Basal Cell Carcinoma of SkinRELINCT07501780
Real-world Evaluation of the Implementation of LC-OCT in Daily Clinical Practice
An observational study of Basal Cell Carcinoma of Skin and Optical Coherence Tomography (OCT), run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Basal cell carcinoma (BCC) is the most common skin cancer in the Netherlands, with incidence rates continuing to rise. The current diagnostic standard combines clinical evaluation and dermoscopy, while biopsy followed by histopathological examination remains the gold standard when uncertainty about the diagnosis… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Basal Cell Carcinoma of Skin, Optical Coherence Tomography (OCT), Neoplasms
- How many people
- 297 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Jun 2026to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients with lesions clinically suspected for BCC who visited the Mohs Clinics between January 2025 and June 2025 and underwent LC-OCT imaging as part of the diagnostic work-up.
Who may be able to join
- Patients aged ≥18 years
- LC-OCT performed as part of diagnostic evaluation between January 2025 and June 2025 at Mohs clinics in the Netherlands
- Histopathological results (biopsy or excision) and/or 6-12 month clinical follow-up data available
Who cannot join
- Patients <18 years of age
- Cases without histopathological confirmation or available follow-up data
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Klara Mosterd, MD PhD contact
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University Medical Center +
Maastricht, Limburg, 6229HX
Yara Valkenburg, MD, +31(0)43- 387 7295, yara.valkenburg@mumc.nl
Klara Mosterd, MD PhD, +31(0)43- 387 7295
About this study
Official title: Real-world Evaluation of the Implementation of LC-OCT in Daily Clinical Practice: a Retrospective Observational Study
Basal cell carcinoma (BCC) is the most common skin cancer in the Netherlands, with incidence rates continuing to rise. The current diagnostic standard combines clinical evaluation and dermoscopy, while biopsy followed by histopathological examination remains the gold standard when uncertainty about the diagnosis persists. However, biopsy is invasive, time-consuming, and costly. Line-field confocal optical coherence tomography (LC-OCT) is a non-invasive imaging technique that has emerged as a promising alternative to biopsy for BCC suspected lesions.
This retrospective study aims to evaluate the real-world clinical performance of LC-OCT in routine dermatological practice, where it has been integrated into the diagnostic work-up for BCC-suspect lesions.
Read the detailed description
Basal cell carcinoma (BCC) is the most common type of skin cancer in the Netherlands, with its incidence having increased substantially in recent years. ). Over the past decades, non-invasive imaging techniques such as line-field confocal optical coherence tomography (LC-OCT) have emerged as promising alternatives to biopsy for the diagnosis of BCC. When BCC can be diagnosed with high confidence using (LC-)OCT, this may reduce the need for biopsies, accelerate treatment initiation, and improve healthcare efficiency. LC-OCT combines the principles of conventional optical coherence tomography (OCT) and reflectance confocal microscopy (RCM), enabling three-dimensional visualization of the skin at a cellular resolution.
Several studies have reported a high specificity of LC-OCT for identifying non-BCC lesions, ranging from 97-99%. In cases where BCC can be diagnosed with high confidence, biopsy may theoretically be omitted, meaning that treatment could be initiated promptly. Reported sensitivities for such "high-confidence" BCC diagnoses range from 95-100%.
Although the diagnostic accuracy of LC-OCT has been investigated extensively in research settings, evidence on its real-world clinical performance remains limited. This retrospective study aims to evaluate the clinical utility of LC-OCT in routine dermatological practice.
- Conditions
- Basal Cell Carcinoma of Skin, Optical Coherence Tomography (OCT), Neoplasms, Neoplasms, Basal Cell, Carcinoma, Basal Cell (BCC), Real-world Study
- Keywords
- Line-Field Optical Coherence Tomography, Real-world evaluation, Non-melanoma skin cancer
- Medical subject headings
- Carcinoma, Basal Cell, Neoplasms, Neoplasms, Basal Cell, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients wit BCC suspected lesions who underwent LC-OCT imaging | Patients with clinically suspected BCC lesions requiring biopsy who underwent LC-OCT imaging as part of routine clinical care at Mohs Clinics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor free survival
Tumor-free survival rate at 6-12 months follow-up among patients with lesion(s) clinically suspicious for BCC, who were treated based on an LC-OCT-guided diagnosis, with treatment success defined as the absence of residual or recurrent tumor.
Measured: From enrollment to end of treatment at 6-12 months.
Secondary outcomes (5)
Diagnostic accuracy for BCC detection
Diagnostic parameters (sensitivity, specificity, positive predictive value, negative predictive value, diagnostic odds ratio) will be estimated for diagnosis made by LC-OCT (with histopathology serving as reference standard).
Measured: From enrollment to end of treatment at 6-12 months.
Treatment strategies
Descriptive evaluation of treatment strategies following LC-OCT-guided diagnosis (ie surgical, topical).
Measured: From enrollment to end of treatment at 6-12 months.
