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Exploring the Utility of a Novel BRAF Test in Patients With Melanoma

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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:


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:


Principal Investigator

Ryan Sullivan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Institutional Review Board

Study ID:




Start Date:

May 2013

Completion Date:

Related Keywords:

  • Melanoma
  • Biomarker
  • BRAF
  • blood-based
  • Melanoma



Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617