Biliary Tract Cancer (BTC)NCT05036486
The Registry of Genetic Alterations of Taiwan Biliary Tract Cancer
An observational study of Biliary Tract Cancer (BTC), run by National Health Research Institutes, Taiwan at 13 sites in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Biliary Tract Cancer (BTC)
- What is being tested?
- next-generation sequencing
- How many people
- 480 participants
- Where
- 13 sitesTaiwan
- Study dates
- 25 Oct 2021to Dec 2030
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ready to have 1st systemic treatment or under 1st line therapy therapy, metastatic or unresectable population s , clinical information , and therapeutic outcomes in advanced BTC
Who may be able to join
- 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
Who cannot join
- Inability to cooperate by providing a complete medical history.
- No available tumor tissues for genetic testing.
- Undesirable compliance.
- Other malignancy within the past 1 years except adequately treated basal or squamous cell skin cancer or cervical cancer in situ.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Taiwan13 sites
Chang Gung Memorial Hospital, Chiayi
Chiayi City
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City
Kaohsiung Medical University Chung-Ho Memorial Hospital,
Kaohsiung City
China Medical University Hospital
Taichung
National Cheng Kung University Hospital
Tainan
Koo Foundation Sun Yat-Sen Cancer Center
Taipei
MacKay Memorial Hospital
Taipei
National Taiwan University Hospital
Taipei
Taipei Medical University-Shuang Ho Hospital
Taipei
Taipei Veterans General Hospital
Taipei
Tri-Service General Hospital
Taipei
Linko Chang Gung Memorial Hospital
Taoyuan
Taoyuan General Hospital, Ministry of Health and Welfare
Taoyuan
About this study
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.
Read the 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.
- Conditions
- Biliary Tract Cancer (BTC)
- Being tested
- next-generation sequencing
- Keywords
- biliary tract cancer, Next-generation sequencing, precision medicine
- Medical subject headings
- Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
next-generation sequencingGenetic
Tumor tissue will be collected from advanced BTC patients for real-time next-generation sequencing analysis
What is being measured
The primary outcome is the main question the study is designed to answer.
To enroll 400 patients who fit the criteria of this study in the enrolled period
To enroll 400 patients who fit the criteria of this study in the enrolled period
Measured: 5 years
To perform large-scale NGS analysis for specific populations
To create a map containing important genetic characteristics
Measured: 5 years
Secondary outcomes (2)
Collect clinical data of Biliary tract cancer patients
Collect clinical data of Biliary tract cancer patients
Measured: 5 years
To correlate the clinical characteristics, treatment and outcome of Biliary tract cancer with the genetic profile in Taiwan.
To correlate the clinical characteristics, treatment and outcome of Biliary tract cancer patients
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start25 Oct 2021
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract Cancer (BTC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 480 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University Hospital, Taipei Veterans General Hospital, Taiwan, Tri-Service General Hospital (TSGH), Chang Gung Medical Foundation (Linkou Branch), Taipei Medical University Shuang Ho Hospital, Koo Foundation Sun Yat-Sen Cancer Center, China Medical University Hospital, National Cheng-Kung University Hospital, Kaohsiung Medical University Chung-Ho Memorial Hospital, Chang Gung Memorial Hospital, Taoyuan General Hospital, Mackay Memorial Hospital
- Responsible party
- Sponsor
- Investigators
- Li-Tzong Chen, MD, Study chair, National Health Research Institutes, TaiwanMing-Huang Chen, MD, PhD, Principal investigator, Taipei Veterans General Hospital, TaiwanNai-Jung Chiang, MD, PhD, Principal investigator, National Health Research Institutes, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05036486
- Sponsor's protocol ID
- T3221
- Status last verified
- Jun 2026
- First submitted
- 9 Aug 2021
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Registry of Genetic Alterations of Taiwan Biliary Tract Cancer
- ClinicalTrials.gov ID
- NCT05036486
- Acronym / sponsor ID
- T3221
- Conditions
- Biliary Tract Cancer (BTC)
- Keywords
- biliary tract cancer, Next-generation sequencing, precision medicine
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 480 participants (actual)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Collaborators
- National Taiwan University Hospital, Taipei Veterans General Hospital, Taiwan, Tri-Service General Hospital (TSGH), Chang Gung Medical Foundation (Linkou Branch), Taipei Medical University Shuang Ho Hospital, Koo Foundation Sun Yat-Sen Cancer Center, China Medical University Hospital, National Cheng-Kung University Hospital, Kaohsiung Medical University Chung-Ho Memorial Hospital, Chang Gung Memorial Hospital, Taoyuan General Hospital, Mackay Memorial Hospital
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ready to have 1st systemic treatment or under 1st line therapy therapy, metastatic or unresectable population s , clinical information , and therapeutic outcomes in advanced BTC
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- Inability to cooperate by providing a complete medical history.
- No available tumor tissues for genetic testing.
- Undesirable compliance.
- Other malignancy within the past 1 years except adequately treated basal or squamous cell skin cancer or cervical cancer in situ.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| next-generation sequencingTumor tissue will be collected from advanced BTC patients for real-time next-generation sequencing analysis | Genetic | – |
Primary outcome
To enroll 400 patients who fit the criteria of this study in the enrolled period
Time frame: 5 years
To enroll 400 patients who fit the criteria of this study in the enrolled period
To perform large-scale NGS analysis for specific populations
Time frame: 5 years
To create a map containing important genetic characteristics
2 secondary outcomes
Collect clinical data of Biliary tract cancer patients
Time frame: 5 years
To correlate the clinical characteristics, treatment and outcome of Biliary tract cancer with the genetic profile in Taiwan.
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li-Tzong Chen, MD study chair
National Health Research Institutes, Taiwan
Ming-Huang Chen, MD, PhD principal investigator
Taipei Veterans General Hospital, Taiwan
Nai-Jung Chiang, MD, PhD principal investigator
National Health Research Institutes, Taiwan
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biliary Tract Cancer (BTC), run by National Health Research Institutes, Taiwan at 13 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To enroll 400 patients who fit the criteria of this study in the enrolled period (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.