Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2025-12-29 @ 8:56 AM
Study NCT ID:
NCT05004792
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-17
First Post:
2021-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dermoscopy Augmented Histology Trial, a Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': '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.'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized clinical trial. Pathologists are randomized to either the control group or the intervention group, allocation ratio of 1:1.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-14', 'studyFirstSubmitDate': '2021-07-06', 'studyFirstSubmitQcDate': '2021-08-09', 'lastUpdatePostDateStruct': {'date': '2024-06-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic value', 'timeFrame': '1 month', 'description': 'Diagnostic accuracy according to specific diagnoses and sensitivity and specificity according to correct classification of malignant vs. benign lesions'}], 'secondaryOutcomes': [{'measure': 'Inter-rater reliability', 'timeFrame': '1 month', 'description': 'comparison of diagnosis between participants'}, {'measure': 'time/case', 'timeFrame': '1 month', 'description': 'Average time spent on each case'}, {'measure': 'Average time spent on each image', 'timeFrame': '1 month', 'description': 'Average time spent looking at the clinical image, dermoscopic image and histopathological image'}, {'measure': 'use of clinical information', 'timeFrame': '1 month', 'description': 'Whether the participants use the clinical information and when they decide to do so (before/after looking at the images)'}, {'measure': 'Self-rated diagnostic confidence', 'timeFrame': '1 month', 'description': 'participants average self-rated confidence on the cases'}, {'measure': 'Perceived diagnostic difficulty', 'timeFrame': '1 month', 'description': 'participants average perceived diagnostic difficulty on the cases'}, {'measure': 'Dermoscopy test results', 'timeFrame': '1 month', 'description': 'Difference between pre and post-dermoscopy tests'}, {'measure': 'Second opinion', 'timeFrame': '1 month', 'description': 'Number of requested second opinions and the underlying reason'}, {'measure': 'Needs for stains', 'timeFrame': '1 month', 'description': 'Needs for additional stains, including which stains'}, {'measure': 'Needs for tests', 'timeFrame': '1 month', 'description': 'Needs for additional tests (NGS, etc.), including which tests'}, {'measure': 'training time vs time spent/DAHT case', 'timeFrame': '1 month', 'description': 'Correlation between time spent training and time spent diagnosing DAHT cases.'}, {'measure': 'MPATH-Dx specificity', 'timeFrame': '1 month', 'description': 'Specificity according to MPATH-Dx classifications'}, {'measure': 'MPATH-Dx sensitivity', 'timeFrame': '1 month', 'description': 'Sensitivity according to MPATH-Dx classifications'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Melanoma', 'Pigmented Lesions']}, 'referencesModule': {'references': [{'pmid': '31858624', 'type': 'BACKGROUND', 'citation': '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': '28659278', 'type': 'BACKGROUND', 'citation': "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': '31220881', 'type': 'BACKGROUND', 'citation': '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': '19404399', 'type': 'BACKGROUND', 'citation': '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': '10733633', 'type': 'BACKGROUND', 'citation': "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': '25491768', 'type': 'BACKGROUND', 'citation': "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': '36630138', 'type': 'BACKGROUND', 'citation': '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': '26902923', 'type': 'RESULT', 'citation': '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': '32596742', 'type': 'RESULT', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': "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.\n\nAim:\n\nTo examine how case-based online training in interpreting clinical and dermoscopic images affects a pathologist's ability to diagnose skin tumors.\n\nData collection of DAHT cases: Department of plastic surgery, Herlev hospital, year 2020-2021,\n\nDAHT platform: Made in 2021-2023 by Melatech,\n\nConsensus agreement: Four dermatopathologists assess all DAHT cases, year 2023-2024\n\nEnrollment of pathologists: Randomization and assessment DAHT cases, year 2025.", 'detailedDescription': "Background Several publications suggest that the increasing melanoma incidence may partly be caused by histopathological overdiagnosis. 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. However, it can be challenging to interpret clinical and dermoscopic images, and mastery typically requires more than six years of clinical experience. This learning journey can be significantly shortened if the trainee receives comprehensive training in pattern recognition for dermoscopy and clinical images, including immediate, accurate, and individualized feedback and access to a library with a large selection of skin lesion cases. This study examines the effect of digital training for pathologists in interpreting dermoscopic and clinical skin tumor images.\n\nFormer studies have only focused on melanocytic lesions. Still, most pathologists will receive both melanocytic and pigmented non-melanocytic lesions (seborrheic keratoses, dermatofibromas, etc.) due to clinical suspicion of melanoma. This study includes an un-filtered selection of 211 clinically melanoma-suspect skin lesions excised at a specialized surgical department; this material is named the DAHT cases.\n\nAim:\n\nTo examine how case-based online training in interpreting clinical and dermoscopic images affects a pathologist's ability to diagnose skin tumors.\n\nMethod Case Database\n\nLesion data were collected from patients between 02.11.2020 and 22.01.2021 at the Department of Plastic Surgery, Herlev Hospital. Requirements for eligibility for the current study are:\n\nThe patient was referred through the clinical cancer pathways for melanoma. The lesion was excised upon evaluation by the plastic surgeon.