Clinical trial NCT01840527: Utility of Novel BRAF Test for Melanoma
Official title: Exploring the Utility of a Novel BRAF Test in Patients With Melanoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma
Keywords: Biomarker
BRAF
blood-based
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-04-25
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients being treated at Massachusetts General Hospital, Dana-Farber Cancer Institute and Beth Isreal Deaconess Medical Center

Brief 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.

Detailed 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

Primary outcomes:
measure: Determine Sensitivity of Blood-Based Assay
timeFrame: 2 years
measure: Determine Specificity of Blood-Based Assay
timeFrame: 2 years
Secondary outcomes:
measure: Explore Pharmacodynamic Effects of MAPK Pathway Inhibitors
timeFrame: 2 years
measure: Define Prognostic Value of Peripheral Blood BRAFV600 Testing in Melanoma
timeFrame: 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Ryan Sullivan, MD
role: PRINCIPAL_INVESTIGATOR
References: