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Mutation analyses of plasma and tumor DNA in EGFR mutation-positive advanced non-small-cell lung cancer.

Mutation analyses of plasma and tumor DNA in EGFR mutation-positive advanced non-small-cell lung cancer. - Liquid Biopsy Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000016879
Enrollment
100
Registered
2015-03-23
Start date
2015-02-18
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

Sponsors

Clinical Research Support Center Kyushu
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Patients with EGFR gene mutation (exon 19 deletion, L858R, G719X, L861M, T790M, etc) -positive non-small-cell lung cancer determined with a histological diagnosis or cytodiagnosis. 2)Patients with treatment plan of EGFR-TKI alone or combination therapy including EGFR-TKI. In addition, plasma samples of patients before treatment are stored at -80 degrees Celsius even if after the start of treatment. 3)Patients with more than 20 years. 4)Patients providing written informed consent.

Exclusion criteria

Exclusion criteria: 1) Patient with positive HBs antigen or HVC antibody. 2) Patient with definite positive HIV antibody (need not for examination). 3) Any other patients who are regarded as unsuitable for this study by the investigators.

Design outcomes

Primary

MeasureTime frame
Detection of EGFR gene mutation from cfDNA collected before and after treatment with EGFR-TKI in patients with EGFR gene mutation- positive non-small-cell lung cancer.

Secondary

MeasureTime frame
Detection of a biomarker about EGFR-TKI tolerance. Coincidence ratio of detection of EGFR gene mutation between tissue samples and cfDNA. Association between the clinical background including a presence or absence of T790M gene mutation and the prognosis.

Countries

Japan

Contacts

Public ContactNoriko Hidaka

Graduate School of Medical Sciences, Kyushu University Research Institute for Disease of the Chest

noriko-f@kokyu.med.kyushu-u.ac.jp092-642-5378

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026