Melanoma Molecular Profiling Analysis

Completed

• Conditions: Melanoma
• Interventions: Other: Biospecimen banking

• Registration Number: NCT00889980
• Lead Sponsor: University of Pittsburgh

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2009-04-28
• Study First Submitted QC: 2009-04-28
• Study First Posted: 2009-04-29
• Primary Completion: 2019-07-22
• Study Completion: 2019-07-22
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-05
• Last Update Posted: 2020-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 237

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.

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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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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Melanoma	Biospecimen banking	Patients with primary melanoma

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hillman Cancer Center; 🇺🇸 Pittsburgh, Pennsylvania, United States