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.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: yan zhang
- Número de teléfono: 8618769783511
- Correo electrónico: yuyanbo2000@126.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Diagnostic Performance of Combined FIT+FC for UCAN
Periodo de tiempo: 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)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
UCAN Detection Rate
Periodo de tiempo: 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
Periodo de tiempo: 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" :
(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
Periodo de tiempo: 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
Periodo de tiempo: At 4-week follow-up
|
Patient acceptance scores for stool testing and colonoscopy, discomfort scores, willingness to repeat, assessed by standardized questionnaire.
|
At 4-week follow-up
|
|
Optimal Cut-off Values
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Yanbo Yu, Qilu Hospital of Shandong University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- DETECT-UCAN-2026-07
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .