Completed

Analysis of BRAFV600E Gene Mutation in Melanoma Patients

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Study Aim

This observational study aims to determine the sensitivity and specificity of a blood-based assay in detecting the BRAFV600E gene mutation, compared to tissue-based analysis, in patients with advanced and high-risk melanoma, to better guide BRAF-directed therapy when needed.

What is being collected

Data Collection

Collected from today forward - Prospective
DNA Samples
Who is being recruted

Neoplasms+9

+ Neoplasms by Histologic Type

+ Neoplasms by Site

Over 18 Years
+3 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Control

Comparing exposures between individuals with and without disease in order to identify potential risk factors.
Observational
Study Start: May 2013
See protocol details

Summary

Principal SponsorMassachusetts General Hospital
Last updated: September 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01840527
Principal SponsorMassachusetts General Hospital
Last updated: September 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

220 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-Control

These studies compare people who have a disease (cases) with those who don't (controls). The goal is to look back at previous exposures or risk factors to identify what might have contributed to the disease.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

NeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueSkin DiseasesSkin NeoplasmsSkin and Connective Tissue DiseasesNeuroectodermal TumorsNevi and MelanomasNeuroendocrine TumorsMelanoma

Criteria

1 inclusion criteria required to participate
Biopsy proven advanced (unresectable stage IIIC or stage IV)or high risk (stage II or stage III) malignant melanoma
2 exclusion criteria prevent from participating
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 Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Massachusetts General Hospital

Boston, United StatesOpen Massachusetts General Hospital in Google Maps

Beth Israel Deaconess Medical Center

Boston, United States

Dana-Farber Cancer Institute

Boston, United States
Completed3 Study Centers