Number of performed LC-OCT scans
Descriptive evaluation: number of LC-OCT scans performed
Measured: From enrollment to 6-12 months
Lesion characteristics
Descriptive: lesion characteristics (size, location)
Measured: At baseline
Proportion of biopsies omitted
Proportion of biopsies omitted
Measured: From enrollment to end of treatment at 6-12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start15 Jun 2026
- Primary completion15 Aug 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basal Cell Carcinoma of SkinStudies 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
- 297 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Mohs Klinieken
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07501780
- Sponsor's protocol ID
- METC2025-0250
- Acronym
- RELI
- Status last verified
- Oct 2026
- First submitted
- 16 Mar 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD may be shared with other researchers upon reasonable request. Requests will be evaluated on a case by case manner.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Evaluation of the Implementation of LC-OCT in Daily Clinical Practice: a Retrospective Observational Study
- ClinicalTrials.gov ID
- NCT07501780
- Acronym / sponsor ID
- RELI / METC2025-0250
- Conditions
- Basal Cell Carcinoma of Skin, Optical Coherence Tomography (OCT), Neoplasms, Neoplasms, Basal Cell, Carcinoma, Basal Cell (BCC), Real-world Study
- Keywords
- Line-Field Optical Coherence Tomography, Real-world evaluation, Non-melanoma skin cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 297 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Mohs Klinieken
- Study start
- 15 Jun 2026 (actual)
- Primary completion
- 15 Aug 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 30 Mar 2026 (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 skin cancer in the Netherlands, with incidence rates continuing to rise. The current diagnostic standard combines clinical evaluation and dermoscopy, while biopsy followed by histopathological examination remains the gold standard when uncertainty about the diagnosis persists. However, biopsy is invasive, time-consuming, and costly. Line-field confocal optical coherence tomography (LC-OCT) is a non-invasive imaging technique that has emerged as a promising alternative to biopsy for BCC suspected lesions.
This retrospective study aims to evaluate the real-world clinical performance of LC-OCT in routine dermatological practice, where it has been integrated into the diagnostic work-up for BCC-suspect lesions.
Detailed description
Basal cell carcinoma (BCC) is the most common type of skin cancer in the Netherlands, with its incidence having increased substantially in recent years. ). Over the past decades, non-invasive imaging techniques such as line-field confocal optical coherence tomography (LC-OCT) have emerged as promising alternatives to biopsy for the diagnosis of BCC. When BCC can be diagnosed with high confidence using (LC-)OCT, this may reduce the need for biopsies, accelerate treatment initiation, and improve healthcare efficiency. LC-OCT combines the principles of conventional optical coherence tomography (OCT) and reflectance confocal microscopy (RCM), enabling three-dimensional visualization of the skin at a cellular resolution.
Several studies have reported a high specificity of LC-OCT for identifying non-BCC lesions, ranging from 97-99%. In cases where BCC can be diagnosed with high confidence, biopsy may theoretically be omitted, meaning that treatment could be initiated promptly. Reported sensitivities for such "high-confidence" BCC diagnoses range from 95-100%.
Although the diagnostic accuracy of LC-OCT has been investigated extensively in research settings, evidence on its real-world clinical performance remains limited. This retrospective study aims to evaluate the clinical utility of LC-OCT in routine dermatological practice.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients wit BCC suspected lesions who underwent LC-OCT imaging | – | –Patients with clinically suspected BCC lesions requiring biopsy who underwent LC-OCT imaging as part of routine clinical care at Mohs Clinics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with lesions clinically suspected for BCC who visited the Mohs Clinics between January 2025 and June 2025 and underwent LC-OCT imaging as part of the diagnostic work-up.
Key inclusion criteria (3 listed)
- Patients aged ≥18 years
- LC-OCT performed as part of diagnostic evaluation between January 2025 and June 2025 at Mohs clinics in the Netherlands
- Histopathological results (biopsy or excision) and/or 6-12 month clinical follow-up data available
Key exclusion criteria (2 listed)
- Patients <18 years of age
- Cases without histopathological confirmation or available follow-up data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Tumor free survival
Time frame: From enrollment to end of treatment at 6-12 months.
Tumor-free survival rate at 6-12 months follow-up among patients with lesion(s) clinically suspicious for BCC, who were treated based on an LC-OCT-guided diagnosis, with treatment success defined as the absence of residual or recurrent tumor.
5 secondary outcomes
Diagnostic accuracy for BCC detection
Time frame: From enrollment to end of treatment at 6-12 months.
Treatment strategies
Time frame: From enrollment to end of treatment at 6-12 months.
Number of performed LC-OCT scans
Time frame: From enrollment to 6-12 months
Lesion characteristics
Time frame: At baseline
Proportion of biopsies omitted
Time frame: From enrollment to end of treatment at 6-12 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: Undecided. IPD may be shared with other researchers upon reasonable request. Requests will be evaluated on a case by case manner.
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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.
Klara Mosterd, MD PhD contact
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 of Skin and Optical Coherence Tomography (OCT), 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: looking for participants now, as of the sponsor's last update on 19 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yara Valkenburg, MD (+31(0)43- 387 7295, yara.valkenburg@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor free survival (time frame: From enrollment to end of treatment at 6-12 months.). 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 19 Oct 2026.