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临床试验/NCT00882791
NCT00882791已完成不适用

Basal Cell Carcinoma Recurrence

Northwestern University2 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2008年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
115
试验地点
2
主要终点
Recurrence of BCC

研究概览

简要总结

Basal cell carcinoma (BCC) is the most common skin cancer in the US and can cause significant adverse effects.

Mohs micrographic surgery, the treatment of choice for higher risk BCC, allows for removal of lesions with preservation of healthy tissue. Although the BCC recurrence rate post Mohs surgery is estimated at 1-2%, recent data is lacking to validate this historical measurement.

Our purpose is to determine the current recurrence rate of BCC after Mohs surgery.

详细描述

Basal cell carcinoma (BCC) is the most common nonmelanoma skin cancer in the United States, affecting nearly one million of all Americans. While BCC is rarely mortal, it has significant associated physical, psychological, and monetary costs to patients such as disfigurement and sensory loss. Individuals who have been diagnosed with at least one BCC lesion are likely to be diagnosed with more in the future. Treatment of these lesions and recurrent physician appointments can be a great inconvenience to patients, resulting in expenses to patients and loss of work and family time.

The Mohs surgery technique is associated with a low recurrence rate for BCC and is preferred for higher risk tumors and for tumors in cosmetically sensitive sites on the head and neck. While recurrence rates of BCC post Mohs are 1-2% for primary basal cells, recent data is not available to validate this historical assessment. Currently, comprehensive rates of recurrence are not available because a national registry of recurrence rates for BCC and squamous cell carcinoma (SCC) does not exist.

The purpose of this study is to both historically and prospectively assess current basal cell carcinoma recurrence rates in patients undergoing Mohs micrographic surgery.

研究设计

研究类型
Observational
观察模型
Cohort
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

入选标准

  • Subjects with BCC lesions on the head, neck, genitalia, hands, or feet
  • Subjects who have undergone Mohs micrographic surgery for BCC on or before December 31, 2006
  • Subjects with a medical record at the respective site
  • Subjects in a stable health condition, as determined by the principle investigator

排除标准

  • Subjects with basal cell nevus syndrome
  • Subjects with lesions only in areas other than the head, neck, genitalia,
  • hands and feet
  • Subjects who have not followed up through the Department of Dermatology
  • Subjects with recurrent BCC lesions diagnosed on or prior to the recorded date of Mohs surgery

结局指标

主要结局

Recurrence of BCC

时间窗: either after 1 study visit (historical arm), or 3 years (prospective arm)

次要结局

  • Risk Factors for recurrence of BCC(either after 1 study visit (historical arm), or 3 years (prospective arm))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Murad Alam

Professor in Dermatology, Otolaryngology- Head and Neck Surgery, and Surgery-Organ Transplantation

Northwestern University

研究点 (2)

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