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Sponsors and Collaborators: |
Sidney Kimmel Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | Sidney Kimmel Comprehensive Cancer Center |
ClinicalTrials.gov Identifier: | NCT00348088 |
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 in normal controls. If the levels are elevated in metastatic melanoma, further studies to determine if this correlates with presence and extent of disease will be pursued.
Condition |
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Metastatic Melanoma |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | CXCL1 Biomarker Study in Metastatic Melanoma |
Estimated Enrollment: | 40 |
Study Start Date: | May 2006 |
Estimated Study Completion Date: | May 2007 |
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. While the majority of early melanomas can be surgically cured, advanced melanoma has an extremely poor prognosis. Current chemotherapy and immunotherapy options for advanced melanoma still offer response rates of only 10-20%. Thus, the elucidation of biomarkers in melanoma, both diagnostic and prognostic, is an important area for investigation.
CXCL1 is a chemokine whose expression is upregulated in melanoma. We postulate that CXCL1 plays an important role in the progression of melanoma to invasive disease. Our hypothesis states that serum CXCL1 levels correlate with the presence of melanoma.
Aims:
Blood will be collected from metastatic melanoma patients on one occasion, both peripherally and centrally. Control will have blood collected peripherally on one occasion. The blood will be processed and then tested in a blinded, batched fashion.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: William H Sharfman, MD | (410)583-2970 | sharfwi@jhmi.edu |
Contact: Leslie A Fecher, MD | (410)614-4459 | lfecher1@jhmi.edu |
United States, Maryland | |
Johns Hopkins University - Sidney Kimmel Comprehensive Cancer Center | Recruiting |
Baltimore, Maryland, United States, 21231 | |
Contact: Robin Lewis 410-614-1022 |
Principal Investigator: | William H Sharfman, MD | Johns Hopkins University - Sidney Kimmel Comprehensive Cancer Center |
Responsible Party: | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( William Sharfman, M.D. ) |
Study ID Numbers: | J05122, NA_00001940 |
Study First Received: | June 30, 2006 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00348088 |
Health Authority: | United States: Institutional Review Board |
Metastatic Melanoma Untreated Biomarker |
Neuroectodermal Tumors Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Nevus Neuroendocrine Tumors Melanoma |
Neoplasms Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nevi and Melanomas |