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Report for Clinical Trial NCT01734915

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Detecting EGFR T790M Mutations From Circulating Tumor Cells

The purpose of this research study is to determine if the EGFR mutation can be detected in CTCs. CTCs are cancer cells that are shed from solid tumors and float freely in the bloodstream. A device called the CTC-chip has been developed to find CTCs in the blood of patients with cancer. This is an experimental device. Using this device, the investigators will test participants' blood to try and find CTCs with the EGFR mutation and compare them with the results from the biopsy your doctor has recommended. The long-term goal of this research is to develop a way to test for the EGFR mutation that is less invasive than a tumor biopsy.

NCT01734915 Non Small Cell Lung Cancer
MeSH: Neoplastic Cells, Circulating

1 Interventions

Name: Circulating tumor cell chip

Description: three tubes (6 teaspoons) of peripheral blood are drawn and are analyzed using the CTC chip

Type: Device

NSCLC


Primary Outcomes

Description: Calculate the number of patients in the study population with detectable EGFR mutations in the CTCs in order to demonstrate the feasibility of testing for EGFR mutations from captured CTCs

Measure: Number of patients with detectable EGFR mutations in their CTCs

Time: 2 years

Description: Determine the concordance of EGFR genotyping from CTCs compared to tumor tissue

Measure: Number of patients with CTC-derived EGFR genotyping matching their tumor-derived EGFR genotyping

Time: 2 yearss

Secondary Outcomes

Description: Explore the feasibility of EGFR genotyping from plasma circulating free DNA (cfDNA)

Measure: Number of patients with EGFR gentoype results detectable from plasma cfDNA

Time: 2 years

Time Perspective: Prospective

Cohort


There is one SNP

SNPs


1 T790M

Detecting EGFR T790M Mutations From Circulating Tumor Cells. --- T790M ---

Detecting EGFR T790M Mutations From Circulating Tumor Cells The purpose of this research study is to determine if the EGFR mutation can be detected in CTCs. --- T790M ---



HPO Nodes