Taxane Induced Peripheral Neuropathy in Chinese Patients With Breast Cancer
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences
临床试验: NCT04068090
BioSeek: nct04068090
关键词
抽象
The purpose of this study is to collect clinical data, blood samples, and self reported symptoms of peripheral neuropathy from Chinese patients with breast cancer after treatment with taxanes. This data will be used to develop predictive markers for neuropathy.
日期
| 最后验证: | 02/29/2020 |
| 首次提交: | 08/14/2019 |
| 提交的预估入学人数: | 08/22/2019 |
| 首次发布: | 08/27/2019 |
| 上次提交的更新: | 03/25/2020 |
| 最近更新发布: | 03/29/2020 |
| 实际学习开始日期: | 08/22/2019 |
| 预计主要完成日期: | 11/30/2020 |
| 预计完成日期: | 11/30/2020 |
状况或疾病
Breast Cancer
干预/治疗
Other: Patient Questionnaires
Other: Blood Collection
相
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手臂组
| 臂 | 干预/治疗 |
|---|---|
| Patients with CIPN Patients with peripheral neuropathy after treatment with taxanes | |
| Patients without CIPN Patients treated with taxanes and don't develop will be enrolled to this cohort and matched to a specified subject with neurotoxicity based on age, tumor stage, chemotherapy regimen or total taxane dosage |
资格标准
| 有资格学习的年龄 | 16 Years 至 16 Years |
| 有资格学习的性别 | Female |
| 取样方式 | Non-Probability Sample |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Diagnosis of breast cancer - Females aged 16 and older - Planning to receive or previous treated with taxanes Exclusion Criteria: - Poorly controlled or insulin-dependent diabetes or other condition likely to predispose to neurotoxicity |
结果
主要结果指标
1. Total score from the FACT-GOG-Ntx questionnaire [Up to 2 years]
Total score from the FACT-GOG-Ntx questionnaire for peripheral neuropathy, ranging from 0-44,higher value represents a worse outcome
次要成果指标
1. Predictive value of genetic variants for the development of neuropathy [In the two weeks before start treatment]
SNPs related to peripheral neuropathy
2. Total score from the EORTC QLQ - CIPN20 questionnaire [Up to 2 years]
Total score from the EORTC QLQ - CIPN20 questionnaire for peripheral neuropathy, ranging from 20-80,higher value represents a worse outcome
