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Basal Cell CarcinomaROCTINCT03848078

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

A study testing Optical Coherence Tomography in people with Basal Cell Carcinoma and Optical Coherence Tomography, run by Maastricht University Medical Center at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Optical Coherence Tomography
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
598 participants
Where
1 siteNetherlands
Study dates
26 Feb 2019to Oct 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Maastricht UMC+

    Maastricht, Limburg, 6229 HX

Other trials in Netherlands

About this study

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

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).

Read the 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.

Being tested
Optical Coherence Tomography
Keywords
Basal Cell Carcinoma, Optical Coherence Tomography, Punch biopsy
Medical subject headings
Carcinoma, Basal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Optical Coherence TomographyDevice

    Also called Vivosight, Michelson diagnostics

    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.

Study groups in NCT03848078
Study groupRoleWhat they receive
Optical Coherence Tomography armOtherIn 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.
Receives: Device: Optical Coherence Tomography
Regular care armNo 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 months

  2. 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).

    Measured: 12 months

Secondary outcomes (4)

  1. The proportion of patients with avoided biopsies

    What percentage of biopsies can be avoided in patients when using optical coherence tomography compared to regular care.

    Measured: 12 months

  2. Diagnostic performance of OCT

    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.

    Measured: 12 months

  3. Discrete Choice Experiment to determine patient preferences

    Patient preferences will be assessed by designing and conducting a discrete choice experiment.

    Measured: 2 months

  4. Quality of life measured with EQ-5D-5L

    Quality of life will be evaluated using the 5-level EQ-5D version (EQ-5D-5L) questionnaire.

    Measured: Baseline, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2019
  2. Study start26 Feb 2019
  3. Primary completion31 Aug 2021 (estimated)
  4. Study completionOct 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Model description
Multi-centre randomised controlled non-inferiority trial
Masking
Single blind
Who is masked
Investigator
Enrolment
598 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03848078
Sponsor's protocol ID
NL67571.068.18
Other IDs
80-85200-98-91060
Acronym
ROCTI
Status last verified
Feb 2021
First submitted
19 Feb 2019
Last updated
25 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 21264452

  • Cheng 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.

    PubMed 26211438

  • NVDV, Dutch evidence based guideline Guideline Basal Cell Carcinoma.

  • Adan 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.

    PubMed 35835136

Questions about this trial

What is this clinical trial studying?

A study testing Optical Coherence Tomography in people with Basal Cell Carcinoma and Optical Coherence Tomography, run by Maastricht University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients with treatment failure (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03848078, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2021.

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