A randomised double blind dose non-inferiority trial of a daily dose of 600mg versus 300mg versus 100mg of enteric coated aspirin as a cancer preventive in carriers of a germline pathological mismatch repair gene defect, Lynch Syndrome. Project 3 in the Cancer Prevention Programme (CaPP3).

ewcastle upon Tyne Hospitals NHS Foundation Trust0 个研究点目标入组 3,000 人开始时间: 2015年10月14日最近更新: 2024年4月22日

适应症

试验速览

暂无简介。

•1. Aged 18 years or over
•2. Confirmed germline pathological variant in one of the mismatch repair genes: MSH2, MLH1, PMS2 or MSH6 or a 3’ EPCAM deletion associated with MSH2 silencing or be a carriers of a constitutional epimutation manifesting a classic Lynch syndrome phenotype
•3. Able to swallow tablets
•4. Willing to complete the CaPP3 consent process as described in the patient information sheet

•1. Regular use of a non-steroidal anti-inflammatory agent (except aspirin*) on a prescription and/or long-term basis. Regular is defined as > 3 doses per week
•2. Regular use of aspirin (> 3 doses per week or on a prescription basis) that cannot be replaced with any one of the randomised arms of the study followed by 100mg dose
•3. Known aspirin intolerance or hypersensitivity, including aspirin-sensitive asthma
•4. Existing clinically significant liver impairment
•5. Existing renal failure
•6. Confirmed active peptic ulcer disease within the previous three months
•7. Known bleeding diathesis or concomitant anticoagulant therapy
•8. Inability to comply with study procedures and agents
•9. Women reporting that they are pregnant or actively planning to achieve a pregnancy within the next two years
•10. Women who are breastfeeding
•11. Any significant medical illness that would interfere with study participation. (If hypertension is discovered, the participant should be advised to have this treated before commencing trial medication)
•12. Participation in the previous CAPP2 study will not exclude patients from this study, apart from the small number recruited less than 10 years previously
•*Previous use of aspirin for medicinal purposes does not exclude enrollment but duration and quantity need to be documented in detail.

发起方

ewcastle upon Tyne Hospitals NHS Foundation Trust