Repeatability and Stability of Healthy Skin Features on OCT

February 15, 2024 updated by: Maastricht University Medical Center

Assessing the Stability and Repeatability of OCT Features in Healthy Skin: a Test-retest Study

A test-retest study on the stability and repeatability of healthy skin features on OCT

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229HX
        • Maastricht UMC+

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

A total of 30 healthy volunteers (colleages from the department of dermatology (MUMC+) and precision medicine (UM) will be asked to participate in this study. They must have at least three naevi.

Description

Inclusion Criteria:

  • At least18 years of age

Exclusion Criteria:

  • Unable to sign informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Repeatable hand-crafted radiomics-features
Time Frame: Interval of 10 minutes
The number of HRFs that are repeatable in a test-retest setting
Interval of 10 minutes
Interclass Correlation Coefficient (ICC)
Time Frame: 1 month

Intraclass Correlation Coefficient (ICC) will be used to assess the correlation and repeatability of the HRFs resulting from OCT scans. ICC will be calculated after all scans have been obtained.

ICC will be used to rank the HRFs. This statistical test is commonly used reliability index in test re-test studies.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Collaborators

Maastricht University (Precision medicine The D-lab)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

August 24, 2022

First Submitted That Met QC Criteria

August 24, 2022

First Posted (Actual)

August 26, 2022

Study Record Updates

Last Update Posted (Actual)

February 16, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2022-3219

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Gathered data will only be available to the prinicpal invesitgators and involved research staff (one PhD-candidate from dermatology (MUMC+), one PhD-candidate from precision medicine (UM)).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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