Immune Repertoire Decoding Enables Dynamic Risk Stratification During Chronic Pancreatitis-to-Pancreatic Cancer Transition
Sponsor: Changhai Hospital
Trial Details
| Condition | Chronic Pancreatitis, Pancreatic Cancer |
| Status | Not_yet_recruiting |
| Participants | 800 |
| Est. Completion | 31 Dec 2028 |
| Last Updated | 28 May 2026 |
Primary Outcome
Change in Peripheral Blood TCR/BCR Immune Repertoire Features Over 30 Months
Eligibility Criteria
Inclusion Criteria
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.
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