Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Pancreatitis | — | UNRESOLVED | — |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- Healthy Controls
- description
- 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.
- label
- Chronic Pancreatitis
- description
- 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.
- label
- Pancreatic Ductal Adenocarcinoma
- description
- 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.
Primary outcomes (1)
- measure
- Change in Peripheral Blood TCR/BCR Immune Repertoire Features Over 30 Months
- timeFrame
- Baseline and every 6 to 12 months for up to 30 months after enrollment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available