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

Not Applicable

Completed

• Conditions: Basal Cell Carcinoma

• Registration Number: NCT05581342
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-15
• Primary Completion: 2022-03-04
• Study Completion: 2022-03-04
• Status Verified: 2022-09
• Study First Submitted: 2022-09-29
• Study First Submitted QC: 2022-10-12
• Last Update Submitted: 2022-10-12
• Study First Posted: 2022-10-14
• Last Update Posted: 2022-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Non-invasively treated sBCC patients
• 18+ years of age

Exclusion Criteria

• Unable to sign informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The added value of OCT for the detection of recurrent BCC	1- 56 months post treatment	The investigators evaluated the difference in sensitivity between CDE and CDE + OCT

Secondary Outcome Measures

Name	Time	Method
The number of false-positive OCT test results	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)
Subtyping recurrent BCC by OCT	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.

Trial Locations

Locations (1)

Maastricht University Medical Center+; 🇳🇱 Maastricht, Limbrug, Netherlands