Cutaneous MelanomaNET-DAMNCT04789421
Advanced Non-invasive Diagnostics for Early Cutaneous Tumor Diagnosis, Clinical-therapeutic and Economic Management
A study testing Clinical, dermoscopy and Reflective confocal microscopy evaluations and Clinical, dermoscopy evaluations in people with Cutaneous Melanoma, run by Azienda Ospedaliero-Universitaria di Modena.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Melanoma
- What is being tested?
- Clinical, dermoscopy and Reflective confocal microscopy evaluations and Clinical, dermoscopy evaluations
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,248 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2016to 16 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient's with at least 1 unequivocal lesion following standard of care (clinical and dermoscopy evaluations), >= 18 years old
Who cannot join
- (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.).
About this study
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
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
- Being tested
- Clinical, dermoscopy and Reflective confocal microscopy evaluations, Clinical, dermoscopy evaluations
- Keywords
- diagnostic accuracy, number needed to excise, reflectance confocal microscopy, histopathology, dermoscopy, early diagnosis
- Medical subject headings
- Melanoma, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical, dermoscopy and Reflective confocal microscopy evaluationsDevice
Adjunctive reflective confocal microscopy to dermoscopy and clinical dermatological evaluation.
Clinical, dermoscopy evaluationsDevice
Dermoscopy and clinical dermatological evaluation only
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (interventional) | Active comparator | Patients with equivocal skin lesions suspicious for melanoma, randomised to adjunctive RCM evaluation, following clinical and dermoscopy evaluation. Receives: 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. Receives: Device: Clinical, dermoscopy evaluations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number needed to excise (NNE)
Measure the number of lesions needed to excise for a cutaneous melanoma diagnosis
Measured: 03/2016 - 02/2020
Early diagnosis
Measure the breslow index of excised lesions
Measured: 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)
Measured: 03/2016 - 02/2020
Secondary outcomes (2)
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).
Measured: 03/2016 - 02/2020
Diagnostic accuracy of non melanoma skin cancer
Pre-and intra-operative imaging for surgical margins
Measured: 03/2016 - 02/2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start1 Mar 2016
- Primary completion28 Feb 2020
- Study completion16 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cutaneous MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- 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).
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 3,248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria di Modena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pellacani Giovanni, Azienda Ospedaliero-Universitaria di Modena
- Investigators
- Giovanni Pellacani, MD, Principal investigator, Azienda Ospedaliera Modena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04789421
- Sponsor's protocol ID
- NET-2011-02347213
- Other IDs
- 3844/C.E.
- Acronym
- NET-DAM
- Status last verified
- Mar 2021
- First submitted
- 5 Mar 2021
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data will be shared on a sharing platform
Publications
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.
PubMed 41685950Longo 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.
PubMed 38296197Pellacani 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.
PubMed 35648432
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04789421
- Acronym / sponsor ID
- NET-DAM / NET-2011-02347213
- Conditions
- Cutaneous Melanoma
- Keywords
- diagnostic accuracy, number needed to excise, reflectance confocal microscopy, histopathology, dermoscopy, early diagnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,248 participants (actual)
- Lead sponsor
- Azienda Ospedaliero-Universitaria di ModenaUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 16 Mar 2020 (actual)
- First posted
- 9 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (interventional) | Active comparator | Device: Clinical, dermoscopy and Reflective confocal microscopy evaluationsPatients with equivocal skin lesions suspicious for melanoma, randomised to adjunctive RCM evaluation, following clinical and dermoscopy evaluation. |
| Arm 2 (control) | Placebo comparator | Device: Clinical, dermoscopy evaluationsPatients with equivocal skin lesions suspicious for melanoma, randomised to clinical and dermoscopy evaluation only; adjunctive RCM evaluation refused. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient's with at least 1 unequivocal lesion following standard of care (clinical and dermoscopy evaluations), >= 18 years old
Key exclusion criteria (4 listed)
- (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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical, dermoscopy and Reflective confocal microscopy evaluationsAdjunctive reflective confocal microscopy to dermoscopy and clinical dermatological evaluation. | Device | Arm 1 (interventional) |
| Clinical, dermoscopy evaluationsDermoscopy and clinical dermatological evaluation only | Device | Arm 2 (control) |
Primary outcome
Number needed to excise (NNE)
Time frame: 03/2016 - 02/2020
Measure the number of lesions needed to excise for a cutaneous melanoma diagnosis
Early diagnosis
Time frame: 03/2016 - 02/2020
Measure the breslow index of excised lesions
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)
2 secondary outcomes
Head and neck pigmented lesions
Time frame: 03/2016 - 02/2020
Diagnostic accuracy of non melanoma skin cancer
Time frame: 03/2016 - 02/2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- Derived from this study: PubMed 41685950Guida 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.
- Derived from this study: PubMed 38296197Longo 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.
- Derived from this study: PubMed 35648432Pellacani 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.
- Individual participant dataSharing planned: Yes. Data will be shared on a sharing platform
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giovanni Pellacani, MD principal investigator
Azienda Ospedaliera Modena
Questions about this trial
What is this clinical trial studying?
A study testing Clinical, dermoscopy and Reflective confocal microscopy evaluations and Clinical, dermoscopy evaluations in people with Cutaneous Melanoma, run by Azienda Ospedaliero-Universitaria di Modena.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number needed to excise (NNE) (time frame: 03/2016 - 02/2020). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04789421, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2021.