Dermatoscopy Guided Resection for Skin Cancer

Not Applicable

Recruiting

• Conditions: Basal Cell Carcinoma; Cutaneous Squamous Cell Carcinoma; Surgical Margin
• Interventions: Device: Dermatoscopy

• Registration Number: NCT06342297
• Lead Sponsor: Region Örebro County

Brief Summary

In this randomizid controlled trial the aim is to use dermatoscopy in deciding the resection margin for patients with suspected or verified basal cell carcinoma or cutaneous squamous cell carcinoma. The outcome is radical/non radical resection of the lateral margins in the pathology report.

Detailed Description

In basal cell carcinoma and especially cutaneous squamous cell carcinoma the prognosis is very good if the tumour is radically removed in the primary resection. In this study we propose that the use of dermatoscopy in deciding the surgical margins can increase the proportion of radically removed tumours. In this randomized clinical trial the use of dermatoscopy in deciding the surgical margins in patients with suspected or verified basal cell carcinoma or cutaneous squamous cell carcinoma is assessed. The outcome measure is radical/non radical resection of the lateral margins. In the control group dematoscopy is not used in deciding the surgical margin. 400 patients with suspected or verified BCC or cSCC will be included, 200 in each group.

Study Timeline

• Study Start: 2024-01-14
• Status Verified: 2024-03
• Study First Submitted: 2024-03-26
• Study First Submitted QC: 2024-03-26
• Last Update Submitted: 2024-03-26
• Study First Posted: 2024-04-02
• Last Update Posted: 2024-04-02
• Primary Completion: 2025-12-15
• Study Completion: 2026-01-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Patients with primary suspected or verified basal cell carcinoma or cutaneous cell carcinoma

Exclusion Criteria

• Recurrent tumours
• Previous radiotherapy of the tumour area
• If the patient cannot understand the study i nformation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dermatoscopy	Dermatoscopy	Dermatoscopy is used in decision of surgical margin

Primary Outcome Measures

Name	Time	Method
Pathology resection side margin (radical/not radical)	Pathology report usually within two weeks after surgery	If the side margins in the pathology report is radical or not

Trial Locations

Locations (1)

Örebro University Hospital; 🇸🇪 Örebro, Sweden