Utility of Novel BRAF Test for Melanoma
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Skin Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/16/2018 |
| Start Date: | May 2013 |
| End Date: | March 2019 |
Exploring the Utility of a Novel BRAF Test in Patients With Melanoma
This primary purpose of this study is to obtain blood samples from participants with both
early and later stages of melanoma (Stage II/III and Stage IV). The researchers hope to
better understand an abnormal protein found in many melanoma tumors called the BRAFV600
mutation.
There will be two separate cohorts (groups) of participants on this study. You will be placed
in one of the Groups.
Group 1-For participants with advanced melanoma: Your existing tumor tissue sample will be
compared to the blood samples given in order to further analyze and to understand the
BRAFV600E gene mutation.
Group 2-For participants with stage II/III melanoma: Following surgery, blood samples will be
collected and analyzed.
Understanding the BRAFV600E gene mutation in melanoma will help the researchers better
understand the disease, and help plan treatment options for people with melanoma of all
stages in the future.
early and later stages of melanoma (Stage II/III and Stage IV). The researchers hope to
better understand an abnormal protein found in many melanoma tumors called the BRAFV600
mutation.
There will be two separate cohorts (groups) of participants on this study. You will be placed
in one of the Groups.
Group 1-For participants with advanced melanoma: Your existing tumor tissue sample will be
compared to the blood samples given in order to further analyze and to understand the
BRAFV600E gene mutation.
Group 2-For participants with stage II/III melanoma: Following surgery, blood samples will be
collected and analyzed.
Understanding the BRAFV600E gene mutation in melanoma will help the researchers better
understand the disease, and help plan treatment options for people with melanoma of all
stages in the future.
There will be no extra clinic visits for this study. These research blood samples will be
drawn at the same time as your regularly scheduled blood draws that are part of standard care
for melanoma.
About 2 to 4 teaspoons of blood will be drawn for each research sample.
Depending on which group you are in, you will have either a one time blood draw or ongoing
blood work for 1-2 years.
drawn at the same time as your regularly scheduled blood draws that are part of standard care
for melanoma.
About 2 to 4 teaspoons of blood will be drawn for each research sample.
Depending on which group you are in, you will have either a one time blood draw or ongoing
blood work for 1-2 years.
Inclusion Criteria:
- Biopsy proven advanced (unresectable stage IIIC or stage IV)or high risk (stage II or
stage III) malignant melanoma
Exclusion Criteria:
- History of a different malignancy except for the following circumstances: disease-free
for at least 2 years and deemed by the investigator to be at low risk for recurrence;
or non-metastatic prostate cancer, cervical cancer in situ and basal cell or squamous
cell carcinoma
- Known history of a different BRAF mutant malignancy
We found this trial at
3
sites
185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
Phone: 617-643-3614
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330 Brookline Ave
Boston, Massachusetts 02215
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: Elizabeth Buchbinder, MD
Phone: 617-667-6735
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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450 Brookline Ave
Boston, Massachusetts 2215
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Stephen Hodi, MD
Phone: 617-632-4715
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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