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临床试验/NCT00755898
NCT00755898已完成2 期

Urinary Excretion of Acetylamantadine by Cancer Patients

University of Manitoba1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2003年12月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

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

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

DanielSitar

Professor Emeritus

University of Manitoba

研究点 (1)

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