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Detecting EGFR T790M Mutations From Circulating Tumor Cells

18 Years
Open (Enrolling)
Non Small Cell Lung Cancer

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Trial Information

Detecting EGFR T790M Mutations From Circulating Tumor Cells

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

Inclusion Criteria:

- Histologically confirmed NSCLC that is metastatic or unresectable

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

Exclusion Criteria:


Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Number of patients with detectable EGFR mutations in their CTCs

Outcome 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

Outcome Time Frame:

2 years

Safety Issue:



United States: Dana-Farber Cancer Institute IRB

Study ID:




Start Date:

November 2012

Completion Date:

Related Keywords:

  • Non Small Cell Lung Cancer
  • Advanced
  • EGFR mutation
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Neoplastic Cells, Circulating



Memorial Sloan Kettering Cancer Center New York, New York  10021
MD Anderson Cancer Center Houston, Texas  77030-4096
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617