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NCT01840527 · ClinicalTrials.gov registry record
Utility of Novel BRAF Test for Melanoma
A clinical trial, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- 220
- Enrollment target
NCT01840527: Completed study, sponsored by Massachusetts General Hospital.
NCT01840527 is a clinical trial that has completed, run by Massachusetts General Hospital. The registered enrollment target is 220 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01840527 has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- 220 participants
- Enrollment target
Study 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.
Primary Outcome
The specificity and sensitivity of the blood-based assay will be determined vis-à-vis tissue-based BRAF analysis in patients with advanced and high-risk melanoma in order to provide BRAF-directed therapy when indicated. The sensitivity of an assay is expressed as the probability (as a percentage) that a sample tests positive for BRAF mutation given that the participant has BRAF mutation; it is used to assess the risk of false negative results. A percentage greater than 50% indicates that the tes
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 220 participants |
| Start Date | 2013-05 |
| Est. Completion | 2022-09 |
What the finished NCT01840527 record still lists
NCT01840527 is an observational study that tracks outcomes without assigning an intervention. The registered 220 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01840527 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01840527 about?
NCT01840527 is a clinical study titled "Utility of Novel BRAF Test for Melanoma". 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 separ...
What is the current status of trial NCT01840527?
This trial is currently completed. The enrollment target is 220 participants. The study started on 2013-05. Estimated completion is 2022-09.
Who is sponsoring clinical trial NCT01840527?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
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