ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12615000268549

Ethics application status

Approved

Date submitted

2/03/2015

Date registered

23/03/2015

Date last updated

26/06/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

Efficacy of Smartphone applications in diagnosing and detecting melanoma

Scientific title

For a patient with naevi, do smart phone applications when compared to diagnosis by gold standard histo-pathological report/dermatologist provide an effective way for individuals to self-detect melanoma.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1167-5675

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

melanoma

Condition category

Condition code

Cancer

Malignant melanoma

Cancer

Non melanoma skin cancer

Skin

Dermatological conditions

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Study of the efficacy of use of Dr Mole, Skinvision and Spotmole Plus smartphone applications in the self diagnosis of melanoma from images of naevi. Photos of naevi will be taken by smartphones. A dermatology consultation will determine if lesions are suspicious or benign. For patients with suspicious lesions, photos will be taken prior to the traditional dermatological intervention involving excision of the lesion. The smartphone photo's will be submitted to each of the smartphone applications for evaluation. The smartphone application evaluations will then be compared to the histo-pathological report and dermatologist diagnosis for suspect lesions, and to the dermatologist diagnosis for benign lesions (as no histo-pathological diagnosis will be available for benign lesions).

Intervention code [1]

Diagnosis / Prognosis

Comparator / control treatment

Histo-pathological report/Dermatologist diagnosis of naevi images

Control group

Active

Outcomes

Primary outcome [1]

Statistically significant results from analysis of outcomes of original image evaluations by the smartphone applications compared to gold standard histo-pathological reports/dermatologist diagnosis. Overall sensitivity, specificity, positive predictive value and negative predictive value for each application will be determined. McNemar chi-square test will be used to compare the respective sensitivities of the various smartphone applications. This is a composite primary outcome to determine the overall accuracy of the smartphone applications in detecting suspicious lesions.

Timepoint [1]

Primary timepoint is when the smartphone application evaluation of the smartphone naevi photo is compared to the gold standard histo-pathological report/dermatologist diagnosis of the same naevi

Secondary outcome [1]

Statistically significant results from analysis of outcomes of smartphone photo's taken from high quality printouts of original images (original smartphone photos of the actual naevi on the patient), with evaluations by the smartphone applications compared to gold standard histo-pathological report/dermatologist diagnosis. Overall sensitivity, specificity positive predictive value and negative predictive value for each application will be determined. McNemar chi-square test will be used to compare the respective sensitivities of the various smartphone applications. This is a composite secondary outcome to determine the overall accuracy of the smartphone applications for detecting suspicious lesions when using smartphone photos of high quality printouts of the original naevi photos (rather than the original naevi photos taken and used in Primary Outcome 1).

Timepoint [1]

High quality print outs of the original naevi photo's will be made. Smartphone photo's of these print outs will be taken and submitted to the smartphone applications for evaluation. These secondary photo evaluations by the smartphone applications with be compared to the gold standard histo-pathological report/dermatologist diagnosis of the same naevi.

Eligibility

Key inclusion criteria

Patients with suspected melanoma and/or clinically benign lesions

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

No suspected melanoma or clinically benign lesions

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

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Each of the applications will be presented with each skin lesion. Each result will be determined as positive, negative or unevaluable. The percentage of images presented to each application that are evaluable will be described. For each photo, we will assign the app a score of “correct” if it identified a melanoma as such, and “incorrect” if a melanoma received a different or benign diagnosis, using the histo-pathological reports as the gold standard. For benign lesions, the clinical diagnosis by a board certified dermatologist will be used as the gold standard. Histology and clinical diagnosis are both best clinical practice in each respective case and hence there is no confounding effect. We will assign a score of “correct” to benign lesions which were identified as such by the apps, and “incorrect” if it was given a higher grade of suspicion. Statistical analysis of these results will be performed using commercially available software. Overall sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) for each application will be determined for both real time imaging and photos taken later from printouts.
Within the study period we expect to be able to recruit 10 patients with a suspected melanoma and 20 patients with clinically benign lesions. Allowing for 10% of these lesions being unavailable for photographing due to exclusion criteria (lesions with uncertain histological diagnoses, Spitz nevi, pigmented spindle cell nevus of Reed and other uncommon or potentially ambiguous lesions), this will leave 9 melanomas and 18 benign lesions for evaluation. This estimated number of suitable lesions for evaluation will allow an estimation of sensitivity with a confidence interval of 95%. We will use McNemar chisquare test to compare the respective sensitivities of the various apps. All statistical significance will be accepted at p<0.05.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

