Status:
COMPLETED
Melanoma Molecular Profiling Analysis
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
Schering-Plough
Conditions:
Melanoma
Eligibility:
All Genders
12+ years
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% ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 22 2019
Estimated Enrollment :
237 Patients enrolled
Trial Details
Trial ID
NCT00889980
Start Date
May 1 2008
End Date
July 22 2019
Last Update
June 9 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232