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临床试验/NCT03381846
NCT03381846已完成不适用

Treatment of Dermatofibrosarcoma Protuberans in Patients 10 Years and Younger

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2018年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
7
试验地点
2
主要终点
Patient developing recurrence of a biopsy-proven dermatofibrosarcoma protuberans at one year.

研究概览

简要总结

The purpose of this proposed study is to assess effectiveness of MOHS micrographic surgery as a form of treatment for dermatofibrosarcoma protuberans in patients who are 10 years of age or younger through review of the patients at Mayo Clinic treated from 1988-2017, and to explore the challenges that providers face which may prevent them performing this potentially superior treatment. This study will provide a comparison of outcomes and recurrence rates in pediatric patients treated by MOHS versus traditional excision.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
1 Year 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Patient developing recurrence of a biopsy-proven dermatofibrosarcoma protuberans at one year.

时间窗: Recurrence will be assessed at 1 year.

Developing an additional dermatofibrosarcoma protuberans at any location, but particularly noting local recurrence (defined as being within or contiguous to the field of the previous excision.

次要结局

  • All cause mortality(All cause mortality will be assessed at 1 year, and then annually thereafter for up to 10 years. All patients will have at least one year of follow up.)
  • Patient developing recurrence of a biopsy-proven dermatofibrosarcoma protuberans at two years.(Recurrence will be assessed at 2 years. (Not all patients will have a full two years of follow up))
  • Mortality related to dermatofibrosarcoma protuberans(Mortality related to dermatofibrosarcoma protuberans will be assessed at 1 year, and then annually thereafter for up to 10 years. All patients will have at least one year of follow up.)
  • Morbidity secondary to surgical procedure(Morbidity secondary to surgical procedure will be assessed at 1 year, and then annually thereafter for up to 10 years. All patients will have at least one year of follow up.)
  • Patient developing recurrence of a biopsy-proven dermatofibrosarcoma protuberans at five years.(Recurrence will be assessed at 5 years. (Not all patients will have a full five years of follow up))

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Randall K. Roenigk

Professor of Dermatology

Mayo Clinic

研究点 (2)

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