Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000031662
Ethics application status
Approved
Date submitted
19/07/2005
Date registered
22/07/2005
Date last updated
22/07/2005
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical trial of dermoscopy and digital monitoring in general practice
Scientific title
Crossover trial of dermoscopy and short-term digital monitoring for the management of skin lesions in general practice
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Suspicious pigmented skin lesions 94 0
Condition category
Condition code
Skin 115 115 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two instrumental interventions, dermoscopy (Heine Delta 10, Heine Ltd, Germany) and digital monitoring (SolarScan adapted instrument, Polartechnics Ltd, Sydney) will be used to examine pigmented skin lesions deemed suitable for excision by standard naked eye examination. 80 primary care physicians will be trained in the use of the instruments and will recruit on average 5 lesions/clinician over a 6 month period
Intervention code [1] 35 0
None
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 143 0
The number of skin lesions excised following dermoscopy, digital monitoring and the combined intervention
Timepoint [1] 143 0
Following dermoscopy, digital monitoring and the combined intervention
Secondary outcome [1] 316 0
The change in the confidence of the primary care physician in their diagnosis of the lesion.
Timepoint [1] 316 0
Before and after dermoscopy and digital monitoring.
Secondary outcome [2] 317 0
Satisfaction of the patients with their treatment.
Timepoint [2] 317 0

Eligibility
Key inclusion criteria
Patients with a suspicious pigmented skin lesion that the primary care physician would normally excise or refer to a specialist for diagnosis.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 158 0
Government body
Name [1] 158 0
NHMRC
Country [1] 158 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 115 0
University
Name [1] 115 0
University of Western Australia
Address [1] 115 0
Country [1] 115 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 905 0
University of Western Australia
Ethics committee address [1] 905 0
Ethics committee country [1] 905 0
Australia
Date submitted for ethics approval [1] 905 0
Approval date [1] 905 0
Ethics approval number [1] 905 0

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

Contacts
Principal investigator
Name 35693 0
Address 35693 0
Country 35693 0
Phone 35693 0
Fax 35693 0
Email 35693 0
Contact person for public queries
Name 9224 0
Dr Kiran Shahid
Address 9224 0
Department of General Practice
University of Western Australia
328 Stirling Highway
Claremont WA 6010
Country 9224 0
Australia
Phone 9224 0
+61 8 93219332
Fax 9224 0
+61 8 93846238
Email 9224 0
[email protected]
Contact person for scientific queries
Name 152 0
Assoc Prof Scott Menzies
Address 152 0
Faculty of Medicine
University of Sydney
Sydney Melanoma Diagnostic Centre
Royal Prince Alfred Hospital
Camperdown NSW 2050
Country 152 0
Australia
Phone 152 0
+61 2 95158537
Fax 152 0
+61 2 95155278
Email 152 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.