NCT05133947已完成不适用
A Clinical Study Examining Intraepidermal Nerve Fiber Density (IENFD) in Patients With Chemotherapy-induced Peripheral Neuropathy (CIPN) Compared With Healthy Subjects
Beijing 3E-Regenacy Pharmaceuticals Co., Ltd.1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2021年10月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- IENFD
研究概览
简要总结
This is a non-interventional study examining IENFD levels in patients with CIPN after taxane chemotherapy and in age-matched healthy subjects.
详细描述
This is a non-interventional study examining IENFD levels in patients with CIPN after taxane chemotherapy and in age-matched healthy subjects. After the subjects sign the informed consent, the study physicians will judge the inclusion and exclusion criteria. Subjects meeting the inclusion requirements will register at the study center according to the requirements of the study physicians, and skin samples will be collected by specialized researchers.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Received taxane adjuvant chemotherapy for breast cancer for curative purposes and completed chemotherapy before entering the study; Persistent peripheral neuropathy of the lower extremities;
- •CIPN Severity:
- •The presence of at least one of the following symptoms on both lower extremities in a gloved and sock glove pattern: pain or burning, numbness, or tingling.
- •Examination of the lower extremities showed needling loss of both legs; Neurological symptoms occur after exposure to taxane and cannot be attributed to any other neurological disease; NRS rating ≥ 4.
排除标准
- •Pregnant or lactating women. Presence of any neuropathy other than CIPN. According to the investigator's judgment, there are skin diseases in the affected skin area that may interfere with the evaluation of neuropathic pain symptoms, or diseases at the skin biopsy site that may affect the epidermal nerve morphology, or other factors.
- •The presence of non-CIPN pain may interfere with study evaluation and/or peripheral neuropathic pain self-assessment.
结局指标
主要结局
IENFD
时间窗: 2021.10~2022.6
IENFD change between CIPN patients and healthy subjects
次要结局
未报告次要终点
研究者
研究点 (1)
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