A feasibility study of performance of a novel method for gene mutations in circulating tumor DNA

Clinical performance study of gene mutation test - Clinical performance study of gene mutation test

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000038679

Enrollment

Registered

2019-11-25

Start date

2019-01-28

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) Cell free DNA samples collected in WJOG8014LTR study 2) Residual samples with informed consent that are stocked in WJOG-BBC (Bio-bank Center, West Japan Oncology Group,) 3) Ten samples (20 ng or more DNA) with EGFR T790M positive and other ten samples with EGFR T790M negative detected by the QX100 Droplet Digital PCR system (ddPCR)

Exclusion criteria

Exclusion criteria: none

Design outcomes

Primary

Measure	Time frame
quantification of mutant allele and minimum detection limit	—

Secondary

Measure	Time frame
1) Calculation of backgroud noise 2) Seach for cut-off value	—

Countries

Japan

Contacts

Public ContactKazuko Sakai

Kindai University Faculty of Medicine Department of Genome Biology

kasakai@med.kindai.ac.jp81-72-366-0221

Outcome results