N/A
N=220
Utility of Novel BRAF Test for Melanoma
Melanoma
Bottom Line
View on ClinicalTrials.gov: NCT01840527 ↗Enrolled (actual)
220
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Determine Sensitivity of Blood-Based Assay
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Determine Sensitivity of Blood-Based Assay |
— | — |
| PRIMARY Determine Specificity of Blood-Based Assay |
— | — |
| SECONDARY Explore Pharmacodynamic Effects of MAPK Pathway Inhibitors |
— | — |
| SECONDARY Define Prognostic Value of Peripheral Blood BRAFV600 Testing in Melanoma |
— | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01840527). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.