CXCL1 Biomarker Study in Metastatic Melanoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Observational study only
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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.
结局指标
主要结局
Observational study only
时间窗: May 2006-September 2011
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.
次要结局
- Observational study only(May 2006-September 2011)