Houston, Texas 77030

  • Non Small Cell Lung Cancer

Purpose:

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.


Study summary:

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.


Criteria:

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 is Available At:


Original ID:

12-353


NCT ID:

NCT01734915


Secondary ID:


Study Acronym:


Brief Title:

Detecting EGFR T790M Mutations From Circulating Tumor Cells


Official Title:

Detecting EGFR T790M Mutations From Circulating Tumor Cells


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Massachusetts General Hospital


Oversight Authority:

United States: Dana-Farber Cancer Institute IRB


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Cohort, Time Perspective: Pro


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

40


Enrollment Type:

Anticipated


Study Dates

Start Date:November 2012
Completion Date:September 2016
Completion Type:Actual
Primary Completion Date:September 2016
Primary Completion Type:Actual
Verification Date:September 2016
Last Changed Date:September 23, 2016
First Received Date:November 4, 2012

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Number of patients with EGFR gentoype results detectable from plasma cfDNA
Time Frame:2 years
Safety Issues:False
Description:Explore the feasibility of EGFR genotyping from plasma circulating free DNA (cfDNA)
Outcome Type:Primary Outcome
Measure:Number of patients with CTC-derived EGFR genotyping matching their tumor-derived EGFR genotyping
Time Frame:2 yearss
Safety Issues:False
Description:Determine the concordance of EGFR genotyping from CTCs compared to tumor tissue
Outcome Type:Primary Outcome
Measure:Number of patients with detectable EGFR mutations in their CTCs
Time Frame:2 years
Safety Issues:False
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

Study Interventions

Intervention Type:Device
Name:Circulating tumor cell chip
Description:three tubes (6 teaspoons) of peripheral blood are drawn and are analyzed using the CTC chip
Arm Name:NSCLC
Other Name:Herringbone circulating tumor cell chip, herringbo

Study Arms

Study Arm Type:Other
Arm Name:NSCLC
Description:Subjects with advanced NSCLC, will undergo blood draw

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Massachusetts General Hospital
Agency Class:Other
Agency Type:Collaborator
Agency Name:Dana-Farber Cancer Institute

Samples and Retentions

Sample Retention:Samples With DNA
Description: Circulating Tumor Cells (CTCs)
Study Population: Receiving treatment for NSCLC at one of the participating cancer centers
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: September 23, 2021

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