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

NCT07612566 | Not Yet Recruiting

• 2 other identifiers: CHEC2026-12082541011
• Study Type: observational
• Target: 800
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Chronic Pancreatitis; Pancreatic Cancer

Keywords

Pancreatic Ductal Adenocarcinoma; Immune Repertoire; T-Cell Receptor; B-Cell Receptor; Risk Stratification; Artificial Intelligence

Outcome Measures

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.

  Baseline and every 6 to 12 months for up to 30 months after enrollment

Secondary Outcomes (2)

• Performance of a Multimodal Risk Stratification Model for Pancreatic Cancer in Chronic Pancreatitis

  Baseline and follow-up data collected up to 30 months after enrollment

• Number of Participants With Chronic Pancreatitis Who Develop Pancreatic Ductal Adenocarcinoma

  From enrollment to the last scheduled follow-up, up to 30 months

Study Arms (3)

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.

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.

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changhai Hospital: lead

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood samples, including peripheral blood mononuclear cells (PBMCs), serum, plasma, and whole blood, will be collected and retained. These samples may be used for immune repertoire sequencing, antibody profiling, and germline genetic testing, including whole-exome sequencing or targeted sequencing. Tissue samples may also be retained from selected representative participants when available during routine clinical care or surgery.

MeSH Terms

Conditions

Pancreatitis, Chronic; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Endocrine System Diseases

Study Officials

• Zhuan Liao, PhD

  Changhai Hospital, Naval Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhuan Liao, PhD

CONTACT

+86-21-31161001; zhuanleo@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chief Physician

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: May 28, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 12 months after publication of the main study results and available for 5 years.
• Access Criteria: Researchers with a scientifically sound proposal may submit a data access request to the study investigators or the designated data management platform. Requests will be reviewed for scientific purpose, ethical approval, data security, and consistency with the informed consent and institutional policies. Data will be shared only after approval and, when required, completion of a data use agreement.