Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000452493
Ethics application status
Not yet submitted
Date submitted
27/08/2007
Date registered
10/09/2007
Date last updated
10/09/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prostate Cancer:The early detection and early diagnosis of Prostate Cancer
Scientific 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.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 2301 0
Condition category
Condition code
Cancer 2398 2398 0 0
Prostate

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 2019 0
Early detection / Screening
Comparator / control treatment
Prostate Cancer Patients
Prostate-specific Antigen (PSA) blood test.
Digital Rectal Exam (DRE)
Control group
Active

Outcomes
Primary outcome [1] 3300 0
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 [1] 3300 0
Before traditional diagnostic method
Secondary outcome [1] 5497 0
The secondary objective is to evaluate technical intra-device variability between Medex Test devices.
Timepoint [1] 5497 0
After traditional diagnostic method

Eligibility
Key inclusion criteria
200 male patients with clinical symptoms of Prostate cancer and other related disorders.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1.Amputees 2. Females 3.Local skin damage in areas of “Medex Test” examination. (i.e. hands and feet)

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
3/09/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2556 0
Hospital
Name [1] 2556 0
St Vincent's Hospital
Country [1] 2556 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital
Address
406 Victoria St
Darlinghurst, NSW 2010
Country
Australia
Secondary sponsor category [1] 2315 0
None
Name [1] 2315 0
Address [1] 2315 0
Country [1] 2315 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 4482 0
St Vincent's Hospital Human Research Ethics Committee (EC00140)
Ethics committee address [1] 4482 0
Ethics committee country [1] 4482 0
Australia
Date submitted for ethics approval [1] 4482 0
15/08/2007
Approval date [1] 4482 0
Ethics approval number [1] 4482 0
07/SVH/27

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28009 0
Address 28009 0
Country 28009 0
Phone 28009 0
Fax 28009 0
Email 28009 0
Contact person for public queries
Name 11166 0
Sandra Lazarus
Address 11166 0
Level 4
Xavier Building
390 Victoria Street
Darlinghurst NSW 2010
Country 11166 0
Australia
Phone 11166 0
+61 2 83823379
Fax 11166 0
Email 11166 0
[email protected]
Contact person for scientific queries
Name 2094 0
David Dalley
Address 2094 0
Level 4
Xavier Building
390 Victoria Street
Darlinghurst NSW 2010
Country 2094 0
Australia
Phone 2094 0
+61 2 83823379
Fax 2094 0
Email 2094 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.