Quantitative Targeted Proteomics Detected by Mass Spectrometry With Whole Genome (DNA) and Whole Transcriptome (RNA) Sequencing in Advanced Cancers
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Cota Inc.
- 入组人数
- 40
- 试验地点
- 10
- 主要终点
- Time on original treatment strategy for advanced cancer
研究概览
简要总结
Among patients with advanced (metastatic) cancers, detailed characterizations of the tumor utilizing genomic and proteonomic techniques may help guide treatment. It, however, remains unclear if these new diagnostic technologies truly influence clinical and economic outcomes. This study will evaluate if patients treated according to the results of the NantHealth GPS Cancer test achieve optimal outcomes compared to patients whose treatment are discordant with GPS Cancer recommendations.
详细描述
Personalized Medicine approaches to cancer management require detailed diagnostic evaluations. Broad genomic profiling,using whole genome (DNA) and whole transcriptome(RNA) sequencing platforms,holds the promise of identifying tumor related mutations that are amenable to targeted therapies, with the potential for improved clinical outcomes and lower toxicities compared to traditional cytotoxic chemotherapy. Proteomic approaches may add additional insights into treatment selection by identifying protein biomarkers known to induce drug resistance or indicate drug sensitivity for chemotherapy, monoclonal antibody therapy, hormonal therapy, targeted therapy and immunotherapy. The full value of these approaches has not been realized in routine clinical cancer care.
GPS Cancer™ is a comprehensive test available through NantHealth. GPS Cancer which integrates whole genome (DNA) sequencing, whole transcriptome (RNA) sequencing, and quantitative proteomics through mass spectrometry, provides oncologists with a comprehensive molecular profile of a patient's cancer to inform personalized treatment strategies. GPS Cancer testing is conducted in CLIA-certified and CAP-accredited laboratories.
Hypothesis:
- The addition of proteomics to next generation sequencing (NGS) via the NantHealthGPS Cancer test and the incorporation of whole genome sequencing will identify treatment algorithms with increased likelihood of successful clinical outcomes in patients with advanced cancers.
Study Design(summary):
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
- 否
入选标准
- •Pancreatic cancer patients ineligible for curative surgery at time of entry will be eligible for enrollment.
- •Metastatic breast cancer at any time in their treatment history will be eligible for enrollment.
- •Advanced stage (non-resectable/metastatic/incurable) lung cancer patients will be eligible for enrollment.
- •Metastatic colon cancer patients not amenable to curative therapy will be eligible for enrollment.
- •Metastatic non-resectable malignant melanoma patients will be eligible for enrollment.
- •NantHealth GPS Cancer in Advanced Cancers
- •Metastatic hormone refractory prostate cancer patients will be eligible for enrollment. Patients must have tumor tissue available prior to the initiation of the current line of treatment available for GPS Cancer testing.
- •Metastatic bladder cancer
- •Non-resectable metastatic Renal carcinoma
- •Non-resectable metastatic Head and Neck cancer
- •Metastatic Ovarian cancer
- •Metastatic Cervical cancer
- •Metastatic Sarcoma
- •Patients must sign informed consent for this study.
- •Patients must have private medical insurance coverage through Horizon Blue Cross Blue Shield. This is limited to insured commercial members, including HMO, and excluding, for the avoidance of doubt, members of self-insured customers or Medicare or Medicaid programs.
排除标准
- •Pregnancy.
结局指标
主要结局
Time on original treatment strategy for advanced cancer
时间窗: 2 years
To determine whether patients who are treated with therapies that are concordant with the NantHealth GPS Cancer test are able to stay on their original treatment strategy longer than patients treated with either discordant regimens or a matched Nanthealth GPS untested population.
次要结局
- Total cost of care(1 year)