The Registry of Genetic Alterations of Taiwan Biliary Tra... | NCT05036486

Studies
The Registry of Genetic Alterations of Taiwan Biliary Tract Cancer

NCT05036486

Sponsor

National Health Research Institutes, Taiwan

Status

Active, not recruiting

Last Update Posted

Jul 2, 2026Actual

Enrollment

480Actual

Phase

Not provided

Conditions

Biliary Tract Cancer (BTC)

Interventions

next-generation sequencing

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 25, 2021Actual

Primary Completion Date

Dec 2030Estimated

Completion Date

Dec 2030Estimated

First Submitted Date

Aug 9, 2021

First Submission Date that Met QC Criteria

Aug 30, 2021

First Posted Date

Sep 5, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 1, 2026

Last Update Posted Date

Jul 2, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

National Health Research Institutes, TaiwanOTHER

Collaborators

Name	Class
National Taiwan University Hospital	OTHER
Taipei Veterans General Hospital, Taiwan	OTHER_GOV
Tri-Service General Hospital (TSGH)	OTHER
Chang Gung Medical Foundation (Linkou Branch)

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

480Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
next-generation sequencing	Genetic	Tumor tissue will be collected from advanced BTC patients for real-time next-generation sequencing analysis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	5 years
To perform large-scale NGS analysis for specific populations	To create a map containing important genetic characteristics	5 years

Secondary Outcomes

Measure	Description	Time Frame
Collect clinical data of Biliary tract cancer patients	Collect clinical data of Biliary tract cancer patients	5 years
To correlate the clinical characteristics, treatment and outcome of Biliary tract cancer with the genetic profile in Taiwan.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.
Other malignancy within the past 1 years except adequately treated basal or squamous cell skin cancer or cervical cancer in situ.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Li-Tzong Chen, MD	National Health Research Institutes, Taiwan	Study Chair
Ming-Huang Chen, MD, PhD	Taipei Veterans General Hospital, Taiwan	Principal Investigator
Nai-Jung Chiang, MD, PhD	National Health Research Institutes, Taiwan	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chang Gung Memorial Hospital, Chiayi		Chiayi City			Taiwan
Kaohsiung Chang Gung Memorial Hospital

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001661	Biliary Tract Neoplasms

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D001660	Biliary Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D059014	High-Throughput Nucleotide Sequencing

Ancestor Terms

ID	Term
D017421	Sequence Analysis
D005821	Genetic Techniques
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided