Clinical Research Directory

BCC-One-Stop-Study

Sponsor: University Hospital Augsburg

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.

Official title: Multicentre, Interventional Prospective Study to Evaluate the Efficiency of Pre- and Postoperative Margin Determination of Basal Cell Carcinomas Using Optical Coherence Tomography and Line-field Confocal Optical Coherence Tomography During Micrographically Controlled Surgery

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Locations (5)