BCC-One-Stop-Study

NCT07482956 | Not Yet Recruiting

• 1 other identifier: BCC-One-Stop-Study
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 5

Brief 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

Basal Cell Carcinoma

Keywords

basal cell carcinoma; line-field confocal optical coherence tomography; BCC; LC-OCT; Mohs micrographic surgery; MMS; margin mapping; margin assessment; skin cancer; one stop shop

Outcome Measures

Primary Outcomes (1)

• Number of surgical excision cycles (MMS cycles) required until complete tumour removal

  Primary endpoints: Number of surgical excision cycles (MMS cycles) required until complete tumour removal (R0 status). This target parameter is directly related to the main question of whether preoperative margin assessment using LC-OCT increases the efficiency of MMS. A significant difference (e.g. fewer MMS cycles in the intervention group) would prove that the image-guided procedure is more effective.

  On the day of surgery (Day 0), after the first histopathological margin assessment

Secondary Outcomes (7)

• Total duration of the surgical procedure

  intraoperatively, on the day of surgery (Day 0)

• Area of the surgical defect after complete tumour removal

  after the last excision, before wound closure

• Cosmetic outcome of the scar

  at follow-up 2, approx. week 6-12

• Patient satisfaction

  week 6-12

• Correlation between LC-OCT findings and histopathological margin status

  within 7 days after surgery

Other Outcomes (3)

• The proportion of each BCC subtype (nodular, superficial, or infiltrative BCC) if BCC was not excised in a one-step operation.

  within 7 days after surgery

• the proportion of BCCs whose margins in the first surgical step were not tumor-free (i) laterally and (ii) in depth if BCC was not excised in a one-step operation.

  within 7 days after surgery

• Anatomical Location of Skin Lesions Assessed by LC-OCT Imaging

  Baseline (Day 0)

Study Arms (2)

Intervention group (LC-OCT)

EXPERIMENTAL

Preoperative tumour margin assessment using LC-OCT with targeted extension of resection margins in cases where imaging reveals tumour evidence.

Diagnostic Test: Margin Mapping with Line-field confocal optical coherence tomography

Control group (standard MMS)

NO INTERVENTION

Conventional clinical/dermatoscopic margin determination, as is customary in everyday clinical practice.

Interventions

Margin Mapping with Line-field confocal optical coherence tomography DIAGNOSTIC_TEST

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.

Intervention group (LC-OCT)

Eligibility Criteria

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

You may qualify if:

• Adults (≥18 years) with basal cell carcinoma (BCC) scheduled for Mohs micrographic surgery (MMS),
• Diagnosis confirmed by dermoscopy and histopathology or optical coherence tomography (OCT),
• No limitation regarding tumor size or BCC subgroups.

You may not qualify if:

• Poor LC-OCT image quality,
• Incomplete adherence to the study protocol,
• Previous treatment of the BCC,
• Anatomical sites that are difficult to access with LC-OCT (e.g., inner ear, medial canthus of the eye).

Sponsors & Collaborators

• University Hospital Augsburg: lead

Study Sites (5)

University Hospital Augsburg

Augsburg, Germany

Location

University Hospital Dresden

Dresden, Germany

Location

University Hospital Erlangen

Erlangen, Germany

Location

Ludwig Maximilian University Hospital

Munich, Germany

Location

München Klinik

Munich, Germany

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell; Skin Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Julia Welzel, MD

  University Hospital Augsburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julia Welzel, MD

CONTACT

00498214007401; julia.welzel@uk-augsburg.de

Sandra Schuh, MD, M.Sc.

CONTACT

0049821400167508; sandra.schuh@uk-augsburg.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: March 19, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (5)