RecruitingPHASE4INTERVENTIONAL

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

This study, called the ClearMark Trial, looks at improving how common skin cancers (keratinocyte skin cancers) are removed during surgery. We're comparing two methods of marking the skin before the operation: the standard way using magnifying glasses, and a new way using a handheld magnifying device called a dermatoscope. Up to 1 in 10 surgeries for this type of cancer don't remove everything, which means patients might need more treatment. We want to find out if using a dermatoscope helps surgeons remove all the cancer more often, potentially saving patients from extra operations or hospital stays. Participants will be randomly assigned to one of the marking methods, and their progress will be followed to see if the cancer was fully removed.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

Hull University Teaching Hospitals NHS Trust

Enrolment target

1,376

Start

21 Nov 2024

Estimated completion

31 May 2031

Keratinocyte Skin Cancer

What is this study about?

This study is called the ClearMark Trial, and it's all about improving surgery for a very common type of skin cancer. These are known as keratinocyte skin cancers, and they include basal cell carcinoma and squamous cell carcinoma. We want to see if a special magnifying tool, called a dermatoscope, can help surgeons mark the area to be removed more accurately before your operation, compared to the usual method of using magnifying glasses.

Skin cancer is the most common cancer in the UK. Unfortunately, sometimes after surgery, it's found that not all of the cancer cells were removed. This happens in about 10-11% of cases, which means those patients might need another operation or more treatment. We don't currently know if using a dermatoscope to mark the area before surgery can help improve these numbers. If it does, it could be a real benefit, potentially preventing you from needing further surgery or more time in hospital.

This study will first run as a smaller 'pilot' to make sure everything works smoothly before we involve many more people. We'll check how easy it is to recruit patients, collect information, and identify any areas of the body where a dermatoscope might not be suitable (like around the eyes or nose). This pilot will involve around 200 people, and if successful, we'll then recruit many hundreds more to get a very clear answer about whether using a dermatoscope makes a difference.

Key takeaways

Aims to improve success of common skin cancer removal surgery.
Compares standard marking to marking with a special magnifying tool (dermatoscope).
Could reduce the need for more surgery for patients.
Participation involves random assignment to a marking method and a short questionnaire.
Study will follow up on surgical success over five years.
First phase is a 'pilot' study with around 200 patients to test the process.

Who may be eligible?

You might be able to take part in this study if you are 18 years old or older and are scheduled to have a suspected common skin cancer removed by surgery as a day patient at Hull University Teaching Hospitals.

However, you won't be able to join if the area of skin cancer is in a place where it's difficult to use the dermatoscope, or if the initial checks suggest your lesion isn't actually a common skin cancer. You also won't be eligible if you're having a small sample (biopsy) taken rather than the whole lesion removed, or if you prefer not to take part or are unable to understand and agree to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you having a suspected common skin cancer removed?
Is your surgery planned as a day case at Hull University Teaching Hospitals?
Can you give informed agreement to take part in the study?
Is your skin cancer in a place that a dermatoscope could be used?

Answer every question to see your result.

What does participation involve?

If you decide to take part, a computer will randomly choose whether your skin cancer will be marked using the usual method (magnifying glasses) or with the special magnifying tool (dermatoscope). Your surgeon will then proceed with the operation as they normally would. After your surgery, you’ll be asked to fill in a simple questionnaire about your experience and thoughts. The study team will also look at your hospital notes to see how successful your surgery was and if you needed any further treatments. We'll be looking to see if the entire cancer was removed and also if there were any problems from the marking process. We will also follow up over time to see if the cancer comes back after five years. Your total participation will last for at least five years, as we monitor your health records, but your active involvement (the questionnaire) is a one-off.

Potential risks and benefits

Taking part in this study could help improve how common skin cancers are treated in the future, potentially reducing the need for more surgeries for patients. You will receive the same high standard of care regardless of which marking method is used. There are no additional risks from the marking method itself beyond those usually associated with skin cancer surgery. Your participation is completely voluntary, and you are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Castle Hill Hospital
Verified postcode
Hull, United Kingdom· Recruiting

Common questions

What is a keratinocyte skin cancer?

It's a common type of skin cancer, including basal cell carcinoma and squamous cell carcinoma. They usually grow slowly and are often linked to sun exposure.

What is a dermatoscope?

It's a handheld magnifying device that doctors use to look at skin more closely, often to examine moles or skin lesions.

Will I know which marking method I'm getting?

No, a computer will randomly choose the method for you to ensure the study is fair and unbiased. Your surgeon will not choose.

What if the cancer isn't fully removed?

Regardless of the study, if the cancer isn't fully removed, your medical team will discuss the best next steps for your treatment, which may include further surgery.

How long will I be involved in the study?

Your direct involvement (like filling out a questionnaire) is short, but we will look at your health records for up to five years to see the long-term results of your surgery.

How to find out more

Christos Vosinakis

hyp-tr.hullplasticsresearch@nhs.net 01482622185 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.