Detecting EGFR T790M Mutations From Circulating Tumor Cells
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Lung Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | November 2012 |
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.
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.
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.
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.
Inclusion Criteria:
- Histologically confirmed NSCLC that is metastatic or unresectable
- Have agreed to undergo a clinically recommended invasive repeat tumor itssue biopsy
Exclusion Criteria:
We found this trial at
4
sites
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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