\n\nPatients received oral and written information about the project and were asked to sign a consent form before participation. The participation did not affect the included patients' treatment, diagnostics, or follow-up. Upon consent, the following information was collected for each lesion:\n\nClinical image Dermoscopic image Patients´ CPR-number (personal ID-number) Sex and age of the patient Location of skin tumor (on a 3D avatar) Medical history (former treatment, congenital nevi, if pregnant, time of appearance of skin lesion, change in appearance, symptoms, former melanoma or other skin diseases, family history of melanoma, sun exposure within the last six months)\n\nAfter excision, the specimen was prepared for pathological examination and a representative hematoxylin-eosin stain and, if available, a MelanA stain for each skin lesion was chosen for the study by an experienced dermatopathologist. These stains were subsequently digitized and coupled with the relevant information (dermoscopic and clinical image, tumor location, sex, age, lesion information, etc.). The CPR number was deleted, rendering the case anonymous. Each case is stored in a database under a random anonymous ID number.\n\nWeb-based IT platform\n\nTo maximize the number of pathologists that can be included in the study, the investigators have developed an IT platform for the trial (The DAHT platform). The platform enables the following features:\n\nSign-in Automated randomization Login Case presentation Diagnosis of cases and subquestions Tracking\n\nThe diagnostic options will be based on the standardized MPATH-Dx version 2.0 with additional non-melanocytic options based on the most common diagnoses to be excised due to suspicion of malignancy. After diagnosing the lesion, participating pathologists will rate their confidence and difficulty in the chosen diagnosis on a 6-step Likert scale similar to the one used in the MPATH-Dx system. They will also be asked whether they want a second opinion, if they need additional stains or tests, and which tests/stains. All cases will be presented in a randomized order unique to each participant.\n\nThe tracking feature will enable search pattern analysis, including time per diagnosis and percentage of time spent looking at the histology stain, dermoscopic image, clinical image, and clinical information.\n\nExecutive phase\n\nGeneral pathologists and dermatopathologists from Denmark, Australia, and other countries will be enrolled between 1.09.2023 and 1.12.2023. All participants will be sent an email informing them about the trial and the handling of their data before signing a digital consent. Upon inclusion, each enrolled pathologist will be asked to fill out a digital sign-in form with the following variables:\n\nName E-mail address (including verification) Age Sex Country Subspecialization (general pathologist or dermatopathologist) Number of years interpreting skin lesions Caseload from melanocytic lesions per month Percentage of caseload from melanocytic lesions Number of second opinion assessments per month Number of second opinion referrals per month Former training in dermoscopy (yes/no) Perceived relevance of dermoscopic images during histopathological evaluation on a 5-step Likert scale Routine with the use of digitized slides\n\nFollowing the sign-in, all participants will be asked to answer a dermoscopy test consisting of 25 formerly validated test items. They will automatically be randomized (allocation ratio 1:1) to either the intervention or control group. Participants in the intervention group will receive immediate access to a previously developed digital (tablet or smartphone) educational platform for the dermoscopy of melanocytic lesions, watch educational videos on the correlation between dermoscopy and histology, and then answer the dermoscopy test again before diagnosing the lesions in this study. Participants in the control group will not be given access to the learning intervention but will diagnose the lesions from this study immediately after signing up and taking the dermoscopy test. Each participant will be asked to assess a minimum of 50 cases within 21 days, preferably all 211 cases.\n\nStatistics:\n\nThe accuracy will be measured as the number of correct answers (validated by a former DAHT study: AISC-DAHT, consensus agreement) divided by the total number of answers. Inter-rater reliability will be measured using generalizability theory that allows calculations in nested and unbalanced designs. Mean time spent per diagnosis, perceived difficulty, and diagnostic confidence during the evaluation will be compared between the study groups using independent t-tests. A post hoc ANOVA will compare the time spent per diagnosis and the confidence of pathologists grouped by time spent training in dermoscopy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathologists are required to evaluate melanocytic lesions routinely\n* Doctors must be registered authorized health personnel\n* Access to a smartphone/tablet/computer with internet\n\nExclusion Criteria:\n\n\\- Assessment of less than 50 DAHT cases'}, 'identificationModule': {'nctId': 'NCT05004792', 'acronym': 'DAHT-RCT', 'briefTitle': 'Dermoscopy Augmented Histology Trial, a Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Herlev Hospital'}, 'officialTitle': 'Correlation Between Online Case-based Training of Pathologists in Dermoscopic Images and Diagnostic Accuracy in Histopathological Interpretation of Skin Lesions Suspicious of Melanoma', 'orgStudyIdInfo': {'id': 'AISC-DAHT, RCT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention', 'description': 'Access to DermLoop Learn IT platform', 'interventionNames': ['Other: DermLoop Learn']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'No access to DermLoop Learn'}], 'interventions': [{'name': 'DermLoop Learn', 'type': 'OTHER', 'description': "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.", 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Louisa Bønløkke Nervil', 'role': 'CONTACT', 'email': 'LouisaBoenloekke@gmail.com', 'phone': '28356465'}], 'overallOfficials': [{'name': 'Louisa Bønløkke Nervil', 'role': 'STUDY_CHAIR', 'affiliation': 'Herlev Hospital, Denmark - Department of plastic surgery'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Herlev Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical doctor', 'investigatorFullName': 'Louisa Bønløkke Nervil', 'investigatorAffiliation': 'Herlev Hospital'}}}}