Real-world Evaluation of the Implementation of LC-OCT in Daily Clinical Practice

NCT07501780 | Not Yet Recruiting

• 1 other identifier: METC2025-0250
• Study Type: observational
• Target: 297
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Basal Cell Carcinoma of Skin; Optical Coherence Tomography (OCT); Neoplasms; Neoplasms, Basal Cell; Carcinoma, Basal Cell (BCC); Real-world Study; Implementation

Keywords

Line-Field Optical Coherence Tomography; Real-world evaluation; Non-melanoma skin cancer

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (5)

• Diagnostic accuracy for BCC detection

  From enrollment to end of treatment at 6-12 months.

• Treatment strategies

  From enrollment to end of treatment at 6-12 months.

• Number of performed LC-OCT scans

  From enrollment to 6-12 months

• Lesion characteristics

  At baseline

• Proportion of biopsies omitted

  From enrollment to end of treatment at 6-12 months.

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• Patients \<18 years of age
• Cases without histopathological confirmation or available follow-up data

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Mohs Klinieken: collaborator

Study Sites (1)

Maastricht University Medical Center +

Maastricht, Limburg, 6229HX, Netherlands

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell; Neoplasms; Neoplasms, Basal Cell; Carcinoma

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Central Study Contacts

Yara Valkenburg, MD

CONTACT

+31(0)43- 387 7295; yara.valkenburg@mumc.nl

Klara Mosterd, MD PhD

CONTACT

+31(0)43- 387 7295

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 30, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): March 15, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

NL (1)