Real-world clinical outcomes associated with gene mutation patterns in patients with biliary tract cancer (BTC) in Japan

Real-world clinical outcomes associated with gene mutation patterns in patients with biliary tract cancer (BTC) in Japan - Real-world clinical outcomes associated with gene mutation patterns in patients with biliary tract cancer (BTC) in Japan

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000055174

Enrollment

4700

Registered

2024-10-01

Start date

2024-07-16

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary tract cancer (BTC)

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients aged 18 years and older at registration in the C-CAT database. 2. Patients who have BTC diagnostic information. 3. Patients with a medical record in the C-CAT database.

Exclusion criteria

Exclusion criteria: None.

Design outcomes

Primary

Measure	Time frame
The following outcomes will be described among subgroups categorized by gene mutation patterns (HER2/MDM2/TP53), first-line treatment types, as well as BTC subtype-based cohorts. 1. HER2 alterations, MDM2 amplification, TP53 mutation 2. First-line treatment types 3. Baseline demographics and clinical characteristics 4. Overall response rate (ORR) 5. Disease control rate (DCR) 6. Time on treatment (ToT) 7.Overall survival (OS)	—

Measure

Time frame

The following outcomes will be described among subgroups categorized by gene mutation patterns (HER2/MDM2/TP53), first-line treatment types, as well as BTC subtype-based cohorts. 1. HER2 alterations, MDM2 amplification, TP53 mutation 2. First-line treatment types 3. Baseline demographics and clinical characteristics 4. Overall response rate (ORR) 5. Disease control rate (DCR) 6. Time on treatment (ToT) 7.Overall survival (OS)

—

Secondary

Measure	Time frame
The following outcomes will be examined among subgroups categorized by BTC subtype-based cohorts. 1. To describe the OS following the administration of each 1L treatment type by thirty genes with the highest frequency of gene mutations 2. To examine association between co-mutations identified by the clustering analysis and the drug response to 1L treatment (ORR and DCR) 3. To examine association between identify mutations in the gene sets by the molecular-interaction pathway analysis and the drug response to 1L treatment (ORR and DCR)	—

Measure

Time frame

The following outcomes will be examined among subgroups categorized by BTC subtype-based cohorts. 1. To describe the OS following the administration of each 1L treatment type by thirty genes with the highest frequency of gene mutations 2. To examine association between co-mutations identified by the clustering analysis and the drug response to 1L treatment (ORR and DCR) 3. To examine association between identify mutations in the gene sets by the molecular-interaction pathway analysis and the drug response to 1L treatment (ORR and DCR)

—

Countries

Japan

Contacts

Public ContactTakeaki Ishii

Nippon Boehringer Ingelheim Co., Ltd Oncology Medicine Department. 1 Medical Affairs

takeaki.ishii@boehringer-ingelheim.com03-6683-3935

Outcome results