Basal Cell CarcinomaNCT06024629
cOCT Versus LC-OCT for Diagnosing Basal Cell Carcinoma: a Diagnostic Cohort Study
An observational study of Basal Cell Carcinoma, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Basal cell carcinoma (BCC) is the most common form of cancer among the Caucasian population. Equivocal BCC lesions are usually diagnosed by means of a punch biopsy, but since the last few decades, non-invasive imaging techniques for the diagnosis of BCC gained popularity within the field of dermatology. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Basal Cell Carcinoma
- What is being tested?
- cOCT and LC-OCT
- Type of treatment
- Medical device
- How many people
- 197 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Sep 2023to 1 Sep 2024
- Phase
- Observational
- 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
- Adult, Older adult
Study population: The study population will consist of patients visiting the outpatient clinic of Maastricht University Medical Center+ (MUMC+). All included patients (18+) will undergo a punch biopsie for their equivocal BCC lesion conform regular care.
Who may be able to join
- Patients (18+) with equivocal BCC lesions undergoing biopsy conform regular care
Who cannot join
- Patients unable to sign informed consent
- Patients with clinically evident BCC lesions who do not undergo biopsy
Trial locations and contacts
1 site in 1 country.
About this study
Basal cell carcinoma (BCC) is the most common form of cancer among the Caucasian population. Equivocal BCC lesions are usually diagnosed by means of a punch biopsy, but since the last few decades, non-invasive imaging techniques for the diagnosis of BCC gained popularity within the field of dermatology. Conventional optical coherence tomography (cOCT) is an example of a non-invasive imaging technique. Recent studies revealed that OCT assessors may achieve high diagnostic certainty and accuracy for diagnosing BCC. However, cOCT has a limited axial and lateral resolution and can therefore only visualize the gross architecture of the skin. It has been proposed that the diagnostic certainty and accuracy of cOCT could be optimized by improving the resolution. Line-field confocal optical coherence tomography (LC-OCT) is a new non-invasive imaging technique that provides tridimensional images of the skin with a cellular resolution. Although the resolution of LC-OCT is superior to cOCT, the penetration depth of LC-OCT (500µm) is limited compared to that of cOCT (1.0-1.5mm). In the proposed study, we aim to assess whether LC-OCT is superior to cOCT in terms of diagnostic accuracy for diagnosing BCC in equivocal BCC lesions.
- Conditions
- Basal Cell Carcinoma
- Being tested
- cOCT and LC-OCT
- Keywords
- Optical coherence tomography, Line-field confocal optical coherence tomography
- 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.
cOCT and LC-OCTDevice
cOCT: conventional optical coherence tomography (cOCT) is an established imaging modality within dermatology that enables visualization of the architecture of the skin with a penetration depth of 1.0 - 1.5mm.
LC-OCT: Line-field confocal optical coherence tomography (LC-OCT) is a new emerging diagnostic modality within the field of dermatology. LC-OCT enables tridimensional imaging of the skin with a cellular resolution and BCC features on LC-OCT have been described. However, the penetration depth of LC-OCT (500µm), is limited compared to the penetration depth of cOCT (1.0-1.5mm)
| Study group | Role | What they receive |
|---|---|---|
| Patients with equivocal BCC lesions | Patients with equivocal BCC lesions (18+ years) who will undergo biopsy conform regular care will undergo a cOCT and LC-OCT scan. Receives: Device: cOCT and LC-OCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of cOCT and LC-OCT
Diagnostic parameters such as sensitivity, specificity, PPV, NPV and DOR will be evaluated for diagnosing BCC in patients with equivocal lesions and compared between both imaging devices.
Measured: Measured before september 1st 2024
Secondary outcomes (1)
Diagnostic accuracy for BCC subtyping on cOCT and LC-OCT
Diagnostic parameter for differentiating BCC subtypes (sBCC/nBCC/iBCC) will be evaluated and compared between both imaging devices.
