Utility of Novel BRAF Test for Melanoma

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Melanoma

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Advanced Melanoma | |
| Group 2<br>Stage II/III Melanoma | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine Specificity and Sensitivity of Blood Based Assay | 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 | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Explore Pharmacodynamic Effects of MAPK Pathway Inhibitors | 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 patients with advanced melanoma, (non-resectable Stage III or Stage IV) | 2 years | 
| Define Prognostic Value of Peripheral Blood BRAFV600 Testing in Melanoma | To define the prognostic value of peripheral blood BRAFV600 mutational testing in patients with Stage II and resectable Stage III melanoma | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biomarker, BRAF, blood-based