TFE Renal Cell Carcinoma: A Prospective Registry and Translational Research Initiative
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Improving Future Research
研究概览
简要总结
There are limited data regarding the biology and treatment of TFE Renal Cell Carcinoma (TFE RCC). This project provides the infrastructure for acquisition of biological specimens, imaging, and correlative clinical data to facilitate biology studies and characterization of TFE RCC. This registry will collect clinical, demographic, and pathological data, specimens (as available) and imaging from patients with TFE RCC, prospectively. Cases are identified through:
- Existing clinical and/or cancer registry databases
- Referrals from clinicians, surgeons, or pathologists
- Families initiating contact with Registry staff directly
详细描述
The following data/materials will be collected for this registry study:
Clinical Data: Demographic data, date of diagnosis, pathology, radiological imaging at diagnosis and relapse, signs and symptoms at diagnosis, molecular and biological data, staging details including sites of disease, detailed treatment data (e.g. types and dates of surgeries/interventional therapy (if any), medical/systemic therapy, radiotherapy), response to treatment, dates of progression, types of progression (local or metastatic), and follow-up data. The demographic and clinical data collected are abstracted and entered into an electronic data system secured by password protection (see section 4.3.3). Collection of existing molecular and/or genomic data or analysis that has been performed will also be included.
Research Specimens:
Tissue (fresh/frozen/FFPE) will be requested for all enrolled patients and sent for central review to study pathologist. Then tissue will be stored at CCHMC and future research testing may be conducted on this tissue.
Optional research specimens:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients of any age with a suspected diagnosis or confirmed diagnosis of a TFE Renal Cell Carcinoma.
- •Unless the patient is deceased, all patients and/or one parent or legal guardian must provide written informed consent as well as HIPAA/release of information consent.
排除标准
- •Any patient that has not been diagnosed with TFE Renal Cell Carcinoma
结局指标
主要结局
Improving Future Research
时间窗: From enrollment until data analysis is complete - assessed up to 40 years
Improving future research by releasing tumor tissue for tumor modeling and drug testing, tumor biology insights, and clinical insights ultimately leading to the development of more effective therapies for children with TFE RCC.
次要结局
未报告次要终点