26/03/2015

Actual

2/04/2015

Date of last participant enrolment

Anticipated

Actual

12/07/2016

Date of last data collection

Anticipated

Actual

12/07/2016

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Princess Alexandra Hospital - Woolloongabba

Recruitment postcode(s) [1]

4102 - Woolloongabba

Funding & Sponsors

Funding source category [1]

University

Name [1]

Dermatology Research Centre, School of Medicine, University of Queensland

Address [1]

Translational Research Institute (TRI)
37 Kent St,
Woolloongabba, QLD, 4102

Country [1]

Australia

Primary sponsor type

University

Name

Dermatology Research Centre, School of Medicine, University of Queensland

Address

Translational Research Institute (TRI)
37 Kent St,
Woolloongabba, QLD, 4102

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Metro South Human Research Ethics Committee

Ethics committee address [1]

Centres for Health Research
Lvl 7, Translational Research Institute,
37 Kent St,
Woolloongabba, QLD, 4102

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

02/10/2014

Ethics approval number [1]

HREC/14/QPAH/473

Ethics committee name [2]

University of Queensland Institutional Human Research Ethics Committee

Ethics committee address [2]

University of Queensland
UQ Research and Innovation
Cumbrae-Stewart Building,
St Lucia, QLD, 4072

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

13/10/2014

Ethics approval number [2]

2014001372

Summary

Brief summary

This study aims to determine whether the smartphone applications for skin screening are effective at providing an accurate diagnosis of melanoma.
Who is it for?
You may be eligible to join this study if you are aged 18 years or above and have a suspected melanoma and/or clinically benign skin lesion.
Study details.
The accuracy of smartphone applications will be tested by taking photos of the skin lesions and comparing the smartphone applications evaluation against the histological gold standard diagnosis by a dermatologist.
If the study shows that these applications are accurate, this will allow greater acceptance of them for medical use.  If inaccurate, it will raise concerns about the need for regulation of these applications due to the health risk posed.

Trial website

Trial related presentations / publications

Alex Ngoo, Anna Finnane, Jean-Marie Tan, Monika Janda, H. Peter Soyer. 'The Efficacy of smartphone applications in detecting melanoma. Asia-pacific combined dermatology research conference 2016 – poster presentation

Alex Ngoo. 'The efficacy of smartphone applications in detecting melanoma'. 2nd Global advances and controversies in skin cancer 2015 – oral presentation

Alex Ngoo. 'The efficacy of smartphone applications in detecting melanoma'.UQ undergraduate research conference 2015 – oral presentation

Public notes

Contacts

Principal investigator

Name

Prof H. Peter Soyer

Address

Dermatology Research Centre
Level 5, Translational Research Institute
37 Kent St,
Woolloongabba, QLD, 4102

Country

Australia

Phone

+61 07 3443 8017

Fax

p.soyer@uq.edu.au

Contact person for public queries

Name

Elizabeth Payne

Address

Dermatology Research Centre
Level 5, Translational Research Institute
37 Kent St,
Woolloongabba, QLD, 4102

Country

Australia

Phone

+61 07 3443 7397

Fax

e.payne@uq.edu.au

Contact person for scientific queries

Name

Elizabeth Payne

Address

Dermatology Research Centre
Level 5, Translational Research Institute
37 Kent St,
Woolloongabba, QLD, 4102

Country

Australia

Phone

+61 07 3443 7397

Fax

e.payne@uq.edu.au

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

Source	Title	Year of Publication	DOI
Dimensions AI	Efficacy of smartphone applications in high-risk pigmented lesions	2017	https://doi.org/10.1111/ajd.12599

N.B. These documents automatically identified may not have been verified by the study sponsor.

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