TRACERx Renal (TRAcking Renal Cell Carcinoma Evolution Through Therapy (Rx)) CAPTURE: COVID-19 Antiviral Response in a Pan-tumour Immune Study
试验速览
- 阶段
- 不适用
- 入组人数
- 360
- 试验地点
- 4
- 主要终点
- CAPTURE Sub-study: Describe the population characteristics between SARS-CoV-2 positive and negative cancer patients
研究概览
简要总结
TRACERx Renal: This is a translational study, which, aims to develop prognostic and predictive biomarkers for patients with renal cell carcinoma (RCC).
CAPTURE Sub-study: Covid-19 antiviral response in a pan-tumour immune monitoring study
详细描述
There is a need for improved understanding of renal cell carcinoma (RCC) biology in order to characterise the mechanisms of metastatic progression, drug resistance, develop predictive & prognostic biomarkers and to identify novel therapeutic targets for this disease. The TRACERx consortium was established to achieve this using large longitudinal clinical studies, in collaboration with laboratory, advanced sequencing and informatics expertise to identify the relationships between intratumour heterogeneity and clinical outcome.
Response and Resistance: TRACERx Renal is a prospective longitudinal cohort study. It will draw on the methodology already being used within the TRACERx Lung & (planned) Breast studies as part of the TRACERx consortium.
Primary Endpoint
• To validate ITH index and WGII as stage and grade independent prognostic markers of progression free survival in patients with ccRCC
The Investigators plan to collect the following biological samples:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Age 18- years or older
- •Patients with histopathologically confirmed renal cell carcinoma, or suspected renal cell carcinoma, proceeding to neoadjuvant therapy and/or nephrectomy/metastasectomy, or identified as having progressive disease
- •Or in patients undergoing nephrectomy for non-malignant disease
- •Medical and/or surgical management in accordance with national and/or local guidelines
- •Written informed consent
排除标准
- •Any concomitant medical or psychiatric problems which, in the opinion of the investigator, would prevent completion of treatment or follow-up
- •Lack of adequate tissue
- •CAPTURE Inclusion criteria
- •Documented informed consent
- •Age 18 years or older
- •Confirmed cancer diagnosis (irrespective of cancer type, disease burden or treatment)
- •Group A: Suspected infection with SARS-CoV-2 or positive test for SARS-CoV-2
- •Group B: no clinical indication to test for SARS-CoV-2 (by current Trust guidelines*) or tested negative for SARS-CoV-2
- •Group C: Volunteers without cancer with SARS-CoV-2 (symptomatic and asymptomatic) and those without clinical indication (current national guidelines*) for SARS-CoV-2 testing or tested negative for SARS-CoV-2
- •Exclusion criteria
- •Medical or psychological condition that would preclude informed consent
结局指标
主要结局
CAPTURE Sub-study: Describe the population characteristics between SARS-CoV-2 positive and negative cancer patients
时间窗: From sub-study activation until trial closure approximately 2027
Outcomes will be quantified using descriptive statistics
To validate ITH index and WGII as stage and grade independent prognostic markers of progression free survival in patients with ccRCC mutation in a gene of interest
时间窗: From trial activation until trial closure approximately 1st September 2023
Outcomes will be quantified using descriptive statistics with the intention of providing hypothesis-generating data for use in future studies.
次要结局
未报告次要终点