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

NCT06627036 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1376

Last updated 2025-01-24

No results posted yet for this study

Summary

What is the study about? This study aims to improve the success rate of removal surgery for a common type of skin cancer. We will compare two different methods of marking (drawing where to remove) the skin before removing the lump: the normal method using magnifying glasses and theatre lights, and our proposed method using a handheld magnifying device called a dermatoscope.

Why is this study important? Skin cancer is the most common cancer in the UK. Currently, up to 10-11% of surgeries do not remove all of the cancer, which means patients may need more treatment. We do not know whether using a dermatoscope can help surgeons remove all of the cancer more often or not. If it does, it could prevent patients needing more surgery or time in hospital.

What will happen during the study? A computer will randomly allocate each participant to marking using the normal method, or using a dermatoscope. The surgery will then proceed as usual. After the surgery, patients will be asked to fill in a simple questionnaire about their thoughts. We will collect data from patients' notes to monitor the success of the surgery and any more treatments needed.

What will we measure? We will check participants records to see if the cancer was entirely removed. This is reported by a pathologist whenever a skin lump or bump is removed. In time, we will also look at 5-year recurrence of cancer, the need for additional treatments, any problems from the marking process, how happy patients are with the process, and the time it takes to perform the marking.

What is the pilot for? The study will need many hundreds of patients to pick up a meaningful result. Before we commit to recruiting this many people, we want to make sure that the way we run the study is acceptable. This means looking at the number of people we recruit each week, how easy it is to collect their data after their operation, and whether there are any areas that we can't use a dermatoscope, such as the curves around the eye, nose and ears. We will run the study in a smaller number of people (around 200) before deciding whether we can commit to recruiting everyone. This will also give us the chance to see whether we can run the study in more than one hospital.

Conditions

  • Keratinocyte Skin Cancer

Interventions

DEVICE

Dermatoscope

For participants in the dermoscopy group, the marking will also be done preoperatively with a marker pen, but the lesion borders will be determined using a dermatoscope. A peripheral margin based on BAD guidelines will be marked similarly.

Sponsors & Collaborators

  • Hull University Teaching Hospitals NHS Trust

    lead OTHER_GOV

Principal Investigators

  • Joshua Totty, MBBS MRCS PGCert MD(Res) FHEA · Hull York Medical School

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-21
Primary Completion
2026-05-31
Completion
2031-05-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06627036 on ClinicalTrials.gov