Dermatoscopy Guided Resection for Skin Cancer

NCT ID: NCT06342297

Last Updated: 2024-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-14

Study Completion Date

2026-01-14

Brief Summary

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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

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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.

Conditions

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Basal Cell Carcinoma Cutaneous Squamous Cell Carcinoma Surgical Margin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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No dermatoscopy

Dermatoscopy not used in decision of surgical margin

Group Type NO_INTERVENTION

No interventions assigned to this group

Dermatoscopy

Dermatoscopy is used in decision of surgical margin

Group Type EXPERIMENTAL

Dermatoscopy

Intervention Type DEVICE

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

Interventions

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Dermatoscopy

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region Örebro County

OTHER

Sponsor Role lead

Responsible Party

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Fredrik Landström

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Örebro University Hospital

Örebro, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Fredrik Landström, MD, PhD

Role: CONTACT

019 602 14 68 ext. 0046

Facility Contacts

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Örebro U Hospital

Role: primary

0729655663

Other Identifiers

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OLL-1003043

Identifier Type: -

Identifier Source: org_study_id

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