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

Recruiting

• Conditions: Gallbladder Cancer; Pancreatic Cancer; Cholangiocarcinoma
• Interventions: Diagnostic Test: cell free DNA in blood and urine, metabolite/microbiome in urine and stool

• Registration Number: NCT05596370
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-06
• Study First Submitted: 2022-10-24
• Study First Submitted QC: 2022-10-24
• Study First Posted: 2022-10-27
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-02
• Last Update Posted: 2022-11-07
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
biliary cancer	cell free DNA in blood and urine, metabolite/microbiome in urine and stool	cholangiocarcinoma gallbladder cancer
pancreatic tumor	cell free DNA in blood and urine, metabolite/microbiome in urine and stool	pancreatic cancer pancreatic ductal adenocarcinoma pancreatic neuroendocrine tumor

Primary Outcome Measures

Name	Time	Method
correlation of genetic mutation burden and prognosis	the day of study enrollment and follow-up till end of the study	correlation of genetic mutation burden and prognosis
correlation of genetic mutation	the day of study enrollment or the day of tissue and blood acquisition	concordance of genetic mutation between tissue and blood of treatment-naive status

Secondary Outcome Measures

Name	Time	Method
correlation of microbiome in stool and prognosis	the day of study enrollment and follow-up till end of the study	analysis of correlation of microbiome in stool and prognosis
correlation of metabolic change in urine metabolite and prognosis	the day of study enrollment and follow-up till end of the study	analysis of correlation of metabolic change in urine metabolite and prognosis

Trial Locations

Locations (2)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Sang Hyub Lee; 🇰🇷 Seoul, Korea, Republic of