ISRCTN22037489已完成不适用
POET: Prevention Of Endometrial Tumours
St George's, University of London & Queen Mary and Westfield College, University of London (UK)0 个研究点目标入组 220 人开始时间: 2007年2月21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
- 入组人数
- 220
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •Women aged 35 to 65 years are eligible if:
- •1. Proven to carry a pathogenic germline mutation in a DNA mismatch repair gene causing Lynch syndrome (usually MSH2, MLH1, MSH6)
- •a. from a family fulfilling the Amsterdam or the modified Amsterdam criteria for Lynch syndrome (three relatives with an Lynch syndrome-related cancer (colorectal, small bowel, endometrial, ovarian, urothelial or hepatobiliary), one the first-degree relative of the other two, two generations affected, and one diagnosis before the age of 50 years)
- •b. who themselves have had colorectal cancer, a large, villous or severely dysplastic colorectal adenoma before the age of 40 years, or small bowel, hepatobiliary, or urothelial cancer, and where abnormal immunohistochemistry staining for Lynch syndrome proteins in the tumour has been demonstrated in an affected family member.
- •The aim is to randomise 220 women within 18 months of opening the trial. However, randomising as many as 800 women could be justified in order to evaluate the effect of Mirena separately pre- and post-menopause.
- •3. Risk equivalent
- •A patient may be randomised in the POET trial if it can be proved that she is a carrier. For example, this could be due to the woman being an obligate carrier in a family meeting the Amsterdam Criteria and including other evidence of a mis-match repair defect.
- •Having a ?risk equivalent? entry point will also allow for someone who was only a second degree relative of an affected family member, but who herself had had bowel cancer at age 35, for instance, to be eligible in the trial.
- •Eligibility will be confirmed in writing by Prof. Hodgson, Dr Sheridan or Dr Murday and a copy of the email/letter will be kept with the patient?s notes for monitoring purposes.
排除标准
- •1. Women without an intact uterus (or who are planning a prophylactic hysterectomy)
- •2. Known or suspected pregnancy
- •3. Women trying to become pregnant in the next three years
- •4. Infected abortion during the three months before Mirena insertion is planned
- •5. Concomitant use of intrauterine devices
- •6. History of, or active, genital malignancy or breast carcinoma or other oestrogen dependent tumours
- •7. Any kind of active malignancy
- •8. Currently on therapy for cancer
- •9. Pelvic inflammatory disease (PID) during previous 6 months (before the Mirena IUS insertion) or recurrent PID
- •10. Clinically significant submucous myomas requiring treatment. Small subserous or intramural myomas, clinically assessed as insignificant, are acceptable
- •11. Any known hypersensitivity to the constituents of the Mirena IUS
- •12. An unresolved abnormal cervical smear
- •13. Trophoblastic disease while hCG levels remain elevated
- •14. Any clinically significant condition or laboratory result that might, in the opinion of the investigator, compromise patient safety, interfere with the evaluations or prevent the completion of the trial
- •15. Outside the age-range for the study
- •16. Current or previous severe arterial disease (Stroke, M1) or severe liver disease
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