Immune Repertoire Decoding Enables Dynamic Risk Stratification During Chronic Pancreatitis-to-Pancreatic Cancer Transition

Changhai Hospital0 个研究点目标入组 800 人开始时间: 2026年8月1日最近更新: 2026年8月13日

适应症

试验速览

阶段: 不适用
状态: 尚未招募
发起方: Changhai Hospital
入组人数: 800
主要终点: Serum or Plasma CXCL10 (IP-10) Concentration

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

The goal of this observational study is to learn more about pancreatic cancer risk in people with chronic pancreatitis. Researchers will study blood markers and gut microorganisms, which are bacteria and other microbes living in the intestine.

Researchers will compare healthy participants, participants with chronic pancreatitis, and participants with newly diagnosed pancreatic cancer. The study will examine whether blood markers and gut microorganisms differ among these groups. It will also study how these features change over time and whether they may help identify people with chronic pancreatitis who are at higher risk of pancreatic cancer.

Participants will provide blood and stool samples. Researchers will also collect health information, laboratory test results, and abdominal scan results. Participants with chronic pancreatitis will be followed about every 6 to 12 months. Participants with pancreatic cancer will also be followed according to their routine medical care schedule. Researchers will collect information about their treatment, disease changes, test results, scans, and survival status.

Some participants with chronic pancreatitis or pancreatic cancer may be asked to provide additional blood or stool samples. Their permission will be confirmed before each additional sample is collected. Refusing an additional sample will not affect their routine medical care or continued follow-up in the study.

No treatment will be assigned as part of this study. The findings may help improve future methods for assessing pancreatic cancer risk in people with chronic pancreatitis.

详细描述

Chronic pancreatitis is associated with an increased risk of pancreatic ductal adenocarcinoma, but the biological changes that occur during disease progression remain incompletely understood. Changes in circulating inflammatory and immune-related biomarkers, disruption of the gut microbiota, and the movement of microbial products from the intestine into the bloodstream may reflect interactions among chronic inflammation, gut microbial imbalance, and impaired immune surveillance.

This is a single-center, prospective observational cohort study conducted at Changhai Hospital. The study plans to enroll up to 800 participants, including 200 healthy controls, 300 participants with chronic pancreatitis, and 300 patients with newly diagnosed pancreatic ductal adenocarcinoma. Healthy controls will serve as a reference group. Participants with chronic pancreatitis will form the main longitudinal cohort, and patients with pancreatic ductal adenocarcinoma will serve as the pancreatic cancer comparison cohort.

At baseline, participants will provide peripheral blood and fresh stool samples. Blood samples will be used to measure inflammatory, immune-related, and tumor-associated biomarkers, including CXCL10 (IP-10), GLYR1, TGF-beta, Artemin, and other candidate biomarkers. Markers related to gut barrier dysfunction and the movement of microbial products into the circulation, such as lipopolysaccharide, endotoxin-related measures, and soluble CD14, may also be assessed.

Stool samples will be analyzed using 16S ribosomal RNA gene sequencing, metagenomic sequencing, and related microbiome analysis methods. These analyses will characterize microbial diversity, taxonomic composition, functional pathways, and selected microbial metabolites, including pathways related to short-chain fatty acids and bile acids. Whenever feasible, blood and stool samples collected at the same time point will be analyzed as paired samples to investigate associations between circulating biomarkers and gut microbiota features.

Participants with chronic pancreatitis will generally be followed every 6 to 12 months. Follow-up may occur earlier or more frequently if there are changes in the participant's condition, an acute episode, imaging progression, an important treatment, or another clinical reason for evaluation. Follow-up information will include treatment, changes in disease status, laboratory test results, abdominal imaging findings, and relevant clinical outcomes.

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•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.

排除标准

•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.

研究组 & 干预措施

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.