The Fecal Immunoassay Occult Blood Test Combined With Calprotectin Sequential Linkage Imaging Endoscopy Screening Strategy for Monitoring Tumor Changes Associated With Long-duration Ulcerative Colitis

Официальное название

Diagnostic Performance of Fecal Immunochemical Test Combined With Fecal Calprotectin Sequential Linked Color Imaging Endoscopy for Surveillance of Colitis-Associated Neoplasia in Long-standing Ulcerative Colitis: A Multicenter, Prospective Cohort Study

Обзор

Ulcerative colitis (UC) is a chronic inflammatory bowel disease associated with an increased risk of colorectal cancer, known as UC-associated neoplasia (UCAN). Current guidelines recommend regular colonoscopy surveillance for long-standing UC patients, but this strategy faces challenges including poor adherence and low neoplasia detection rates. This study aims to evaluate the diagnostic performance of a non-invasive pre-screening strategy combining fecal immunochemical test (FIT) and fecal calprotectin (FC), followed by linked color imaging (LCI) colonoscopy, for detecting UCAN in patients with long-standing UC. This is a multicenter, prospective, diagnostic cohort study. Eligible patients with long-standing UC (disease duration \>8 years for extensive colitis or \>10 years for left-sided colitis, or with PSC) will undergo FIT and FC testing, followed by LCI colonoscopy within 4 weeks regardless of stool test results. The primary outcome is the diagnostic performance (sensitivity, specificity, PPV, NPV) of combined FIT+FC testing for UCAN, using LCI colonoscopy with histopathology as the reference standard. A total of 250 participants will be enrolled from 6 centers in China. Secondary outcomes include UCAN detection rate, feasibility indicators, patient adherence and acceptability, optimal cut-off values for FIT and FC, and 12-month miss rate.

Первичные конечные точки

• Diagnostic Performance of Combined FIT+FC for UCAN [Срок оценки: At time of colonoscopy (within 4 weeks after stool sample collection)]

Вторичные конечные точки (6)

• UCAN Detection Rate [Срок оценки: At time of colonoscopy]
• Comprehensive completion rate of the joint screening process [Срок оценки: Week 4 LCI colonoscopy]
• Patient Adherence [Срок оценки: Within 4 weeks after stool collection]
• Patient Acceptability [Срок оценки: At 4-week follow-up]
• Optimal Cut-off Values [Срок оценки: Week 52]
• 12-Month Miss Rate [Срок оценки: 12 months after baseline]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07742410 · DETECT-UCAN-2026-07

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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