Efficacy of Smartphone applications in diagnosing and detecting melanoma

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000268549
• Date of registration: 23/03/2015
• Prospective Registration: Yes
• Primary sponsor: Dermatology Research Centre, School of Medicine, University of Queensland
• 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.
• Date of first enrolment: 02/04/2015
• Target sample size: 30
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12615000268549.aspx
• Study type: Interventional
• Study design: Purpose: Diagnosis; Allocation: Non-randomised trial;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Mrs Elizabeth Payne

• Name: Mrs Elizabeth Payne

Key inclusion & exclusion criteria

Inclusion criteria: Patients with suspected melanoma and/or clinically benign lesions
Exclusion criteria: No suspected melanoma or clinically benign lesions

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

melanoma;
melanoma

Cancer - Non melanoma skin cancer

Skin - Dermatological conditions

Cancer - Malignant melanoma

Intervention(s)

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).

Primary Outcome(s)

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.[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(s)

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).[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.]

Secondary ID(s)

Nil

Source(s) of Monetary Support

Dermatology Research Centre, School of Medicine, University of Queensland

Ethics review

Status: Approved
Approval date:
Contact:

Metro South Human Research Ethics Committee

Status: Approved
Approval date:
Contact:

University of Queensland Institutional Human Research Ethics Committee