Measured: Measured before september 1st 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start1 Sep 2023
- Primary completion1 Feb 2024
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06024629
- Sponsor's protocol ID
- 2023-0086
- Status last verified
- Feb 2024
- First submitted
- 29 Aug 2023
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD may be shared upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- cOCT Versus LC-OCT for Diagnosing Basal Cell Carcinoma: a Diagnostic Cohort Study
- ClinicalTrials.gov ID
- NCT06024629
- Acronym / sponsor ID
- 2023-0086
- Conditions
- Basal Cell Carcinoma
- Keywords
- Optical coherence tomography, Line-field confocal optical coherence tomography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 6 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Basal cell carcinoma (BCC) is the most common form of cancer among the Caucasian population. Equivocal BCC lesions are usually diagnosed by means of a punch biopsy, but since the last few decades, non-invasive imaging techniques for the diagnosis of BCC gained popularity within the field of dermatology. Conventional optical coherence tomography (cOCT) is an example of a non-invasive imaging technique. Recent studies revealed that OCT assessors may achieve high diagnostic certainty and accuracy for diagnosing BCC. However, cOCT has a limited axial and lateral resolution and can therefore only visualize the gross architecture of the skin. It has been proposed that the diagnostic certainty and accuracy of cOCT could be optimized by improving the resolution. Line-field confocal optical coherence tomography (LC-OCT) is a new non-invasive imaging technique that provides tridimensional images of the skin with a cellular resolution. Although the resolution of LC-OCT is superior to cOCT, the penetration depth of LC-OCT (500µm) is limited compared to that of cOCT (1.0-1.5mm). In the proposed study, we aim to assess whether LC-OCT is superior to cOCT in terms of diagnostic accuracy for diagnosing BCC in equivocal BCC lesions.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with equivocal BCC lesions | – | Device: cOCT and LC-OCTPatients with equivocal BCC lesions (18+ years) who will undergo biopsy conform regular care will undergo a cOCT and LC-OCT scan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of patients visiting the outpatient clinic of Maastricht University Medical Center+ (MUMC+). All included patients (18+) will undergo a punch biopsie for their equivocal BCC lesion conform regular care.
Key inclusion criteria (1 listed)
- Patients (18+) with equivocal BCC lesions undergoing biopsy conform regular care
Key exclusion criteria (2 listed)
- Patients unable to sign informed consent
- Patients with clinically evident BCC lesions who do not undergo biopsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cOCT and LC-OCTcOCT: conventional optical coherence tomography (cOCT) is an established imaging modality within dermatology that enables visualization of the architecture of the skin with a penetration depth of 1.0 - 1.5mm. LC-OCT: Line-field confocal optical coherence tomography (LC-OCT) is a new emerging diagnostic modality within the field of dermatology. LC-OCT enables tridimensional imaging of the skin with a cellular resolution and BCC features on LC-OCT have been described. However, the penetration depth of LC-OCT (500µm), is limited compared to the penetration depth of cOCT (1.0-1.5mm) | Device | Patients with equivocal BCC lesions |
Primary outcome
Diagnostic accuracy of cOCT and LC-OCT
Time frame: Measured before september 1st 2024
Diagnostic parameters such as sensitivity, specificity, PPV, NPV and DOR will be evaluated for diagnosing BCC in patients with equivocal lesions and compared between both imaging devices.
1 secondary outcome
Diagnostic accuracy for BCC subtyping on cOCT and LC-OCT
Time frame: Measured before september 1st 2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
- Individual participant dataSharing planned: Undecided. IPD may be shared upon reasonable request
Related trials for Basal Cell Carcinoma
RecruitingPhase 2
Evaluation of Efficacy and Safety of Cemiplimab as First Line Treatment for Advanced Basal Cell Carcinoma (BCC) Patients
Basal Cell Carcinoma (BCC), First Line Treatment
RecruitingPhase 3
Basal Cell Carcinoma Chemoprevention Trial
Basal Cell Carcinoma
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Not yet recruitingPhase 2
A Study Comparing Cemiplimab-based Treatments for Adult Participants With Locally Advanced Basal Cell Skin Cancer (laBCC)
Locally Advanced Basal Cell Carcinoma
Enrolling by invitation
TruScore Standalone Clinical Study
Melanoma and Other Malignant Neoplasms of Skin, Basal Cell Carcinoma of Skin
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Basal Cell Carcinoma, 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 1 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 16 Feb 2024. 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?
Diagnostic accuracy of cOCT and LC-OCT (time frame: Measured before september 1st 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Feb 2024.