Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-26 @ 4:26 AM
Study NCT ID:
NCT01840527
Status:
COMPLETED
Last Update Posted:
2024-09-04
First Post:
2013-04-23
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Utility of Novel BRAF Test for Melanoma
Sponsor:
Massachusetts General Hospital
Organization:
Study Overview
Official Title:
Exploring the Utility of a Novel BRAF Test in Patients With Melanoma
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1UH2CA207355 | NIH | None | https://reporter.nih.gov/quic… | View |