Validation of a Blood Assay for the Detection of BRAF Mutation Status in Patients with Metastatic Melanoma
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 14-007404
Sponsor Protocol Number: 14-007404
About this study
The purpose of this study is to validate an internally developed assay for the detection of BRAF V600E mutations in cfDNA from the peripheral blood of patients with melanoma.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Age 18 years or older
- Histologic evidence of metastatic melanoma with documented or pending BRAF mutation status from a metastatic site
- Patients with either unresectable melanoma or recent progression on systemic therapy for metastatic melanoma
- An understanding of the protocol and its requirements, risks, and discomforts
- The ability and willingness to sign an informed consent
Exclusion Criteria:
- Pregnancy or lactation (for females)
- Inability on the part of the patient to understand the informed consent or be compliant with the protocol
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
Contact |
Rochester, Minn.
Mayo Clinic principal investigator George Vasmatzis, Ph.D. |
Closed for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
More information
Publications
Publications are currently not available