The Registry of Genetic Alterations of Taiwan Biliary Tract Cancer (NCT05036486) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The Registry of Genetic Alterations of Taiwan Biliary Tract Cancer
Taiwan480 participantsStarted 2021-10-25
Plain-language 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.
Who can participate
Age range20 Years
SexALL
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Inclusion criteria
✓. Ages 20 and above.
✓. Pathological reported showed adenocarcinoma or adenosquamous carcinoma for patients with BTC (include IHCC, EHCC, GBC or AVC) or hepatocholangiocarcinoma as locally advanced or metastatic status.
✓. Willingness to provide the residual biopsy/operative slides.
✓. Life expectancy more than 3 months.
✓. Patients fully understand the protocol with the willingness to have regular follow-up.
✓. Patients are ready to have 1st systemic treatment or under 1st line therapy
✓. Total bilirubin ≦5 mg/dL, and ECOG≦2
Exclusion criteria
✕. Inability to cooperate by providing a complete medical history.
✕. No available tumor tissues for genetic testing.
✕. Undesirable compliance.
What they're measuring
1
To enroll 400 patients who fit the criteria of this study in the enrolled period
Timeframe: 5 years
2
To perform large-scale NGS analysis for specific populations
Timeframe: 5 years
Trial details
NCT IDNCT05036486
SponsorNational Health Research Institutes, Taiwan