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(Cost)-Effectiveness of Optical Coherence Tomography (OCT) in Basal Cell Carcinoma (BCC) (ROCTI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03848078
Recruitment Status : Active, not recruiting
First Posted : February 20, 2019
Last Update Posted : February 25, 2021
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Maastricht University Medical Center

Study Description
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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).

Condition or disease Intervention/treatment Phase
Basal Cell Carcinoma Optical Coherence Tomography Device: Optical Coherence Tomography Not Applicable

Detailed Description:
Skin cancer incidence rises worldwide due to high sun exposure and ageing. Basal cell carcinoma (BCC) is the most prevalent form, with a lifetime risk of 16-20% in the Netherlands. Currently, the gold standard for diagnosing and subtyping BCC is a punch biopsy. Since this technique is invasive, new non-invasive diagnostic methods have been developed, including optical coherence tomography (OCT). In patients with clinical and dermoscopic suspicion of BCC, OCT makes it possible to confirm and subtype BCC with high confidence, thereby obviating the need for a punch biopsy in a substantial part of patients. Hence, BCC diagnosis and treatment can be accomplished in one day. As a result, patients experience less distress and costs can be saved. By discussing diagnosis and treatment with the patient directly, care can be provided more efficiently, preventing treatment delay and saving extra hospital visits. The investigators hypothesize that the use of OCT is a cost-effective strategy when compared to regular care (always punch biopsy). However, it is important to evaluate whether an alternative OCT guided diagnostic approach does not lead to an unacceptable increase in risk of recurrent BCC.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 598 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multi-centre randomised controlled non-inferiority trial
Masking: Single (Investigator)
Masking Description: The investigator is blinded for the result of the punch biopsy.
Primary Purpose: Diagnostic
Official Title: (Cost)-Effectiveness of Optical Coherence Tomography Versus Regular Punch Biopsy in the Diagnosis and Subtyping of Basal Cell Carcinoma: a Multi Center Randomized Non-inferiority Trial
Actual Study Start Date : February 26, 2019
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arms and Interventions
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Arm Intervention/treatment
Optical Coherence Tomography arm
In 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.
 Device: Optical Coherence Tomography

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.

Other Name: Vivosight, Michelson diagnostics
No Intervention: Regular care arm
In 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.


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of patients with treatment failure [ Time Frame: 12 months ]
    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.

  2. Cost-effectiveness of OCT [ Time Frame: 12 months ]
    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).


Secondary Outcome Measures :
  1. The proportion of patients with avoided biopsies [ Time Frame: 12 months ]
    What percentage of biopsies can be avoided in patients when using optical coherence tomography compared to regular care.

  2. Diagnostic performance of OCT [ Time Frame: 12 months ]
    The design of the study also enables evaluation of the ability of OCT to discriminate between BCC and non-BCC and between BCC subtypes (superficial, nodular and infiltrative BCC) using punch biopsy as reference standard. Diagnostic performance will be expressed as sensitivity, specificity, positive and negative predictive value. A receiver operating characteristic (ROC) curve with area under the curve (AUC) will also be calculated.

  3. Discrete Choice Experiment to determine patient preferences [ Time Frame: 2 months ]
    Patient preferences will be assessed by designing and conducting a discrete choice experiment.

  4. Quality of life measured with EQ-5D-5L [ Time Frame: Baseline, 12 months ]
    Quality of life will be evaluated using the 5-level EQ-5D version (EQ-5D-5L) questionnaire.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03848078


Locations
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Netherlands
Maastricht UMC+
Maastricht, Limburg, Netherlands, 6229 HX
Sponsors and Collaborators
Maastricht University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
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Principal Investigator: Klara Mosterd, MD, PhD Maastricht University Medical Center
More Information
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Publications:
NVDV, Dutch evidence based guideline Guideline Basal Cell Carcinoma.

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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT03848078    
Other Study ID Numbers: NL67571.068.18
80-85200-98-91060 ( Other Grant/Funding Number: ZonMw )
First Posted: February 20, 2019    Key Record Dates
Last Update Posted: February 25, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maastricht University Medical Center:
Basal Cell Carcinoma
Optical Coherence Tomography
Punch biopsy
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell