Five-year follow-up of participants in a randomised controlled trial examining the management of suspicious pigmented lesions in primary care
Problem
From 2008-2010 a randomised controlled trial was conducted to assess the effect of adding a diagnostic tool, the MoleMate system (SIAscopy with primary care scoring algorithm), to best practice for the management of suspicious pigmented lesions in primary care. 1297 participants (1580 lesions) were randomised to the trial, with 36 melanomas diagnosed. We have now conducted a 5-year follow-up to identify all new cases of skin cancers among trial participants.
Approach
Cancer Registry data was obtained to assess the histology and site of new skin cancer diagnoses among trial participants until March 2015. This was compared to outcome data from the trial.
Findings
Twenty trial participants were diagnosed with 24 new skin cancers in the five years following their trial participation; 6 melanomas and 18 non-melanotic skin cancers (13 basal cell carcinomas, BCC; 5 squamous cell carcinomas, SCC). Of the six newly diagnosed melanomas, five were diagnosed in different anatomical locations to the trial lesion (control group 3, intervention group 2), while one was diagnosed at the same site as the trial lesion (control group). This participant had taken an alternative follow-up route (non-protocol) for their lesion, where the melanoma was subsequently identified: this case could represent a single ‘missed diagnosis’ within the trial. The 18 non-melanotic skin cancers identified during the follow-up period were all in different locations to the trial lesions; 13 BCCs (control group 9, intervention group 4), 5 SCCs (control group 3, intervention group 2).
Consequences
Our follow-up data indicate that lesions were appropriately managed within the trial where the protocol was followed. The results highlight the importance of encouraging all patients to regularly appraise their skin and consult promptly with changes, particularly those at higher risk following skin cancer treatment.