Objectives
Primary Aim 1. Determine the association of GEP test result with SLNB surgical decisions in patients with SLNB-eligible T1-T2 melanoma
Primary Aim 2: Track and evaluate 5-year clinical outcomes for patients in each GEP subclass and/or i31-GEP risk group, including those who did and did not undergo SLNB and those with T3-T4 melanoma.
Eligibility
Inclusion criteria:
Patients must meet all of the inclusion criteria with no exclusions seen :
1. Patient newly diagnosed (within two months of primary biopsy) with invasive cutaneous melanoma
2. Patient being tested with the DecisionDx-Melanoma 31-GEP test as part of their clinical care
3. Patient whose DecisionDx-Melanoma result is being used to inform the use of sentinel lymph node biopsy (i.e.: whether or not to perform)
4. Patient is at least 18 years of age at the time of GEP testing
5. Patient is being considered for sentinel lymph node biopsy
6. 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
7. Patient is reasonably able to follow up with the enrolling physician at regular intervals for assessment of outcome data
Exclusion criteria:
1. Employees and family members of Investigator
2. Inability to obtain informed consent
3. Patients with known Stage III or IV melanoma at diagnosis
4. Patients with an invasive 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
5. Patient who is only being tested with DecisionDx-Melanoma 31-GEP test for reasons other than to inform the use of SLNB
6. Patient who at the time of consent has had a sentinel lymph node biopsy for the tumor under study or a sentinel lymph node biopsy performed in the same nodal basin for any reason
Note: Patients who do not receive a successful DecisionDx-Melanoma test result (insufficient tissue or technical failure) will be withdrawn from study and will not be followed for long term outcomes.