NCT07582770尚未招募不适用
Validation of Neuropsychological Tests for the Assessment of Cognitive Impairment in Breast Cancer Survivors
European Institute of Oncology1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2026年5月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
研究概览
简要总结
This study is a monocentric, observational, cross-sectional study with a case-control design, aimed at evaluating the construct validity, discriminative ability, and diagnostic accuracy of a second-level neuropsychological test battery for the detection of cancer-related cognitive impairment in breast cancer survivors.
详细描述
Participants will undergo a comprehensive neuropsychological assessment including both paper-and-pencil tests to be validated and their corresponding comparator instruments, in order to evaluate sensitivity, specificity, and convergent validity across multiple cognitive domains.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 65 years old
- •Patient with a previous documented diagnosis of non-metastatic breast cancer (only for breast cancer survivor gruop)
- •Patient has completed chemotherapy for at least 6 months and for a maximum of 36 months if planned (only for breast cancer survivor gruop)
- •Understanding of the Italian language and ability to give informed consent
排除标准
- •Presence of brain metastases or history of brain radiation therapy (only for breast cancer survivor gruop)
- •Patient with previous diagnosis of other malignant tumors in addition to breast cancer (only for breast cancer survivor gruop)
- •Patient with a previous diagnosis of malignant carcinomas (only for control gruop)
- •Patient with a history of brain damage with unresolved neurological consequences
- •Patient with previous or current serious neurological pathologies
- •Patient with severe psychiatric conditions
- •Patient with systemic pathologies that could interfere with cognitive abilities
- •Patient taking medications that have a strong cognitive impact and that have not been stabilized for at least 4 weeks prior to enrollment
- •Patient with visual or hearing impairments that are not properly corrected
- •Patient with any disability that might compromise the validity of cognitive tests
研究者
研究点 (1)
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