KidneyCare Cohort Study: Biologic Interrogation of Sarcopenia in Patients With Renal Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 161
- 试验地点
- 2
- 主要终点
- Percent of Scheduled Assessments Completed
研究概览
简要总结
This research study aims to learn how lifestyle factors (e.g., obesity) impact the risk of developing kidney cancer and impact survival after nephrectomy (removal of a kidney). The study team's long-term goals are to learn: 1) How to improve treatment success in future patients by tailoring therapies to each patient's unique biology; and 2) What future patients can do to improve their health after diagnosis. To this end, the study team will collect samples (such as blood and extra tissue from surgery) from patients and store and test these samples. The study team also asks patients about their health behaviors (e.g., diet and physical activity) and well-being before their diagnosis and afterwards by filling out questionnaires.
详细描述
If patients decide to participate in this study, they will be asked to complete the following assessments:
Health questionnaires: The study team will ask participants to complete this health questionnaire within two weeks before their surgery. The questionnaire will ask information about medical history and health-related behaviors.
Follow-up questionnaires: After participants undergo surgery, the study team will contact participants periodically to ask questions about any symptoms they may be experiencing, as well as current physical activity, diet, and quality of life (this will take about 60 minutes to complete). The study team will contact participants with additional questionnaires about 3-6 months post-surgery, 12 months, 24 months, and 60 months later to learn how to improve cancer treatment and overall health after diagnosis for kidney cancer patients.
Performance status assessments: Various measurements of performance status such as handgrip strength, time up & go test, 6-min walk test, and 30-second chair stand will be taken prior to surgery and during follow-up visits (3-6 months and 12 months).
Blood samples: A blood sample will be requested at baseline, as well as at standard of care follow-up visits about 3-6 months and 12 months later during standard follow-up appointments. The study team will request blood samples again at approximately 2 years and 5 years post-surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Renal Cell Cancer (RCC) stage I-IV
- •Undergoing radical nephrectomy (entire kidney resection) or partial nephrectomy
- •Patients with or without prior systemic therapy for renal cell carcinoma and > 1 year from systemic therapy for other non-cutaneous malignancy
- •Cytoreductive nephrectomy (nephrectomy in the setting of limited metastatic disease)
排除标准
- •Does not consent to tissue collection
- •Patients with only an MRI abdomen/pelvis within 4 months of surgery will be excluded
- •Known biopsy-proven non-clear cell RCC
结局指标
主要结局
Percent of Scheduled Assessments Completed
时间窗: End of Participation (60-months post-surgery)
Feasibility of the study will be assessed by calculating a percentage of scheduled body composition, performance status measurements, performance status questionnaires and biospecimen collections completed.
次要结局
- Change in Muscle Mass(Pre-operative baseline, and at 3, 6, 12, 24, and 60 months post-surgery.)
- Change in Visceral Fat(Pre-operative baseline, and at 3, 6, 12, 24, and 60 months post-surgery.)
- Change in Functional Status(Pre-operative baseline, and at 3, 6, 12, 24, and 60 months post-surgery.)