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

Cutaneous Melanoma Clinical Trial

— NET-DAM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04789421
• Other study ID #: NET-2011-02347213
• Secondary ID: 3844/C.E.
• Status: Completed
• Phase: N/A
• Start date: March 1, 2016
• Est. completion date: March 16, 2020

Study information

• Verified date: March 2021
• Source: Azienda Ospedaliero-Universitaria di Modena
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3248
• Est. completion date: March 16, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.).

Related Conditions & MeSH terms

• Cutaneous Melanoma
• Melanoma
• Skin Neoplasms

Intervention

Device:
• Clinical, dermoscopy and Reflective confocal microscopy evaluations
Adjunctive reflective confocal microscopy to dermoscopy and clinical dermatological evaluation.
• Clinical, dermoscopy evaluations
Dermoscopy and clinical dermatological evaluation only

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero-Universitaria di Modena

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number needed to excise (NNE)	Measure the number of lesions needed to excise for a cutaneous melanoma diagnosis	03/2016 - 02/2020
Primary	Early diagnosis	Measure the breslow index of excised lesions	03/2016 - 02/2020
Primary	RCM diagnostic sensibility and sensitivity	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	Head and neck pigmented lesions	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
Secondary	Diagnostic accuracy of non melanoma skin cancer	Pre-and intra-operative imaging for surgical margins	03/2016 - 02/2020