Brief Title
The Registry of Genetic Alterations of Taiwan Biliary Tract Cancer
Official Title
The Registry of Genetic Alterations of Taiwan Biliary Tract Cancer
Brief Summary
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 Type
Observational [Patient Registry]
Primary Outcome
To enroll 200 patients who fit the criteria of this study in the enrolled period
Secondary Outcome
Collect clinical data of Biliary tract cancer patients
Condition
Biliary Tract Cancer (BTC)
Intervention
next-generation sequencing
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Genetic
Estimated Enrollment
200
Start Date
September 1, 2021
Completion Date
December 2030
Primary Completion Date
December 2030
Eligibility Criteria
Inclusion Criteria:
1. Ages 20 and above.
2. Pathological reported showed adenocarcinoma or adenosquamous carcinoma for patients
with Biliary tract cancer (include intrahepatic cholangiocarcinoma (IHCC),
extrahepatic cholangiocarcinoma (EHCC), gallbladder cancer (GBC) and ampulla of Vater
cancer (AVC) ) or hepatocholangiocarcinoma.
3. Willingness to provide the residual biopsy/operative slides.
4. Life expectancy more than 3 months.
5. Patients fully understand the protocol with the willingness to have regular follow-up.
6. Patients are systemic treatment-naïve or under 1st line therapy
Exclusion Criteria:
1. Inability to cooperate by providing a complete medical history.
2. No available tumor tissues for genetic testing.
3. Undesirable compliance.
4. Other malignancy within the past 1 years except adequately treated basal or squamous
cell skin cancer or cervical cancer in situ.
Gender
All
Ages
20 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Li-Tzong Chen, MD, 886-2-28757270, [email protected]
Administrative Informations
NCT ID
NCT05036486
Organization ID
T3221
Responsible Party
Sponsor
Study Sponsor
National Health Research Institutes, Taiwan
Collaborators
National Taiwan University Hospital
Study Sponsor
Li-Tzong Chen, MD, Study Chair, National Health Research Institutes, Taiwan
Verification Date
August 2021