Stool test duo could revolutionize cancer surveillance in colitis
NCT ID NCT07742410
First seen Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time
Summary
This study tests whether combining two stool tests—fecal immunochemical test (FIT) and fecal calprotectin (FC)—can accurately detect precancerous or cancerous changes in people with long-standing ulcerative colitis. Participants will provide stool samples and then undergo a special colonoscopy (linked color imaging) to confirm findings. The goal is to see if this non-invasive approach can effectively guide surveillance and potentially reduce the need for frequent invasive procedures.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Fecal immunochemical test (FIT) and fecal calprotectin (FC) stool tests, followed by linked color imaging (LCI) colonoscopy
- What this could lead to
- If effective, this stool test combo could become a routine pre-screening step, helping catch precancerous changes earlier and reducing the need for frequent colonoscopies in ulcerative colitis patients.
- What could go wrong
- The trial is observational and relatively small, so results may not apply broadly. Stool tests may miss some early cancers, and the added testing could increase anxiety or costs without clear benefit.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 250 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients with long-standing ulcerative colitis at high risk for UCAN, including those with disease duration \>10 years (E1/E2) or \>8 years (E3), those with primary sclerosing cholangitis (PSC), those with a first-degree family history of colorectal cancer, or those with a history of colorectal neoplasia resected.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age 18-75 years, any gender. * Definite diagnosis of ulcerative colitis by clinical, endoscopic, and pathological criteria. * Meeting at least one of the following high-risk criteria (with first onset of mucopurulent bloody stool as the starting time): E1/E2 disease duration \>10 years; E3 disease duration \>8 years; with primary sclerosing cholangitis (PSC); first-degree family history of colorectal cancer; history of colorectal neoplasia resected. * Discontinued any form of glucocorticoids for at least 4 weeks prior to enrollment. * In clinical remission at enrollment (stool frequency score \<3, rectal bleeding score = 0). * Able to understand the study, voluntarily participate, and sign written informed consent. Exclusion Criteria: * Presence of other gastrointestinal diseases or tumors. * Severe comorbidities (e.g., cardiopulmonary insufficiency, hepatic or renal failure) that may affect study results or preclude tolerance of endoscopy. * Currently taking antiplatelet or anticoagulant medications (aspirin, warfarin, rivaroxaban, etc.). * Pregnant or breastfeeding women. * History of total or subtotal colectomy.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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