Viewing Study NCT00348088



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Study NCT ID: NCT00348088
Status: COMPLETED
Last Update Posted: 2012-12-13
First Post: 2006-06-30

Brief Title: Melanoma Biomarker Study
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Overview

Official Title: CXCL1 Biomarker Study in Metastatic Melanoma
Status: COMPLETED
Status Verified Date: 2012-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 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
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 59000 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

1 To measure serum levels of CXCL1 in untreated metastatic melanoma patients and to compare to serum CXCL1 levels in normal controls
2 To measure and compare centrally and peripherally collected serum CXCL1 levels in untreated metastatic melanoma

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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
NA_00001940 None None None