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Sponsors and Collaborators: |
University of Manitoba Canadian Institutes of Health Research (CIHR) BioMark Technologies Inc. |
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Information provided by: | University of Manitoba |
ClinicalTrials.gov Identifier: | NCT00755898 |
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.
Condition | Intervention | Phase |
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Cancer |
Drug: Ingestion of a 200 mg dose of amantadine hydrochloride |
Phase II |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics Study |
Official Title: | Urinary Excretion of Acetylamantadine by Cancer Patients |
Enrollment: | 150 |
Study Start Date: | December 2003 |
Study Completion Date: | July 2008 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Patients with a medical diagnosis of cancer appearing at outpatient clinics for treatment and/or monitoring of their disease status
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Drug: Ingestion of a 200 mg dose of amantadine hydrochloride
Volunteer cancer patients ingest 2 x 100 mg tablets of amantadine hydrochloride with a glass of cold water 2 hours after supper.
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2: Active Comparator
Healthy adult volunteers
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Drug: Ingestion of a 200 mg dose of amantadine hydrochloride
Healthy subject ingests 2 x 100 mg tablets of amantadine hydrochloride with a glass of cold water 2 hours after supper
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Canada, Manitoba | |
University of Manitoba | |
Winnipeg, Manitoba, Canada, R3E 0W3 |
Principal Investigator: | Daniel S Sitar, PhD | University of Manitoba |
Responsible Party: | University of Manitoba ( Daniel S. Sitar, PhD ) |
Study ID Numbers: | B2003:089 |
Study First Received: | September 18, 2008 |
Last Updated: | September 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00755898 |
Health Authority: | Canada: Health Canada |
cancer diagnostic test urine amantadine acetylation |
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