Cutaneous Melanoma
Conditions
Keywords
diagnostic accuracy, number needed to excise, reflectance confocal microscopy, histopathology, dermoscopy, early diagnosis
Brief summary
The incidence of cutaneous melanoma (MM) is increasing worldwide. The best therapeutical solution for MM is early diagnosis and efforts over the last 50 years have been directed towards early and precise diagnoses. Dermoscopy has improved diagnostic accuracy compared to the naked eye, but is limited by an associated higher number of unnecessary excisions. Reflectance confocal microscopy (RCM) is a novel technique enabling in vivo examination of the skin at cellular-level resolution, with excellent diagnostic accuracy. This study hypothesis is that the systematic application of RCM in the triage and management of patients suspicious for skin cancer, may improve diagnostic accuracy and reduce the number of unnecessary biopsy. Reducing the burden of unnecessary surgery excisions should benefit the health system, both in saving surgical and pathology procedural associated costs and reducing the overwhelming waiting lists for excisions and consequent risk for delayed diagnoses.
Interventions
DEVICEClinical, dermoscopy and Reflective confocal microscopy evaluations
Adjunctive reflective confocal microscopy to dermoscopy and clinical dermatological evaluation.
DEVICEClinical, dermoscopy evaluations
Dermoscopy and clinical dermatological evaluation only
Sponsors
Azienda Ospedaliero-Universitaria di Modena
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Caregiver)
Masking description
Randomisation of patients to Arm 1 (with RCM evaluation) or Arm 2 (without RCM evaluations) was performed following clinical and dermoscopy evaluation, and was only revealed to the clinician at presentation of RCM evaluation request.
Intervention model description
A two-arm prospective, multi-center study of the triage of patients with equivocal skin lesions suspicious for melanoma, compared with the standard of care (i.e. clinical and dermoscopic examination). A 1:1 randomization into the interventional or control arms occurred at the time of enrolment. Arm 1 (interventional) included lesions that were evaluated with RCM with management decisions taken according with overall information (2 possible outcomes: excision or digital monitoring. Arm 2 (control) included lesions that were not evaluated with RCM, with management decisions taken according to clinical and dermoscopy evaluations only (2 possible outcomes: excision or follow-up).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Patient's with at least 1 unequivocal lesion following standard of care (clinical and dermoscopy evaluations), \>= 18 years old
Exclusion criteria
* (i) the presence of an unequivocal aspect of melanoma or of any other malignant skin cancer, * (ii) lesion located on a skin area where reflectance confocal microscopy cannot be performed (for example: skin folds, mucosa, etc.), * (iii) lesion larger than 2 cm in its largest diameter * (iv) lesion where RCM examination is hampered for over the 30% of its surface (for example, for presence of crusting, oozing, erosion, ulceration, etc.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number needed to excise (NNE) | 03/2016 - 02/2020 | Measure the number of lesions needed to excise for a cutaneous melanoma diagnosis |
| Early diagnosis | 03/2016 - 02/2020 | Measure the breslow index of excised lesions |
| RCM diagnostic sensibility and sensitivity | 03/2016 - 02/2020 | Diagnostic sensibility of RCM in identifying cutaneous melanoma among equivocal lesions suspicious for melanoma (without clear demoscopy criteria for melanoma) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Head and neck pigmented lesions | 03/2016 - 02/2020 | Diagnostic accuracy of pigmented head and neck lesions where differential diagnosis is difficult to achieve and improper treatments (cryotherapy, laser, radiofrequency). |
| Diagnostic accuracy of non melanoma skin cancer | 03/2016 - 02/2020 | Pre-and intra-operative imaging for surgical margins |
Outcome results
None listed