Back to resultsAdded Value of OCT for Diagnosing Recurrent BCC After Non-invasive Treatment (TOBI)
Primary Purpose
Basal Cell Carcinoma
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Punch biopsy (3mm)
Sponsored by
About this trial
This is an interventional diagnostic trial for Basal Cell Carcinoma focused on measuring Optical coherence tomography
Eligibility Criteria
Inclusion Criteria:
- Non-invasively treated sBCC patients
- 18+ years of age
Exclusion Criteria:
- Unable to sign informed consent
Sites / Locations
- Maastricht University Medical Center+
Outcomes
Primary Outcome Measures
The added value of OCT for the detection of recurrent BCC
The investigators evaluated the difference in sensitivity between CDE and CDE + OCT
Secondary Outcome Measures
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)
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.
Full Information
NCT ID
NCT05581342
First Posted
September 29, 2022
Last Updated
October 12, 2022
Sponsor
Maastricht University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05581342
Brief Title
Added Value of OCT for Diagnosing Recurrent BCC After Non-invasive Treatment
Acronym
TOBI
Official Title
Optical Coherence Tomography for Diagnosing Recurrent Basal Cell Carcinoma After Non-invasive Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
January 15, 2021 (Actual)
Primary Completion Date
March 4, 2022 (Actual)
Study Completion Date
March 4, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Basal Cell Carcinoma
Keywords
Optical coherence tomography
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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
Outcomes Assessor
Masking Description
The OCT assessor was blinded to the histopathological examination of the independent dermatopathologist, whereas the dermatopathologist was blinded to the OCT assessment.
Allocation
Non-Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Diagnostic Test
Intervention Name(s)
Punch biopsy (3mm)
Intervention Description
In case of suspicion of recurrence or a voluntary control biopsy; a punch biopsy (3mm) was obtained conform regular care.
Primary Outcome Measure Information:
Title
The added value of OCT for the detection of recurrent BCC
Description
The investigators evaluated the difference in sensitivity between CDE and CDE + OCT
Time Frame
1- 56 months post treatment
Secondary Outcome Measure Information:
Title
The number of false-positive OCT test results
Description
The investigators evaluated whether the addition of OCT to CDE led to false-positive test results. (i.e a decrease in specificity)
Time Frame
1- 56 months post treatment
Title
Subtyping recurrent BCC by OCT
Description
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.
Time Frame
1- 56 months post treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Non-invasively treated sBCC patients
18+ years of age
Exclusion Criteria:
Unable to sign informed consent
Facility Information:
Facility Name
Maastricht University Medical Center+
City
Maastricht
State/Province
Limbrug
ZIP/Postal Code
6202AZ
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Added Value of OCT for Diagnosing Recurrent BCC After Non-invasive Treatment
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