Colorectal AdenomaNCT07302139
Risk of Metachronous Advanced Colorectal Neoplastic Among Individuals With Varying Numbers of Non-Advanced Adenomas Detected During Screening Colonoscopy
An observational study of Colorectal Adenoma, run by Fudan University at 1 site in China.
Trial summary
A retrospective observational study to evaluate the risk of metachronous advanced colorectal neoplastic (ACRN) among individuals with varying numbers of non-advanced adenomas (NAA) detected during screening colonoscopy Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Adenoma
- How many people
- 2,955 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Individuals who underwent their first-time screening colonoscopy between 2012 and 2023 at the endoscopy centers of Huadong Hospital and Shanghai Tongji Hospital, and who completed at least one surveillance colonoscopy.
Who may be able to join
- First-time screening colonoscopy
- Only non-advanced adenomas (no villous features, no high-grade dysplasia, and diameter <10 mm) were detected during first-time screening colonoscopy
- Individuals with at least one surveillance colonoscopy
- Complete electronic medical record and pathology information
Who cannot join
- Inadequate bowel preparation (BBPS < 6)
- Emergency colonoscopy
- History of colorectal cancer
- Incomplete pathology information or incompletely resected polyps
- Screening colonoscopies performed by endoscopists with a low dynamic adenoma detection rate (ADR < 15%)
- Follow-up duration < 6 months
Trial locations and contacts
1 site in 1 country.
China1 site
Huadong hospital, Fudan university
Shanghai, Shanghai Municipality, 200040
About this study
Official title: Risk of Metachronous Advanced Colorectal Neoplastic Among Individuals With Varying Numbers of Non-Advanced Adenomas Detected During Screening Colonoscopy: A Retrospective Observational Study
A retrospective observational study to evaluate the risk of metachronous advanced colorectal neoplastic (ACRN) among individuals with varying numbers of non-advanced adenomas (NAA) detected during screening colonoscopy
Read the detailed description
Colorectal cancer (CRC) is the third most commonly diagnosed malignancy worldwide and the second leading cause of cancer-related mortality. In recent years, with increasing westernization of diet and lifestyle, both the incidence and prevalence of CRC in China have risen sharply. CRC has become the most common gastrointestinal malignancy in the country, ranking second in incidence and fifth in mortality among all cancers. Screening colonoscopy and appropriate surveillance intervals can substantially reduce CRC-related deaths.
The latest 2020 U.S. Multi-Society Task Force (USMSTF) guidelines classify patients with 1-2 non-advanced adenomas (NAAs), 3-4 NAAs, and >4 NAAs as having low-, intermediate-, and high-risk colonoscopic findings, respectively, and recommend surveillance intervals of 7-10 years, 3-5 years, and 3 years for these groups. However, accumulating evidence suggests that the risk of developing metachronous advanced colorectal neoplastic lesions (ACRN) in individuals with 3-4 NAAs may be comparable to those with only 1-2 NAAs, raising concerns regarding the appropriateness of current surveillance recommendations.
Using a real-world, endoscopy database, this study systematically evaluates the association between different NAA counts and the subsequent risk of ACRN, providing evidence to inform optimization of post-polypectomy surveillance intervals.
- Conditions
- Colorectal Adenoma
- Being tested
- No Intervention: Observational Cohort
- Keywords
- Screening colonoscopy, Surveillance, Advanced colorectal adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
No Intervention: Observational Cohort
| Study group | Role | What they receive |
|---|---|---|
| Individuals with <3 NAAs detected during screening colonoscopy | Individuals with <3 non-advanced adenomas detected during screening colonoscopy Receives: Other: No Intervention: Observational Cohort | |
| Individuals with 3-4 NAAs detected during screening colonoscopy | Individuals with 3-4 non-advanced adenomas detected during screening colonoscopy Receives: Other: No Intervention: Observational Cohort | |
| Individuals with >4 NAAs detected during screening colonoscopy | Individuals with >4 non-advanced adenomas detected during screening colonoscopy Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Metachronous Advanced Colorectal Neoplasia
Metachronous advanced colorectal neoplasia is defined as advanced adenoma (≥10 mm, villous component, or high-grade dysplasia) or colorectal cancer detected at any follow-up colonoscopy after the baseline index colonoscopy.
Measured: Through study completion, an average of 1 month
Secondary outcomes (1)
Incidence of Metachronous Colorectal Neoplasia
Metachronous colorectal neoplasia is defined as any adenoma or colorectal cancer detected at any follow-up colonoscopy after the baseline index colonoscopy.
