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

NCT05581342 | Completed

• 1 other identifier: NL74245.068.20
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Basal Cell Carcinoma

Keywords

Optical coherence tomography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The number of false-positive OCT test results

  1- 56 months post treatment

• Subtyping recurrent BCC by OCT

  1- 56 months post treatment

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Unable to sign informed consent

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Center+

Maastricht, Limbrug, 6202AZ, Netherlands

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The OCT assessor was blinded to the histopathological examination of the independent dermatopathologist, whereas the dermatopathologist was blinded to the OCT assessment.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 29, 2022
• First Posted: October 14, 2022
• Study Start: January 15, 2021
• Primary Completion: March 4, 2022
• Study Completion: March 4, 2022
• Last Updated: October 14, 2022

Record last verified: 2022-09

Locations

NL (1)