Clinical Diagnosis Versus Histological Diagnosis by Punch Biopsy to Determine the Subtype of Basal Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Diagnostic value of punch biopsy
研究概览
简要总结
Skin cancer is the most common cancer in Caucasians. Basal cell carcinoma (BCC) is the most frequent skin cancer with around 44.000 new tumours per year in the Netherlands, and its incidence is still rising. Prior to treatment, a punch biopsy (PB) is taken from the suspected lesion, in order to determine the subtype of BCC. There are three different histological subtypes of BCC, from least to most aggressive: superficial, nodular and aggressive. Based on the most aggressive subtype seen in the PB, a suitable surgical margin is chosen. Surgical excision (SE) is the treatment of first choice in all BCC subtypes according to the Dutch guidelines. Recent developments of non-invasive therapies for superficial BCC might be the first choice of treatment in the future. These non-invasive treatments (photodynamic therapy (PDT), Imiquimod and 5-fluorouracil (5-FU)) have better cosmetic results than SE and are therefore also used in the Maastricht University Medical Center. Drawback is a higher recurrence rate than SE. As nodular and aggressive subtypes grow deeper into the dermis, they have to be treated with SE with a 3 mm and 5 mm margin respectively. If BCC are located in the H-zone, the treatment will be Mohs micrographic surgery (MMS). Unfortunately, 30% of subtypes seen in the PB do not correspond with the subtype seen in the subsequent SE/MMS. The consequence is overtreatment and undertreatment. A potential better or equal way to determine the BCC subtype might be the clinical diagnosis. To our knowledge, there is no literature about the diagnostic value of the clinical diagnosis to determine the subtype of BCC seen in the SE/MMS specimen. We want to confirm the hypothesis that the clinical diagnosis is as good as, or even better than the histological diagnosis by PB to determine the BCC subtype in the subsequent SE/MMS. In this case, patients don't have to undergo an extra procedure, diagnostic route is shortened.
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Primary objective: to establish the observed agreement of clinical diagnosis compared to histological diagnosis by to determine the most aggressive subtype of BCC
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Secondary objectives: inter-observer and intra-observer variability of dermatologists and pathologists to determine subtype BCC.
详细描述
- Basal cell carcinoma throughout the world:
Skin cancer is the most common form of cancer, with basal cell carcinoma (BCC) being the most frequent form of all skin cancers, and the incidence is still rising without future signs of a plateau. Because there is no national registry for BCC in the Netherlands, incidence rates are derived from the only register centre in the southern part of our country. From a recent study we know that approximately 26.625 new patients with BCCs occurred in 2006 in the Netherlands. The average number of BCC per patient is 1.65, resulting in 44.000 new BCCs in that year. With an increase of approximately 10% per year the estimated incidence rate at 2011 will be around 70.800 in the Netherlands. Three important histopathologic subtypes of BCC can be distinguished, namely superficial, nodular and aggressive. In the past, nodular basal cell carcinoma (nBCC) was the most common histopathologic subtype, but superficial basal cell carcinoma (sBCC) and aggressive basal cell carcinoma (aBCC) are the subtypes with the fastest growing incidences. Nowadays, the distribution of histopathologic subtypes of BCC is 40.6% nodular, 30.7% superficial and 28.7% aggressive. The shift from nodular BCCs to other subtypes needs accurate detection of the correct subtype, as treatment per subtype is different. The sharp raising incidence of 10% annually makes BCC an even bigger health problem in the near future.
- Diagnosis of BCC:
BCC is diagnosed with a 3 mm punch biopsy (PB) of the suspected skin lesion. Based on the most aggressive histopathologic subtype seen in this biopsy, an appropriate treatment is chosen. Three subtypes are relevant for a suitable treatment choice: superficial, nodular and aggressive. The last one includes all BCCs with aggressive growth, such as infiltrative/morpheaform BCC, micronodular BCC, and BCC with squamous differentiation. Unfortunately, 31-33% of histopathologic subtypes seen on punch biopsies of primary and recurrent BCCs do not correspond with the subtype seen in the subsequent surgical excision (SE)/ Mohs micrographic surgery (MMS). The consequence is overtreatment and undertreatment.
- Guidelines on the treatment of basal cell carcinoma:
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
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
- •All patients aged 18 years or older, otherwise healthy, with ≤ three primary (no previous treatment) clinically determined BCC will be recruited for this study.
排除标准
- •Patients using immunosuppressive drugs. Genetic skin cancer disorders. Earlier treatments at the same site. Age under 18 years. More than 3 clinical suspected BCCs. Not capable of informed consent.
结局指标
主要结局
Diagnostic value of punch biopsy
时间窗: Histology within 2-3 weeks after the clinical diagnosis
The current proposal aims at establishing the observed agreement of the clinical diagnosis to and histological diagnosis to detect the most aggressive BCC subtype of the entire tumour.
Diagnostic value of the surgical excision (SE)/ Mohs micrographic surgery (MMS)
时间窗: Within 1 month after the punch biopsy
The current proposal aims at establishing the observed agreement of the clinical diagnosis to and histological diagnosis to detect the most aggressive BCC subtype of the entire tumour.
Diagnostic value of clinical diagnosis
时间窗: Within 24 hours after the patient presents at the outpatient department of dermatology
The current proposal aims at establishing the observed agreement of the clinical diagnosis to and histological diagnosis to detect the most aggressive BCC subtype of the entire tumour.
次要结局
- Interobserver and intraobserver variability(After clinical diagnosis, punch biopsy and surgical excision have been performed)