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| Name | Class |
|---|---|
| Schering-Plough | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Melanoma | Patients with primary melanoma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen banking | Other | SLN and one non-SLN (8mm and larger in longest dimension). fourteen 10cc tubes or a total of 140mL of blood will be collected from subjects weighing over 102.6 pounds. If the subject weighs less than 102.6 pounds, the amount of blood drawn will be based on exact body weight. The amount of blood drawn will be no more than 3mL/kg of body weight. |
| Measure | Description | Time Frame |
|---|---|---|
| Molecularly characterize the regional nodal status of positive and negative SLNs (SLN+ and SLN-) in patients undergoing SLN mapping and dissection for routine staging of melanoma. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarkers differentially expressed between SLN+ and SLN- specimens, molecular profiling the SLN+ node and adjacent non-SLN, and if association exists between specific gene signatures for positive and negative SLN and clinical outcomes. | 2 years |
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Inclusion Criteria:
Primary melanoma with the following Breslow 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:
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Melanoma patients
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| Name | Affiliation | Role |
|---|---|---|
| Ahmad Tarhini, MD | University of Pittsburgh Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | United States |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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Lymph nodes (less than 20% of any node), blood will be drawn at the pre study visit (serum and peripheral blood mononuclear cells) and appropriate lineage control tissue will be collected.
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| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |