Colorectal AdenomaNCT07795788
Correlation Between Artificial Intelligence-Based Fecal Coverage Area-Quantified Bowel Preparation Quality Score (FQ-BBPS) and Adenoma Detection Rate
An observational study of Colorectal Adenoma, run by Fudan University at 1 site in China.
Trial summary
A single-center prospective observational study evaluates the correlation between an AI-based bowel preparation quality score (FQ-BBPS[25%]), which quantifies fecal coverage area during colonoscopy withdrawal, and the adenoma detection rate (ADR) in screening/surveillance patients. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Colorectal Adenoma
- How many people
- 560 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2026to 31 Dec 2027
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing screening/surveillance colonoscopy
Who may be able to join
- aged 45-75 years
- No colonoscopy within the past 3 years
Who cannot join
- Patients scheduled for therapeutic colonoscopy, postoperative surveillance after colorectal surgery, or treatment of histologically confirmed polyps
- Patients with highly suspected or pathologically confirmed colorectal cancer
- Patients presenting with alarm symptoms or signs (hematochezia, melena, unexplained anemia or weight loss, palpable abdominal mass, or a positive digital rectal examination)
- Pregnant or breastfeeding women
- Patients with gastrointestinal obstruction
- Patients with inflammatory bowel disease, familial adenomatous polyposis, or serrated polyposis syndrome
Show all 10Show fewer
- Patients who have taken anticoagulants (e.g., aspirin, warfarin) within 7 days before colonoscopy or who have coagulation disorders
- Failed cecal intubation due to any cause other than excessive feces preventing intubation (e.g., obstructive lesions preventing scope passage, or patient intolerance to the procedure).
- Use of non-guideline-recommended bowel preparation agents
- Patients undergoing emergency colonoscopy
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
Huadong hospital, Fudan university
Shanghai, Shanghai Municipality, 200040
Danian Ji, M.D., +86-18019094606, arctg4@163.com
Zhiyu Dong, M.D., 18817870866, 18817870866@163.com
About this study
Official title: Correlation Between Artificial Intelligence-Based Fecal Coverage Area-Quantified Bowel Preparation Quality Score (FQ-BBPS) and Adenoma Detection Rate: A Single-Center, Prospective, Observational Study
A single-center prospective observational study evaluates the correlation between an AI-based bowel preparation quality score (FQ-BBPS[25%]), which quantifies fecal coverage area during colonoscopy withdrawal, and the adenoma detection rate (ADR) in screening/surveillance patients.
Read the detailed description
The FQ-BBPS system uses image segmentation to automatically calculate the percentage of mucosa obscured by feces/fluid, providing a continuous, objective alternative to the conventional Boston Bowel Preparation Scale (BBPS). Preliminary retrospective data showed a strong correlation (Spearman ρ = -0.829) between FQ-BBPS(25%) and ADR, and adding this metric improved adenoma prediction over e-BBPS alone. This prospective study (October 2026 - September 2027) will consecutively enroll patients aged 45-75 years undergoing colonoscopy for screening or polyp surveillance, excluding those with prior colorectal surgery, cancer, alarm symptoms, anticoagulant use, or recent trial participation. With a conservative assumed correlation of -0.70, a sample size of 560 (allowing 10% dropout) is planned.
The primary outcome is ADR (proportion with ≥1 histologically confirmed adenoma), and secondary outcomes include detection rates for serrated lesions, advanced adenomas, and polyp detection by size/location; safety endpoints (perforation, immediate/delayed bleeding) will also be recorded. The FQ-BBPS(25%) score will be computed automatically from withdrawal videos, while endoscopists record BBPS and polyp characteristics. Spearman correlation will assess the association, and ROC analysis will explore the optimal cutoff against the 35% ADR reference. The study adheres to the Declaration of Helsinki, with ethics approval and written informed consent from all participants.
