NCT05634421

Brief Summary

In this study, various health care professionals will follow an E-learning module in which BCC detection on OCT is explained. Thereafter, the participants will test their skill by assessing OCT-scans. Their performance will be monitored using cumulative-sum analysis. After completion, newly trained OCT assessors will test their diagnostic accuracy for BCC detection on OCT in a exploratory study. The trainability, amount of required training and diagnostic accuracy will be compared between dermatologist and non-dermatologists.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2022

Completed
9 days until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

February 16, 2024

Status Verified

February 1, 2024

Enrollment Period

1.1 years

First QC Date

November 22, 2022

Last Update Submit

February 15, 2024

Conditions

Keywords

Optical coherence tomography

Outcome Measures

Primary Outcomes (4)

  • Achieving and maintaining an acceptable error rate (16%) for BCC detection on OCT

    Measured before december 31st 2023

  • Number of practice scans needed in order to achieve an acceptable error rate

    Measured before december 31st 2023

  • Median time that dermatologists and non-dermatologists need to assess OCT scans

    Measured before december 31st 2023

  • Diagnostic accuracy of newly trained dermatologists and non-dermatologists expressed as sensitivity, specificity, PPV, NPV and DOR.

    Measured before december 31st 2023

Study Arms (5)

Dermatologists

Dermatologists who have no experience with OCT.

Other: E-learning

Residents

Residents who have no experience with OCT

Other: E-learning

Medical students

Medical students who have no experience with OCT

Other: E-learning

Nurses

Nurses who have no experience with OCT

Other: E-learning

Research physicians

Other: E-learning

Interventions

The E-learning is under development at the department of Dermatology from MUMC+.

DermatologistsMedical studentsNursesResearch physiciansResidents

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of various health care provides; dermatologists, residents/clinical researchers, nurses and medical students. We aim to include at least 5 participants per category of healthcare providers.

You may qualify if:

  • Health care provider or medical student

You may not qualify if:

  • Previous experience with OCT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht UMC+

Maastricht, Limburg, 6229HX, Netherlands

Location

Related Publications (1)

  • Wolswijk T, Nelemans PJ, Adan F, van Leersum F, Kreiter D, Adams T, van Dorsten S, Mosterd K. Cumulative Sum Analysis-Integrated E-Learning for Differentiation Between Basal Cell Carcinoma and Non-Basal Cell Carcinoma on Optical Coherence Tomography: An Observational Cohort Study. Int J Dermatol. 2025 Oct;64(10):1870-1878. doi: 10.1111/ijd.17918. Epub 2025 Jun 27.

MeSH Terms

Conditions

Carcinoma, Basal Cell

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Basal Cell

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2022

First Posted

December 2, 2022

Study Start

December 1, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

February 16, 2024

Record last verified: 2024-02

Locations