跳至主要内容
临床试验/NCT00994240
NCT00994240终止不适用

Cure Rates of Superficial Basal Cell Carcinoma Following 1 Versus 3 Cycles of Electrodessication & Curettage: A Randomized Prospective Study

University of Wisconsin, Madison2 个研究点 分布在 1 个国家目标入组 85 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
终止
入组人数
85
试验地点
2
主要终点
Difference in Cure Rates of Superficial BCC Following One Cycle of ED&C Versus Three Cycles of ED&C.

研究概览

简要总结

This is a prospective, randomized clinical trial conducted at the Unviersity of Wisconsin (UW) Dermatology Clinic located at 1 S. Park Street, Madison, WI 53715. There are no controls. Subjects meeting eligibility criteria are randomly divided into one of two treatment groups (ED&C x 1 cycle or ED&C x 3 cycles) using computer generated random numbers. One cycle of ED&C is defined according to standard technique currently employed. It involves scraping away the tumor with a curette (ring- shaped instrument) and then burning the curetted site with a small electric needle (electrodessication). During Visit 1, the surgical site is marked, local numbing medication is injected, and 1 or 3 cycles of ED&C is/are performed by board-certified dermatologists or a dermatology resident under the direct supervision of a board certified dermatologist. All follow-up visits (3, 6, 9, and 12 months after Visit 1) include skin evaluations by the physician who performed the ED&C. The lesion site is examined, measured, and photographed for clinical evidence of recurrence, as defined by a new lesion within the previously treated site. If there is evidence of possible tumor recurrence at the treated surgical site during Visit 2, 3, 4 or 5, then the lesion will be biopsied using a shave procedure.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

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

  • Untreated, biopsy proven superficial type basal cell carcinoma (BCC-S) on the trunk and/or extremities
  • Age greater than 21
  • Women with childbearing potential (including those who are pregnant/lactating)
  • Able to provide written informed consent

排除标准

  • Aggressive histology on initial biopsy (i.e. morpheaform, infiltrative, desmoplastic, or purely micronodular)
  • Prior history of BCC or other skin cancer at the same location
  • Lesion > 2 cm
  • Patients with basal cell nevus syndrome
  • Transplant patients
  • Immunocompromised patients
  • Recurrent BCC
  • Greater than 2 BCC-S on the trunk and/or extremities
  • Prisoners
  • Allergy to lidocaine or epinephrine

结局指标

主要结局

Difference in Cure Rates of Superficial BCC Following One Cycle of ED&C Versus Three Cycles of ED&C.

时间窗: base line, every 3 months until 12 month completion

Clinical evidence of BCC recurrence post treatment

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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