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Utility of Novel BRAF Test for Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01840527
Recruitment Status : Active, not recruiting
First Posted : April 25, 2013
Last Update Posted : December 4, 2019
Sponsor:
Information provided by (Responsible Party):
Ryan Sullivan, M.D., Massachusetts General Hospital

Tracking Information
First Submitted Date April 23, 2013
First Posted Date April 25, 2013
Last Update Posted Date December 4, 2019
Study Start Date May 2013
Actual Primary Completion Date March 29, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 23, 2013)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01840527 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 23, 2013)
  • 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)
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Utility of Novel BRAF Test for Melanoma
Official Title Exploring the Utility of a Novel BRAF Test in Patients With Melanoma
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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Peripheral blood lymphocytes (PBLs); Plasma; Tumor Tissue
Sampling Method Non-Probability Sample
Study Population Patients being treated at Massachusetts General Hospital, Dana-Farber Cancer Institute and Beth Isreal Deaconess Medical Center
Condition Melanoma
Intervention Not Provided
Study Groups/Cohorts
  • Group 1
    Advanced Melanoma
  • Group 2
    Stage II/III Melanoma
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: April 23, 2013)
220
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2021
Actual Primary Completion Date March 29, 2017   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01840527
Other Study ID Numbers 12-488
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Ryan Sullivan, M.D., Massachusetts General Hospital
Study Sponsor Massachusetts General Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Ryan Sullivan, MD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date December 2019