Clinical trial NCT05036486: The Registry of Genetic Alterations of Taiwan Biliary Tract Cancer
Official title: The Registry of Genetic Alterations of Taiwan Biliary Tract Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Biliary Tract Cancer (BTC)
Keywords: biliary tract cancer
Next-generation sequencing
precision medicine
Lead sponsor: National Health Research Institutes, Taiwan
Sponsor class: OTHER
Collaborators: name: National Taiwan University Hospital
name: Taipei Veterans General Hospital, Taiwan
name: Tri-Service General Hospital
name: Chang Gung Medical Foundation (Linkou Branch)
name: Taipei Medical University Shuang Ho Hospital
name: Koo Foundation Sun Yat-Sen Cancer Center
name: China Medical University Hospital
name: National Cheng-Kung University Hospital
name: Kaohsiung Medical University Chung-Ho Memorial Hospital
name: Chang Gung Memorial Hospital
name: Chang Gung Memorial Hospital, Chiayi
name: Taoyuan General Hospital, Ministry of Health and Welfare
name: Mackay Memorial Hospital
First posted: 2021-09-05
Enrollment: 480
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Ages 20 and above.
2. 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.
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 ready to have 1st systemic treatment or under 1st line therapy
7. Total bilirubin ≦5 mg/dL, and ECOG≦2

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.

Primary outcomes:
measure: To enroll 400 patients who fit the criteria of this study in the enrolled period
timeFrame: 5 years
measure: To perform large-scale NGS analysis for specific populations
timeFrame: 5 years
Secondary outcomes:
measure: Collect clinical data of Biliary tract cancer patients
timeFrame: 5 years
measure: To correlate the clinical characteristics, treatment and outcome of Biliary tract cancer with the genetic profile in Taiwan.
timeFrame: 5 years
Other outcomes:
Locations:
city: Chiayi City
country: Taiwan
facility: Chang Gung Memorial Hospital, Chiayi
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital,
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: Koo Foundation Sun Yat-Sen Cancer Center
city: Taipei
country: Taiwan
facility: MacKay Memorial Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Medical University-Shuang Ho Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
city: Taoyuan
country: Taiwan
facility: Linko Chang Gung Memorial Hospital
city: Taoyuan
country: Taiwan
facility: Taoyuan General Hospital, Ministry of Health and Welfare
Study officials:
affiliation: National Health Research Institutes, Taiwan
name: Li-Tzong Chen, MD
role: STUDY_CHAIR
affiliation: Taipei Veterans General Hospital, Taiwan
name: Ming-Huang Chen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Health Research Institutes, Taiwan
name: Nai-Jung Chiang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: