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

NCT06627036 | Recruiting Phase 4

• 1 other identifier: To be confirmed
• Study Type: interventional
• Target: 1,376
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Keratinocyte Cancer; Skin Cancer; Loupe magnification; Dermoscopy

Outcome Measures

Primary Outcomes (1)

• Excision completeness at the lateral margin

  The primary outcome will assess the completeness of excision at the peripheral margin, confirmed by histological examination of the skin lesion, for patients undergoing excision biopsy of suspected keratinocyte skin cancer. As dermoscopy can only assess up to the depth of the reticular dermis, the completeness of excision at the deep margin will not be evaluated in this study.

  Measured on histology reports available 6 weeks post-operatively

Secondary Outcomes (5)

• 5 Year Recurrence Rate

  5 years

• 5 Year additional treatment rate

  5 years

• Adverse Events relating to lesion marking

  During the time of the procedure and for up to 3 hours post-operatively

• Patient acceptability and satisfaction

  During the time of procedure, measured within 1 hour of the end of the surgical procedure

• Time required for marking

  The interval from the patient entering the theatre to knife-to-skin

Study Arms (2)

Intervention - Dermoscopy

EXPERIMENTAL

Those allocated to this arm will have their suspicious skin lesion marked using a dermatoscope - a commercially available CE marked medical device used to magnify skin lesions and examine them with polarised light, in order to better characterise their borders and features

Device: Dermatoscope

Control - Loupe magnification

NO INTERVENTION

Those allocated to this arm will have their suspicious skin lesion marked using the conventional method of surgical loupe magnification (2.5x - 3.5x) and theatre lights

Interventions

Dermatoscope DEVICE

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.

Intervention - Dermoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Lesions that are inaccessible to dermoscopic assessment due to anatomical locations or conditions that prevent effective use of the dermatoscope.
• Lesions that are determined to be benign or pigmented upon initial evaluation and therefore do not meet the criteria for suspected keratinocyte skin cancer.
• Lesions scheduled for incisional, punch, or shave biopsy procedures, as these methods do not provide complete peripheral margin clearance.
• Lesions that are histologically confirmed as benign following excision and examination by a pathologist.
• Patients who decline to participate in the study.
• Patients who are unable to provide informed consent due to a lack of mental capacity or other reasons.

Sponsors & Collaborators

• Hull University Teaching Hospitals NHS Trust: lead

Study Sites (1)

Castle Hill Hospital

Hull, United Kingdom

RECRUITING

MeSH Terms

Conditions

Skin Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Joshua Totty, MBBS MRCS PGCert MD(Res) FHEA

  Hull York Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christos Vosinakis

CONTACT

01482622185; hyp-tr.hullplasticsresearch@nhs.net

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 4, 2024
• Study Start: November 21, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2031
• Last Updated: January 24, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: IPD will be available for the duration of the study and for up to 3 years following publication in a peer reviewed journal.

Locations

GB (1)