NCT03718897

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 14, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 23, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 25, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2022

Completed
Last Updated

October 25, 2018

Status Verified

October 1, 2018

Enrollment Period

2 years

First QC Date

October 23, 2018

Last Update Submit

October 23, 2018

Conditions

Biliary Tract Cancer

Outcome Measures

Primary Outcomes (1)

  • Overall survival rate

    Comparisons of overall survival rates between patients with gene mutations and without.

    48 months

Interventions

Endoscopic retrograde cholangiopancreatogramDIAGNOSTIC_TEST

Biopsy specimens are attained via endoscopic retrograde cholangiopancreatogram in patients with suspicious biliary tract cancer.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Patients diagnosed with biliary tract cancer via endoscopic retrograde cholangiopancreatogram

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

1. Whole genome sequencing of biopsy specimen of biliary tract cancer 2. Peripheral blood circulating tumor DNA in patients with biliary tract cancer

MeSH Terms

Conditions

Biliary Tract Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsBiliary Tract DiseasesDigestive System Diseases

Study Officials

  • Ji Kon Ryu, MD, phD

    Seoul National University Hospital

    STUDY DIRECTOR

Central Study Contacts

Min su You, MD

CONTACT

82-2-2072-2228bass105@hanmail.net

Ji Kon Ryu, MD, phD

CONTACT

82-2-2072-2228jkryu@snu.ac.kr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 23, 2018

First Posted

October 25, 2018

Study Start

September 14, 2018

Primary Completion

September 2, 2020

Study Completion

September 2, 2022

Last Updated

October 25, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)