Identification of biomarkers of aspirin's efficacy/toxicity in cancer
Research type
Research Study
Full title
Identification of mechanisms of action and associated biomarkers for an effect of aspirin in preventing disease recurrence in cancer patients.
IRAS ID
291965
Contact name
Belinda Nedjai
Contact email
Sponsor organisation
Queen Mary University of London
Duration of Study in the UK
2 years, 0 months, 13 days
Research summary
Identification of the mechanism of action leading to aspirin chemopreventive effect in patients with cancer. This study's first aim is to evaluate the role of aspirin as an adjuvant treatment and its role in preventing recurrence of cancer. The Add-Aspirin trial provides prospectively collected samples linked to high-quality clinical data from a large cohort comprising four of the most common tumour types. Tumour samples and a baseline blood sample are collected at the time of registration from all participants and are stored centrally at one of two laboratories (Wales Cancer Bank, Tayside Tissue Bank), providing a unique opportunity for investigation of biomarkers of aspirin efficacy in patients with different tumour types. In a subgroup of approximately 500 participants, urine will be collected at the following time points ((i) registration, prior to aspirin use; (ii) end of the run-in period, after 8 weeks treatment with 100mg aspirin; (iii) 3 months after initiating randomised treatment with 100mg aspirin,300mg aspirin or placebo).
There is a possibility that the Add-Aspirin team will facilitate further sample collection through a protocol amendment for the 500 patient subgroup of blood samples at the 3 timepoints specified above and also blood and urine samples at 2, 3 and 5 years follow up. We will request these samples if they subsequently become available as part of the Add-aspirin biobank.
These samples will be used to investigate platelet activation and gene expression, genomics and methylation profiles as a potential marker of aspirin efficacy. This will help us to better understand how aspirin works and identify those patients most/least likely to benefit from taking aspirin.
REC name
London - Chelsea Research Ethics Committee
REC reference
21/PR/1445
Date of REC Opinion
25 Oct 2021
REC opinion
Favourable Opinion