Colorectal CancerM3-CANNCT05381792
Serial Gut Microbiome and Bacterial Gene Markers Changes After Endoscopic Resection of 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 hypothesize that gut microbiome composition and the four bacterial gene markers (M3) show dynamic changes after endoscopic resection of advanced neoplasia, some key bacteria are associated with restoration of gut microbiome after endoscopic resection. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Colorectal Cancer, Colorectal Neoplasms, Colorectal Adenoma
- What is being tested?
- Bacterial gene markers test
- How many people
- 50 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Sep 2022to 15 Dec 2024
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with known colorectal advanced neoplasia
Who may be able to join
- Subjects require endoscopic resection (e.g. endoscopic mucosal resection or endoscopic submucosal dissection) for advanced adenoma or early-stage colorectal cancer;
- Aged 18-90 years old;
- Written informed consent obtained.
Who cannot join
- Absolute contraindications to colonoscopy (e.g. perforation, intestinal obstruction, unstable cardiopulmonary status);
- Contraindications to endoscopic resection (e.g. active gastrointestinal bleeding, uninterrupted anticoagulation or dual antiplatelets);
- 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.
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Shatin, New Territories
About this study
Official title: A Pilot Study to Assess Serial Gut Microbiome and a Panel of Bacterial Gene Markers (M3) Changes After Endoscopic Resection of Colorectal Advanced Neoplasia
The investigators hypothesize that gut microbiome composition and the four bacterial gene markers (M3) show dynamic changes after endoscopic resection of advanced neoplasia, some key bacteria are associated with restoration of gut microbiome after endoscopic resection.
Read the detailed description
Colorectal cancer (CRC) is one of the most common cancers in Hong Kong with more than 5,500 new cases annually. The majority of CRC cases are derived from benign colorectal adenomas through the process of adenoma-carcinoma sequence. Since this process takes several years, early detection and endoscopic resection of colorectal adenomas are important to reduce the incidence and mortality of CRC. Currently, colonoscopy is the gold standard for detection for colorectal adenomas. Endoscopic resection including endoscopic submucosal dissection (ESD) and endoscopic mucosal resection (EMR) can serve as minimally invasive treatment options for colorectal neoplasia. Compared with EMR, due to the general association with higher rates of en bloc, R0, and curative resections and a lower rate of local recurrence, ESD is an established and effective treatment modality for advanced adenoma (AA) and early-stage CRC.
Increasing studies showed a close crosstalk between the gut microbiome and colorectal neoplasia. Altered microbiome environment is associated with the initiation and progression of CRC and its precancerous lesions. Most studies focused on the gut microbiota changes in individuals with CRC and adenomas, and the potential microbial role in the progression of colorectal neoplasia. Conversely, the potential influence of CRC or adenomas on the gut microbiota is unclear. Only one study has depicted microbiota changes after the endoscopic removal of colorectal adenomas with limited follow up timepoints. Due to a high rate of recurrence of colorectal adenomas after endoscopic removal, surveillance colonoscopy is required depending on the size, number, and histology of polyps in the index coloscopy. Apart from these risk factors, reestablishment of gut microbiome after polyp resection may also play a role in the recurrence of adenomas.
Recently, a panel of bacterial gene markers including "m3" from Lachnoclostridium, Fusobacterium nucleatum (Fn), Bacteroides clarus (Bc) and Clostridium hathewayi (Ch) showed high diagnostic accuracy for CRC (82.3%) and adenomas (64.2%). The combination of these four bacterial gene markers (known as M3) has also been proven to be useful in detecting adenoma recurrence after polypectomy in a retrospective study. However, how these bacteria markers change after polypectomy and whether there are some associations between changes of bacteria gene markers and post resection restoration of the gut microbiome remain unclear.
This pilot study aims to determine serial gut microbiome composition changes, and changes in levels of the panel of four bacterial gene markers (M3) after endoscopic resection of colorectal advanced neoplasia, and factors associated with restoration of gut microbiome composition after endoscopic resection.
- Conditions
- Colorectal Cancer, Colorectal Neoplasms, Colorectal Adenoma
- Being tested
- Bacterial gene markers 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.
Bacterial gene markers testDiagnostic test
Bacterial gene markers test using qPCR
| Study group | Role | What they receive |
|---|---|---|
| Known colorectal advanced neoplasia group | Subjects with known colorectal advanced neoplasia and requiring endoscopic resection Receives: Diagnostic Test: Bacterial gene markers test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serial bacterial gene markers changes (Fn, m3, Bc and Ch) after endoscopic resection of colorectal advanced neoplasia.
Bacterial gene markers change tested by quantitative polymerase chain reaction (qPCR)
Measured: 6 months
Serial gut microbiome changes after endoscopic resection of colorectal advanced neoplasia.
