EGFR Mutation Detection From Advanced NSCLC Patient Tissue and Plasma in EGFR-TKI Treatment

Epidermal Growth Factor Receptor (EGFR) Mutation Detection From Advanced Non-small Cell Lung Cancer Tissue and Plasma in Tyrosine Kinase Inhibitor (TKI) Treatment

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02644889

Enrollment

100

Registered

2016-01-01

Start date

2016-01-31

Completion date

Unknown

Last updated

2016-01-07

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

Keywords

Epidermal growth factor receptor(EGFR), NSCLC

Brief summary

This study has been designed in order to detect EGFR mutation abundance of tissue and concentration of plasma from Advanced Non-small Cell Lung Cancer during treatment with Tyrosine Kinase Inhibitor (TKI) .Through this experiment the investigators aim to evaluate the feasibility of plasma EGFR detection and evaluate the correlation of EGFR mutations and prognosis.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Age older than 18 years and under 75 years * Histologically and cytologically proven non-small Cell Lung Cancer * Clinical stages Ⅲ \ Ⅳ * Not receive any anti-tumor treatment * Eastern cooperative oncology group performance status (ECOG PS) =1\ 2 * Estimated survival time more than 3 months * EGFR-TKI treatment for first-line or second-line * Voluntary to participate in this clinical trial and sign the consent form

Exclusion criteria

* Patients have received EGFR-TKI therapy before the study * With other malignancy history in the recent 5 years before the study * Pregnancy or breast feeding phase * Inadequate samples for testing * Follow-up compliance is poor

Design outcomes

Primary

Measure	Time frame	Description
EGFR Mutation Detection of FFPE and plasma samples	baseline	To evaluate the feasibility of plasma EGFR detection from non-small cell lung cancer patients harboring EGFR activating mutation who are being treated with EGFR TKIs and evaluate the correlation of EGFR mutations and prognosis.
EGFR Mutation Detection of plasma samples for the following-up patients who take TKI.	From start of treatment to time of progression or death, whichever occurs first, assessed up to 3 years	In order to monitor the change of plasma EGFR mutation copy number.

Outcome results