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Urinary Excretion of Acetylamantadine by Normal Healthy Volunteers

NCT01467258 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2013-07-29

No results posted yet for this study

Summary

Amantadine appears to be a specific substrate for acetylation by spermidine/spermine N1-acetyltransferase (SSAT). SSAT activity in cancer cells is higher by several-fold compared to normal cells. Amantadine can be used to determine SSAT cellular activity, and may indicate the presence of cancer.

This study will provide additional information in conjunction with data from a previous study which include cancer patients and normal health age matched controls to determine whether urinary excretion of acetylamantadine is predictive for the presence of cancer, and if so whether excretion of this metabolite is associated with any particular site of the tumor. Based on the results of the first study additional data in normal healthy volunteers is required.

The data from both studies will be analyzed to account for subject gender, stage of disease at time of testing, concurrent diseases, alcohol and tobacco use and occupational characteristics. This is an important first step in validating a cancer detection method that can be implemented economically for screening of large numbers of people at sites remote from limited and expensive diagnostic instrumentation. Thus there is a possibility that this design can be prognosis biomarker as well as a positive/negative indicator.

Conditions

  • Healthy Metabolism

Interventions

DRUG

Amantadine

Single dose

Sponsors & Collaborators

  • St. Boniface Hospital

    collaborator OTHER

  • University of Manitoba

    lead OTHER

Principal Investigators

  • Bram Ramjiawan, Ph.D. · St. Boniface Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01467258 on ClinicalTrials.gov