Dermoscopy vs. Standard Marking Practices for the Completeness of Excision of Keratinocyte Skin Cancers: a Single-centre Randomised Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 1,376
- 试验地点
- 1
- 主要终点
- Excision completeness at the lateral margin
研究概览
简要总结
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.
详细描述
5 BACKGROUND AND RATIONALE 5.1.1 DESCRIPTION OF THE CONDITION Non-melanoma skin cancer (NMSC), also known as keratinocyte skin cancer (KSC), is the most prevalent cancer worldwide, particularly affecting fair-skinned individuals who lack protective skin pigment. In the United Kingdom (UK), the lifetime risk of developing keratinocyte skin cancer is 1 in 4 for men and 1 in 5 for women. The two primary types of keratinocyte cancer are basal cell carcinoma (BCC) and cutaneous squamous cell carcinoma (cSCC), accounting for approximately 80% and 20% of cases, respectively. Other rare types of skin cancer, such as Merkel cell carcinoma (MCC) and adenocarcinoma originating from skin gland cells, each constitute about 0.2% to 0.4% of all NMSCs.
BCCs generally develop after intense ultraviolet (UV) exposure during childhood and adolescence, whereas cSCCs are associated with cumulative UV exposure and chronic sun damage. The incidence of NMSC is rapidly increasing globally, with the UK experiencing an 8% annual rise. The incidence of cSCC appears to be growing faster than BCC, particularly among elderly men who have accumulated substantial sun damage over their lifetimes. This rise in incidence is primarily due to increased exposure to UV radiation, both from the sun and artificial sources like tanning beds.
Other significant risk factors for NMSC include advancing age, male gender, fair skin (Fitzpatrick types I and II), a history of skin cancer or severe sunburn, immunosuppression, family history of skin cancer, and exposure to carcinogens such as arsenic and ionizing radiation. However, the true incidence of NMSC is uncertain due to underreporting and inconsistencies in registration practices. In many countries, NMSCs are not always documented, and patients with multiple lesions may be registered only once, leading to a potential underestimation of the actual burden.
Despite their low mortality rates, NMSCs cause significant morbidity and represent a growing economic burden on healthcare systems worldwide (3). They frequently appear on the head and neck, where they can cause considerable local tissue destruction and disfigurement if treatment is inadequate or delayed. While BCCs are generally localized and rarely metastasize, cSCCs have the potential to spread to distant sites and become fatal.
The typical presentation of NMSC includes ulcers, nodules, or scaly patches that do not heal and continue to grow at varying rates. These lesions may bleed, itch, or cause significant local destruction. BCCs predominantly arise on the head, face, and neck, though some subtypes, such as superficial BCCs, are more common on the trunk and legs. Conversely, cSCCs typically occur on sun-exposed areas of the face, such as the ears, lips, and scalp, as well as on the neck, shins, and dorsum of the hands and forearms. However, both types can potentially develop anywhere on the body.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older who are scheduled for the excision of a suspected non-melanoma skin cancer lesion as part of a day-case surgery list at Hull University Teaching Hospitals are eligible for inclusion in the study.
排除标准
- •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.
结局指标
主要结局
Excision completeness at the lateral margin
时间窗: Measured on histology reports available 6 weeks post-operatively
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.
次要结局
- 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)