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)
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.
Studienübersicht
Status
Bedingungen
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: yan zhang
- Telefonnummer: 8618769783511
- E-Mail: yuyanbo2000@126.com
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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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.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Diagnostic Performance of Combined FIT+FC for UCAN
Zeitfenster: At time of colonoscopy (within 4 weeks after stool sample collection)
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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.
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At time of colonoscopy (within 4 weeks after stool sample collection)
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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UCAN Detection Rate
Zeitfenster: At time of colonoscopy
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Proportion of patients with pathologically confirmed UCAN (LGD, HGD, or CRC) among all patients who complete LCI colonoscopy
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At time of colonoscopy
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Comprehensive completion rate of the joint screening process
Zeitfenster: Week 4 LCI colonoscopy
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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" :
(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
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Patient Adherence
Zeitfenster: Within 4 weeks after stool collection
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Proportion of patients completing colonoscopy within the 4-week time window
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Within 4 weeks after stool collection
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Patient Acceptability
Zeitfenster: At 4-week follow-up
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Patient acceptance scores for stool testing and colonoscopy, discomfort scores, willingness to repeat, assessed by standardized questionnaire.
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At 4-week follow-up
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Optimal Cut-off Values
Zeitfenster: Week 52
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Optimal cut-off values for FIT and FC alone and in combination for predicting UCAN, determined by ROC curve analysis
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Week 52
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12-Month Miss Rate
Zeitfenster: 12 months after baseline
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Proportion of new UCAN cases detected during 12-month follow-up among patients with negative baseline colonoscopy
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12 months after baseline
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Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Hauptermittler: Yanbo Yu, Qilu Hospital of Shandong University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- DETECT-UCAN-2026-07
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