Status:
COMPLETED
Melanoma Biomarker Study
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Metastatic Melanoma
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to measure the level of a specific protein, CXCL1, in the blood of patients with untreated, metastatic (Stage IV) melanoma. These levels will be compared to blood levels i...
Detailed Description
Malignant Melanoma has rapidly increased in incidence over the past thirty years, at a rate of roughly 3% per year. In 2005, approximately 59,000 new cases of melanoma were diagnosed with 8000 deaths....
Eligibility Criteria
Inclusion
- Histologic diagnosis of melanoma; primary may be cutaneous, mucosal or ocular.
- Evidence of metastatic disease based on standard AJCC staging.
- Willing to give written informed consent.
- Willing and able to comply with protocol procedures.
- At least 18 years of age.
- No prior chemotherapy, immunotherapy, or radiotherapy.
- Are able to safely donate 50 mL of blood.
- Have a central venous catheter in place (this will not be placed for participation in this trial)
Exclusion
- Known diagnosis of a chronic inflammatory disease, ie: Rheumatoid Arthritis, Systemic Sclerosis, Inflammatory bowel disease
- Known diagnosis of NYHA class 3 or 4 Congestive Heart Failure
- Are unable to safely donate 50 mL blood
- Known HIV, Hepatitis B, or Hepatitis C infection.
- Any malignancy within 5 years, other than melanoma (for patients); Have any malignancy within the past 5 years including melanoma (for normal controls). Basal cell and squamous cell skin cancers are permitted in all participants.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00348088
Start Date
May 1 2006
End Date
September 1 2011
Last Update
December 13 2012
Active Locations (1)
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1
Johns Hopkins University - Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21231