Detecting EGFR T790M Mutations From Circulating Tumor Cells

NCT01734915 | Completed

• 1 other identifier: 12-353
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Non Small Cell Lung Cancer

Keywords

Advanced; EGFR mutation

Outcome Measures

Primary Outcomes (2)

• Number of patients with detectable EGFR mutations in their CTCs

  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

  2 years

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

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

  2 yearss

Secondary Outcomes (1)

• Number of patients with EGFR gentoype results detectable from plasma cfDNA

  2 years

Study Arms (1)

NSCLC

Subjects with advanced NSCLC, will undergo blood draw

Device: Circulating tumor cell chip

Interventions

Circulating tumor cell chip DEVICE

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

Also known as: Herringbone circulating tumor cell chip, herringbone CTC chip, HBCTC chip

NSCLC

Eligibility Criteria

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

Study Population

Receiving treatment for NSCLC at one of the participating cancer centers

You may qualify if:

• Histologically confirmed NSCLC that is metastatic or unresectable
• Have agreed to undergo a clinically recommended invasive repeat tumor itssue biopsy

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Dana-Farber Cancer Institute: collaborator
• Memorial Sloan Kettering Cancer Center: collaborator
• M.D. Anderson Cancer Center: collaborator

Study Sites (4)

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Circulating Tumor Cells (CTCs)

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: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 4, 2012
• First Posted: November 28, 2012
• Study Start: November 1, 2012
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 26, 2016

Record last verified: 2016-09

Locations

US (4)