Gut microbiome change tested by metagenomic sequencing
Measured: 6 months
Secondary outcomes (3)
The differences in the bacterial gene markers (Fn, m3, Bc and Ch) between different sites/sizes/pathology of advanced adenoma
Bacterial gene markers tested by qPCR
Measured: 6 months
The differences in the bacterial gene markers (Fn, m3, Bc and Ch) between different stages of CRC
Bacterial gene markers tested by qPCR
Measured: 6 months
The differences in the bacterial gene markers (Fn, m3, Bc and Ch) between advanced adenoma and CRC
Bacterial gene markers tested by qPCR
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start1 Sep 2022
- Primary completion15 Dec 2024 (estimated)
- Study completion15 Dec 2024 (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
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Louis Ho Shing Lau, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05381792
- Sponsor's protocol ID
- 2022.127
- Acronym
- M3-CAN
- Status last verified
- Aug 2024
- First submitted
- 12 May 2022
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- 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 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess Serial Gut Microbiome and a Panel of Bacterial Gene Markers (M3) Changes After Endoscopic Resection of Colorectal Advanced Neoplasia
- ClinicalTrials.gov ID
- NCT05381792
- Acronym / sponsor ID
- M3-CAN / 2022.127
- Conditions
- Colorectal Cancer, Colorectal Neoplasms, Colorectal Adenoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 15 Dec 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 19 May 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 hypothesize that gut microbiome composition and the four bacterial gene markers (M3) show dynamic changes after endoscopic resection of advanced neoplasia, some key bacteria are associated with restoration of gut microbiome after endoscopic resection.
Detailed description
Colorectal cancer (CRC) is one of the most common cancers in Hong Kong with more than 5,500 new cases annually. The majority of CRC cases are derived from benign colorectal adenomas through the process of adenoma-carcinoma sequence. Since this process takes several years, early detection and endoscopic resection of colorectal adenomas are important to reduce the incidence and mortality of CRC. Currently, colonoscopy is the gold standard for detection for colorectal adenomas. Endoscopic resection including endoscopic submucosal dissection (ESD) and endoscopic mucosal resection (EMR) can serve as minimally invasive treatment options for colorectal neoplasia. Compared with EMR, due to the general association with higher rates of en bloc, R0, and curative resections and a lower rate of local recurrence, ESD is an established and effective treatment modality for advanced adenoma (AA) and early-stage CRC.
Increasing studies showed a close crosstalk between the gut microbiome and colorectal neoplasia. Altered microbiome environment is associated with the initiation and progression of CRC and its precancerous lesions. Most studies focused on the gut microbiota changes in individuals with CRC and adenomas, and the potential microbial role in the progression of colorectal neoplasia. Conversely, the potential influence of CRC or adenomas on the gut microbiota is unclear. Only one study has depicted microbiota changes after the endoscopic removal of colorectal adenomas with limited follow up timepoints. Due to a high rate of recurrence of colorectal adenomas after endoscopic removal, surveillance colonoscopy is required depending on the size, number, and histology of polyps in the index coloscopy. Apart from these risk factors, reestablishment of gut microbiome after polyp resection may also play a role in the recurrence of adenomas.
Recently, a panel of bacterial gene markers including "m3" from Lachnoclostridium, Fusobacterium nucleatum (Fn), Bacteroides clarus (Bc) and Clostridium hathewayi (Ch) showed high diagnostic accuracy for CRC (82.3%) and adenomas (64.2%). The combination of these four bacterial gene markers (known as M3) has also been proven to be useful in detecting adenoma recurrence after polypectomy in a retrospective study. However, how these bacteria markers change after polypectomy and whether there are some associations between changes of bacteria gene markers and post resection restoration of the gut microbiome remain unclear.
This pilot study aims to determine serial gut microbiome composition changes, and changes in levels of the panel of four bacterial gene markers (M3) after endoscopic resection of colorectal advanced neoplasia, and factors associated with restoration of gut microbiome composition after endoscopic resection.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Known colorectal advanced neoplasia group | – | Diagnostic Test: Bacterial gene markers testSubjects with known colorectal advanced neoplasia and requiring endoscopic resection |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with known colorectal advanced neoplasia
Key inclusion criteria (3 listed)
- Subjects require endoscopic resection (e.g. endoscopic mucosal resection or endoscopic submucosal dissection) for advanced adenoma or early-stage colorectal cancer;
- Aged 18-90 years old;
- Written informed consent obtained.
Key exclusion criteria (4 listed)
- Absolute contraindications to colonoscopy (e.g. perforation, intestinal obstruction, unstable cardiopulmonary status);
- Contraindications to endoscopic resection (e.g. active gastrointestinal bleeding, uninterrupted anticoagulation or dual antiplatelets);
- Known pregnancy or lactation;
- Advanced comorbid conditions (defined as American Society of Anesthesiologists grade 4 or above);
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 |
|---|---|---|
| Bacterial gene markers testBacterial gene markers test using qPCR | Diagnostic test | Known colorectal advanced neoplasia group |
Primary outcome
Serial bacterial gene markers changes (Fn, m3, Bc and Ch) after endoscopic resection of colorectal advanced neoplasia.
Time frame: 6 months
Bacterial gene markers change tested by quantitative polymerase chain reaction (qPCR)
Serial gut microbiome changes after endoscopic resection of colorectal advanced neoplasia.
Time frame: 6 months
Gut microbiome change tested by metagenomic sequencing
3 secondary outcomes
The differences in the bacterial gene markers (Fn, m3, Bc and Ch) between different sites/sizes/pathology of advanced adenoma
Time frame: 6 months
The differences in the bacterial gene markers (Fn, m3, Bc and Ch) between different stages of CRC
Time frame: 6 months
The differences in the bacterial gene markers (Fn, m3, Bc and Ch) between advanced adenoma and CRC
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- 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.
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 4 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: status not confirmed, as of the sponsor's last update on 27 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min Dai (6049 0760, mindai@link.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serial bacterial gene markers changes (Fn, m3, Bc and Ch) after endoscopic resection of colorectal advanced neoplasia. (time frame: 6 months). 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 27 Aug 2024.