Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04871321
Status:
RECRUITING
Last Update Posted:
2024-02-07
First Post:
2021-04-26
Brief Title:
Biomarker Discovery in Patients With Advanced Biliary Tract Cancer
Sponsor:
CHA University
Organization:
CHA University
Study Overview
Official Title:
Discovery of Molecular Biomarkers for Predicting Response Through RNA Sequencing in Patients With Advanced Biliary Tract Cancer Who Received Nab-paclitaxel Plus Gemcitabine-cisplatin
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Biliary tract cancer is a rare gastrointestinal malignant neoplasm and includes intrahepatic cholangiocarcinoma extrahepatic cholangiocarcinoma and gall bladder cancer Curative surgical resection offers the only chance for cure However most patients with BTC are diagnosed at an unresectable stage Therefore the survival outcomes of patients with advanced biliary tract cancer remain dismal
The combination of gemcitabine and cisplatin has become the current standard for advanced BTCs since the landmark ABC-02 trial in 2010 However the median overall survival of GemCis chemotherapy is less than 1 year Recently a triplet regimen of gemcitabine cisplatin and nab-paclitaxel showed promising results in a single-arm phase II multicenter study
However biliary tract cancer is a group of heterogenous diseases by site and genetic alteration and this diversity may lead differences in response to systemic chemotherapy
Transcriptome analysis through RNA-sequencing has rarely been performed in advanced biliary tract cancer and even if it has performed only small number of patients were included Further research on multi-omics data is needed on the necessity and clinical significance in treatment of biliary tract cancer
The combination of gemcitabine and cisplatin has become the current standard for advanced BTCs since the landmark ABC-02 trial in 2010 However the median overall survival of GemCis chemotherapy is less than 1 year Recently a triplet regimen of gemcitabine cisplatin and nab-paclitaxel showed promising results in a single-arm phase II multicenter study
However biliary tract cancer is a group of heterogenous diseases by site and genetic alteration and this diversity may lead differences in response to systemic chemotherapy
Transcriptome analysis through RNA-sequencing has rarely been performed in advanced biliary tract cancer and even if it has performed only small number of patients were included Further research on multi-omics data is needed on the necessity and clinical significance in treatment of biliary tract cancer
Detailed Description:
Using biopsy specimen formalin fixed paraffin embedded tissue in-house NGS and RNA-sequencing will be performed simultaneously Through this investigators will discover biomarkers based on multi-omics data that predict response to systemic chemotherapy nab-paclitaxel plus gemcitabine-cisplatin In addition blood sampling will be performed in parallel to conduct research on cell-free DNA and circulating tumor cell analysis related to response and progression on chemotherapy before administration of chemotherapy 3 months after chemotherapy 6 months after chemotherapy the time of disease progression if possible before curative resection if possible
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None