NCT07638007招募中不适用
Impact of Targeted Therapy on Cancer-Related Cognitive Impairment
University of Rochester NCORP Research Base1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2025年11月21日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
研究概览
简要总结
This study examines whether there are differences in brain health or well-being in patients receiving TKI therapy for leukemia compared to individuals who do not receive TKI therapy.
详细描述
PRIMARY OBJECTIVE:
I. Characterize differences in subjective CRCI longitudinally among patients receiving TKIs for CML or CLL.
OUTLINE: This is an observational study. Participants are assigned to 1 of 2 groups.
GROUP I: TKI recipients complete surveys, undergo cognitive assessments, undergo saliva sample collection, and have their medical records reviewed on study.
GROUP II: Cancer-free individuals complete surveys, undergo cognitive assessments, undergo saliva sample collection, and have their medical records reviewed on study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •TKI RECIPIENTS: Participants must have a diagnosis of CML or CLL
- •TKI RECIPIENTS: Participants must be scheduled to receive their first dose of TKI therapy for CML or CLL within 30 days or have received their first dose of TKI therapy for CML or CLL within the previous 30 days
- •TKI RECIPIENTS: Participants must be ≥ 18 years of age
- •TKI RECIPIENTS: Participants must be able to speak and read English
- •TKI RECIPIENTS: Participants must be able to understand and willing to sign an informed consent document
- •CANCER-FREE INDIVIDUALS SERVING AS CONTROLS: Participants must be ≥ 18 years of age
- •CANCER-FREE INDIVIDUALS SERVING AS CONTROLS: Participants must be able to speak and read English
- •CANCER-FREE INDIVIDUALS SERVING AS CONTROLS: Participants must be able to understand and willing to sign an informed consent document
- •CANCER-FREE INDIVIDUALS SERVING AS CONTROLS: Each participant must be matched to a TKI recipient participant based on sex and age ±5 years (i.e., must be no more than 5 years older or younger than the TKI recipient participant)
排除标准
- •Participants must have no history of metastatic cancer, primary brain tumor, or brain irradiation
- •Participants must have no history of TKI therapy
- •Participants must have no history of cytotoxic chemotherapy, immune checkpoint inhibitor therapy, hormonal therapy, biologic therapy, radiotherapy within the past 5 years. However, permitted treatments include prior use of hydroxyurea for the treatment of CML or CLL as well as treatment with obinutuzumab or rituximab concurrent with TKI therapy for CLL
- •Participants must have no history of stroke within the past year and no remaining cognitive symptoms from any stroke prior to the past year
- •Participants must have no history of head trauma with loss of consciousness within the year prior to consent
- •Participants must have no diagnosis of dementia or severe neurodegenerative disease impairing daily functioning
- •Participants must have no psychiatric condition that led to hospitalization within the past year
- •Participants must not be currently pregnant
- •Participants must not be colorblind based on self-report
- •Participants must not be study staff who have previously viewed or administered the objective cognitive function measures (e.g., CANTAB)
研究者
Michelle Janelsins, PhD, MPH
URCC Study Chair
University of Rochester NCORP Research Base
研究点 (1)
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