Utility of Novel BRAF Test for Melanoma

• Conditions: Melanoma

• Registration Number: NCT01840527
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study First Submitted: 2013-04-23
• Study First Submitted QC: 2013-04-23
• Study First Posted: 2013-04-25
• Study Start: 2013-05
• Primary Completion: 2017-03-29
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-28
• Last Update Posted: 2021-10-29
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 220

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determine Sensitivity of Blood-Based Assay	2 years	The specificity and sensitivity of the blood-based assay will be determined vis-à-vis tissue-based BRAF analysis in patients with advanced and high-risk melanoma in order to provide BRAF-directed therapy when indicated. The sensitivity of an assay is expressed as the probability (as a percentage) that a sample tests positive for BRAF mutation given that the participant has BRAF mutation; it is used to assess the risk of false negative results. A percentage greater than 50% indicates that the test is a better predictor of sample diagnosis than random chance.
Determine Specificity of Blood-Based Assay	2 years	The specificity and sensitivity of the blood-based assay will be determined vis-à-vis tissue-based BRAF analysis in patients with advanced and high-risk melanoma in order to provide BRAF-directed therapy when indicated. The specificity of an assay is expressed as the probability (as a percentage) that a test returns a negative result for BRAF mutation given that the that participant does not BRAF mutation; it is used to assess the risk of false positive results. A percentage greater than 50% indicates that the test is a better predictor of sample diagnosis than random chance.

Secondary Outcome Measures

Name	Time	Method
Explore Pharmacodynamic Effects of MAPK Pathway Inhibitors	2 years	To explore the pharmacodynamic effects of MAPK pathway inhibitors (including selective BRAF inhibitors, MEK inhibitors, and ERK inhibitors) utilizing pre-and on-treatment peripheral blood BRAFV600E mutational testing in participants with advanced melanoma.
Define Prognostic Value of Peripheral Blood BRAFV600 Testing in Melanoma	2 years	To define the prognostic value of peripheral blood BRAFV600 mutational testing in participants with Stage II/III melanoma

Trial Locations

Locations (3)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States