Quantitative followup study of the driver mutation fraction in cell-free DNA from non small cell lung cancer patient during TKI therapy

Quantitative followup study of the driver mutation fraction in cell-free DNA from non small cell lung cancer patient during TKI therapy - Quantitative followup study of the driver gene mutation in cell-free DNA

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000017581

Enrollment

200

Registered

2015-05-15

Start date

2014-08-04

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 harboring driver mutation.

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patients with driver gene mutation (i.e. EGFR/ALK/RET/ROS1) -positive non-small-cell lung cancer determined with a histological diagnosis or cytodiagnosis. 2)Patients with treatment plan of EGFR-TKI therapy. 3)Patients with more than 20 years. 4)Patients providing written informed consent.

Exclusion criteria

Exclusion criteria: 1)Patient who need other anti-malignant medicine, radiotherapy or immunity. 2)Patient with positive HBs antigen and HBV-DNA. 3)Patient with definite positive HIV antibody (need not for examination). 4)Patient with other active cancer (except cancer treated without recurrence in more than 5 years and after carcinoma complete excision in situ) 5)TPatient with interstitial pneumonia 6)Any other patients who are regarded as unsuitable for this study by the investigators.

Design outcomes

Primary

Measure	Time frame
To evaluate the quantitative analysis using of EGFR mutation sensitive mutation and T790M mutation in the cfDNA of NSCLC patients who were treated with the conventional EGFR-TKI. To evaluate the quantitative analysis using of driver mutation (i.e. ALK/RET/ROS1 fusion)and resistant mutation in the cfDNA of NSCLC patients who were treated with the TKIs.	—

Secondary

Measure	Time frame
To evaluate treatment benefit and acquiring resistance from change of fraction of sensitivity mutation and resistant mutation. To evaluate the concordance between the amount of cfDNA and clinical course.	—

Countries

Japan

Contacts

Public ContactYoshitaka Seki

National Cancer Center Research Institute Division of genome biology

yoseki@ncc.go.jp0335422511

Outcome results