Cytogenetic and Flow Cytometric Analysis of : Renal Cell Carcinoma: A Companion Protocol to SWOG-8949
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 主要终点
- Correlation of time from first diagnosis of metastatic disease until death with the type and number of abnormalities
研究概览
简要总结
RATIONALE: DNA analysis of tumor tissue may help doctors predict how well patients will respond to treatment.
PURPOSE: This laboratory study is analyzing the DNA in tumor tissue from patients with metastatic kidney cancer.
详细描述
OBJECTIVES:
- Determine if cytogenetic abnormalities can predict clinical outcome, in terms of response to treatment and survival, in patients with metastatic renal cell carcinoma registered to the nephrectomy arm (arm I) of SWOG-8949.
- Correlate cytogenetic abnormalities and DNA content analysis (DNA index and S-phase fraction) with clinical outcome.
OUTLINE: This is a partially prospective, partially retrospective, multicenter, companion study.
Paraffin-embedded tumor tissue specimens from patients enrolled in SWOG-8949 are evaluated by cytogenetic analysis (e.g., presence of trisomy and loss of Y chromosome) and flow cytometric analysis (e.g., presence of nondiploid cells and presence of abnormal proliferation index).
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Correlation of time from first diagnosis of metastatic disease until death with the type and number of abnormalities
时间窗: up to 4 years after registration
Abnormality is defined as at lease one clonal chromosomal abnormality.
Number of abnormalities per number of successes
时间窗: up to 4 years after registration
Abnormality is defined as at lease one clonal chromosomal abnormality.
Correlation of time from diagnosis to development of metastatic disease with the type and number of abnormalities
时间窗: up to 4 years after registration
Abnormality is defined as at lease one clonal chromosomal abnormality.
Correlation of tumor response to treatment with the type and number of abnormalities
时间窗: up to 4 years after registration
Abnormality is defined as at lease one clonal chromosomal abnormality.
Number of successes per number of evaluable samples
时间窗: up to 4 years after registration
Success is defined as obtaining at least 10 analyzable metaphases.
次要结局
未报告次要终点