Moletest Clinical Study in Scotland

Completed

• Conditions: Melanoma

• Registration Number: NCT02196246
• Lead Sponsor: Moletest Scotland Ltd

Brief Summary

To evaluate an iPad based photoimage analysis system (Moletest) for improving discrimination of benign from malignant suspicious skin lesions or moles. Specifically the objective is to demonstrate that the Moletest system is able with a sufficient degree of confidence (95%) to identify lesions which are benign

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-17
• Study First Submitted QC: 2014-07-21
• Study First Posted: 2014-07-22
• Study Start: 2015-03-27
• Primary Completion: 2016-10-12
• Study Completion: 2017-05-31
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-01
• Last Update Posted: 2017-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1120

Inclusion Criteria

All patients referred to the Dermatology Department, Lanarkshire Hospitals during a period to be defined for assessment of suspicious skin lesions (cutaneous moles) will be eligible for inclusion in the study. There are no age limits but patients under the age of 18 years will also have their inclusion subject to parental/guardian consent

Exclusion Criteria

There is no exclsion criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical accuracy of Moletest application, the combined measured attributes of a suspect legion compared to the outcome of a biopsy performed on the legion	6 weeks turnaround for each sample	The image and analysis by the application are performed within 10 minutes of the patient giving consent to be part of this study. The biopsy that will be used for comarison with the image analysis will be available to the Investigators approximatly 6 weeks later

Trial Locations

Locations (1)

NHS Lanarkshire R&D; 🇬🇧 Airdrie, United Kingdom