Melanoma Molecular Profiling Analysis
| Status: | Recruiting |
|---|---|
| Conditions: | Skin Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 12 - Any |
| Updated: | 8/23/2018 |
| Start Date: | May 2008 |
| End Date: | May 2019 |
| Contact: | John Kirkwood, MD |
| Email: | kirkwoodjm@upmc.edu |
| Phone: | 412-623-3272 |
Sentinel Node and Non-Sentinel Lymph Nodes (SLN and Non-SLN) Procurement From Melanoma Subjects for Molecular Profiling Analysis
There is a significant need to develop new and more effective ways to treat melanoma that
will decrease patient morbidity and mortality. This protocol intends to collect and process a
portion (< 20% of any node) of lymph nodes from melanoma patients undergoing routine surgical
SLN resection: the SLN(s) and 1 adjacent non-SLN(s) are planned for study. In addition, blood
will be drawn at the pre study visit (serum and peripheral blood mononuclear cells) and
appropriate lineage control tissue will be collected. Material only from already-indicated
and planned procedures as part of standard medical care will be used. The main goal of this
study will be to properly collect and process material to be analyzed and explore the
molecular features melanoma biological samples.
will decrease patient morbidity and mortality. This protocol intends to collect and process a
portion (< 20% of any node) of lymph nodes from melanoma patients undergoing routine surgical
SLN resection: the SLN(s) and 1 adjacent non-SLN(s) are planned for study. In addition, blood
will be drawn at the pre study visit (serum and peripheral blood mononuclear cells) and
appropriate lineage control tissue will be collected. Material only from already-indicated
and planned procedures as part of standard medical care will be used. The main goal of this
study will be to properly collect and process material to be analyzed and explore the
molecular features melanoma biological samples.
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.
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