Sentinel Node and Non-Sentinel Lymph Nodes (SLN and Non-SLN) Procurement From Melanoma Subjects for Molecular Profiling Analysis
Inclusion Criteria:
- Primary melanoma with the following Breslow thickness and stage
- ≥ 2 mm with ulceration, T3b
- ≥ 4 mm without (T4a) or with (T4b) ulceration
- Patients with a biopsied tumor that has not been widely resected will also be
eligible for study according to the above-specified criteria for tumor thickness
and stage.
- Age 12 years or older.
- Patients must have documented hemoglobin level of 10g/dL or higher. This can be drawn
on the day of consent, or be documented from a previous visit within the past 30 days
- Subjects must have provided written, informed consent prior to any study procedures:
collection of blood and LN tissue specimens for this protocol.
Exclusion Criteria:
- Serious illnesses that may be considered a contraindication to surgery as determined
by the physician investigator. If a subject is cleared for surgery as clinically
indicated (wide excision of the primary melanoma and sentinel lymph node biopsy),
subject would be eligible.
- Any significant psychiatric disease, medical intervention, or other condition, which
in the opinion of the Principal Investigator or Co-Investigators, could prevent
adequate informed consent or compromise participation in the clinical trial.
- Active infection or antibiotics within one-week prior to study
- Systemic steroid or other immunosuppressive therapy administered for more than 10
days within 4 weeks of enrollment.