Advanced Non-invasive Diagnostics for Early Cutaneous Tumor Diagnosis, Clinical-therapeutic and Economic Management

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3248 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-01

Study Completion Date

2020-03-16

Brief Summary

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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.

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Detailed Description

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Conditions

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Cutaneous Melanoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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).

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Caregivers

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.

Study Groups

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Arm 1 (interventional)

Patients with equivocal skin lesions suspicious for melanoma, randomised to adjunctive RCM evaluation, following clinical and dermoscopy evaluation.

Group Type ACTIVE_COMPARATOR

Clinical, dermoscopy and Reflective confocal microscopy evaluations

Intervention Type DEVICE

Adjunctive reflective confocal microscopy to dermoscopy and clinical dermatological evaluation.

Arm 2 (control)

Patients with equivocal skin lesions suspicious for melanoma, randomised to clinical and dermoscopy evaluation only; adjunctive RCM evaluation refused.

Group Type PLACEBO_COMPARATOR

Clinical, dermoscopy evaluations

Intervention Type DEVICE

Dermoscopy and clinical dermatological evaluation only

Interventions

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Clinical, dermoscopy and Reflective confocal microscopy evaluations

Adjunctive reflective confocal microscopy to dermoscopy and clinical dermatological evaluation.

Intervention Type DEVICE

Clinical, dermoscopy evaluations

Dermoscopy and clinical dermatological evaluation only

Intervention Type DEVICE

Eligibility Criteria

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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.).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No