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Melanoma Molecular Profiling Analysis

Sentinel Node and Non-Sentinel Lymph Nodes (SLN and Non-SLN) Procurement From Melanoma Subjects for Molecular Profiling Analysis

NCT00889980•University of Pittsburgh

View on ClinicalTrials.gov

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.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Key Dates

Start Date

May 1, 2008

Primary Completion Date

July 22, 2019

Completion Date

July 22, 2019

Last Updated

June 9, 2020

Enrollment

237

ACTUAL participants

Conditions

Melanoma

Interventions

Biospecimen banking

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 9, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Melanoma Molecular Profiling Analysis

Inclusion Criteria

Exclusion Criteria

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