Performance Evaluation of ALK IHC Testing in the Detection of ALK in Non-Small Cell Lung Cancer

Performance Evaluation of ALK IHC Testing in the Detection of ALK in Non-Small Cell Lung Cancer - Performance Evaluation of ALK IHC Testing in the Detection of ALK in NSCLC

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000057400

Enrollment

500

Registered

2025-03-26

Start date

2025-04-01

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

Non small cell lung cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: NSCLC cases diagnosed from January 1, 2019, to June 30, 2024 at each participating medical institution.

Exclusion criteria

Exclusion criteria: Patients who is judged as not suitable in this study

Design outcomes

Primary

Measure	Time frame
Detection rate of ALK mutations by ALK IHC testing in cases negative for all driver gene mutations in multiplex testing.	—

Secondary

Measure	Time frame
The concordance rate of ALK mutations between ALK IHC testing and CGP testing in cases negative for all driver gene mutations in multiplex testing. Confirmation of the ALK mutation positivity rate during the target period.	—

Countries

Japan

Contacts

Public ContactAsami Okumura

Hokkaido University Hospital Center for Development of Advanced Diagnostics

aokumura@huhp.hokudai.ac.jp011-706-7933

Outcome results