Detecting EGFR T790M Mutations From Circulating Tumor Cells

Non Small Cell Lung Cancer Clinical Trial

Official title:

Detecting EGFR T790M Mutations From Circulating Tumor Cells

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01734915
• Other study ID #: 12-353
• Status: Completed
• Phase: N/A
• First received: November 4, 2012
• Last updated: September 23, 2016
• Start date: November 2012
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Dana-Farber Cancer Institute IRB
• Study type: Observational

Clinical Trial 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.

Description:

In order to participate in this study you need to have a diagnosis of NSCLC that has spread or is unable to be surgically removed. In addition, your cancer must have an EGFR mutation and you must have a scheduled (or recently performed) biopsy to check on the presence of any other mutations related to targeted drug resistance.

After you sign consent to participate in this study we will draw a blood sample (three tubes of blood). This is about 6 teaspoons of blood.

The number of CTCs in your blood will not be reported to you since it is not known if this number has any meaning or if it impacts your medical care in any way. These results will not become part of your medical record. They will be kept in a separate, secure location.

We will collect information from your medical records and store it in a research record that we create about you. The study team will use this information to compare details about your medical history with the results of the experiments done on your blood.

Genetic material (DNA) will be removed from the CTCs found in your blood. This genetic material will be stored at the Massachusetts General Hospital and studied along with samples from other participants on this research study. Your samples will not be labeled with your name or any information that identifies you. Your samples will have a study-specific code number on them. The code linking your name to the sample will be kept in a secure location, available only to the investigators of the study and select study team members.

After the blood draw we will follow your status every 6 months by reviewing your medical records.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically confirmed NSCLC that is metastatic or unresectable

• Have agreed to undergo a clinically recommended invasive repeat tumor itssue biopsy

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Neoplastic Cells, Circulating
• Non Small Cell Lung Cancer

Intervention

Device:
• Circulating tumor cell chip
three tubes (6 teaspoons) of peripheral blood are drawn and are analyzed using the CTC chip

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	MD Anderson Cancer Center	Houston	Texas
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (4)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Dana-Farber Cancer Institute, M.D. Anderson Cancer Center, Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Number of patients with EGFR gentoype results detectable from plasma cfDNA	Explore the feasibility of EGFR genotyping from plasma circulating free DNA (cfDNA)	2 years	No