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Utility of Novel BRAF Test for Melanoma

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ClinicalTrials.gov Identifier: NCT01840527
Recruitment Status : Active, not recruiting
First Posted : April 25, 2013
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Ryan Sullivan, M.D., 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.


Condition or disease
Melanoma

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.


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Study Type : Observational
Actual Enrollment : 220 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Exploring the Utility of a Novel BRAF Test in Patients With Melanoma
Study Start Date : May 2013
Actual Primary Completion Date : March 29, 2017
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Group/Cohort
Group 1
Advanced Melanoma
Group 2
Stage II/III Melanoma



Primary Outcome Measures :
  1. Determine Specificity and Sensitivity of Blood Based Assay [ Time Frame: 2 years ]
    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


Secondary Outcome Measures :
  1. Explore Pharmacodynamic Effects of MAPK Pathway Inhibitors [ Time Frame: 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 patients with advanced melanoma, (non-resectable Stage III or Stage IV)

  2. Define Prognostic Value of Peripheral Blood BRAFV600 Testing in Melanoma [ Time Frame: 2 years ]
    To define the prognostic value of peripheral blood BRAFV600 mutational testing in patients with Stage II and resectable Stage III melanoma


Biospecimen Retention:   Samples With DNA
Peripheral blood lymphocytes (PBLs); Plasma; Tumor Tissue


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients being treated at Massachusetts General Hospital, Dana-Farber Cancer Institute and Beth Isreal Deaconess Medical Center
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01840527


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Ryan Sullivan, MD Massachusetts General Hospital

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Responsible Party: Ryan Sullivan, M.D., Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01840527     History of Changes
Other Study ID Numbers: 12-488
First Posted: April 25, 2013    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019
Keywords provided by Ryan Sullivan, M.D., Massachusetts General Hospital:
Biomarker
BRAF
blood-based
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas