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临床试验/NCT03169036
NCT03169036已完成不适用

Melanomas Excised in Primary Care vs Secondary Care Excision

University of Aberdeen0 个研究点目标入组 9,367 人开始时间: 2015年7月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
9,367
主要终点
All-cause mortality

研究概览

简要总结

Melanoma is the most dangerous skin cancer and is becoming commoner, largely due to increased foreign holidays and use of sun-beds. Melanoma usually begins as a new or changing mole. If it is picked-up quickly enough it can be removed in a simple operation and effectively cured. GPs can do this operation and many are highly experienced and skilled in minor skin surgery. However, guidelines written by hospital specialists insist that all patients who might have a melanoma should not be treated by GPs, but should be referred to hospital. This contrasts with Australia, where melanoma is commoner and initial treatment by GPs is standard practice. This creates several potential problems. First, melanoma can be difficult to diagnose. Many moles that do not look concerning based on checklists do turn out to be melanoma, and the opposite frequently occurs too, moles that look worrying at initial examination are not melanoma. Second, people are becoming more skin aware and GPs are checking moles much more often. Sensibly many of these patients are being sent to hospital for a check, although most will not have melanoma. Third, as a result hospital skin clinics and minor surgery lists are becoming very busy and waiting times are ever increasing. Fourth, the many people who have a melanoma that is not clinically obvious are waiting an increasingly long time to have it diagnosed and treated in hospital, and this could actually mean that melanoma has more chance to spread while they wait. The investigators conducted studies on 1200 people diagnosed with a melanoma in Northeast Scotland between 1991 and 2008 and found that 20% of these people had had their melanoma diagnosed and first treated by their GP. These patients were no more likely to receive improper treatment than those that had been referred to hospital. Also people who had had their melanoma cut out by a GP were no more likely to die from melanoma, and they actually required less hospital visits afterward. This suggests that the guidelines could be changed to allow GPs to treat suspicious moles. The investigators think this will be better for patients and the NHS in the long-run. However, the investigators cannot recommend changes to the guidelines on the basis of local research. For this reason, the investigators wish to extend the study using data from 18,000 patients diagnosed with melanoma from across Scotland. The results of this inclusive study will inform how the health service should deal with the growing problem of suspicious moles in the future.

详细描述

Cutaneous melanoma is increasing in incidence. UK incidence has quadrupled since 1970. With corresponding increased public skin cancer awareness, GPs are frequently asked to examine pigmented lesions. Definitively diagnosing melanoma on clinical features alone is extremely challenging and many lesions exhibiting worrying features require a skin biopsy. Existing guidelines discourage initial primary care biopsy of suspicious skin lesions despite evidence that it leads to earlier diagnosis and may benefit patients and the NHS.

Results from Previous Research To the investigators conducted the first blinded study comparing relative performance of primary and secondary care in excising melanomas and found patients receiving initial excision of melanoma in primary care were no more likely to have it inadequately excised than those initially biopsied in secondary care. In a further study, we found that patients receiving their initial diagnostic excision biopsy for melanoma in primary versus secondary care were no more likely to be dead, or to have died of metastatic malignant melanoma. Patients who had their initial diagnostic excision biopsy for melanoma in primary care had significantly fewer subsequent hospital admissions and spent fewer days in hospital.

Aims

  1. To determine whether there is any difference in mortality for people diagnosed with cutaneous melanoma in Scotland between 2005-2013 following initial excision in primary versus secondary care.
  2. To determine whether there is any difference in morbidity following initial excision in primary versus secondary care.

Research Questions

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

性别
All
接受健康志愿者

入选标准

  • A diagnosis of malignant melanona

排除标准

  • 未提供

结局指标

主要结局

All-cause mortality

时间窗: Until December 2015

次要结局

  • Number of hospital outpatient attendances(Until December 2015)
  • Number of hospital admissions(Until December 2015)
  • Melanoma specific mortality(Until December 2015)

研究者

申办方类型
Other
责任方
Sponsor

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