Melanoma Clinical Trial
Utility of Novel BRAF Test for Melanoma
Summary
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.
Full Description
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.
Eligibility Criteria
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
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There are 2 Locations for this study
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02215, United States
Boston Massachusetts, 02215, United States
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