Melanoma Molecular Profiling Analysis

NCT ID: NCT00889980

Last Updated: 2020-06-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 237 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2019-07-22

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.

Conditions

Melanoma

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Melanoma

Patients with primary melanoma

Biospecimen banking

Intervention Type: 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.

Interventions

Biospecimen banking

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Schering-Plough

INDUSTRY

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

John Kirkwood

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmad Tarhini, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh Medical Center

Locations

Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

07-133

Identifier Type: -

Identifier Source: org_study_id