Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03718897
Other study ID # 1808-056-964
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT05489211 - Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03) Phase 2
Withdrawn NCT03110510 - FOLFIRI as Salvage Treatment in Metastatic Biliary Tract Cancer (BTC) Patients Who Were Failed After Gemcitabine Containing Chemotherapy: A Phase II Single Arm Prospective Study Phase 2
Completed NCT05116891 - A Phase 1/2 Study of CAN04 in Combination With Different Chemotherapy Regimens in Subjects With Advanced Solid Tumors Phase 1/Phase 2
Completed NCT00380588 - Randomized Phase 2 Study With Gemcitabine Alone and Combination Therapy for Patients With Advanced Biliary Tract Cancer Phase 2
Terminated NCT00090025 - XL119 Versus 5-Fluorouracil (5-FU) Plus Leucovorin (LV) in Subjects With Advanced Biliary Tumors Phase 3
Terminated NCT04066491 - Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) in Participants With 1L BTC Phase 2/Phase 3
Recruiting NCT05998447 - GEN-001 Plus Pembrolizumab for Patients With Advanced Refractory Biliary Tract Cancer Phase 2
Recruiting NCT05056116 - A Safety and Efficacy Study of Surufatinib Combination With Toripalimab in Patients With Recurrent Biliary Tract Cancer N/A
Recruiting NCT04692051 - A Phase II Study for Nab-paclitaxel Plus Cisplatin vs Gemcitabine Plus Cispatin as First Line Chemotherapy in Advanced Biliary Tract Cancer Phase 2
Terminated NCT04057365 - Study of the Combination of DKN-01 and Nivolumab in Previously Treated Patients With Advanced Biliary Tract Cancer (BTC) Phase 2
Recruiting NCT04907643 - Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes N/A
Completed NCT02829918 - Study of Nivolumab in Patients With Advanced Refractory Biliary Tract Cancers Phase 2
Recruiting NCT04584996 - CIRcular and Non-coding RNAs as Clinically USeful Biomarkers in Pancreaticobiliary Cancers
Completed NCT02579616 - Study of Lenvatinib (E7080) in Unresectable Biliary Tract Cancer (BTC) Who Failed Gemcitabine-based Combination Chemotherapy Phase 2
Recruiting NCT05052099 - Phase Ib/II Single-arm Study of mFOLFOX6, Bevacizumab and Atezolizumab in Advanced Biliary Tract Cancer Phase 1/Phase 2
Recruiting NCT01494363 - Phase II Study of FOLFOXIRI in Patients With Locally Advanced or Metastatic Biliary Tract Cancer Phase 2
Completed NCT00753675 - Vandetanib Gemcitabine Or Placebo Plus Gemcitabine Or Vandetanib Monotherapy In Advanced Biliary Tract Cancer Phase 2
Terminated NCT00630890 - Cyberknife Radiosurgery Boost for Hilar Cholangiocarcinoma (Klatskin Tumor) Phase 1
Recruiting NCT04445532 - Hepatobiliary Tumors Tissue Samples Acquisition
Recruiting NCT06037980 - CisPlatin plUs Gemcitabine and Nabpaclitaxel (GAP) as pReoperative Chemotherapy Versus Immediate Resection in patIents With resecTable BiliarY Tract Cancers (BTC) at High Risk for Recurrence Phase 2/Phase 3