Clinical performance study of a lung fusion kit

Clinical performance study of a lung fusion kit - Clinical performance study of a lung fusion kit

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000022311

Enrollment

150

Registered

2016-05-23

Start date

2016-05-23

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: 1) Patients diagnosed with NSCLC 2) Formalin-fixed paraffin embedded tissues archived for a period less than 2 years

Exclusion criteria

Exclusion criteria: 1) Formalin fixed paraffin embedded tissues archived for a period longer than two years 2) Patients diagnosed with EGFR mutation-positive NSCLC 3) Patients who are judged inappropriate to be enrolled in this study.

Design outcomes

Primary

Measure	Time frame
To compare the clinical performance of a lung fusion kit for ALK fusion diagnosis with that of a conventional IVD kit. Sensitivity, specificity, and concordance in the detection of ALK gene fusions using a lung fusion kit.	—

Countries

Japan

Contacts

Public ContactSakai Kazuko

Kindai University Faculty of Medicine Department of Genome Biology

kasakai@med.kindai.ac.jp072-366-0221

Outcome results