ClearMark Trial V1.0
Research type
Research Study
Full title
DERMOSCOPY VS STANDARD MARKING PRACTICES FOR THE COMPLETENESS OF EXCISION OF NON-MELANOMA SKIN CANCERS: A SINGLE-CENTRE RANDOMISED CONTROLLED TRIAL
IRAS ID
348080
Contact name
Joshua Totty
Contact email
Sponsor organisation
Hull University Teaching Hospitals NHS Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 11 months, 31 days
Research summary
This study aims to improve the success rate of removal surgery for a common type of skin cancer, called non-melanoma skin cancer (NMSC). We will compare two different methods of marking (drawing where to remove) the skin before removing the lump: the normal method using magnifying glasses (loupes) and theatre lights, and our proposed method using a handheld magnifying device called a dermatoscope.
NMSC is the most common cancer in the UK. Currently, around 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 effectively. If it does, it could reduce the need for more surgery or hospital visits.
Adults who are having skin cancer removed at Hull University Teaching Hospitals NHS Trust (HUTH) can take part in the study. A computer will randomly assign each participant to marking using the usual method, or the dermatoscope. The surgery itself will proceed as normal. After the procedure, patients will be asked to complete a short questionnaire about their experience. We will collect data from patients’ medical notes to check if the cancer was entirely removed. We will also look at 5-year recurrence of cancer, whether further treatments were needed, any problems from the marking process, how happy patients are with the process, and the time it takes to perform the marking.
Patients will be recruited at HUTH over the course of eighteen (18) months, but information will be collected and analysed for 5 years after the operation to answer all research questions. Participants will not need to attend any extra appointments or follow-up visits, as all information can be found in their patient records.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
24/YH/0215
Date of REC Opinion
25 Oct 2024
REC opinion
Favourable Opinion