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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 juillet 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Type d'étude

Observationnel

Inscription (Estimé)

250

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Diagnostic Performance of Combined FIT+FC for UCAN
Délai: 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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
UCAN Detection Rate
Délai: 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
Délai: 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
Délai: 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
Délai: At 4-week follow-up

Patient acceptance scores for stool testing and colonoscopy, discomfort scores, willingness to repeat, assessed by standardized questionnaire.

  1. Fecal Test Acceptability Questionnaire, score range: 6 to 30 points. The meaning of the score: A higher score = better results (higher acceptance).

  2. 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)
  3. 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Qilu Hospital of Shandong University

Collaborateurs

Linyi People's Hospital
Shouguang people's Hospital
Qilu Hospital of Shandong University (Qingdao)
Zaozhuang Municipal Hospital
Weifang Traditional Chinese Medicine Hospital

Les enquêteurs

  • Chercheur principal: Yanbo Yu, Qilu Hospital of Shandong University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

23 juillet 2026

Achèvement primaire (Estimé)

31 août 2029

Achèvement de l'étude (Estimé)

31 décembre 2029

Dates d'inscription aux études

Première soumission

24 juillet 2026

Première soumission répondant aux critères de contrôle qualité

29 juillet 2026

Première publication (Réel)

3 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

3 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

29 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • DETECT-UCAN-2026-07

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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