Viewing Study NCT05036486



Ignite Creation Date: 2024-05-06 @ 4:36 PM
Last Modification Date: 2024-10-26 @ 2:13 PM
Study NCT ID: NCT05036486
Status: RECRUITING
Last Update Posted: 2023-11-09
First Post: 2021-08-09

Brief Title: The Registry of Genetic Alterations of Taiwan Biliary Tract Cancer
Sponsor: National Health Research Institutes Taiwan
Organization: National Health Research Institutes Taiwan

Study Overview

Official Title: The Registry of Genetic Alterations of Taiwan Biliary Tract Cancer
Status: RECRUITING
Status Verified Date: 2023-08
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: Recent progress in comprehensive genomic profiling for advanced BTC has helped to clarify tumorigenesis and facilitate the coming era of precision medicine To further elucidate the underlying molecular genomic aberrations as well as the clinical demographics and therapeutic outcomes it is necessary to have a national multi-centers and population-focused research project to collect data completely Tumor tissue will be collected from advanced BTC patients for real-time next-generation sequencing analysis in a platform of data storage and sharing The purpose of the precision medicine project is to establish tumor molecular profiling of BTC populations in Taiwan to facilitate patients to have corresponding potential targeted therapeutics and suitable clinical trials
Detailed Description: Biliary tract cancer BTC compromises a heterogenous group of tumors with poor prognoses Curative surgery remains the first choice for localized disease however most BTC patients had unresectable or metastatic disease The gold standard therapy for these patients is chemotherapy with gemcitabine and cisplatin There are no consensus guidelines for standard treatment in a second-line setting although the data of the ABC-06 trial showed a slight survival benefit from oxaliplatin and 5-fluorouracil combination chemotherapy

Recent progress in comprehensive genomic profiling for advanced BTC has helped to clarify tumorigenesis and facilitate the coming era of precision medicine To further elucidate the underlying molecular genomic aberrations as well as the clinical demographics and therapeutic outcomes it is necessary to have a national multi-centers and population-focused research project to collect data completely Tumor tissue will be collected from advanced BTC patients for real-time next-generation sequencing analysis in a platform of data storage and sharing The purpose of the precision medicine project is to establish tumor molecular profiling of BTC populations in Taiwan to facilitate patients to have corresponding potential targeted therapeutics and suitable clinical trials

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