Investigation of Peripheral Blood Biomarkers Associated With CIPN
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- Collection of blood samples, medical history, CIPN symptomology (via questionnaire) and clinical laboratory data for a correlative evaluation of potential CIPN related molecular and cellular variance (biomarkers).
研究概览
简要总结
The investigators are doing a research study that will teach us about the tingly pain that people develop when they get chemotherapy.
详细描述
The investigators are asking for a blood sample, information about patients symptoms during chemotherapy, and past medical history from people who have taken or will take certain types of chemotherapy. The investigators hope to examine blood for proteins that could help us learn which patients get neurological symptoms while getting chemotherapy. The investigators' main research goal is to improve the treatment of patients getting chemotherapy to help their quality of life and/or help to increase the chance of their cancer being cured.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
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
- •Diagnosis of a tumor for which Platinums, Vinca Alkaloids, Bortezomib or Taxanes are indicated
- •No prior history of diabetic, anatomical or regional neuropathies (except pre-existing CIPN)
- •Age ≥ 18 years
- •Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent.
排除标准
- •Inability to give consent
- •Inability to tolerate venipuncture for any reason
- •Age < 18 years
- •Any known medical, surgical or psychiatric condition that may interfere with the conduct of the study or be detrimental to the donor in the opinion of the PI or caring physician
- •Consent Refusal by patient
结局指标
主要结局
Collection of blood samples, medical history, CIPN symptomology (via questionnaire) and clinical laboratory data for a correlative evaluation of potential CIPN related molecular and cellular variance (biomarkers).
时间窗: 3 years
Variant S1P/S1PR related biomarkers; CIPN Questionnaire for Blood Collection Protocol (non-standardized questionnaire, 0-4 rating scales, 0 = no symptoms, 4 = very severe symptoms, symptoms: neuropathic pain severity/unpleasantness, sharpness, depth, tingling, numbness)
次要结局
未报告次要终点
研究者
Raymond C. Tait, PhD
Professor
St. Louis University