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

NCT02644889 | Unknown

• 1 other identifier: EGFR2015-02
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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

Keywords

Epidermal growth factor receptor(EGFR); NSCLC

Outcome Measures

Primary Outcomes (2)

• EGFR Mutation Detection of FFPE and plasma samples

  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.

  baseline

• EGFR Mutation Detection of plasma samples for the following-up patients who take TKI.

  In order to monitor the change of plasma EGFR mutation copy number.

  From start of treatment to time of progression or death, whichever occurs first, assessed up to 3 years

Study Arms (1)

Patients advanced NSCLC EGFR mutated

This is an observational study, there is no intervention.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with stage Ⅲ-Ⅳ NSCLC with EGFR mutations and who began a treatment by TKI .

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GenoSaber: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2015
• First Posted: January 1, 2016
• Study Start: January 1, 2016
• Primary Completion: November 1, 2018
• Last Updated: January 7, 2016

Record last verified: 2015-11