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临床试验/ISRCTN98495886
ISRCTN98495886已完成2 期

Phase II clinical trial investigating the use of EPIgallocatechin-3-gallate (Veregen) in the treatment of Vulval Intraepithelial Neoplasia

niversity of Birmingham (UK)0 个研究点目标入组 26 人开始时间: 2013年12月17日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
26

研究概览

简要总结

2020 Results article in https://pubmed.ncbi.nlm.nih.gov/33075197/ results (added 18/11/2020)

研究设计

研究类型
Interventional

入排标准

性别
Female

入选标准

  • 1. Female = 18 years of age
  • 2. Histological confirmation of 'usual' type vulval intraepithelial neoplasia (VIN3)*
  • 3. At least one lesion that can be accurately measured (using the RECIST 1.1 criteria) in at least one dimension with longest diameter = 20 mm
  • 4. Using a reliable method of contraception (excluding condoms)
  • 5. Written informed consent to participate in the trial
  • * All histological material generated by this study will be assessed by Specialist Consultant in Gynaecological Pathology, 10% of biopsies will be independently reviewed by a second pathologist

排除标准

  • 1. Suspected anogenital carcinoma or those considered by the attending clinician to be at high risk of developing invasive disease
  • 2. Pregnant, breastfeeding or trying to conceive
  • 3. Treated for VIN within the previous four weeks
  • 4. Known allergy to Veregen or any of its components
  • 5. Patients suffering from immunosuppressive disorder or taking immunosuppressives
  • 6. Unable to comply with the protocol

研究者

发起方
niversity of Birmingham (UK)

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