Detecting EGFR T790M Mutations From Circulating Tumor Cells

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Memorial Sloan-Kettering Cancer Center
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
Lecia V. Sequist, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01734915
First received: November 4, 2012
Last updated: February 2, 2014
Last verified: February 2014
  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.


Condition Intervention
Non Small Cell Lung Cancer
Device: Circulating tumor cell chip

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Detecting EGFR T790M Mutations From Circulating Tumor Cells

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Number of patients with detectable EGFR mutations in their CTCs [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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

  • Number of patients with CTC-derived EGFR genotyping matching their tumor-derived EGFR genotyping [ Time Frame: 2 yearss ] [ Designated as safety issue: No ]
    Determine the concordance of EGFR genotyping from CTCs compared to tumor tissue


Secondary Outcome Measures:
  • Number of patients with EGFR gentoype results detectable from plasma cfDNA [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Explore the feasibility of EGFR genotyping from plasma circulating free DNA (cfDNA)


Biospecimen Retention:   Samples With DNA

Circulating Tumor Cells (CTCs)


Estimated Enrollment: 40
Study Start Date: November 2012
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
NSCLC
Subjects with advanced NSCLC, will undergo blood draw
Device: Circulating tumor cell chip
three tubes (6 teaspoons) of peripheral blood are drawn and are analyzed using the CTC chip
Other Name: Herringbone circulating tumor cell chip, herringbone CTC chip, HBCTC chip

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Receiving treatment for NSCLC at one of the participating cancer centers

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:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01734915

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Massachusetts General Hospital
Dana-Farber Cancer Institute
Memorial Sloan-Kettering Cancer Center
M.D. Anderson Cancer Center
  More Information

No publications provided

Responsible Party: Lecia V. Sequist, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01734915     History of Changes
Other Study ID Numbers: 12-353
Study First Received: November 4, 2012
Last Updated: February 2, 2014
Health Authority: United States: Dana-Farber Cancer Institute IRB

Keywords provided by Massachusetts General Hospital:
Advanced
EGFR mutation

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Neoplastic Cells, Circulating
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014