Immune Repertoire Decoding for Chronic Pancreatitis-to-Pancreatic Cancer Risk Stratification

Brief summary public domain (ClinicalTrials.gov)

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.

Detailed description public domain (ClinicalTrials.gov)

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.