Immune Repertoire Decoding for Chronic Pancreatitis-to-Pancreatic Cancer Risk Stratification
Immune Repertoire Decoding Enables Dynamic Risk Stratification During Chronic Pancreatitis-to-Pancreatic Cancer Transition
This study will follow people with chronic pancreatitis, people with pancreatic cancer, and healthy volunteers. The goal is to better understand why some people with chronic pancreatitis may later develop pancreatic cancer.
Participants will provide blood samples and health information. Some participants may also provide tissue samples if these are available during routine medical care. The study team will look for changes in the immune system, genes, medical images, and clinical information that may be linked to the development of pancreatic cancer.
People with chronic pancreatitis will be followed over time. The information collected in this study may help researchers develop a model to identify patients with chronic pancreatitis who have a higher risk of pancreatic cancer.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Chronic pancreatitis is considered an important precancerous condition for pancreatic ductal adenocarcinoma, but the immune changes associated with malignant transformation remain incompletely understood. This prospective observational cohort study will enroll healthy controls, patients with chronic pancreatitis, and patients with newly diagnosed pancreatic ductal adenocarcinoma at Changhai Hospital.
The study will collect standardized clinical information, laboratory data, abdominal CT or MRI imaging data, peripheral blood samples, and, when available, tissue samples. Peripheral blood samples will be used for immune repertoire profiling, including T-cell receptor and B-cell receptor sequencing. Additional analyses may include antibody repertoire profiling, germline genetic testing, single-cell sequencing, spatial transcriptomics, and multiplex immunofluorescence in selected representative cases.
Patients with chronic pancreatitis will undergo longitudinal follow-up approximately every 6 to 12 months. The study will compare immune repertoire features across healthy controls, chronic pancreatitis, and pancreatic ductal adenocarcinoma, and will evaluate dynamic immune changes during disease progression. The collected immune, genetic, imaging, and clinical data will be integrated to develop and validate an artificial intelligence-based risk stratification model for identifying patients with chronic pancreatitis who may be at increased risk of pancreatic cancer. Participant enrollment and baseline sample collection are planned to be completed by June 2028. Follow-up, data processing, model development, and final data collection are planned to continue through December 2028.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Zhuan Liao, PhD
- Número de teléfono: +86-21-31161001
- Correo electrónico: zhuanleo@126.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Participants will be selected from healthy volunteers and patients receiving care at Changhai Hospital. The study population will include healthy controls, patients with chronic pancreatitis, and patients with newly diagnosed pancreatic ductal adenocarcinoma. Patients with chronic pancreatitis and pancreatic ductal adenocarcinoma will be identified through outpatient clinics, inpatient wards, and routine clinical evaluation. Healthy volunteers will be recruited as a reference cohort.
Participants will be recruited using a non-probability sampling approach from outpatient clinics, inpatient wards, and healthy volunteer sources at Changhai Hospital.
Descripción
Inclusion Criteria:
- Adults aged 18 years or older.
- Able to understand the study procedures and provide written informed consent.
- Healthy controls: participants without a known history of chronic pancreatitis or pancreatic cancer.
- Chronic pancreatitis cohort: participants diagnosed with chronic pancreatitis according to clinical guidelines, based on clinical, imaging, and/or genetic information.
- Pancreatic ductal adenocarcinoma cohort: participants with newly diagnosed pancreatic ductal adenocarcinoma based on clinical, imaging, and/or pathological evaluation.
- Willing to provide blood samples and relevant clinical information.
- For participants with chronic pancreatitis, willing to undergo longitudinal follow-up approximately every 6 to 12 months.
Exclusion Criteria:
- Unable or unwilling to provide written informed consent.
- Unable to provide required clinical information or biological samples.
- Prior diagnosis of another active malignant tumor, except adequately treated non-melanoma skin cancer or carcinoma in situ, if considered not to affect study participation by the investigator.
- Current severe acute infection or other serious medical condition that, in the investigator's judgment, may interfere with study participation or interpretation of immune-related analyses.
- Use of systemic immunosuppressive therapy or immunotherapy within a period considered clinically relevant by the investigator.
- Any condition that, in the investigator's judgment, makes the participant unsuitable for this study.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Healthy Controls
Healthy volunteers without chronic pancreatitis or pancreatic cancer will be enrolled as the reference cohort for comparison with the chronic pancreatitis and pancreatic ductal adenocarcinoma cohorts.
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Chronic Pancreatitis
Participants with chronic pancreatitis will be enrolled as the main longitudinal cohort.
This cohort will be followed over time to evaluate clinical, imaging, genetic, and immune features associated with pancreatic cancer risk.
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Pancreatic Ductal Adenocarcinoma
Participants with newly diagnosed pancreatic ductal adenocarcinoma will be enrolled as the pancreatic cancer cohort for comparison with the healthy control and chronic pancreatitis cohorts.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Peripheral Blood TCR/BCR Immune Repertoire Features Over 30 Months
Periodo de tiempo: Baseline and every 6 to 12 months for up to 30 months after enrollment
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Peripheral blood T-cell receptor and B-cell receptor immune repertoire features will be measured from blood samples.
Features will include clonotype diversity, clonal expansion, V/J gene usage, CDR3 sequence characteristics, B-cell receptor somatic hypermutation, and shared immune clonotype clusters.
These features will be compared across healthy controls, participants with chronic pancreatitis, and participants with pancreatic ductal adenocarcinoma, and longitudinal changes will be evaluated in participants with chronic pancreatitis.
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Baseline and every 6 to 12 months for up to 30 months after enrollment
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Performance of a Multimodal Risk Stratification Model for Pancreatic Cancer in Chronic Pancreatitis
Periodo de tiempo: Baseline and follow-up data collected up to 30 months after enrollment
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A risk stratification model will be developed using immune repertoire, germline genetic, imaging, and clinical features to identify participants with chronic pancreatitis who may be at increased risk of pancreatic cancer.
Model performance will be assessed using discrimination, calibration, sensitivity, specificity, and other predictive performance measures.
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Baseline and follow-up data collected up to 30 months after enrollment
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Number of Participants With Chronic Pancreatitis Who Develop Pancreatic Ductal Adenocarcinoma
Periodo de tiempo: From enrollment to the last scheduled follow-up, up to 30 months
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The number of participants with chronic pancreatitis who develop pancreatic ductal adenocarcinoma during follow-up will be recorded.
The diagnosis will be based on clinical evaluation, imaging findings, pathology when available, and follow-up information.
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From enrollment to the last scheduled follow-up, up to 30 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Zhuan Liao, PhD, Changhai Hospital, Naval Medical 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
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del sistema endocrino
- Procesos Patológicos
- Neoplasias por sitio
- Neoplasias
- Enfermedad crónica
- Atributos de la enfermedad
- Neoplasias del Sistema Digestivo
- Enfermedades del Sistema Digestivo
- Neoplasias de glándulas endocrinas
- Enfermedades pancreáticas
- Condiciones Patológicas, Signos y Síntomas
- Pancreatitis
- Neoplasias pancreáticas
- Pancreatitis Crónica
Otros números de identificación del estudio
- CHEC2026-120
- 82541011 (Otro número de subvención/financiamiento: National Natural Science Foundation of China)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
Información sobre medicamentos y dispositivos, documentos del estudio
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