Melanoma Molecular Profiling Analysis

University of Pittsburgh

Status: Completed

Conditions: Melanoma

Treatments: Other: Biospecimen banking

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00889980

07-133

Details and patient eligibility

About

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.

Enrollment: 237 patients

Sex: All

Ages: 12+ years old

Volunteers: No 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.

Trial design

237 participants in 1 patient group

Melanoma

Description:

Patients with primary melanoma

Treatment:

Other: Biospecimen banking