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| ID | Type | Description | Link |
|---|---|---|---|
| 3844/C.E. | Other Identifier | University-Hospital of Modena Provincial Ethics Committee |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 (interventional) | Active Comparator | Patients with equivocal skin lesions suspicious for melanoma, randomised to adjunctive RCM evaluation, following clinical and dermoscopy evaluation. |
|
| Arm 2 (control) | Placebo Comparator | Patients with equivocal skin lesions suspicious for melanoma, randomised to clinical and dermoscopy evaluation only; adjunctive RCM evaluation refused. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical, dermoscopy and Reflective confocal microscopy evaluations | Device | Adjunctive reflective confocal microscopy to dermoscopy and clinical dermatological evaluation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Diagnostic accuracy of non melanoma skin cancer |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Giovanni Pellacani, MD | Azienda Ospedaliera Modena | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41685950 | Derived | Guida S, Spadafora M, Ciardo S, Mirra M, Magi S, Mazzoni L, Kaleci S, Farnetani F, Rongioletti F, Stanganelli I, Pellacani G, Longo C. Improving basal cell carcinoma subtype diagnosis with dermoscopy and reflectance confocal microscopy: a multicentre prospective study. Clin Exp Dermatol. 2026 Jun 25;51(7):1247-1254. doi: 10.1093/ced/llag037. | |
| 38296197 |
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Data will be shared on a sharing platform
Data will be available in 2021
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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).
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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.
| Clinical, dermoscopy evaluations | Device | Dermoscopy and clinical dermatological evaluation only |
|
Pre-and intra-operative imaging for surgical margins |
| 03/2016 - 02/2020 |
| 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. |
| 35648432 | 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. |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D004194 | Disease |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D046169 | Dermoscopy |
| ID | Term |
|---|---|
| D000069416 | Intravital Microscopy |
| D008853 | Microscopy |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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