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NCT06342297 Clinical Trial

Dermatoscopy Guided Resection for Skin Cancer

Basal Cell Carcinoma Clinical Trial

Official title:
Dermatoscopy Guided Resection Margins in Basal Cell Carcinoma and Cutaneos Squamous Cell Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06342297
Other study ID # OLL-1003043
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 14, 2024
Est. completion date January 14, 2026

Study information
Verified date March 2024
Source Region Örebro County
Contact Fredrik Landström, MD, PhD
Phone 019 602 14 68
Email fredrik.landstrom@regionorebrolan.se
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 400
Est. completion date January 14, 2026
Est. primary completion date December 15, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Dermatoscopy
Dermatoscopy used in decision of surgical margin before resection of basal cell carcinoma or cutaneous squamous cell carcinoma

Locations
Country Name City State
Sweden Örebro University Hospital Örebro

Sponsors (1)
Lead Sponsor Collaborator
Region Örebro County

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pathology resection side margin (radical/not radical) If the side margins in the pathology report is radical or not Pathology report usually within two weeks after surgery
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