- Conditions
- Colorectal Adenoma
- Keywords
- adenoma detection rate, Bowel preparation assessment, Artificial intelligence
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 |
|---|---|---|
| Screening/Surveillance colonoscopy | Patients undergoing screening or surveillance colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
adenoma detection rate
Measured: 2 weeks after the procedure
Secondary outcomes (3)
sessile serrated lesion detection rate
Measured: 2 weeks after the procedure
advanced adenoma detection rate
Measured: 2 weeks after the procedure
polyp detection rate
Measured: 2 weeks after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal AdenomaStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Cross-sectional
- Enrolment
- 560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhijun Bao, Fudan University
- Investigators
- Danian Ji, M.D., Study director, Huadong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07795788
- Sponsor's protocol ID
- 2026K353
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Artificial Intelligence-Based Fecal Coverage Area-Quantified Bowel Preparation Quality Score (FQ-BBPS) and Adenoma Detection Rate: A Single-Center, Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT07795788
- Acronym / sponsor ID
- 2026K353
- Conditions
- Colorectal Adenoma
- Keywords
- adenoma detection rate, Bowel preparation assessment, Artificial intelligence
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 560 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 31 Aug 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.
A single-center prospective observational study evaluates the correlation between an AI-based bowel preparation quality score (FQ-BBPS[25%]), which quantifies fecal coverage area during colonoscopy withdrawal, and the adenoma detection rate (ADR) in screening/surveillance patients.
Detailed description
The FQ-BBPS system uses image segmentation to automatically calculate the percentage of mucosa obscured by feces/fluid, providing a continuous, objective alternative to the conventional Boston Bowel Preparation Scale (BBPS). Preliminary retrospective data showed a strong correlation (Spearman ρ = -0.829) between FQ-BBPS(25%) and ADR, and adding this metric improved adenoma prediction over e-BBPS alone. This prospective study (October 2026 - September 2027) will consecutively enroll patients aged 45-75 years undergoing colonoscopy for screening or polyp surveillance, excluding those with prior colorectal surgery, cancer, alarm symptoms, anticoagulant use, or recent trial participation. With a conservative assumed correlation of -0.70, a sample size of 560 (allowing 10% dropout) is planned.
The primary outcome is ADR (proportion with ≥1 histologically confirmed adenoma), and secondary outcomes include detection rates for serrated lesions, advanced adenomas, and polyp detection by size/location; safety endpoints (perforation, immediate/delayed bleeding) will also be recorded. The FQ-BBPS(25%) score will be computed automatically from withdrawal videos, while endoscopists record BBPS and polyp characteristics. Spearman correlation will assess the association, and ROC analysis will explore the optimal cutoff against the 35% ADR reference. The study adheres to the Declaration of Helsinki, with ethics approval and written informed consent from all participants.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening/Surveillance colonoscopy | – | –Patients undergoing screening or surveillance colonoscopy |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing screening/surveillance colonoscopy
Key inclusion criteria (2 listed)
- aged 45-75 years
- No colonoscopy within the past 3 years
Key exclusion criteria (10 listed)
- Patients scheduled for therapeutic colonoscopy, postoperative surveillance after colorectal surgery, or treatment of histologically confirmed polyps
- Patients with highly suspected or pathologically confirmed colorectal cancer
- Patients presenting with alarm symptoms or signs (hematochezia, melena, unexplained anemia or weight loss, palpable abdominal mass, or a positive digital rectal examination)
- Pregnant or breastfeeding women
- Patients with gastrointestinal obstruction
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
adenoma detection rate
Time frame: 2 weeks after the procedure
3 secondary outcomes
sessile serrated lesion detection rate
Time frame: 2 weeks after the procedure
advanced adenoma detection rate
Time frame: 2 weeks after the procedure
polyp detection rate
Time frame: 2 weeks after the procedure
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 31 Aug 2026.
- Individual participant dataSharing planned: Yes. All collected IPD
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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.
Danian Ji, M.D. study director
Huadong 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 Adenoma, run by Fudan 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 2 inclusion and 10 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: opening soon, as of the sponsor's last update on 31 Aug 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 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 Danian Ji, M.D. (+86-18019094606, arctg4@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adenoma detection rate (time frame: 2 weeks after the procedure). 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 31 Aug 2026.