Colonic LesionsNCT07401264
Prospective Image Collection of Colorectal Polyps.
An observational study of Colonic Lesions, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
It concerns a study in which we wish to collect images and corresponding histological information (microscopic characteristics) in a prospective manner in various European and non-European centers (multicentric). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colonic Lesions
- How many people
- 5,000 participants
- Where
- 1 siteBelgium
- Study dates
- 7 Apr 2022to 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: patients who need a standard or therapeutic colonoscopy
Who may be able to join
- Referral for standard or therapeutic colonoscopy
- Digital video material of standard colonoscopy containing at least one colorectal polyp (≥ 10mm) and/or with suspicion of malignancy/submucosal invasion
- Digital images of colorectal polyps ≥ 10mm made during standard colonoscopy and/or with suspicion of malignancy/submucosal invasion Page 11 of 21
- Videos and/or images can be made in white light or any virtual of dye-based enhancement technique
- Colonoscopies performed after IRB approval for this particular study.
- Material collected in adult patients of all sex or race, including pregnant women.
Who cannot join
- Any contraindication to undergo a standard colonoscopy
- Any uncontrolled coagulopathy or bleeding disorder
- Colonoscopy videos not containing any or colorectal polyps < 10mm
- Colonoscopy videos or images of low quality due to unstable imaging, stool remnants, bowel or patient movements or blurry vision
- Colonoscopy videos with visualization of the polyp less than 5 seconds due to unstable positioning, passing stool remnants, bowel or patient movements or blurry visions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven
Leuven, 3000
Raf Bisschops, MD, +32 16 342161, raf.bisschops@uzleuven.be
About this study
Official title: Multicenter Prospectively Collected Registry of Images and Videos of Colonic Lesions to Develop Artificial Intelligence to Predict Submucosal Invasion
It concerns a study in which we wish to collect images and corresponding histological information (microscopic characteristics) in a prospective manner in various European and non-European centers (multicentric). This means that the collection of images is new and happens in the context of a procedure that has not yet been carried out. The relevant procedure will involve a standard colonoscopy during which we wish to collect digital images and videos of large colorectal polyps (colorectal lesions). These images will later be used for the development of a new computer software (artificial intelligence) that is able to predict the histology (microscopic characteristics) and extent of invasion in the intestinal wall (submucosal invasion) all by itself. The latter is one of the goals in the European project ECOPOP in which the sponsor is involved.
- Conditions
- Colonic Lesions
- Keywords
- image registry
What is being measured
The primary outcome is the main question the study is designed to answer.
registry of images of colonic lesions
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start7 Apr 2022
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic LesionsStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Raf Bisschops, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07401264
- Sponsor's protocol ID
- S65253
- Status last verified
- Sep 2025
- First submitted
- 3 Feb 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospectively Collected Registry of Images and Videos of Colonic Lesions to Develop Artificial Intelligence to Predict Submucosal Invasion
- ClinicalTrials.gov ID
- NCT07401264
- Acronym / sponsor ID
- S65253
- Conditions
- Colonic Lesions
- Keywords
- image registry
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 7 Apr 2022 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 10 Feb 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.
It concerns a study in which we wish to collect images and corresponding histological information (microscopic characteristics) in a prospective manner in various European and non-European centers (multicentric). This means that the collection of images is new and happens in the context of a procedure that has not yet been carried out. The relevant procedure will involve a standard colonoscopy during which we wish to collect digital images and videos of large colorectal polyps (colorectal lesions). These images will later be used for the development of a new computer software (artificial intelligence) that is able to predict the histology (microscopic characteristics) and extent of invasion in the intestinal wall (submucosal invasion) all by itself. The latter is one of the goals in the European project ECOPOP in which the sponsor is involved.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients who need a standard or therapeutic colonoscopy
Key inclusion criteria (6 listed)
- Referral for standard or therapeutic colonoscopy
- Digital video material of standard colonoscopy containing at least one colorectal polyp (≥ 10mm) and/or with suspicion of malignancy/submucosal invasion
- Digital images of colorectal polyps ≥ 10mm made during standard colonoscopy and/or with suspicion of malignancy/submucosal invasion Page 11 of 21
- Videos and/or images can be made in white light or any virtual of dye-based enhancement technique
- Colonoscopies performed after IRB approval for this particular study.
Key exclusion criteria (5 listed)
- Any contraindication to undergo a standard colonoscopy
- Any uncontrolled coagulopathy or bleeding disorder
- Colonoscopy videos not containing any or colorectal polyps < 10mm
- Colonoscopy videos or images of low quality due to unstable imaging, stool remnants, bowel or patient movements or blurry vision
- Colonoscopy videos with visualization of the polyp less than 5 seconds due to unstable positioning, passing stool remnants, bowel or patient movements or blurry visions
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
registry of images of colonic lesions
Time frame: 5 year
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 10 Feb 2026.
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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.
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 Colonic Lesions, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 6 inclusion and 5 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 10 Feb 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 Belgium. 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 Raf Bisschops, MD (+32 16 342161, raf.bisschops@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
registry of images of colonic lesions (time frame: 5 year). 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 10 Feb 2026.