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

NCT ID: NCT02644889

Last Updated: 2016-01-07

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-31

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.

Conditions

Non-small Cell Lung Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Patients advanced NSCLC EGFR mutated

This is an observational study, there is no intervention.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GenoSaber

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

EGFR2015-02

Identifier Type: -

Identifier Source: org_study_id