NCT05014399招募中不适用
Cognitive Impairment in Colorectal Cancer Patients Receiving Cytotoxic Chemotherapy
Joseph McCollom1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年9月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Survey
研究概览
简要总结
The purpose of this research study is to see how the brain changes in patients receiving chemotherapy (cytotoxic drug) treatment for colon or rectal cancer at Parkview Cancer Institute. This information will be used to identify helpful tests to diagnose individuals at risk for developing difficulties with thinking and memory due to their cancer treatments.
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
- •Signed written informed consent must be obtained and documented according to International Conference on Harmonisation (ICH)- Good Clinical Practice (GCP), the local regulatory requirements, and permission to use private health information in accordance with the Health Insurance Portability and Accountability Act (HIPAA) prior to study-specific screening procedures. Must be able to provide study-specific informed consent prior to study entry.
- •A histologically-confirmed colorectal tumor
- •Patients who will be treated with cytotoxic chemotherapies including Capecitabine, Oxaliplatin, 5 fluorouracil, and Irinotecan are eligible.
- •Patients must not have received cytotoxic chemotherapy previous to enrollment.
排除标准
- •Prior administration of anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents
- •Patients having mental incompetence as assessed by study PI, which would hinder completion of the surveys
- •Pregnant or breastfeeding
- •Any known brain metastases
- •Non-English speaking patients
- •Patients who have been diagnosed with any neuro-cognitive disorder including traumatic brain injuries, Alzheimer's disease, Parkinson's disease, Huntington's disease, and Creutzfeldt-Jakob disease.
- •Patients deemed inappropriate to participate in this study by the study PI or coordinator will be excluded.
结局指标
主要结局
Survey
时间窗: 7 Years
FACT-Cog V3
The Proteome Profiler Human XL Cytokine Array Kit (https://www.rndsystems.com/products/proteome-profiler-human-xl-cytokine-array-kit_ary022b)
时间窗: 7 years
This panel of plasma factors will be will be used to detect protein from the blood of patients throughout and after chemotherapy treatment.
次要结局
未报告次要终点
研究者
Joseph McCollom
Oncologist
Parkview Health
研究点 (1)
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