Actively Recruiting

Phase 4
Age: 18Years +
All Genders
ID06627036

Dermoscopy Versus Standard Marking for Complete Removal of Keratinocyte Skin Cancers A Single-Center Randomized Controlled Trial Comparing Dermatoscope and Loupe Magnification Methods

Led by Hull University Teaching Hospitals NHS Trust · Updated on 2025-01-24

1376

Participants Needed

1

Research Sites

340 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating ways to improve surgical removal success for keratinocyte skin cancers, the most common form of skin cancer in the UK. This study compares two methods of marking the skin before surgery: the standard technique using magnifying glasses and theatre lights, and a newer approach using a handheld dermatoscope device. The goal is to see if dermatoscopy helps surgeons completely remove the cancer more often, which could reduce the need for additional treatments and hospital time. This trial is a phase 4 randomized controlled study conducted at a single center. Participants will be randomly assigned to have their skin lesion marked before surgery either by the usual method or using a dermatoscope, which provides high magnification and special lighting to better define lesion borders. Both groups will have the lesion borders marked with a pen according to established guidelines. Surgery will proceed as normal following marking. This study includes a pilot phase involving about 200 patients to assess recruitment rates, data collection feasibility, and any limitations in dermatoscope use on certain body areas. Throughout the study, researchers will collect medical records and pathology reports to determine if the cancer was completely removed, measured six weeks after surgery. Patients will also complete a short questionnaire about their experience. Additional long-term outcomes include cancer recurrence over five years, need for further treatments, marking process issues, patient satisfaction, and marking duration. The study monitors the completeness of excision as the primary outcome and aims to gather data to support future larger trials.

CONDITIONS

Official Title

Dermoscopy vs Standard Marking for the Completeness of Excision of Keratinocyte Skin Cancers: The ClearMark Trial

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older scheduled for excision of suspected non-melanoma skin cancer as part of day-case surgery at Hull University Teaching Hospitals
Not Eligible

You will not qualify if you...

  • Lesions inaccessible to dermatoscope use due to location or condition
  • Lesions initially assessed as benign or pigmented, not suspected keratinocyte skin cancer
  • Lesions planned for incisional, punch, or shave biopsy instead of excision
  • Lesions confirmed benign on pathology after excision
  • Patients who decline study participation
  • Patients unable to provide informed consent due to lack of mental capacity or other reasons

AI-Screening

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Trial Site Locations

Total: 1 location

1

Castle Hill Hospital

Hull, United Kingdom

Actively Recruiting

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Research Team

C

Christos Vosinakis

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

Frequently Asked Questions

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Dermoscopy Versus Standard Marking for Complete Removal of Keratinocyte Skin Cancers A Single-Center Randomized Controlled Trial Comparing Dermatoscope and Loupe Magnification Methods | DecenTrialz