Measured: Through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start1 Sep 2025
- Primary completion30 Sep 2025
- 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 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
- Retrospective
- Enrolment
- 2,955 participants (actual)
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
- NCT07302139
- Sponsor's protocol ID
- 2025K369
- Status last verified
- Dec 2025
- First submitted
- 29 Nov 2025
- Last updated
- 24 Dec 2025
- 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 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of Metachronous Advanced Colorectal Neoplastic Among Individuals With Varying Numbers of Non-Advanced Adenomas Detected During Screening Colonoscopy: A Retrospective Observational Study
- ClinicalTrials.gov ID
- NCT07302139
- Acronym / sponsor ID
- 2025K369
- Conditions
- Colorectal Adenoma
- Keywords
- Screening colonoscopy, Surveillance, Advanced colorectal adenoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,955 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 24 Dec 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.
A retrospective observational study to evaluate the risk of metachronous advanced colorectal neoplastic (ACRN) among individuals with varying numbers of non-advanced adenomas (NAA) detected during screening colonoscopy
Detailed description
Colorectal cancer (CRC) is the third most commonly diagnosed malignancy worldwide and the second leading cause of cancer-related mortality. In recent years, with increasing westernization of diet and lifestyle, both the incidence and prevalence of CRC in China have risen sharply. CRC has become the most common gastrointestinal malignancy in the country, ranking second in incidence and fifth in mortality among all cancers. Screening colonoscopy and appropriate surveillance intervals can substantially reduce CRC-related deaths.
The latest 2020 U.S. Multi-Society Task Force (USMSTF) guidelines classify patients with 1-2 non-advanced adenomas (NAAs), 3-4 NAAs, and >4 NAAs as having low-, intermediate-, and high-risk colonoscopic findings, respectively, and recommend surveillance intervals of 7-10 years, 3-5 years, and 3 years for these groups. However, accumulating evidence suggests that the risk of developing metachronous advanced colorectal neoplastic lesions (ACRN) in individuals with 3-4 NAAs may be comparable to those with only 1-2 NAAs, raising concerns regarding the appropriateness of current surveillance recommendations.
Using a real-world, endoscopy database, this study systematically evaluates the association between different NAA counts and the subsequent risk of ACRN, providing evidence to inform optimization of post-polypectomy surveillance intervals.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Individuals with <3 NAAs detected during screening colonoscopy | – | Other: No Intervention: Observational CohortIndividuals with <3 non-advanced adenomas detected during screening colonoscopy |
| Individuals with 3-4 NAAs detected during screening colonoscopy | – | Other: No Intervention: Observational CohortIndividuals with 3-4 non-advanced adenomas detected during screening colonoscopy |
| Individuals with >4 NAAs detected during screening colonoscopy | – | Other: No Intervention: Observational CohortIndividuals with >4 non-advanced adenomas detected during screening colonoscopy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals who underwent their first-time screening colonoscopy between 2012 and 2023 at the endoscopy centers of Huadong Hospital and Shanghai Tongji Hospital, and who completed at least one surveillance colonoscopy.
Key inclusion criteria (4 listed)
- First-time screening colonoscopy
- Only non-advanced adenomas (no villous features, no high-grade dysplasia, and diameter <10 mm) were detected during first-time screening colonoscopy
- Individuals with at least one surveillance colonoscopy
- Complete electronic medical record and pathology information
Key exclusion criteria (6 listed)
- Inadequate bowel preparation (BBPS < 6)
- Emergency colonoscopy
- History of colorectal cancer
- Incomplete pathology information or incompletely resected polyps
- Screening colonoscopies performed by endoscopists with a low dynamic adenoma detection rate (ADR < 15%)
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 |
|---|---|---|
| No Intervention: Observational CohortNo Intervention: Observational Cohort | Other | Individuals with 3-4 NAAs detected during screening colonoscopy, Individuals with <3 NAAs detected during screening colonoscopy, Individuals with >4 NAAs detected during screening colonoscopy |
Primary outcome
Incidence of Metachronous Advanced Colorectal Neoplasia
Time frame: Through study completion, an average of 1 month
Metachronous advanced colorectal neoplasia is defined as advanced adenoma (≥10 mm, villous component, or high-grade dysplasia) or colorectal cancer detected at any follow-up colonoscopy after the baseline index colonoscopy.
1 secondary outcome
Incidence of Metachronous Colorectal Neoplasia
Time frame: Through study completion, an average of 1 month
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 24 Dec 2025.
- 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. This study is not recruiting at the moment.
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 4 inclusion and 6 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 24 Dec 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?
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?
Incidence of Metachronous Advanced Colorectal Neoplasia (time frame: Through study completion, an average of 1 month). 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 Dec 2025.