The AspECT EXceL study aims to continue to follow up the AspECT study participants to see if esomeprazole effectiveness continues or increases long-term and investigate the long-term benefits and risks of using esomeprazole with or without aspirin in reducing the risk of cancer

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN14949833

Enrollment

1587

Registered

2023-05-22

Start date

2023-07-01

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Barrett's oesophagus (BO) Digestive System Barrett oesophagus

Interventions

AspECT EXceL is a non-interventional, data-collection-only study that involves the long-term follow-up of individuals previously recruited into the AspECT trial. As part of the original AspECT tria

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Participants recruited to the original AspECT trial 2. AspECT participants who have signed an AspECT-EXceL consent form or have the use of personal data covered by another access agreement 3. Participants who have given consent to allow access to AspECT data or have access covered by another access agreement

Exclusion criteria

Exclusion criteria: 1. Participants who are alive and unable or unwilling to give consent to participate in AspECT ExceL and whose personal data is not covered by any other data access agreement 2. Participants unwilling to give consent to allow access to AspECT data and are not covered by any other data access agreement 3. Participants not included in the original AspECT trial

Design outcomes

Primary

Measure	Time frame
The time to all-cause mortality, oesophageal adenocarcinoma, or high-grade dysplasia, whichever occurs first, between randomisation into AspECT and the single data capture of AspECT EXceL. Data will be collected from the participants’ medical records from the date of the participant's last visit for the original AspECT Trial to the time the data snapshot is taken for the AspECT ExCEL study. For deceased patients, this will be from their last AspECT study visit to the date of death.	—

Measure

Time frame

The time to all-cause mortality, oesophageal adenocarcinoma, or high-grade dysplasia, whichever occurs first, between randomisation into AspECT and the single data capture of AspECT EXceL. Data will be collected from the participants’ medical records from the date of the participant's last visit for the original AspECT Trial to the time the data snapshot is taken for the AspECT ExCEL study. For deceased patients, this will be from their last AspECT study visit to the date of death.

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Secondary

Measure	Time frame
1. Effects of combined PPI and aspirin on each of the three components of the primary endpoints separately 2. Time to progression to low-grade dysplasia 3. Death from oesophageal cancer 4. New solid GI tumours 5. COVID-19 related deaths 6. Quality of life assessed using the Charlson Comorbidity Index (CCI) Data will be collected from the participants’ medical records from the date of the participant's last visit for the original AspECT trial to the time the data snapshot is taken for the AspECT ExCEL study. For deceased patients, this will be from their last AspECT study visit to the date of death.	—

Measure

Time frame

1. Effects of combined PPI and aspirin on each of the three components of the primary endpoints separately 2. Time to progression to low-grade dysplasia 3. Death from oesophageal cancer 4. New solid GI tumours 5. COVID-19 related deaths 6. Quality of life assessed using the Charlson Comorbidity Index (CCI) Data will be collected from the participants’ medical records from the date of the participant's last visit for the original AspECT trial to the time the data snapshot is taken for the AspECT ExCEL study. For deceased patients, this will be from their last AspECT study visit to the date of death.

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Countries

England, Northern Ireland, Scotland, United Kingdom

Contacts

Public ContactKatherine Chan

katherine.chan@ucl.ac.uk-

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026