(Cost)-Effectiveness of Optical Coherence Tomography (OCT) in Basal Cell Carcinoma (BCC)
ROCTI
2 other identifiers
interventional
598
1 country
1
Brief Summary
A multi-centre randomized non-inferiority trial investigating the (cost-)effectiveness of Optical Coherence Tomography (OCT) versus regular punch biopsy in the diagnosis and subtyping of Basal Cell Carcinoma (BCC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 19, 2019
CompletedFirst Posted
Study publicly available on registry
February 20, 2019
CompletedStudy Start
First participant enrolled
February 26, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2021
CompletedFebruary 25, 2021
February 1, 2021
2.5 years
February 19, 2019
February 24, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Proportion of patients with treatment failure
The main endpoint for the non-inferiority trial is the proportion of patients with treatment failure after 12 months follow-up, where treatment failure is defined as inadequate treatment or recurrence of malignant or premalignant lesions.
12 months
Cost-effectiveness of OCT
The main endpoint for the cost-effectiveness analysis is the Incremental Cost-Effectiveness Ratio (ICER) defined as extra cost per gained Quality-Adjusted Life Year (QALY).
12 months
Secondary Outcomes (4)
The proportion of patients with avoided biopsies
12 months
Diagnostic performance of OCT
12 months
Discrete Choice Experiment to determine patient preferences
2 months
Quality of life measured with EQ-5D-5L
Baseline, 12 months
Study Arms (2)
Optical Coherence Tomography arm
OTHERIn the intervention arm, OCT imaging is performed which will take about 3 minutes. The decision on the most adequate treatment strategy will be based directly on the OCT diagnosis, but only when there is certainty about the presence of BCC and BCC subtype according to the OCT diagnosis. A 'safety' biopsy will be performed after the OCT scan. In patients where the OCT diagnosis leaves doubt or it is certain that there is no BCC, a biopsy will be taken anyway and the treatment decision will be based on the result of this punch biopsy.
Regular care arm
NO INTERVENTIONIn patients assigned to regular care, the result of punch biopsy will always be used to decide which treatment is most adequate. Therefore, a next consultation will be planned to discuss the outcome of the biopsy and the intended treatment strategy.
Interventions
OCT is an imaging technique, which is able to produce real-time, in vivo, cross-sectional images of lesions with a depth of 1,5-2 mm. OCT imaging is based on light-interferometry, calculating the interference of an optical beam reflected by the tissue with a reference. In such ways, microscopic details of lesions and tissues can be visualized. This information can be used to identify a lesion as BCC, and to specify the subtype. Therefore, we assume that the use of the OCT might reduce the number of biopsies and the accompanying morbidity. The investigator scans 6mm of skin with the OCT (30 seconds) and decides whether the lesion is a BCC or not.
Eligibility Criteria
You may qualify if:
- Adult patient (\>18 years)
- Clinical and dermoscopic suspicion of BCC
- BCC is in the differential diagnosis and a biopsy would normally be obtained to confirm the diagnosis and subtype or exclude other skin lesions.
You may not qualify if:
- Patients with BCC in the high-risk zone of the face (ear, nose, eye region)
- Patients with a large BCC referred to our (tertiary care) head and neck tumour working group.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maastricht UMC+
Maastricht, Limburg, 6229 HX, Netherlands
Related Publications (4)
Flohil SC, de Vries E, Neumann HA, Coebergh JW, Nijsten T. Incidence, prevalence and future trends of primary basal cell carcinoma in the Netherlands. Acta Derm Venereol. 2011 Jan;91(1):24-30. doi: 10.2340/00015555-1009.
PMID: 21264452BACKGROUNDCheng HM, Guitera P. Systematic review of optical coherence tomography usage in the diagnosis and management of basal cell carcinoma. Br J Dermatol. 2015 Dec;173(6):1371-80. doi: 10.1111/bjd.14042. Epub 2015 Oct 27.
PMID: 26211438BACKGROUNDNVDV, Dutch evidence based guideline Guideline Basal Cell Carcinoma.
BACKGROUNDAdan F, Nelemans PJ, Essers BAB, Brinkhuizen T, Dodemont SRP, Kessels JPHM, Quaedvlieg PJF, Dermont GJ, Winnepenninckx VJL, Abdul Hamid M, Kelleners-Smeets NWJ, Mosterd K. Optical coherence tomography versus punch biopsy for diagnosis of basal cell carcinoma: a multicentre, randomised, non-inferiority trial. Lancet Oncol. 2022 Aug;23(8):1087-1096. doi: 10.1016/S1470-2045(22)00347-3. Epub 2022 Jul 11.
PMID: 35835136DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Klara Mosterd, MD, PhD
Maastricht University Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- The investigator is blinded for the result of the punch biopsy.
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2019
First Posted
February 20, 2019
Study Start
February 26, 2019
Primary Completion
August 31, 2021
Study Completion
October 1, 2021
Last Updated
February 25, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share