Advanced Non-invasive Diagnostics for Early Cutaneous Tumor Diagnosis, Clinical-therapeutic and Economic Management (NET-DAM)
Multicenter, Randomised Study of the Impact of Advanced, Non-invasive Diagnostic Instrumentation for Early Cutaneous Tumor Diagnosis, Clinical-therapeutic Pathways and an Economic-management Perspective
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Arm 1 (interventional)
Patients with equivocal skin lesions suspicious for melanoma, randomised to adjunctive RCM evaluation, following clinical and dermoscopy evaluation.
|
Adjunctive reflective confocal microscopy to dermoscopy and clinical dermatological evaluation.
|
|
PLACEBO_COMPARATOR: Arm 2 (control)
Patients with equivocal skin lesions suspicious for melanoma, randomised to clinical and dermoscopy evaluation only; adjunctive RCM evaluation refused.
|
Dermoscopy and clinical dermatological evaluation only
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number needed to excise (NNE)
Time Frame: 03/2016 - 02/2020
|
Measure the number of lesions needed to excise for a cutaneous melanoma diagnosis
|
03/2016 - 02/2020
|
|
Early diagnosis
Time Frame: 03/2016 - 02/2020
|
Measure the breslow index of excised lesions
|
03/2016 - 02/2020
|
|
RCM diagnostic sensibility and sensitivity
Time Frame: 03/2016 - 02/2020
|
Diagnostic sensibility of RCM in identifying cutaneous melanoma among equivocal lesions suspicious for melanoma (without clear demoscopy criteria for melanoma)
|
03/2016 - 02/2020
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Head and neck pigmented lesions
Time Frame: 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).
|
03/2016 - 02/2020
|
|
Diagnostic accuracy of non melanoma skin cancer
Time Frame: 03/2016 - 02/2020
|
Pre-and intra-operative imaging for surgical margins
|
03/2016 - 02/2020
|
Collaborators and Investigators
Investigators
- Principal Investigator: Giovanni Pellacani, MD, Azienda Ospedaliera Modena
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NET-2011-02347213
- 3844/C.E. (OTHER: University-Hospital of Modena Provincial Ethics Committee)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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