AspECT EXceL
Research type
Research Study
Full title
Aspirin Esomeprazole Chemoprevention Trial – EXtension Long-term Clinical Study : A cohort follow up of a phase III randomised study of Aspirin and Esomeprazole Chemoprevention in Barrett’s Metaplasia.
IRAS ID
1006239
Contact name
Shola Ogegbo
Contact email
Sponsor organisation
University College London Comprehensive Clinical Trials Unit (UCL CCTU)
ISRCTN Number
ISRCTN14949833
Research summary
Barrett's Oesophagus is a condition which affects approximately 2% of the adult population in the western world. The condition develops when some of the cells in the lining of the lower part of food pipe becomes inflamed & damaged due to frequent gastric acid reflux . In a very small number of Barrett's Oesophagus patients, the condition may develop into oesophageal cancer years later.
AspECT EXceL study is a non-interventional follow up extension of the AspECT study. In the AspECT trial, patients with Barrett’s oesophagus were followed up for an average of 9 years to see if using 40mg/day or 80mg/day of Esomeprazole (a Proton Pump Inhibitor drug) with or without 300mg/day of aspirin, decreased the rate of all causes of death or the conversion to Oesophageal cancer or high grade dysplasia (pre- cancer and oesophageal adenocarcinoma). AspECT study results showed that using 80mg/day of Esomeprazole significantly reduced the combination of all cause mortality, high grade dysplasia and Barret’s adenocarcinoma. In addition, the combination of high dose PPI with 300mg/day aspirin appeared to be more effective than either drug was used alone.
AspECT EXceL is an extension of AspECT which aims to continue to follow up the AspECT participants at ~14 years to see if aspirin with/out PPI effectiveness continues or increases long term and to see if any complications from PPI use occur over a longer period of time. The results from the AspECT EXceL may also help to define the best age to start Aspirin therapy, best dose and duration of therapy in cancer prevention in the general population. This follow-up will take place in the form of a single data snapshot of AspECT participant health status from when the study closed in 2017 to present date.
To be eligible for the AspECT EXceL study, patients must have participated in the AspECT study. Participants will be recruited at 30 recruiting AspECT sites over a period of 6 months.REC name
South Central - Hampshire A Research Ethics Committee
REC reference
23/SC/0015
Date of REC Opinion
19 May 2023
REC opinion
Further Information Favourable Opinion