BCC-One-Stop-Study
ConditionBasal Cell Carcinoma
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital Augsburg
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Margin Mapping with Line-field confocal optical coherence tomography
Diagnostic testBoth 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.
Treatment groups
290 Participants
are divided into 2 treatment groupsGroup A: Intervention group (LC-OCT)Experimental treatment 1 intervention
Group B: Control group (standard MMS)No intervention 0 interventions
Trial outcomes
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.
Time frame
On the day of surgery (Day 0), after the first histopathological margin assessmentSecondary outcomes
1
Total duration of the surgical procedure
Total duration of the surgical procedure (in minutes) → Recorded from the incision to the end of the operation.
Time frame
intraoperatively, on the day of surgery (Day 0)2
Area of the surgical defect after complete tumour removal
Area of the surgical defect after complete tumour removal (in cm²) → Documented for the purpose of assessing tissue preservation.
Time frame
after the last excision, before wound closure3
Cosmetic outcome of the scar
Cosmetic outcome of the scar (e.g. using Patient and Observer Scar Assessment Scale (POSAS)). The observer scale of the POSAS consists of six items (vascularity, pigmentation, thickness, relief, pliability and surface area). All items are scored on a scale ranging from 1 ('like normal skin') to 10 ('worst scar imaginable'). The sum of the six items results in a total score of the POSAS observer scale. Categories boxes are added for each item. Furthermore, an overall opinion is scored on a scale ranging from 1 to 10. All parameters should preferably be compared to normal skin on a comparable anatomic location. → Assessment after a defined post-operative period.
Time frame
at follow-up 2, approx. week 6-124
Patient satisfaction
Patient satisfaction → Determined by validated questionnaire (e.g. Likert scale for subjective evaluation of the process and result). A 5-point Likert scale is a popular rating scale for surveys that uses five options to measure opinions, attitudes, or perceptions, typically ranging from "Strongly Disagree" to "Strongly Agree," with a neutral option in the middle.
Time frame
week 6-12Other outcomes
1
The proportion of each BCC subtype (nodular, superficial, or infiltrative BCC) if BCC was not excised in a one-step operation.
For lesions in which (LC)-OCT margin assessment did not result in a one-step operation, the proportion of each BCC subtype (nodular, superficial, or infiltrative BCC) should be determined.
Time frame
within 7 days after surgery2
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.
For lesions in which (LC)-OCT margin assessment did not result in a one-step operation, the proportion of BCCs whose margins in the first surgical step were not tumor-free (i) laterally and (ii) in depth should be determined.
Time frame
within 7 days after surgery3
Anatomical Location of Skin Lesions Assessed by LC-OCT Imaging
For lesions in which (LC)-OCT margin assessment did not result in a one-step operation, it should be assessed, whether the anatomical location had an influence. The anatomical location of each included skin lesion will be documented using standardized dermatological body site mapping (International Classification of Anatomical Sites for Dermatology). Assessment will be performed by line-field confocal optical coherence tomography (LC-OCT), which provides high-resolution vertical and horizontal images of epidermal and dermal structures. For each lesion, the exact body site (e.g., face - nasal sidewall; trunk - upper back; extremities - dorsal forearm) will be recorded according to the predefined anatomical site categories.
Time frame
Baseline (Day 0)Sponsors and contacts
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Source ClinicalTrials.gov
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