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BCC-One-Stop-Study

NCT07482956 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 290

Last updated 2026-03-19

No results posted yet for this study

Summary

Basal cell carcinoma (BCC) is the most common malignant skin tumour. The standard treatment is micrographically controlled surgery (MMS), which achieves high cure rates but requires considerable time and personnel. A key problem is the inadequate preoperative determination of tumour margins, which often leads to multiple cycles of excision.

The aim of this multicentre, prospective, randomised controlled intervention study is to evaluate line-field confocal optical coherence tomography (LC-OCT) for preoperative margin determination in BCC within the framework of MMS.

Research question:

Can preoperative LC-OCT-assisted margin marking increase the efficiency of MMS by reducing the number of excision cycles required without compromising oncological safety?

Methodology:

Approximately 290 patients with histologically confirmed BCC will be enrolled at five German centres and randomly assigned to either standard MMS or MMS with upstream LC-OCT margin determination. In the intervention group, the excision margin will be specifically extended if a tumour is detected in the LC-OCT.

Primary endpoint:

Number of MMS cycles required to achieve R0 resection.

Secondary endpoints:

Total duration of surgery, size of surgical defect, cosmetic outcome (POSAS), patient satisfaction and stress, sensitivity and specificity of LC-OCT compared to histopathology.

Significance:

The study addresses the clinical conflict of objectives between complete tumour removal and maximum tissue preservation. Successful implementation could optimise MMS through modern imaging, conserve surgical resources and improve patient care in the long term.

Conditions

Interventions

DIAGNOSTIC_TEST

Margin Mapping with Line-field confocal optical coherence tomography

Both groups undergo micrographically controlled excision (Mohs surgery) in accordance with standard procedure. Surgical margins are examined histopathologically as usual (e.g. Tübingen cake, Munich method). If tumour remnants are detected, re-excision (MMS cycle) is performed until the tumour is completely removed (R0). The difference in the intervention group is that they will receive preoperative (and if available) postoperative margin mapping of the BCC before surgery.

Sponsors & Collaborators

  • University Hospital Augsburg

    lead OTHER

Principal Investigators

  • Julia Welzel, MD · University Hospital Augsburg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2026-08-31
Completion
2027-12-31

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07482956 on ClinicalTrials.gov