Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2025-12-24 @ 9:43 PM
NCT ID:
NCT04385732
Brief Summary:
This randomised controlled trial will investigate the role of melanoma surveillance photography (MSP) in the surveillance of patients at high or ultra-high risk of melanoma. MSP is a comprehensive method of melanoma monitoring which includes total body photography and digital dermoscopy which is performed at prescribed intervals. The study will test whether participants under surveillance with MSP have less unnecessary biopsies (false positives) compared to those without MSP. Participants will be Australian residents with a new diagnosis of primary melanoma, who have multiple naevi and are at high or ultra-high risk of developing melanoma. Participants will be randomised 1:1 to either groups.
It is hypothesised that those randomised to surveillance with MSP will have better patient outcomes. Improved diagnostic performance as measured by the number of unnecessary biopsies will be the primary outcome measure.
Detailed Description:
The primary aim is to test whether melanoma surveillance with MSP, comprising either 2D or 3D TBP tagged with digital dermoscopy, compared to clinical surveillance without MSP, results in improved diagnostic performance, specifically reduced number of unnecessary biopsies (i.e. false positives due to an excision or biopsy of a lesion being performed to diagnose melanoma and that lesion being identified on pathology as benign), in high (and very high) risk individuals whose risk is contributed to by high naevus counts.
The secondary aims are to:
1. Evaluate whether MSP:
1. Results in improved sensitivity of doctors' diagnosis of melanoma (i.e. reduction in false negatives)
2. Improves health-related quality of life, patient satisfaction, and reduces patient anxiety
3. Reduces costs to patients and health care system
2. Evaluate the safety and acceptability of MSP
3. Evaluate benefit of MSP in high risk patients prior to a primary melanoma diagnosis (Sub-study 1)
4. Evaluate diagnostic performance of tele-dermatology compared to en-face clinical visits (Sub-study 2).
Investigators hypothesise that for ultra-high and high risk patients with multiple naevi, clinical surveillance with melanoma surveillance photography (compared to without MSP) will lead to better patient outcomes, in particular a reduction in the number of unnecessary biopsies (i.e. false positives) as a measure of diagnostic performance. Secondary hypotheses include that for ultra-high, and high risk patients with multiple naevi, clinical surveillance with MSP (compared to without MSP) will lead to:
1. Reduction in the number of misclassified melanoma malignancies (i.e. false negatives);
2. Reduction in the number of misclassified melanocytic and keratinocyte lesions combined;
3. Improved quality of life; and
4. Favourable health economic outcomes.
Study:
NCT04385732
Study Brief:
Protocol Section:
NCT04385732