NCT06342297

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 14, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 2, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2026

Completed
Last Updated

April 2, 2024

Status Verified

March 1, 2024

Enrollment Period

1.9 years

First QC Date

March 26, 2024

Last Update Submit

March 26, 2024

Conditions

Basal Cell CarcinomaCutaneous Squamous Cell CarcinomaSurgical Margin

Keywords

Dermatoscopy

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

No dermatoscopy

NO INTERVENTION

Dermatoscopy not used in decision of surgical margin

Dermatoscopy

EXPERIMENTAL

Dermatoscopy is used in decision of surgical margin

Device: Dermatoscopy

Interventions

DermatoscopyDEVICE

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

Dermatoscopy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Örebro University Hospital

Örebro, 70375, Sweden

RECRUITING

MeSH Terms

Conditions

Carcinoma, Basal CellMargins of Excision

Interventions

Dermoscopy

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Basal CellMorphological and Microscopic FindingsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Intravital MicroscopyMicroscopyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Central Study Contacts

Fredrik Landström, MD, PhD

CONTACT

019 602 14 68fredrik.landstrom@regionorebrolan.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

March 26, 2024

First Posted

April 2, 2024

Study Start

January 14, 2024

Primary Completion

December 15, 2025

Study Completion

January 14, 2026

Last Updated

April 2, 2024

Record last verified: 2024-03

Locations

SE(1)