NCT07401264 Prospective Image Collection of Colorectal Polyps.
| NCT ID | NCT07401264 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Condition | Colonic Lesions |
| Study Type | OBSERVATIONAL |
| Enrollment | 5,000 participants |
| Start Date | 2022-04-07 |
| Primary Completion | 2030-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 5,000 participants in total. It began in 2022-04-07 with a primary completion date of 2030-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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). 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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07401264 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colonic Lesions. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07401264 currently recruiting?
Yes, NCT07401264 is actively recruiting participants. Contact the research team at raf.bisschops@uzleuven.be for enrollment information.
Where is the NCT07401264 trial being conducted?
This trial is being conducted at Leuven, Belgium.
Who is sponsoring the NCT07401264 clinical trial?
NCT07401264 is sponsored by Universitaire Ziekenhuizen KU Leuven. The trial plans to enroll 5,000 participants.