clostridium hathewayi (Ch) and Bacteroides clarus (Bc). However, these molecular markers had low accuracy in distinguishing adenomas from normal tissue. Recently, a new Lachnoclostridium gene marker (labelled as 'm3') has been shown to have high diagnostic yield for the detection of colorectal adenomas. In a case-control study of 1012 subjects, a linear increasing trend of m3 level was observed from fecal samples of healthy subjects to those with adenomas and cancers. The overall sensitivity of m3 was significantly higher than FIT in detecting all adenomas (48% vs 9.3%), AA (50.8% vs 16.1%) and non-advanced adenomas (44.2% vs 0%). The diagnostic accuracy of m3 could be further enhanced by combining with a panel of fecal microbial markers composing of Fusobacterium nucleatum (Fn), Bacteroides clarus (Bc), Clostridium hathewayi (Ch) for CRC (82.3%) and adenomas (64.2%). We hypothesized that the combination of these 4 bacterial gene markers (known as M3) is more sensitive than FIT in detecting colorectal advanced neoplasia.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colorectal neoplasia screening/surveillance cohort | – | Diagnostic Test: Fecal immunochemical test (FIT)Subjects with average risk of colorectal neoplasias requiring screening/surveillance colonoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with average risk of colorectal neoplsia requring screening/surveillance colonoscopy
Key inclusion criteria (3 listed)
- They require elective colonoscopy for colorectal cancer screening or polyp surveillance, or investigation of symptoms (e.g. anemia, change of bowel habit, abdominal pain);
- Aged ≥18 years old;
- Written informed consent obtained.
Key exclusion criteria (9 listed)
- Contraindications to colonoscopy (e.g. perforation, intestinal obstruction, unstable cardiopulmonary status);
- Contraindication to polyp resection (e.g. active gastrointestinal bleeding, uninterrupted anticoagulation or dual antiplatelets);
- Known colorectal cancer or adenoma for staged procedure;
- Previous colonic resection;
- Personal history of colorectal cancer;
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 test (FIT)Also: Bacterial gene marker testA kind of stool test | Diagnostic test | Colorectal neoplasia screening/surveillance cohort |
Primary outcome
Sensitivity of bacterial gene markers panel (M3)
Time frame: 1 month
The proportion of subjects with true positive results of M3 among those with one of more advanced neoplasia detected in the index colonoscopy.
Sensitivity of FIT/FOBT
Time frame: 1 month
The proportion of subjects with true positive results of FIT among those with one of more advanced neoplasia detected in the index colonoscopy.
13 secondary outcomes
Sensitivity of M3 for early-stage (stage 1) or invasive (stage 2-4) colorectal cancers
Time frame: 1 month
Sensitivity of FIT/FOBT for early-stage (stage 1) or invasive (stage 2-4) colorectal cancers
Time frame: 1 month
Sensitivity of FIT/FOBT for advanced adenomas
Time frame: 1 month
Sensitivity of M3 for advanced adenomas
Time frame: 1 month
Sensitivity of FIT/FOBT for all adenomas
Time frame: 1 month
Sensitivity of M3 for all adenomas
Time frame: 1 month
Sensitivity of FIT/FOBT for sessile serrated lesions (SSL)
Time frame: 1 month
Sensitivity of M3 for sessile serrated lesions (SSL)
Time frame: 1 month
Specificity
Time frame: 1 month
Positive predictive value (PPV)
Time frame: 1 month
Negative predictive value (NPV)
Time frame: 1 month
Overall diagnostic accuracy
Time frame: 1 month
Microbiota changes in subjects with adenomas or normal findings after polypectomy
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No
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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 and Colorectal Neoplasms, 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 3 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 24 Sep 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?
This study is still under way. Results are not available in the source record yet.
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?
Sensitivity of bacterial gene markers panel (M3) (time frame: 1 month). The study lists 2 primary outcomes in all. 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 24 Sep 2026.