Exploring the Utility of a Novel BRAF Test in Patients With Melanoma
18 Years
N/A
Both
Melanoma
Trial Information
Exploring the Utility of a Novel BRAF Test in Patients With Melanoma
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.
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
Type of Study:
Observational
Study Design:
Observational Model: Case Control, Time Perspective: Prospective
Outcome Measure:
Determine Specificity and Sensitivity of Blood Based Assay
Outcome Description:
To determine the specificity and sensitivity of the blood based assay vis-a-vis tissue based BRAF analysis in patients with advanced and high-risk melanoma
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Ryan Sullivan, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Massachusetts General Hospital
Authority:
United States: Institutional Review Board
Study ID:
12-488
NCT ID:
NCT01840527
Start Date:
May 2013
Completion Date:
Related Keywords:
- Melanoma
- Biomarker
- BRAF
- blood-based
- Melanoma
Name | Location |
|---|---|
| Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
| Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
