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Detection characteristics of ALK fusion genes in surgically resected lung cancer specimens using immunohistochemistry and multigene PCR panel

Detection characteristics of ALK fusion genes in surgically resected lung cancer specimens using immunohistochemistry and multigene PCR panel - DET-ALK study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000061732
Enrollment
1004
Registered
2026-05-29
Start date
2026-06-15
Completion date
Unknown
Last updated
2026-09-14

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

Sponsors

Tohoku University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Histologically diagnosed as non-small cell lung cancer using surgically resected specimens. (2) Meeting one of the following conditions: (a) Surgery was performed between January 2018 and December 2021, and ALK testing by IHC was conducted using surgical specimens. (b) Surgery was performed between January 2022 and December 2025, and ALK testing by the AmoyDx assay was conducted using surgical specimens.

Exclusion criteria

Exclusion criteria: (1) Cases in which the study participant (or a legally authorized representative) expressed a wish not to participate in the study. (2) Cases unable to undergo additional IHC testing because of insufficient remaining specimen material.

Design outcomes

Primary

MeasureTime frame
The number and proportion of ALK fusion positive cases identified by immunohistochemistry (IHC) among cases that were negative for all driver gene alterations by the AmoyDx assay.

Secondary

MeasureTime frame
The number and proportion of ALK fusion gene detection by the AmoyDx assay before and after changes in specimen handling procedures, etc.

Countries

Japan

Contacts

Public ContactKen Onodera

Tohoku University Hospital Department of Thoracic Surgery

ken.onodera.c3@tohoku.ac.jp022-717-8521

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026