CaPP3

• Conditions: ynch Syndrome also known as HNPCC (non hereditary non polyposis colorectal cancer).; MedDRA version: 17.0Level: LLTClassification code 10051981Term: Lynch syndromeSystem Organ Class: 100000004850; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2014-000411-14-GB
• Lead Sponsor: The Newcastle upon Tyne Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06-13
• Last Update Posted: 16 February 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

1. Age over 18
2. Proven MMR gene defect carrier
3. CAPP2 participants, at least 10 years since enrolled into that study
4. Willing to take randomised blinded dose (100, 300, 600mg) of aspirin for two years & self-report numbers of tablets taken
5. Agreement for indefinite clinical follow up with a minimum of 5 years
6. Availability of Micro satellite instability and or immunohistochemical analysis of mismatch repair proteins to establish whether any lesions are likely to be Lynch syndrome related, are all non-negotiable
7. Biobanking (bloods for DNA & serum) and sharing tissue sections to allow pharmacogenetic sub studies, FSP(Frame shift peptide) antibody testing and effects of aspirin on molecular tumour phenotype are desirable but not essential.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2750
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 250

Exclusion Criteria

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. Current methotrexate use.
4. Known aspirin intolerance or hypersensitivity, including aspirin-sensitive asthma.
5. Existing clinically significant liver impairment.
6. Existing renal failure defined as creatinine clearance <10ml/min.
7. Active peptic ulcer disease within the previous three months or any previous proven peptic ulcer.
8. Known bleeding diathesis or concomitant warfarin therapy.
9. Inability to comply with study procedures and agents.
10. Women reporting that they are pregnant or actively planning to achieve a pregnancy within the next two years.
11. Women who are currently breastfeeding.
12. Any significant medical illness that would interfere with study participation.
13. Previous participation in this trial. [Participation in the previous CAPP2 study will not exclude patients from this study. The protocol requires that it be at least 10 years since they joined CAPP2. Recruitment to CAPP2 closed in 2006].

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified