Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000450011
Ethics application status
Approved
Date submitted
25/05/2010
Date registered
2/06/2010
Date last updated
2/06/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Use of bifocal scanning (Vivascope, trademark [TM]) versus tissue biopsy in diagnosis of skin cancers
Scientific title
Assessment of Reflectance Confocal Microscopy in
the Diagnosis of Non-Melanoma Skin Cancer and Benign
Lesions Versus Normal Skin: Observer-Blinded Evaluation by
Surgeons and Pathologists
Secondary ID [1] 251859 0
None
Universal Trial Number (UTN)
U1111-1115-1217
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Melanoma skin Cancer 257459 0
Condition category
Condition code
Skin 257606 257606 0 0
Dermatological conditions
Cancer 257649 257649 0 0
Non melanoma skin cancer

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Use of Confocal reflectance Microscopy in diagnosis of Non-melanoma skin cancers as compared to histological diagnosis
1-Confocal micrscopy involves a 10 to 25 minute session, where an adherent probe is placed over the lesion of interest. The operator of the microscope then proceeds to generate images of the lesion. This can take anything from 10 to 25 minutes, depending on the size of the lesion. At the end of the session the probe is removed. No sensation other than slight pressure from the weight of the probe will be felt by the patient.
2-All participant will have a confocal imaging of their skin lesion, prior to having the lesion removed, either by biopsy or by excision.
Intervention code [1] 256549 0
Not applicable
Comparator / control treatment
Histological evaluation of tissue samples after excision or biopsy, which typically takes 4 to 5 working days. The histological evaluation is carried out by a pathologist blind to the findings of the confocal imaging.
Control group
Active

Outcomes
Primary outcome [1] 258519 0
Comparability of Confocal Reflectance Microscopy to Histopathology
This will be evaluated by use of sensitivity, specificity, and negative predictive value calculations. The aim of the calculations is to determine if there is comparability between histology and confocal diagnoses.
Timepoint [1] 258519 0
Immediate
Secondary outcome [1] 264332 0
Positive predictive value of Confocal Reflectance Microscopy in determining margins of spread of skin malignancies
Assessed through calculation of positive predictive value of confocal imaging, as compared to histology (gold standard).
Timepoint [1] 264332 0
Immediate

Eligibility
Key inclusion criteria
All patients referred to Plastic and Reconstructive Surgery Department of Royal Adelaide Hospital or The Queen Elizabeth Hospital for excision, excisional biopsy, or biopsy of non-melanoma skin lesion who are willing to participate in the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients not willing to participate in the study,
patients not able to understand the study information,
patients under the age of 18

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/04/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257046 0
University
Name [1] 257046 0
University of Adelaide
Country [1] 257046 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
North Terrace
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 256304 0
University
Name [1] 256304 0
University of Adelaide
Address [1] 256304 0
North Terrace
Adelaide SA 5000
Country [1] 256304 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259056 0
Royal Adelaide Hospital Human Research Ethics Committee
Ethics committee address [1] 259056 0
North Terrace
Adelaide SA 5000
Ethics committee country [1] 259056 0
Australia
Date submitted for ethics approval [1] 259056 0
Approval date [1] 259056 0
04/03/2009
Ethics approval number [1] 259056 0
090301
Ethics committee name [2] 259057 0
The Queen Elizabeth Hospital Human Research Ethics Committee
Ethics committee address [2] 259057 0
28 Woodville Road
Woodville South SA 5011
Ethics committee country [2] 259057 0
Australia
Date submitted for ethics approval [2] 259057 0
Approval date [2] 259057 0
04/09/2009
Ethics approval number [2] 259057 0
2009127

Summary
Brief summary
Purpose of the study is to determine the place, if any, of bifocal tissue scanning in diagnosis of skin cancers as compared to tissue biopsy. We hope to determine if a) there is a better and easier way of diagnosis of skin lesion other than biopsy and b) if there is a reliable method of determining the limits of spread of the skin lesion to reduce the need for repeated surgeries.
Trial website
Trial related presentations / publications
- Use of Confocal Laser Microscopy in in vivo Management of Skin Lesions, Royal Australasian College of Surgeons (RACS) Annual Scientific Conference (ASC), 6 May 2010, Perth, Australia
- M Amjadi, B Coventry; Use of Confocal Laser Microscopy in in vivo Management of Skin Lesions, ANZ Journal of Surgery, 2010; 80 (Suppl. 1) : A62
Public notes

Contacts
Principal investigator
Name 31218 0
Address 31218 0
Country 31218 0
Phone 31218 0
Fax 31218 0
Email 31218 0
Contact person for public queries
Name 14465 0
Dr Mahyar Amjadi
Address 14465 0
Royal Adelaide Hospital
North Terrace
Adelaide, SA 5000
Country 14465 0
Australia
Phone 14465 0
+61 8 82224000
Fax 14465 0
Email 14465 0
[email protected]
Contact person for scientific queries
Name 5393 0
Dr Mahyar Amjadi
Address 5393 0
Royal Adelaide Hospital
North Terrace
Adelaide, SA 5000
Country 5393 0
Australia
Phone 5393 0
+61 8 82224000
Fax 5393 0
Email 5393 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.