Blood Biomarkers and Gut Microbiota for Pancreatic Cancer Risk in Chronic Pancreatitis

ConditionsChronic Pancreatitis Pancreatic Cancer

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorChanghai Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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 groups

Group A: Healthy Controls

Group B: Chronic Pancreatitis

Group C: Pancreatic Ductal Adenocarcinoma

Trial outcomes

Primary outcomes

Serum or Plasma CXCL10 (IP-10) Concentration

CXCL10 (IP-10) concentration will be measured in serum or plasma using a prespecified laboratory assay. Baseline concentrations will be compared among healthy controls, participants with chronic pancreatitis, and participants with newly diagnosed pancreatic ductal adenocarcinoma. Longitudinal within-participant changes will also be evaluated in participants who provide repeat blood samples during follow-up.

Time frame