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Trial Details
indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.
Request Number:
082240
ACTR Number:
ACTRN12607000452493
Trial Status:
Registered
Date Submitted:
27/08/2007
Date Registered:
10/09/2007
Page 1
Public title:
Prostate Cancer:The early detection and early diagnosis of Prostate Cancer
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Reason:
ANZCTR registration title:
The objective of the clinical trial is to compare findings achieved by traditional diagnostic procedures with those of the Medex Test in order to define specificity and accuracy of the Medex Test device as a diagnostic tool for early Prostate Cancer detection.
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UTN:
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Page 2
Health condition(s) or problem(s) studied:
Prostate Cancer
Condition category:
Condition code:
Cancer
Prostate
Page 3
Description of intervention(s) / exposure:
The Medex Test device is a non-invasive and radiation free diagnostic tool. It is used for the assessment of functional abnormalities of the Prostate by electronic evaluation of the dermal-visceral connections. The principle of the Medex Test is based on detecting the change in the electrical impedance of certain dermal-visceral zones (DVZs) due to the organ’s disease. The Medex Test take around 20 minutes to conduct and the duration of the trial period is one year.
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Intervention code:
Early detection / Screening
Comparator / control treatment:
Prostate Cancer Patients Prostate-specific Antigen (PSA) blood test. Digital Rectal Exam (DRE)
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Control group:
Active
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Page 4
Primary outcome:
The primary objective is to evaluate the sensitivity, specificity and total accuracy of the device, through its ability to accurately and effectively diagnose Prostate Cancer.
Timepoint:
Before traditional diagnostic method
Secondary outcome:
The secondary objective is to evaluate technical intra-device variability between Medex Test devices.
Timepoint:
After traditional diagnostic method
Page 5
Key inclusion criteria:
200 male patients with clinical symptoms of Prostate cancer and other related disorders.
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Minimum Age:
18
Years
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Maximum Age:
No limit
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Gender:
Males
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Healthy volunteers?
No
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Key exclusion criteria:
1.Amputees 2. Females 3.Local skin damage in areas of “Medex Test” examination. (i.e. hands and feet)
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Page 6
Study type:
Interventional
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Purpose of the study:
Diagnosis
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Allocation to intervention:
Nonrandomised trial
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Assignment:
Parallel
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Page 7
Phase
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Anticipated or actual date of first participant enrolement:
3/09/2007
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Target sample size:
200
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Recruitment status:
Terminated
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Page 8
Funding source:
Hospital
Name:
St Vincent's Hospital
Address:
406 Victoria St Darlinghurst, NSW 2010
Country:
Australia
Primary sponsor:
Hospital
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Name:
St Vincent's Hospital
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Address:
406 Victoria St Darlinghurst, NSW 2010
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Country:
Australia
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Secondary sponsor:
None
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Other collaborator:
Page 9
Has the study received approval from at least one ethics committee?
No
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Reason:
Ethics Committee name:
St Vincent's Hospital Human Research Ethics Committee (EC00140)
Address:
406 Victoria St Darlinghurst, NSW 2010
Country:
Australia
Date submitted/Date which intend to submit to ethics committee:
15/08/2007
Countries of recruitment:
Australia
Brief summary:
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Page 10
Contact person for public queries
Name:
Sandra Lazarus
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Address:
Level 4
Xavier Building
390 Victoria Street
Darlinghurst NSW 2010
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Country:
Australia
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Tel:
+61 2 83823379
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Fax:
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Email:
s_lazarus_@hotmail.com
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Contact person for scientific queries
Name:
David Dalley
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Address:
Level 4
Xavier Building
390 Victoria Street
Darlinghurst NSW 2010
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Country:
Australia
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Tel:
+61 2 83823379
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Email:
d.dalley@stvincents.org.au
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