ACTRN12617000804381进行中（未招募）3 期
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).
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 141
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Age over 18.
- •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. Age over 18.
- •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.
排除标准
- •1. Regular use of a non-steroidal anti-inflammatory agent on a prescription and/or long-term basis. Regular is defined as > 3 doses per week, for more than 3 months in the last 3 years.
- •2. Previous regular use of aspirin at a daily dose of 150mg or less does not exclude enrolment but duration and quantity need to be documented in detail. More than 3 months use of > 150mg or more per day in the last 3 years is an exclusion
- •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; 1. Regular use of a non-steroidal anti-inflammatory agent on a prescription and/or long-term basis. Regular is defined as > 3 doses per week, for more than 3 months in the last 3 years.
- •2. Previous regular use of aspirin at a daily dose of 150mg or less does not exclude enrolment but duration and quantity need to be documented in detail. More than 3 months use of > 150mg or more per day in the last 3 years is an exclusion
- •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
研究者
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