Analysis of EGFR mutation using highly sensitive droplet digital PCR in non-small cell lung cancer patients with EGFR mutations.

Analysis of EGFR mutation using highly sensitive droplet digital PCR in non-small cell lung cancer patients with EGFR mutations. - Analysis of EGFR mutation using highly sensitive droplet digital PCR in non-small cell lung cancer patients with EGFR mutations.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000038648

Enrollment

Registered

2019-11-22

Start date

2019-12-01

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

lung cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Pathologically proven non-small cell lung cancer. 2)EGFR-TKIs naive patients with relapsed disease or advance stage (III or IV). 3)EGFR mutations positive. 4)Available of tumor tissues or cytologically samples for DNA extraction. 5)Expected survival more than 90 days. 6)ECOG Performance status 0-1. 7)Meets all following laboratory data Nt>=1000/mm3 Hb>=9.0g/dl Plt>=10x10^4/mm3 AST, ALT<=100IU/L T-Bil<=1.5mg/dL Cr<=2.0mg/dL SpO2<=90%(room air) 8)More than 20 years old on the enrollment day. 9)Patients with written informed consent.

Exclusion criteria

Exclusion criteria: 1)Patients cannot ingest EGFR-TKIs. 2)Patients with paresis of intestine or ileus of intestine. 3)With chronic diarrhea. 4)Interstitial pulmonary disease, drug-induced interstitial pulmonary disease and irradiation pneumonitis clearly detected by chest CT. 5)Uncontrollable pleural/ abdominal/ pericardial effusion. 6)Symptomatic brain metastasis required for radiation therapy or surgical resection. 7)Patients with a radiation therapy included lung field within 28 days before enrollment. 8)Active infection to need systemic treatment. 9)Patients with severe complications (bleeding of digestive tract, heart disease, glaucoma, diabetes, etc.). 10)Patients who are different for the participation in the study by complication of mental disease or psychiatric symptom. 11)Patients with pregnant or possibly pregnant, nursing. 12)Any other patients regarded as unsuitable for this study by the investigators.

Design outcomes

Primary

Measure	Time frame
Compare the quantity of T790M clones between pre and post EGFR-TKIs treatment	—

Secondary

Measure	Time frame
Detection of resistant mechanism, response rate, progression free survival	—

Countries

Japan

Contacts

Public ContactShinnosuke Takemoto

Nagasaki University Hospital Department of Respiratory Medicine

shinnosuke-tgakemoto@umin.ac.jp095-819-7273

Outcome results