Association Between Cell-free Nucleic Acid in Blood, Urine and Microbiome in Stool With Pancreatobiliary Cancer

Seoul National University

Status

Enrolling

Conditions

Gallbladder Cancer

Cholangiocarcinoma

Pancreatic Cancer

Treatments

Diagnostic Test: cell free DNA in blood and urine, metabolite/microbiome in urine and stool

Study type

Observational

Funder types

Other

Identifiers

NCT05596370

H-2111-199-1281

Details and patient eligibility

About

Based on the cell free nucleic acid analysis information of blood samples, the results of microbiome and metabolite analysis of stool and urine samples of pancreatic cancer and bile duct cancer patients, the clinical correlations of them with primary cancer are evaluated. And based on these information, biomarkers for diagnosis, treatment, and prognosis of pancreatic and bile duct cancer are explored.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Patients diagnosed with pancreatic cancer through histological or radiologic examination and before treatment begins
Patients diagnosed with biliary tract cancer (cholangiocarcinoma, gallbladder cancer) through histological or radiologic examination and before treatment begins
Patients aged 18 or older who voluntarily agrees to participate in the study and is willing to understand and comply with the subsequent treatment procedures and sample collection schedule

Exclusion criteria

Where the subject himself/herself refuses to fill out the consent form or is unable to fill out the consent form
In the case where the sample storage conditions suggested by the reagent manufacturer are not satisfied
Only samples that can cause errors when determining results are acquired:
- Heat treated specimen
  - Incompletely coagulated serum and bacterial samples ③ Samples with particulate matter elements (e.g., fibroblasts, red blood cells) remaining in the sample
    
    ④ Specimens previously frozen and stored with blood clots that have confirmed an increase in non-specific reactivity in which samples appear to have denatured during storage
    
    ⑤ Sample from deceased patient
    
    ⑥ A patient specimen with a malignancy of ohter site
    
    ⑦ Sample from vulnerable persons such as pregnant women, minors, etc