Epidermal Growth Factor Receptor Mutations in the Blood of Patients With Advanced Non-Small Cell Lung Cancer

February 12, 2019 updated by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study of Mutations of Epidermal Growth Factor Receptor in the Blood of Patients With Advanced Non Small Cell Lung Cancer

RATIONALE: Collecting and storing samples of blood from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.

PURPOSE: This laboratory study is looking at epidermal growth factor receptor mutations in the blood of patients with advanced non-small cell lung cancer.

Study Overview

Status

Completed

Conditions

Lung Cancer

Intervention / Treatment

Detailed Description

OBJECTIVES:

Determine if epidermal growth factor receptor (EGFR) mutation exists in the peripheral blood of patients with advanced non-small cell lung cancer (NSCLC).
Estimate the frequency of EGFR mutation in these patients.
Correlate the presence of EGFR mutation in blood with EGFR mutation in primary or metastatic NSCLC tumor block.

OUTLINE: Patients undergo blood collection for analysis of epidermal growth factor receptor mutation by DNA sequencing.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Singapore
- - Singapore, Singapore, 308433
    - Alex Chang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Any adult patient diagnosed with NSCLC with archiaved tissue availble.

Description

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed advanced non-small cell lung cancer
Must have available tumor tissue block

PATIENT CHARACTERISTICS:

Not specified

PRIOR CONCURRENT THERAPY:

Not specified

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Existence of epidermal growth factor receptor (EGFR) mutations in peripheral blood Time Frame: Day 1		Day 1
Frequency of EGFR mutation Time Frame: Day 1	Number of participants with EGFR mutation in tissue and plasma.	Day 1
Number of participants with EGFR mutation in peripheral blood and in tumor tissue. Time Frame: Day 1		Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Investigators

Study Chair: Alex Y. Chang, MD, Johns Hopkins Singapore International Medical Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2006

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

May 9, 2009

First Submitted That Met QC Criteria