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Clinical Trial NCT07501780 (RELI) for Basal Cell Carcinoma of Skin, Optical Coherence Tomography (OCT), Neoplasms, Neoplasms, Basal Cell, Carcinoma, Basal Cell (BCC), Real-world Study, Implementation is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Maastricht University Medical CenterReal-world Evaluation of the Implementation of LC-OCT in Daily Clinical Practice (RELI) 297 Non-Invasive Real-World Evidence
Clinical Trial NCT07501780 (RELI) is an observational study for Basal Cell Carcinoma of Skin, Optical Coherence Tomography (OCT), Neoplasms, Neoplasms, Basal Cell, Carcinoma, Basal Cell (BCC), Real-world Study, Implementation and is currently not yet recruiting. Enrollment is planned to begin on March 15, 2026 and continue until the study accrues 297 participants. Led by Maastricht University Medical Center, this study is expected to complete by December 1, 2027. The latest data from ClinicalTrials.gov was last updated on March 30, 2026.
Brief 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 persists. However, biopsy is invasive, time-consuming, and costly. Line-field confocal optical coherence t...Show More
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 ...Show More
Official Title
Real-world Evaluation of the Implementation of LC-OCT in Daily Clinical Practice: a Retrospective Observational Study
Conditions
Basal Cell Carcinoma of SkinOptical Coherence Tomography (OCT)NeoplasmsNeoplasms, Basal CellCarcinoma, Basal Cell (BCC)Real-world StudyImplementationOther Study IDs
- RELI
- METC2025-0250
NCT ID Number
Start Date (Actual)
2026-03-15
Last Update Posted
2026-03-30
Completion Date (Estimated)
2027-12-01
Enrollment (Estimated)
297
Study Type
Observational
Status
Not yet recruiting
Keywords
Line-Field Optical Coherence Tomography
Real-world evaluation
Non-melanoma skin cancer
Real-world evaluation
Non-melanoma skin cancer
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
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. | N/A |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | From enrollment to end of treatment at 6-12 months. |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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). | 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). | From enrollment to end of treatment at 6-12 months. |
Number of performed LC-OCT scans | Descriptive evaluation: number of LC-OCT scans performed | From enrollment to 6-12 months |
Lesion characteristics | Descriptive: lesion characteristics (size, location) | At baseline |
Proportion of biopsies omitted | Proportion of biopsies omitted | From enrollment to end of treatment at 6-12 months. |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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
- Patients <18 years of age
- Cases without histopathological confirmation or available follow-up data
Maastricht University Medical Center205 active studies to exploreMohs KliniekenStudy Central Contact
Contact: Yara Valkenburg, MD, +31(0)43- 387 7295, [email protected]
Contact: Klara Mosterd, MD PhD, +31(0)43- 387 7295
1 Study Locations in 1 Countries
Limburg
Maastricht University Medical Center +, Maastricht, Limburg, 6229HX, Netherlands
Yara Valkenburg, MD, Contact, +31(0)43- 387 7295, [email protected]
Klara Mosterd, MD PhD, Contact, +31(0)43- 387 7295