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OpenTrials
Completed

NCT Number: NCT04789421

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

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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Key information

Conditions

Cutaneous Melanoma Disease Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

Clinical, dermoscopy and Reflective confocal microscopy evaluations

Device

Adjunctive reflective confocal microscopy to dermoscopy and clinical dermatological evaluation.

Clinical, dermoscopy evaluations

Device

Dermoscopy and clinical dermatological evaluation only

Primary outcomes

  1. Number needed to excise (NNE)

    Time frame: 03/2016 - 02/2020

    Measure the number of lesions needed to excise for a cutaneous melanoma diagnosis

  2. Early diagnosis

    Time frame: 03/2016 - 02/2020

    Measure the breslow index of excised lesions

  3. 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)

Secondary outcomes

  1. 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).

  2. Diagnostic accuracy of non melanoma skin cancer

    Time frame: 03/2016 - 02/2020

    Pre-and intra-operative imaging for surgical margins

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero-Universitaria di Modena

Other

Registry information

Official study 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

Acronym: NET-DAM

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Mar 9, 2021
Registry last updated
Mar 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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