Melanoma Biomarker Study
CXCL1 Biomarker Study in Metastatic Melanoma
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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:
- To measure serum levels of CXCL1 in untreated, metastatic melanoma patients and to compare to serum CXCL1 levels in normal controls.
- 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.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Maryland
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Baltimore, Maryland, Estados Unidos, 21231
- Johns Hopkins University - Sidney Kimmel Comprehensive Cancer Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- 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 Criteria:
- 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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Observational study only
Periodo de tiempo: May 2006-September 2011
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To determine, via sandwiched ELISA, the presence and level of CXCL1 in the serum of patients with metastatic melanoma and to compare these values with CXCL1 levels in normal controls.
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May 2006-September 2011
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Observational study only
Periodo de tiempo: May 2006-September 2011
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To compare serum CXCL1 levels collected peripherally and centrally, in metastatic melanoma patients and To collect serum samples for future study.
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May 2006-September 2011
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Colaboradores e Investigadores
Colaboradores
Investigadores
- Investigador principal: William H Sharfman, MD, Johns Hopkins University Sidney Kimmel Comprehensive Cancer Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- J05122
- NA_00001940
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