Added Value of OCT for Diagnosing Recurrent BCC After Non-invasive Treatment (TOBI)

October 12, 2022 updated by: Maastricht University Medical Center

Optical Coherence Tomography for Diagnosing Recurrent Basal Cell Carcinoma After Non-invasive Treatment

Superficial basal cell carcinoma (sBCC) can be treated non-invasively, but follow-up is necessary because lesions can reoccur. This study aims to evaluate the additional value of optical coherence tomography (OCT) for the detection of recurrent BCC lesions, that may remain unrecognized by clinical and dermoscopic examination (CDE). This study compared the diagnostic accuracy of CDE and CDE combined with OCT for detection of recurrent basal cell carcinoma (BCC) after non-invasive treatment of sBCC.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

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
    • Limbrug
      • Maastricht, Limbrug, Netherlands, 6202AZ
        • Maastricht University Medical Center+

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Non-invasively treated sBCC patients
  • 18+ 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

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The added value of OCT for the detection of recurrent BCC
Time Frame: 1- 56 months post treatment
The investigators evaluated the difference in sensitivity between CDE and CDE + OCT
1- 56 months post treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of false-positive OCT test results
Time Frame: 1- 56 months post treatment
The investigators evaluated whether the addition of OCT to CDE led to false-positive test results. (i.e a decrease in specificity)
1- 56 months post treatment
Subtyping recurrent BCC by OCT
Time Frame: 1- 56 months post treatment
The investigators evaluated to what extent OCT assessors are able to correctly predict the BCC subtype of recurrent BCCs. A distinction was made between superficial BCC (sBCC; non-invasive treatment optional) and nodular/aggressive BCC (nBCC/aBCC; excision required). For BCC subtyping, sensitivity was defined as the proportion of patients with an nBCC/aBCC correctly identified by OCT as nBCC/aBCC. Specificity was defined as the proportion of patients with an sBCC correctly identified as sBCC by OCT.
1- 56 months post treatment

Collaborators and Investigators

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

Sponsor

Maastricht University Medical Center

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)

January 15, 2021

Primary Completion (Actual)

March 4, 2022

Study Completion (Actual)

March 4, 2022

Study Registration Dates

First Submitted

September 29, 2022

First Submitted That Met QC Criteria

October 12, 2022

First Posted (Actual)

October 14, 2022

Study Record Updates

Last Update Posted (Actual)

October 14, 2022

Last Update Submitted That Met QC Criteria

October 12, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL74245.068.20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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