A cost-benefit analysis of the use of reflectance confocal microscopy (RCM) in dermatological clinical practice

A cost-benefit analysis of the use of reflectance confocal microscopy (RCM) in dermatological clinical practice on patients from within a dermatology outpatient clinic

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12617000256370

Acronym

RCM-CBA

Enrollment

177

Registered

2017-02-20

Start date

2017-04-06

Completion date

2018-05-11

Last updated

2018-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Diagnosis

Masking

Blinded (masking used) (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Healthy volunteers

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.

Exclusion criteria

Hyperkeratotic skin lesions. Patients who are unable to consent for themselves. Patients who are unable to mobilise onto the bed for imaging.

Outcome results