Immunophenotyping in Metastatic Renal Cell Carcinoma Patients Receiving Ablative Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in immune markers and peripheral blood mononuclear cell (PBMC) characteristics
研究概览
简要总结
This early phase I trial evaluates blood samples to see if patients undergoing standard of care treatment with either stereotactic body radiation therapy or percutaneous ablation (using radio waves to create heat to destroy the tumor), have an increase in serum immune markers in kidney cancer. Information gained from this study may help doctors make treatment decisions for patients with kidney cancer.
详细描述
PRIMARY OBJECTIVES:
I. Compare pre- and post-treatment immune markers and peripheral blood mononuclear cell (PBMC) characteristics in metastatic renal cell carcinoma (RCC) patients overall.
II. Compare pre- and post-treatment immune markers and PBMC characteristics between patients being treated with stereotactic body radiation therapy (SBRT) versus percutaneous cryoablation (PCA) and are also undergoing immunotherapy.
III. Compare pre- and post-treatment immune markers and PBMC characteristics in patients being treated with either SBRT or PCA and not undergoing immunotherapy.
IV. Assess the impact of post-treatment immune markers and PBMC characteristics on distant disease progression in metastatic RCC patients overall.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Histological diagnosis of primary RCC
- •Histological or radiographic diagnosis of metastatic RCC
- •Age >= 18 years
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-3
- •Feasible vascular access as determined by study staff
- •Undergoing standard of care SBRT or PCA to RCC metastatic lesion(s)
- •Provide written informed consent
- •Willing to consent to research blood draws
- •Willing to return to enrolling institution for follow-up
排除标准
- •Prior local treatment of the index metastatic lesion
- •Pregnant or nursing women
- •Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for study entry
- •Patients receiving prophylactic steroids, defined as initiation of steroids within 1 week prior to local ablative therapy start, including the first day of local ablative therapy.
- •NOTE: Patients initiating steroids after the first day of local ablative therapy and within 14 days after local ablative therapy completion, will be allowed into the study and the use of steroids will be recorded.
结局指标
主要结局
Change in immune markers and peripheral blood mononuclear cell (PBMC) characteristics
时间窗: Baseline up to 6 months
Immune markers and PBMC characteristics will be evaluated overall. For change from baseline, comparisons between groups will be done using Analysis of Covariance (ANCOVA), including the pre-treatment count as a covariate in the model along with group status. The change will be described between groups reporting the mean and inter-quartile range. Linear regression will be used, analysis of covariance for change, for multiple variable models that will include any relevant baseline disease and patient characteristics.
次要结局
- Change in immune markers and PBMC characteristics in patients undergoing stereotactic body radiation therapy (SBRT) versus percutaneous cryoablation (PCA) and receiving concurrent immunotherapy(Baseline up to 6 months)
- Levels of post-treatment immune markers and PBMC characteristics(Up to 6 months)
- Change in immune markers and PBMC characteristics in patients undergoing SBRT or PCA and not receiving concurrent immunotherapy(Baseline up to 6 months)
研究者
Bradley (Brad) Stish
Principal Investigator
Mayo Clinic