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

Study Overview
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Brief Summary
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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.

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

Conditions
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Basal Cell Carcinoma

Intervention / Treatment
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* Diagnostic Test: Punch biopsy (3mm)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non-invasively treated sBCC patients 18+ years of age Exclusion Criteria: Unable to sign informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Patients who were non-invasively treated for superficial basal cell carcinoma within five years post-treatment could be included. If CDE or OCT rose suspicion for recurrence a biopsy was obtained. When no suspicion for recurrence was raised; patients were asked to voluntarily undergo a control biopsy to verify absence of recurrence.
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Punch biopsy (3mm)|In case of suspicion of recurrence or a voluntary control biopsy; a punch biopsy (3mm) was obtained conform regular care.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The added value of OCT for the detection of recurrent BCC | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Optical coherence tomography