IRB Study Number FLA20-060
Status Recruiting
Institute Taussig Cancer Institute
Description
OBJECTIVES
Determine the association of GEP test result with SLNB surgical decisions in patients with SLNB-eligible T1-T2 melanoma
Track and evaluate 5-year clinical outcomes for patients in each GEP subclass, including those who did and did not undergo SLNB and those with T3-T4 melanoma
Inclusion Criteria
Patient with newly diagnosed (within two months) invasive cutaneous melanoma who is being tested with the DecisionDx-Melanoma 31-GEP test as part of their clinical care to inform the use of sentinel lymph node biopsy
Patient is at least 18 years of age at the time of GEP testing
Patient is being considered for sentinel lymph node biopsy
Patient has not had a sentinel lymph node biopsy for this melanoma, and has not previously had a sentinel lymph node biopsy in the same nodal basin for any reason
Patient is reasonably able to follow up with the enrolling physician at regular intervals for assessment of outcome data
Exclusion Criteria
Employees and family members of Investigator
Inability to obtain informed consent
Patients with known Stage III or IV melanoma at diagnosis
Patients with a melanoma diagnosed in the same anatomical region in the last 5 years; anatomical regions are defined as: a) head and neck, b) legs and feet, c) trunk, d) chest, e) arms and hands
