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

Basal Cell Carcinoma Clinical Trial

— TOBI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05581342
• Other study ID #: NL74245.068.20
• Status: Completed
• Phase: N/A
• Start date: January 15, 2021
• Est. completion date: March 4, 2022

Study information

• Verified date: September 2022
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 4, 2022
• Est. primary completion date: March 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Unable to sign informed consent

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Carcinoma
• Carcinoma, Basal Cell

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center+	Maastricht	Limbrug

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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