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

November 2, 2022 updated by: Sang Hyub Lee, Seoul National University Hospital

Confirmation of Association Between Cell-free Nucleic Acid in Blood and Urine Samples and Microbiome in Stool With Pancreatobiliary Cancer and Study Related to Exploration of Biomarkers in Diagnosis and Treatment of Pancreatobiliary Cancers

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 101
        • Recruiting
        • Seoul National University Hospital
        • Contact:
        • Principal Investigator:
          • Sang Hyub Lee, MD PhD
        • Sub-Investigator:
          • Jin Ho Choi, MD
      • Seoul, Korea, Republic of
        • Recruiting
        • Sang Hyub Lee
        • Sub-Investigator:
          • Jin Ho Choi, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients aged 18 or older, who diagnosed with pancreatic cancer or biliary tract cancer (cholangiocarcinoma, gallbladder cancer) through histological or radiologic examination and before treatment begins

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
biliary cancer
cholangiocarcinoma gallbladder cancer
Diagnostic test: cell free DNA in blood and urine, metabolite/microbiome in urine and stool
cell free DNA in blood and urine, metabolite/microbiome in urine and stool
pancreatic tumor
pancreatic cancer pancreatic ductal adenocarcinoma pancreatic neuroendocrine tumor
Diagnostic test: cell free DNA in blood and urine, metabolite/microbiome in urine and stool
cell free DNA in blood and urine, metabolite/microbiome in urine and stool

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
correlation of genetic mutation
Time Frame: 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
the day of study enrollment or the day of tissue and blood acquisition
correlation of genetic mutation burden and prognosis
Time Frame: the day of study enrollment and follow-up till end of the study
correlation of genetic mutation burden and prognosis
the day of study enrollment and follow-up till end of the study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
correlation of metabolic change in urine metabolite and prognosis
Time Frame: the day of study enrollment and follow-up till end of the study
analysis of correlation of metabolic change in urine metabolite and prognosis
the day of study enrollment and follow-up till end of the study
correlation of microbiome in stool and prognosis
Time Frame: the day of study enrollment and follow-up till end of the study
analysis of correlation of microbiome in stool and prognosis
the day of study enrollment and follow-up till end of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

DXOME CO., LTD.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2022

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

October 24, 2022

First Submitted That Met QC Criteria

October 24, 2022

First Posted (Actual)

October 27, 2022

Study Record Updates

Last Update Posted (Actual)

November 7, 2022

Last Update Submitted That Met QC Criteria

November 2, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-2111-199-1281

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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