Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12617000256370
Ethics application status
Approved
Date submitted
15/02/2017
Date registered
20/02/2017
Date last updated
28/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A cost-benefit analysis of the use of reflectance confocal microscopy (RCM) in dermatological clinical practice
Scientific title
A cost-benefit analysis of the use of reflectance confocal microscopy (RCM) in dermatological clinical practice on patients from within a dermatology outpatient clinic
Secondary ID [1] 290556 0
None
Universal Trial Number (UTN)
U1111-1189-9413
Trial acronym
RCM-CBA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Skin cancer 300999 0
Condition category
Condition code
Cancer 300795 300795 0 0
Malignant melanoma
Cancer 300796 300796 0 0
Non melanoma skin cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Reflectance confocal microscopy (RCM) imaging will be performed on patients who were already planned to have a skin biopsy, prior to having the biopsy. The imaging takes from 5-30mins. The patient will have a small amount of oil applied to their skin and then have either a hand-help device pressed against their skin or have a metal ring stuck their skin with a imaging head then attached to this. The imaging and analysis will be performed by a sub-specialised dermatology consultant in a once off intervention occurring in the outpatient dermatology department of the Princess Alexandra Hospital, a tertiary public teaching hospital
Intervention code [1] 296420 0
Diagnosis / Prognosis
Comparator / control treatment
A skin biopsy (the current gold standard in skin cancer diagnosis) will be performed on every lesion imaged. The biopsy and images will be analysed independently and blinded to the result of the other/
Control group
Active

Outcomes
Primary outcome [1] 300212 0
The comparison between the number of biopsies required to make a diagnosis with and without RCM imaging.
This outcome will be measured by comparing the difference between the real management plan and the hypothetical management plan based on RCM imaging.
Timepoint [1] 300212 0
7 days after intervention
Primary outcome [2] 300213 0
The difference in money required to perform the hypothetical management based on the RCM imaging compared to the actual management that occured.
Timepoint [2] 300213 0
7 days after the biopsy
Primary outcome [3] 300214 0
The difference in patient comfort between RCM imaging and having a biopsy through using a questionnaire specifically designed for this study.
Timepoint [3] 300214 0
Collected via a questionaire. To be finalised on day of biopsy and imaging
Secondary outcome [1] 329410 0
Comparison of the diagnostic accuracy RCM imaging compared to that of a skin biopsy. This is be measured through the comparing the diagnosis based on a blinded RCM analysis report and the diagnosis according to the current gold standard, skin biopsy.
Timepoint [1] 329410 0
7 days after biopsy when the pathology results are finalised
Secondary outcome [2] 329487 0
Determining the amount of money a patient would be willing to spend to have RCM imaging through the use of a questionnaire especially designed for this study
Timepoint [2] 329487 0
A questionnaire will be completed on the day after the RCM imaging and biopsy has been completed.

Eligibility
Key inclusion criteria
Patients who have been identified during their routine dermatological appointment to require a skin biopsy of a lesion suspicious for either melanoma or basal cell carcinoma.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Hyperkeratotic skin lesions.
Patients who are unable to consent for themselves.
Patients who are unable to mobilise onto the bed for imaging.

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
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
200 patients. Statistician calculated this based on meta-analysis of RCM sensitivity and specificity.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/03/2017
Actual
6/04/2017
Date of last participant enrolment
Anticipated
26/07/2018
Actual
11/05/2018
Date of last data collection
Anticipated
26/07/2018
Actual
11/05/2018
Sample size
Target
200
Accrual to date
Final
177
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 6955 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 14645 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 295009 0
Government body
Name [1] 295009 0
Queensland Health
Country [1] 295009 0
Australia
Primary sponsor type
Hospital
Name
Princess Alexandra Hospital
Address
Dermatology department
Princess Alexandra Hospital
199 Ipswich Rd
Woollongabba 4102
QLD
Country
Australia
Secondary sponsor category [1] 293827 0
None
Name [1] 293827 0
Address [1] 293827 0
Country [1] 293827 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296953 0
Metro South
Ethics committee address [1] 296953 0
Princess Alexandra Hospital, Metro South Health

Metro South Hospital and Health Service, Queensland Government

Level 7 TRI, 37 Kent Street WOOLLOONGABBA QLD 4102

Ethics committee country [1] 296953 0
Australia
Date submitted for ethics approval [1] 296953 0
17/11/2016
Approval date [1] 296953 0
11/01/2017
Ethics approval number [1] 296953 0
HREC/16/QPAH/790

Summary
Brief summary
The aim of this study is determine what benefits and costs are associated with integrating Reflectance confocal microscopy (RCM) imaging into dermatological clinical practice.

Who is it for?
You may be eligible to join this study if you have been identified during the routine dermatological appointment to require a skin biopsy of a lesion suspicious for either melanoma or basal cell carcinoma.

Study details
The study involves a one-off patient visit that will be incorporated within their standard dermatology visit. During the study visit reflectance confocal imaging will be performed on any lesion which has been identified as requiring a biopsy. Skin biopsy will be performed for every imaged lesion. Participants will also be asked to complete a questionnaire reflecting on their experience of both RCM imaging and having a biopsy, their previous skin cancer history and treatments and their willingness to pay for the service.

Overseas centres have analysed the benefit of integrating RCM in clinical practice, however, to date there has not been a study done in Australia to assess this. As the Australian health system, and particularly the public dermatological service, differs from other countries, it will be beneficial to study the specific benefits of using RCM imaging within the clinical practice of a Queensland public hospital dermatology department.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70530 0
Dr Claudia Curchin
Address 70530 0
Dermatology Dept
Princess Alexandra Hospital
199 Ipswich Rd
Woollongabba 4102
QLD
Country 70530 0
Australia
Phone 70530 0
+61 731767674
Fax 70530 0
+61731767344
Email 70530 0
[email protected]
Contact person for public queries
Name 70531 0
Dr Claudia Curchin
Address 70531 0
Dermatology Dept
Princess Alexandra Hospital
199 Ipswich Rd
Woollongabba 4102
QLD
Country 70531 0
Australia
Phone 70531 0
+61 731767674
Fax 70531 0
+61 731767344
Email 70531 0
[email protected]
Contact person for scientific queries
Name 70532 0
Dr Claudia Curchin
Address 70532 0
Dermatology Dept
Princess Alexandra Hospital
199 Ipswich Rd
Woollongabba 4102
QLD
Country 70532 0
Australia
Phone 70532 0
+61 731767674
Fax 70532 0
+61 731767344
Email 70532 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.