Identification of Prognostic Gene Mutations in Biliary Tract Cancer Using Whole Genome Sequencing

October 23, 2018 updated by: Ji Kon Ryu
The purpose of this study is to investigate genetic mutations affecting prognosis using whole genome sequencing in patients with biliary tract cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Recently, as genome technology such as next-generation sequencing has progressed, precision medicine using genetic analysis in lung cancer, colorectal cancer, and melanoma has been actively studied. The need for such precision medicine is also increasing in biliary tract cancer patients. Although whole genome sequencing is relatively costly, it is known to provide more accurate information than other methods such as exome analysis and RNA sequencing in identifying promoter mutations, regulatory regions, and structural variants. Pancreatic cancer and melanoma have been studied by whole genome sequencing, but there is no previous study using whole genome sequencing method in biliary tract cancer.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

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

Study Contact

  • Name: Ji Kon Ryu, MD, PhD
  • Phone Number: 82-2-2072-2228
  • Email: jkryu@snu.ac.kr

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital
        • Contact:
        • 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

During the study period, all patients who were diagnosed with biliary tract cancer via endoscopic retrograde cholangiopancreatogram at Seoul National University Hospital will be enrolled. The investigators will perform whole genome sequencing of biopsy specimens from patients with biliary tract cancer and analyze the gene mutations associated with patient survival. And additionally, the presence or absence of blood circulating tumor DNA and associated gene mutation will be analyzed.

Description

Inclusion Criteria:

  • Patients diagnosed with biliary tract cancer via endoscopic retrograde cholangiopancreatogram

Exclusion Criteria:

  • Pregnancy
  • Other active tumors within 5 years
  • Coagulopathy
  • Severe mental illness

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival rate
Time Frame: 48 months
Comparisons of overall survival rates between patients with gene mutations and without.
48 months

Collaborators and Investigators

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

Sponsor

Ji Kon Ryu

Investigators

  • Study Director: Ji Kon Ryu, MD, phD, Seoul National University Hospital

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)

September 14, 2018

Primary Completion (Anticipated)

September 2, 2020

Study Completion (Anticipated)

September 2, 2022

Study Registration Dates

First Submitted

October 23, 2018

First Submitted That Met QC Criteria

October 23, 2018

First Posted (Actual)

October 25, 2018

Study Record Updates

Last Update Posted (Actual)

October 25, 2018

Last Update Submitted That Met QC Criteria

October 23, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1808-056-964

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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