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

NCT ID: NCT03718897

Last Updated: 2018-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-14

Study Completion Date

2022-09-02

Brief Summary

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

Detailed Description

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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.

Conditions

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Biliary Tract Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Endoscopic retrograde cholangiopancreatogram

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ji Kon Ryu

OTHER

Sponsor Role lead

Responsible Party

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Ji Kon Ryu

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ji Kon Ryu, MD, phD

Role: STUDY_DIRECTOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Min su You, MD

Role: CONTACT

82-2-2072-2228

Ji Kon Ryu, MD, phD

Role: CONTACT

82-2-2072-2228

Facility Contacts

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Min su You, MD

Role: primary

82-2-2072-2228

Ji Kon Ryu, MD, PhD

Role: backup

82-2-2072-2228

Other Identifiers

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1808-056-964

Identifier Type: -

Identifier Source: org_study_id

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