Culture and Characterization of Circulating Tumor Cells (CTC) From Patients With Malignant Melanoma and Other Cancers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Circulating tumor cell (CTC) isolation and colony counts
研究概览
简要总结
The purpose of this study is to determine if circulating tumor cells (CTC) can be accurately detected and isolated from the blood of participants with melanoma using novel laboratory techniques. Blood samples will be collected from participants with melanoma, and also from participants with other solid tumor cancers and healthy volunteers for purposes of comparison.
Relevant information will be collected from participant's medical record and stored in a coded manner in a password-protected format. This information will be used to look for correlations of research results on blood samples to participant's medical condition. Test results will not be given to participants or their physicians. In some cases, CTC may be grown for long-term cell lines for further research.
详细描述
A strong correlation has been established between CTC and the progression of breast, colon and prostate cancers. The number of CTC appears to act as a prognostic marker for relapse and survival in a number of epithelial cancers. Unfortunately, current CTC assays are not effective in reliably detecting circulating melanoma cells and the assay procedures damage cells prohibiting further study.
This study is designed to evaluate the sensitivity and specificity of the TrueCells assay, a novel approach to isolate and preserve cells for further research.
Primary Objectives:
- Evaluate feasibility and reproducibility of isolation of CTC using TrueCells technology.
- Optimize quantitative CTC recovery
- Provide preliminary data concerning correlation of these measurements with other methods of CTC recovery such as immunofluorescence, lipid-based staining.
Secondary Objectives:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Diagnosis of melanoma, prostate cancer or other solid tumor malignancy; or benign hematologic disorder; or healthy volunteer.
- •18 years of age or older.
- •Signed written informed consent.
排除标准
- 未提供
结局指标
主要结局
Circulating tumor cell (CTC) isolation and colony counts
时间窗: 2 years
次要结局
- Immunophenotyping, somatic (tumor-specific) DNA mutation analysis(2 years)
研究者
Wolfram Samlowski
Physician, Comprehensive Cancer Centers of Nevada; Member, Developmental Therapeutics and Genitourinary Committee, US Oncology Research Clinical; Professor, University of Nevada, Reno
Comprehensive Cancer Centers of Nevada