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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 (DETECT-UCAN)

29 lipca 2026 zaktualizowane przez: Yan Zhang, MD, Qilu Hospital of Shandong University

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

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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Wrzodziejące zapalenie jelita grubego (UC)

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

250

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Nazwa: yan zhang
Numer telefonu: 8618769783511
E-mail: yuyanbo2000@126.com

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

Dorosły
Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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.

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Liczba grup / kohort

Kohorty i interwencje

Grupa / Kohorta
Long-standing Ulcerative Colitis High-risk Cohort Participants with long-standing UC meeting high-risk criteria (disease duration >8/10 years, PSC, family history, or prior neoplasia). All participants undergo a unified surveillance protocol: baseline data collection → fecal sample collection for FIT and FC testing → LCI colonoscopy within 4 weeks regardless of stool test results.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku	Opis środka	Ramy czasowe
Diagnostic Performance of Combined FIT+FC for UCAN Ramy czasowe: At time of colonoscopy (within 4 weeks after stool sample collection)	Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (LR+), and negative likelihood ratio (LR-) of combined FIT+FC testing (either positive defined as positive) for detecting UCAN, using LCI colonoscopy with histopathology as the reference standard.	At time of colonoscopy (within 4 weeks after stool sample collection)

Miary wyników drugorzędnych

Miara wyniku	Opis środka	Ramy czasowe
UCAN Detection Rate Ramy czasowe: At time of colonoscopy	Proportion of patients with pathologically confirmed UCAN (LGD, HGD, or CRC) among all patients who complete LCI colonoscopy	At time of colonoscopy
Comprehensive completion rate of the joint screening process Ramy czasowe: Week 4 LCI colonoscopy	Unit of measurement: Percentage (%) Detailed description To evaluate the overall implementation quality of the "FIT+FC sequential LCI" screening strategy, this indicator was set as a composite endpoint. Summary rule (mathematical definition) : Subjects who simultaneously meet all of the following five conditions are defined as "fully compliant process participants" : Fecal sample collection was successful; The sample quality is qualified; Both the FIT and FC laboratory tests have been completed. ④ Complete the LCI colonoscopy within 4 weeks; ⑤ The Boston Quality of Bowel Preparation Scale (BBPS) score is ≥ 6 points. The reported value of this result measurement item = (the number of fully compliant process participants/the total number of participants in the group) × 100%. (Note: The completion rates of each individual link will be presented as baseline characteristics or descriptive data in the attached materials, and will not be separately used as result measurement items for	Week 4 LCI colonoscopy
Patient Adherence Ramy czasowe: Within 4 weeks after stool collection	Proportion of patients completing colonoscopy within the 4-week time window	Within 4 weeks after stool collection
Patient Acceptability Ramy czasowe: At 4-week follow-up	Patient acceptance scores for stool testing and colonoscopy, discomfort scores, willingness to repeat, assessed by standardized questionnaire. Fecal Test Acceptability Questionnaire, score range: 6 to 30 points. The meaning of the score: A higher score = better results (higher acceptance). Colonoscopy Experience Scale Score range: • Acceptance dimension (Items 1-3) : 3-15 points Comfort/Discomfort dimension (Items 4-6) : 3-15 points (Note direction) Overall experience dimension (Items 7-9) : 3-15 points Total score: 9-45 points Score meaning: A higher score = a better outcome (higher acceptance, less discomfort, and a better overall experience) Willingness for Repeat Examination Score range: 4 to 20 points Score meaning: A higher score = a better outcome (stronger willingness to accept again)	At 4-week follow-up
Optimal Cut-off Values Ramy czasowe: Week 52	Optimal cut-off values for FIT and FC alone and in combination for predicting UCAN, determined by ROC curve analysis	Week 52
12-Month Miss Rate Ramy czasowe: 12 months after baseline	Proportion of new UCAN cases detected during 12-month follow-up among patients with negative baseline colonoscopy	12 months after baseline

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Qilu Hospital of Shandong University

Współpracownicy

Linyi People's Hospital

Shouguang people's Hospital

Qilu Hospital of Shandong University (Qingdao)

Zaozhuang Municipal Hospital

Weifang Traditional Chinese Medicine Hospital

Śledczy

Główny śledczy: Yanbo Yu, Qilu Hospital of Shandong University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

23 lipca 2026

Zakończenie podstawowe (Szacowany)

31 sierpnia 2029

Ukończenie studiów (Szacowany)

31 grudnia 2029

Daty rejestracji na studia

Pierwszy przesłany

24 lipca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

29 lipca 2026

Pierwszy wysłany (Rzeczywisty)

3 sierpnia 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)