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NCT Number: NCT05581342

Added Value of OCT for Diagnosing Recurrent BCC 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.

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Key information

Conditions

Basal Cell Carcinoma Carcinoma Carcinoma, Basal Cell Neoplasms Neoplasms by Histologic Type Neoplasms, Basal Cell Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Center+

Maastricht, Limbrug, 6202AZ, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Unable to sign informed consent

Treatment and study plan

Punch biopsy (3mm)

Diagnostic Test

In case of suspicion of recurrence or a voluntary control biopsy; a punch biopsy (3mm) was obtained conform regular care.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

  2. 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.

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

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

Acronym: TOBI

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 14, 2022
Registry last updated
Oct 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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