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

Biliary Tract Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03718897
• Other study ID #: 1808-056-964
• Status: Recruiting
• Start date: September 14, 2018
• Est. completion date: September 2, 2022

Study information

• Verified date: October 2018
• Source: Seoul National University Hospital
• Contact: Min su You, MD
• Phone: 82-2-2072-2228
• Email: bass105[@]hanmail.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to investigate genetic mutations affecting prognosis using whole genome sequencing in patients with biliary tract cancer.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2, 2022
• Est. primary completion date: September 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Biliary Tract Cancer
• Biliary Tract Neoplasms

Intervention

Diagnostic Test:
• Endoscopic retrograde cholangiopancreatogram
Biopsy specimens are attained via endoscopic retrograde cholangiopancreatogram in patients with suspicious biliary tract cancer.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Ji Kon Ryu

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival rate	Comparisons of overall survival rates between patients with gene mutations and without.	48 months