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 range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this registry is focused on collecting genetic data through large-scale DNA sequencing (NGS) of biliary tract cancer patients in Taiwan, can you explain what my tumor's genetic profile might reveal, and how that information could actually influence my treatment decisions?
2This study is listed as 'active not recruiting,' which means they are no longer enrolling new patients — does that mean there are similar genetic testing programs or registries I could still participate in, or other ways to get comprehensive NGS testing done for my cancer?
3Since this is a registry study rather than a treatment trial, it wouldn't directly change the therapy I receive — so what treatment options, including standard-of-care or other clinical trials, should we be considering at the same time?
4Biliary tract cancer can have specific genetic mutations that affect which targeted therapies might work — given what's known from large-scale genetic studies like this one, should we be testing my tumor for any particular mutations like FGFR2, IDH1, or HER2 right now?
5If my tumor's genetic data were analyzed through a registry like this, who would have access to that data, and how might the findings from studies like this one eventually shape my future treatment options?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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