Immune Repertoire Decoding for Chronic Pancreatitis-to-Pancreatic Cancer Risk Stratification
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChanghai Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
800 Participants
are grouped into 3 trial groupsGroup A: Healthy Controls
Group B: Chronic Pancreatitis
Group C: Pancreatic Ductal Adenocarcinoma
Trial outcomes
Primary outcomes
1
Change in Peripheral Blood TCR/BCR Immune Repertoire Features Over 30 Months
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.
Time frame
Baseline and every 6 to 12 months for up to 30 months after enrollmentSecondary outcomes
1
Performance of a Multimodal Risk Stratification Model for Pancreatic Cancer in Chronic Pancreatitis
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.
Time frame
Baseline and follow-up data collected up to 30 months after enrollment2
Number of Participants With Chronic Pancreatitis Who Develop Pancreatic Ductal Adenocarcinoma
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.
Time frame
From enrollment to the last scheduled follow-up, up to 30 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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