Dermoscopy Augmented Histology Trial, a Randomized Controlled Trial

NCT05004792 | Not Yet Recruiting DMC

• 1 other identifier: AISC-DAHT, RCT
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

Pathologists provide the current gold standard in skin lesion diagnostics, most often primarily based on the interpretation of histological slides. Still, it has been suggested that pathologists' diagnostic accuracy and confidence could be improved if they gained access to additional clinical information and in-vivo clinical and dermoscopic images of melanocytic tumors. This study examines the effect of digital training for pathologists in interpreting dermoscopic and clinical skin tumor images. Aim: To examine how case-based online training in interpreting clinical and dermoscopic images affects a pathologist's ability to diagnose skin tumors. Data collection of DAHT cases: Department of plastic surgery, Herlev hospital, year 2020-2021, DAHT platform: Made in 2021-2023 by Melatech, Consensus agreement: Four dermatopathologists assess all DAHT cases, year 2023-2024 Enrollment of pathologists: Randomization and assessment DAHT cases, year 2025.

Conditions

Melanoma; Pigmented Lesions

Outcome Measures

Primary Outcomes (1)

• Diagnostic value

  Diagnostic accuracy according to specific diagnoses and sensitivity and specificity according to correct classification of malignant vs. benign lesions

  1 month

Secondary Outcomes (13)

• Inter-rater reliability

  1 month

• time/case

  1 month

• Average time spent on each image

  1 month

• use of clinical information

  1 month

• Self-rated diagnostic confidence

  1 month

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Access to DermLoop Learn IT platform

Other: DermLoop Learn

Control group

NO INTERVENTION

No access to DermLoop Learn

Interventions

DermLoop Learn OTHER

DermLoop Learn is our AI-augmented digital educational platform with case training on a library of 18,000+ benign and malignant skin lesions, educational videos on the correlation between dermoscopy and histology, as well as written learning modules for the most common skin lesion diagnosis. The education platform will give the user feedback on the image-based case training in dermoscopic diagnostic accuracy and adjust the cases depending on the user's progression.

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologists are required to evaluate melanocytic lesions routinely
• Doctors must be registered authorized health personnel
• Access to a smartphone/tablet/computer with internet

You may not qualify if:

• \- Assessment of less than 50 DAHT cases

Sponsors & Collaborators

• Herlev Hospital: lead

Related Publications (9)

• Glasziou PP, Jones MA, Pathirana T, Barratt AL, Bell KJ. Estimating the magnitude of cancer overdiagnosis in Australia. Med J Aust. 2020 Mar;212(4):163-168. doi: 10.5694/mja2.50455. Epub 2019 Dec 19.

  PMID: 31858624 BACKGROUND

• Elmore JG, Barnhill RL, Elder DE, Longton GM, Pepe MS, Reisch LM, Carney PA, Titus LJ, Nelson HD, Onega T, Tosteson ANA, Weinstock MA, Knezevich SR, Piepkorn MW. Pathologists' diagnosis of invasive melanoma and melanocytic proliferations: observer accuracy and reproducibility study. BMJ. 2017 Jun 28;357:j2813. doi: 10.1136/bmj.j2813.

  PMID: 28659278 BACKGROUND

• Scolyer RA, Soyer HP, Kelly JW, James C, McLean CA, Coventry BJ, Ferguson PM, Rawson RV, Mar VJ, de Menezes SL, Fishburn P, Stretch JR, Lee S, Thompson JF. Improving diagnostic accuracy for suspicious melanocytic skin lesions: New Australian melanoma clinical practice guidelines stress the importance of clinician/pathologist communication. Aust J Gen Pract. 2019 Jun;48(6):357-362. doi: 10.31128/AJGP-11-18-4759.

  PMID: 31220881 BACKGROUND

• Ferrara G, Argenyi Z, Argenziano G, Cerio R, Cerroni L, Di Blasi A, Feudale EA, Giorgio CM, Massone C, Nappi O, Tomasini C, Urso C, Zalaudek I, Kittler H, Soyer HP. The influence of clinical information in the histopathologic diagnosis of melanocytic skin neoplasms. PLoS One. 2009;4(4):e5375. doi: 10.1371/journal.pone.0005375. Epub 2009 Apr 30.

  PMID: 19404399 BACKGROUND

• Bedlow AJ, Cliff S, Melia J, Moss SM, Seyan R, Harland CC. Impact of skin cancer education on general practitioners' diagnostic skills. Clin Exp Dermatol. 2000 Mar;25(2):115-8. doi: 10.1046/j.1365-2230.2000.00590.x.

  PMID: 10733633 BACKGROUND

• Badertscher N, Tandjung R, Senn O, Kofmehl R, Held U, Rosemann T, Hofbauer GF, Wensing M, Rossi PO, Braun RP. A multifaceted intervention: no increase in general practitioners' competence to diagnose skin cancer (minSKIN) - randomized controlled trial. J Eur Acad Dermatol Venereol. 2015 Aug;29(8):1493-9. doi: 10.1111/jdv.12886. Epub 2014 Dec 10.

  PMID: 25491768 BACKGROUND

• Barnhill RL, Elder DE, Piepkorn MW, Knezevich SR, Reisch LM, Eguchi MM, Bastian BC, Blokx W, Bosenberg M, Busam KJ, Carr R, Cochran A, Cook MG, Duncan LM, Elenitsas R, de la Fouchardiere A, Gerami P, Johansson I, Ko J, Landman G, Lazar AJ, Lowe L, Massi D, Messina J, Mihic-Probst D, Parker DC, Schmidt B, Shea CR, Scolyer RA, Tetzlaff M, Xu X, Yeh I, Zembowicz A, Elmore JG. Revision of the Melanocytic Pathology Assessment Tool and Hierarchy for Diagnosis Classification Schema for Melanocytic Lesions: A Consensus Statement. JAMA Netw Open. 2023 Jan 3;6(1):e2250613. doi: 10.1001/jamanetworkopen.2022.50613.

  PMID: 36630138 BACKGROUND

• Whiteman DC, Green AC, Olsen CM. The Growing Burden of Invasive Melanoma: Projections of Incidence Rates and Numbers of New Cases in Six Susceptible Populations through 2031. J Invest Dermatol. 2016 Jun;136(6):1161-1171. doi: 10.1016/j.jid.2016.01.035. Epub 2016 Feb 20.

  PMID: 26902923 RESULT

• Ternov NK, Vestergaard T, Holmich LR, Karmisholt K, Wagenblast AL, Klyver H, Hald M, Schollhammer L, Konge L, Chakera AH. Reliable test of clinicians' mastery in skin cancer diagnostics. Arch Dermatol Res. 2021 May;313(4):235-243. doi: 10.1007/s00403-020-02097-8. Epub 2020 Jun 28.

  PMID: 32596742 RESULT

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 Officials

• Louisa Bønløkke Nervil

  Herlev Hospital, Denmark - Department of plastic surgery

  STUDY CHAIR

Central Study Contacts

Louisa Bønløkke Nervil

CONTACT

28356465; LouisaBoenloekke@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participating Pathologists are either given access to a learning intervention called DermLoop Learn for a short period or not given access to any learning intervention. During the trial, both groups interpret histopathological skin lesions with access to clinical information, an overview picture, and a dermoscopic picture of the lesion.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Model Details: Randomized clinical trial. Pathologists are randomized to either the control group or the intervention group, allocation ratio of 1:1.

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: August 13, 2021
• Study Start: April 1, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 17, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share