Molecular Correlates of Sensitivity and Resistance to Therapy in Genitourinary Malignancy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Gene expression profile using microarray assays
研究概览
简要总结
This study collects and studies tissue and blood samples from patients with prostate or bladder/urothelial cancer that has recurred (come back) at or near the same place as the original (primary) tumor or has spread to other parts of the body. Studying samples of blood and tissue samples from patients with prostate or bladder/urothelial cancer in the laboratory may help doctors learn more about new biomarkers, potential drug targets, and resistance developing in response to treatment. It may also help doctors find better ways to treat the cancer.
详细描述
OUTLINE:
Patients undergo collection of blood and tissue samples for analysis via mutation mapping, DNA sequencing, gene expression microarray, and gene profiling.
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
- Male
- 接受健康志愿者
- 是
入选标准
- •Patients with localized and/or metastatic bladder/urothelial or prostate cancer who have disease in the primary organ, biopsy accessible bone metastases (collaborating radiologists will determine if bone metastasis is appropriate for biopsy) or soft tissue metastases are eligible; men and women without cancer are eligible to have blood or normal tissue collected if acquired as part of non-research procedures (e.g. transurethral resection of the prostate or bladder); in patients without malignancy, no additional tissue beyond that necessary for care will be procured
- •Ability to adequately understand and give informed consent
- •Local or metastatic disease to soft tissue or bone at sites accessible to biopsy with minimal risk of complications Or the ability to obtain tissue with minimal risk of complication from a surgical procedure being conducted as a part of another research study Or for standard of care purposes or patients who have archival tissue collected for research or standard of care who are willing to donate archival tissue for this study
- •Alternatively, men and women without cancer or who are at risk of developing cancer are eligible to have blood or normal tissue collected if acquired; tissue will only be acquired as part of non-research procedures (e.g. transurethral resection of the prostate or bladder; in patients without malignancy, no additional tissue beyond that necessary for care will be procured
- •Platelet count > 50,000
- •White blood cell (WBC) > 1,500
- •Hemoglobin (Hgb) > 8.0
- •International normalized ratio (INR) < 1.5
- •Partial thromboplastin time (PTT) < 45
- •No history of excessive unexplained bleeding from previous surgery
排除标准
- •Patients unable to stop chronic anticoagulation with warfarin or Lovenox for less than 3 days
- •Serious or uncontrolled infection
- •Treatment with a vascular endothelial growth factor (VEGF) inhibitor (such as Avastin) within the past 28 days
研究组 & 干预措施
Ancillary-correlative (blood and tissue collection)
Patients undergo collection of blood and tissue samples for analysis via mutation mapping, DNA sequencing, gene expression microarray, and gene profiling.
干预措施: Laboratory Biomarker Analysis (Other)
Ancillary-correlative (blood and tissue collection)
Patients undergo collection of blood and tissue samples for analysis via mutation mapping, DNA sequencing, gene expression microarray, and gene profiling.
干预措施: Cytology Specimen Collection Procedure (Other)
结局指标
主要结局
Gene expression profile using microarray assays
时间窗: Up to 6 years
DNA genomic sequencing
时间窗: Up to 6 years
Mutation mapping using the OncoMap and other genotyping techniques
时间窗: Up to 6 years
次要结局
- Proteomic profile(Up to 6 years)
- Expression of androgen metabolic enzymes by quantitative real time-polymerase chain reaction(Up to 6 years)