Urinary Excretion of Acetylamantadine by Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Amount of N-acetylamantadine excreted in a 12 hour urine sample collected after a single oral dose of amantadine hydrochloride ingested two hours after supper
研究概览
简要总结
The investigators have determined that the drug amantadine hydrochloride is metabolized by acetylation by a specific enzyme named spermidine/spermine N-acetyltransferase (SSAT). This enzyme is increased in cancer cells. The investigators hypothesized that the amount of N-acetylamantadine excreted in urine during the first 12 hours after an oral dose would serve as a diagnostic biomarker for the presence of cancer in a human test subject.
详细描述
When patients present to their physician with symptoms of cancer at a later stage of development, survival tends to be poorer. Earlier diagnosis of cancer is expected to provide improved survival of patients due to earlier treatment intervention. However, implementation of this screening process is impaired by access and by cost. A simple and inexpensive test would serve as a screening tool that could be safely repeated at regular intervals to identify persons for whom more expensive and less accessible diagnostic investigations might become more appropriately directed. The specificity for an enzyme that increases markedly in cancer tissue, and the ease of administration of an already licensed pharmaceutical prescription product, amantadine hydrochloride, would appear to provide promise of such a desirable screening test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Either a medical diagnosis of cancer, or determination of general good health after a medical check-up within two weeks of participation in the study
排除标准
- •Allergy to amantadine hydrochloride
- •Chronic liver or kidney disease
- •Chronic disease state not controlled by drug therapy, e.g. hypertension
- •Pregnancy
研究组 & 干预措施
1
Patients with a medical diagnosis of cancer appearing at outpatient clinics for treatment and/or monitoring of their disease status
干预措施: Ingestion of a 200 mg dose of amantadine hydrochloride (Drug)
2
Healthy adult volunteers
干预措施: Ingestion of a 200 mg dose of amantadine hydrochloride (Drug)
结局指标
主要结局
Amount of N-acetylamantadine excreted in a 12 hour urine sample collected after a single oral dose of amantadine hydrochloride ingested two hours after supper
时间窗: 12 hours
次要结局
未报告次要终点
研究者
DanielSitar
Professor Emeritus
University of Manitoba
