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

NCT04789421 | Completed FDA Device

• 2 other identifiers: NET-2011-023472133844/C.E.
• Study Type: interventional
• Target: 3,248
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cutaneous Melanoma

Keywords

diagnostic accuracy; number needed to excise; reflectance confocal microscopy; histopathology; dermoscopy; early diagnosis

Outcome Measures

Primary Outcomes (3)

• Number needed to excise (NNE)

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

  03/2016 - 02/2020

• Early diagnosis

  Measure the breslow index of excised lesions

  03/2016 - 02/2020

• 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 Outcomes (2)

• Head and neck pigmented lesions

  03/2016 - 02/2020

• Diagnostic accuracy of non melanoma skin cancer

  03/2016 - 02/2020

Study Arms (2)

Arm 1 (interventional)

ACTIVE COMPARATOR

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

Device: Clinical, dermoscopy and Reflective confocal microscopy evaluations

Arm 2 (control)

PLACEBO COMPARATOR

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

Device: Clinical, dermoscopy evaluations

Interventions

Clinical, dermoscopy and Reflective confocal microscopy evaluations DEVICE

Adjunctive reflective confocal microscopy to dermoscopy and clinical dermatological evaluation.

Arm 1 (interventional)

Clinical, dermoscopy evaluations DEVICE

Dermoscopy and clinical dermatological evaluation only

Arm 2 (control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Patient's with at least 1 unequivocal lesion following standard of care (clinical and dermoscopy evaluations), \>= 18 years old

You may not qualify if:

• (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.).

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria di Modena: lead

Related Publications (2)

• Longo C, Guida S, Mirra M, Pampena R, Ciardo S, Bassoli S, Casari A, Rongioletti F, Spadafora M, Chester J, Kaleci S, Lai M, Magi S, Mazzoni L, Farnetani F, Stanganelli I, Pellacani G. Dermatoscopy and reflectance confocal microscopy for basal cell carcinoma diagnosis and diagnosis prediction score: A prospective and multicenter study on 1005 lesions. J Am Acad Dermatol. 2024 May;90(5):994-1001. doi: 10.1016/j.jaad.2024.01.035. Epub 2024 Jan 30.

  PMID: 38296197 DERIVED

• Pellacani G, Farnetani F, Ciardo S, Chester J, Kaleci S, Mazzoni L, Bassoli S, Casari A, Pampena R, Mirra M, Lai M, Magi S, Mandel VD, Di Matteo S, Colombo GL, Stanganelli I, Longo C. Effect of Reflectance Confocal Microscopy for Suspect Lesions on Diagnostic Accuracy in Melanoma: A Randomized Clinical Trial. JAMA Dermatol. 2022 Jul 1;158(7):754-761. doi: 10.1001/jamadermatol.2022.1570.

  PMID: 35648432 DERIVED

MeSH Terms

Conditions

Melanoma; Disease

Interventions

Dermoscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Intravital Microscopy; Microscopy; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Giovanni Pellacani, MD

  Azienda Ospedaliera Modena

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Dermatology

Model Details: 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).

Study Record Dates

• First Submitted: March 5, 2021
• First Posted: March 9, 2021
• Study Start: March 1, 2016
• Primary Completion: February 28, 2020
• Study Completion: March 16, 2020
• Last Updated: March 9, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available in 2021