Colorectal PolypNCT06957626
Development and Validation of Microbiota and Metabolite-based Prediction Model for Recurrence of High-risk Colorectal Polyps After Polypectomy
An observational study of Colorectal Polyp and Colorectal Cancer Recurrent, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The characteristics of the intestinal microbiota in high-risk colorectal polyp recurrence and their relationship with disease pathogenesis have not yet been fully elucidated. This study aims to analyze the microbial community characteristics in the intestinal mucosal tissue of patients after polypectomy with… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Colorectal Polyp, Colorectal Cancer Recurrent, Colorectal Adenoma
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 25 Apr 2023to 30 Apr 2026
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with high-risk colorectal polyps
Who may be able to join
- patients aged 40-75 years who undergo the colonoscopy with at least 1 advanced premalignant polyps or ≥ 3 adenoma
Who cannot join
- patient with severe physical diseases that prevented them from adhering to the examination requirements,
- patient with coagulopathy or other contraindications for biopsy or polypectomy,
- patient with previous surgical procedures on the gastrointestinal tract,
- presence of colorectal cancer or other malignant tumor at baseline
- presence of inflammatory bowel disease or hereditary polyposis syndromes (such as family adenomatous polyposis or Lynch syndrome)
- within 1 month before enrollment, oral antibiotics and probiotics were taken;
- inability to provide informed consent or refusal to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital, 1 Shuaifuyuan, Dongcheng District, Beijing, China
Beijing, 100730
Cheng Peng, +86 18500743525, pengchengf@mail.sdu.edu.cn
About this study
The characteristics of the intestinal microbiota in high-risk colorectal polyp recurrence and their relationship with disease pathogenesis have not yet been fully elucidated. This study aims to analyze the microbial community characteristics in the intestinal mucosal tissue of patients after polypectomy with recurrence of colorectal polyps. Additionally, this research holds significant importance for understanding the etiology of adenoma recurrence and develop a microbiota and metabolite-based predicting tool.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients who undergo colonoscopy with precence of high-risk colorectal polyps | For patients who undergo colonoscopy with presence of high-risk colorectal polyps, collect 1-2 pieces of large intestinal mucosa of the polyp and the normal appearing mucosa surrounding the polyp. Collect stool samples and baseline information such as age, gender and eating habit. Each patient will be followed for 3 years, and colonoscopy will be reviewed to determine the recurrence. Biopsies of large intestinal mucosa and stools will be collected at surveillance colonoscopy (follow-up) if allowed. All the samples are stored at -80°C by the study team until the time of DNA extraction for microbiota sequencing analysis and/or metabolomic analysis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The characteristics of the intestinal microbiota in patients with high-risk colorectal polyp recurrence
Analyze the characteristics of the microbiota within the intestinal mucosal tissue of patients with high-risk colorectal polyp recurrence or without recurrence.
Measured: 24 months
Secondary outcomes (1)
Development and validation of Microbiota and metabolite-based model predicting recurrence of high-risk colorectal polyps after polypectomy
Select the recurrence and non-recurrence of polyps during the follow-up period , and develop and validate the recurrence prediction model according to the differences in intestinal mucosal flora and host gene expression levels.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start25 Apr 2023
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal PolypStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jing-Nan Li, Peking Union Medical College Hospital
- Investigators
- Jing nan Li, MD, Ph.D, Study chair, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06957626
- Sponsor's protocol ID
- I-23PJ699
- Status last verified
- Apr 2025
- First submitted
- 26 Apr 2025
- Last updated
- 1 Jul 2025
- 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 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of Microbiota and Metabolite-based Prediction Model for Recurrence of High-risk Colorectal Polyps After Polypectomy
- ClinicalTrials.gov ID
- NCT06957626
- Acronym / sponsor ID
- I-23PJ699
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 4 May 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.
The characteristics of the intestinal microbiota in high-risk colorectal polyp recurrence and their relationship with disease pathogenesis have not yet been fully elucidated. This study aims to analyze the microbial community characteristics in the intestinal mucosal tissue of patients after polypectomy with recurrence of colorectal polyps. Additionally, this research holds significant importance for understanding the etiology of adenoma recurrence and develop a microbiota and metabolite-based predicting tool.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who undergo colonoscopy with precence of high-risk colorectal polyps | – | –For patients who undergo colonoscopy with presence of high-risk colorectal polyps, collect 1-2 pieces of large intestinal mucosa of the polyp and the normal appearing mucosa surrounding the polyp. Collect stool samples and baseline information such as age, gender and eating habit. Each patient will be followed for 3 years, and colonoscopy will be reviewed to determine the recurrence. Biopsies of large intestinal mucosa and stools will be collected at surveillance colonoscopy (follow-up) if allowed. All the samples are stored at -80°C by the study team until the time of DNA extraction for microbiota sequencing analysis and/or metabolomic analysis. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with high-risk colorectal polyps
Key inclusion criteria (1 listed)
- patients aged 40-75 years who undergo the colonoscopy with at least 1 advanced premalignant polyps or ≥ 3 adenoma
Key exclusion criteria (7 listed)
- patient with severe physical diseases that prevented them from adhering to the examination requirements,
- patient with coagulopathy or other contraindications for biopsy or polypectomy,
- patient with previous surgical procedures on the gastrointestinal tract,
- presence of colorectal cancer or other malignant tumor at baseline
- presence of inflammatory bowel disease or hereditary polyposis syndromes (such as family adenomatous polyposis or Lynch syndrome)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The characteristics of the intestinal microbiota in patients with high-risk colorectal polyp recurrence
Time frame: 24 months
Analyze the characteristics of the microbiota within the intestinal mucosal tissue of patients with high-risk colorectal polyp recurrence or without recurrence.
1 secondary outcome
Development and validation of Microbiota and metabolite-based model predicting recurrence of high-risk colorectal polyps after polypectomy
Time frame: 36 months
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 1 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Colorectal Polyp
Recruiting
Artificial Intelligence to Implement Cost-saving Strategies for Colonoscopy Screening Based on in Vivo Prediction of Polyp Histology
Colonic Neoplasms
RecruitingObservational study
KLF4 Epigenetic Modulation
KLF4 Methylation, Epigenetic
Not yet recruiting
Social Software-Based Intelligent Management System for Bowel Preparation
Colorectal Polyp, Colorectal Adenoma
RecruitingObservational study
Malignant Polyp Registry
Malignant Colorectal Polyp, Colorectal Cancer
Active, not recruiting
Virtual Incision Robotically Assisted Surgical Device Use in Minimally Invasive Colectomy
Colon Cancer, Colon Polyp
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.
Jing nan Li, MD, Ph.D study chair
Peking Union Medical College Hospital
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 Polyp and Colorectal Cancer Recurrent, run by Peking Union Medical College Hospital 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 1 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 1 Jul 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?
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?
Contact Cheng Peng, MD (+86 18500743525, pengchengf@mail.sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The characteristics of the intestinal microbiota in patients with high-risk colorectal polyp recurrence (time frame: 24 months). 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 1 Jul 2025.