Validation of a Blood Assay for the Detection of BRAF Mutation Status in Patients with Metastatic Melanoma

Overview

  • Study type

    Observational
  • Study IDs

  • Describes 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.
  • 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. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

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 us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Minetta Liu, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20323754

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