Safety and Avoidance of Futile Excisions Through Skin Tele-triage

NCT05982600 | Completed

• 1 other identifier: SAFEST Trial
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to estimate the triage values, efficiency and safety of tele-dermoscopic triage of skin lesions suspected of melanoma. The main question\[s\] it aims to answer are:

• What is the rate of correct patient management by a single, 2, 3 and 5 dermatologists.
• What is the consequence for the patients if teledermoscopic triage is implemented, in termes of missed melanomas and reduced unnecessary excisions/biopsies. Retrospectively included patients will have their skin lesions re-examined by setups of 1, 2, 3 and 5 tele-dermoscopists who will assign a tentative diagnosis and a recommended clinical action. The investigators will compare the rate of correct patient management between the different setups.

Conditions

Melanoma (Skin); Telemedicine

Keywords

Teledermoscopy; Melanoma; Pigmented Skin Lesions; Telemedicine

Outcome Measures

Primary Outcomes (1)

• Triage Values

  Recommended clinical action, correct vs incorrect. Each teledermatologist will recommend a clinical action for each patient case. We evaluate the correctness of this recommended clinical action (in binary classification of correct vs incorrect) by a list of pre-defined "best practice management rules" for each diagnosis.

  Immediately after all participants have completed the evaluations

Secondary Outcomes (1)

• Diagnostic Values

  Immediately after all participants have completed the evaluations

Study Arms (1)

Cancer Pathway referred patient

Patient referred for assessment and excision of their skin lesion, because of a suspicion of melanoma by the referring doctor.

Diagnostic Test: Single Assessor Teledermatological triage (TDT); Diagnostic Test: 2 people Teledermatological triage (TDT); Diagnostic Test: 3 people Teledermatological triage (TDT); Diagnostic Test: 5 people Teledermatological triage (TDT)

Interventions

Single Assessor Teledermatological triage (TDT) DIAGNOSTIC_TEST

The skin lesion is assessed, diagnosed and triaged by one dermatologist assessors.

Also known as: Single Assessor

Cancer Pathway referred patient

2 people Teledermatological triage (TDT) DIAGNOSTIC_TEST

The skin lesion is assessed, diagnosed and triaged by 2 dermatologist assessors. Worst case overrules.

Also known as: 2 people assessment

Cancer Pathway referred patient

3 people Teledermatological triage (TDT) DIAGNOSTIC_TEST

The skin lesion is assessed, diagnosed and triaged by 3 dermatologist assessors. Worst case and majority consensus assessments are calculated separately.

Also known as: 3 people assessment

Cancer Pathway referred patient

5 people Teledermatological triage (TDT) DIAGNOSTIC_TEST

The skin lesion is assessed, diagnosed and triaged by 5 dermatologist assessors. Worst case and majority consensus assessments are calculated separately.

Also known as: 5 people assessment

Cancer Pathway referred patient

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

250 retrospectively randomly selected patients referred to the Department of Plastic Surgery at Herlev Hospital because of suspicion of melanoma in the period between May 1st and December 31st 2022.

You may qualify if:

• Referred to the Department of Plastic Surgery at Herlev Hospital because of suspicion of melanoma
• Clinical and dermoscopic images registered in Dermloop
• Histopathological diagnosis available for the lesion

You may not qualify if:

• The patient's images cannot be anonymized adequately

Sponsors & Collaborators

• Herlev Hospital: lead

Study Sites (1)

Gustav Gede Nervil

Brønshøj, Copenhagen, 2700, Denmark

Location

MeSH Terms

Conditions

Melanoma

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 8, 2023
• Study Start: September 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: April 24, 2024
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Available after conclusion and for as long as appropriate.

Locations

DK (1)