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
| ISRCTN | ISRCTN14949833 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14949833 |
| IRAS number | 1006239 |
| Secondary identifying numbers | CCTU/2019/340, CPMS 54878, IRAS 1006239 |
- Submission date
- 08/12/2022
- Registration date
- 22/05/2023
- Last edited
- 01/05/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
Barrett's oesophagus is a condition which affects about 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 the food pipe become inflamed and 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.
This 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 40 mg/day or 80 mg/day of esomeprazole (a proton pump inhibitor drug) with or without 300 mg/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). The study results showed that using 80 mg/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 300 mg/day aspirin appeared to be more effective than either drug used alone.
This is an extension of AspECT which aims to continue to follow up the AspECT participants at about 14 years to see if the effectiveness of aspirin with or without PPI continues or increases long-term and to see if any complications from PPI use occur over a longer period of time. The results from this study may also help to define the best age to start aspirin therapy, the best dose and duration of therapy in cancer prevention in the general population.
Who can participate?
Patients with Barrett's oesophagus who participated in the AspECT study
What does the study involve?
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 the present date.
What are the possible benefits and risks of participating?
There are no intended/immediate clinical benefits of taking part in this study. However, it is hoped that the results and information from this follow-up study will help to improve the care and management of Barrett’s oesophagus patients in the UK and beyond and provide more information about effective treatments. There are no study drugs or tests involved in the study and no anticipated clinical risks for participants.
Where is the study run from?
University College London Comprehensive Clinical Trials Unit (UCL CCTU) (UK)
When is the study starting and how long is it expected to run for?
December 2022 to April 2025
Who is funding the study?
Cancer Research UK
Who is the main contact?
cctu.aspect_xl@ucl.ac.uk
https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-looking-at-the-long-term-follow-up-of-people-who-have-taken-aspirin-and-esomeprazole-to-help
Contact information
Public
Comprehensive Clinical Trials Unit
UCL Institute of Clinical Trials and Methodology
2nd Floor 90 High Holborn
London
WC1V 6LJ
United Kingdom
| katherine.chan@ucl.ac.uk |
Scientific
Comprehensive Clinical Trials Unit
UCL Institute of Clinical Trials and Methodology
2nd Floor 90 High Holborn
London
WC1V 6LJ
United Kingdom
| n.begum-ali@ucl.ac.uk |
Principal Investigator
Comprehensive Clinical Trials Unit
UCL Institute of Clinical Trials and Methodology
2nd Floor 90 High Holborn
London
WC1V 6LJ
United Kingdom
| Phone | +44 (0)7968479355 |
|---|---|
| j.jankowski@ucl.ac.uk |
Study information
| Study design | Non-interventional long-term follow-up study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Safety, Efficacy |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific 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 |
| Study acronym | AspECT EXceL |
| Study objectives | Oesophageal adenocarcinoma is the sixth most common cause of cancer death worldwide and Barrett's oesophagus is the biggest risk factor. The original AspECT trial aimed to evaluate the efficacy of high-dose esomeprazole proton-pump inhibitor (PPI) and aspirin for improving outcomes in patients with Barrett's oesophagus. The primary composite endpoint in AspECT was time to all-cause mortality, oesophageal adenocarcinoma, or high-grade dysplasia, which was analysed with accelerated failure time modelling adjusted for minimisation factors (age, Barrett's oesophagus length, intestinal metaplasia) in all participants in the intention-to-treat population. We now wish to follow up the same endpoints in AspPECT trial participants in the AspECT EXceL study. The primary composite endpoint is 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. 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. The Charlson Comorbidity Index (CCI) |
| Ethics approval(s) |
Approved 19/05/2023, South Central - Hampshire A Research Ethics Committee (Temple Quay House, 2 The Square, Temple Quay, Bristol, BS1 6PN, United Kingdom; +44 (0)2071048033 /53; hampshirea.rec@hra.nhs.uk), ref: 23/SC/0015 |
| Health condition(s) or problem(s) studied | Barrett's oesophagus (BO) |
| Intervention | 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 trial, participants were assigned to receive either: 1. Low-dose oral proton pump inhibitor (PPI) (esomeprazole) and no aspirin 2. High-dose PPI (esomeprazole) and no aspirin 3. Low-dose PPI (esomeprazole) and aspirin 4. High-dose PPI (esomeprazole) and aspirin There are no further direct patient interventions required. This study aims to capture a single data snapshot of the original AspECT trial participants’ medical records to see if aspirin and PPI effectiveness increases long term and to investigate the long-term benefits and risks of using a PPI with or without aspirin in reducing the risk of cancer from the date of the participant’s last study visit. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | Prophylaxis, Therapy |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Esomeprazole, aspirin |
| Primary outcome measure | 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. |
| Secondary outcome measures | 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. |
| Overall study start date | 02/12/2022 |
| Completion date | 30/04/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 1587 |
| Total final enrolment | 831 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/07/2023 |
| Date of final enrolment | 14/10/2024 |
Locations
Countries of recruitment
- England
- Northern Ireland
- Scotland
- United Kingdom
Study participating centres
Leicester
LE1 5WW
United Kingdom
Gloucester
GL1 3NN
United Kingdom
Leicester
LE5 4PW
United Kingdom
Cosham
Portsmouth
PO6 3LY
United Kingdom
Wigan
WN1 2NN
United Kingdom
AL7 4HQ
United Kingdom
Derby Road
Nottingham
NG7 2UH
United Kingdom
Liverpool
L7 8XP
United Kingdom
Taunton
TA1 5DA
United Kingdom
Kirkcaldy
KY2 5AH
United Kingdom
Dunfermline
KY12 0SU
United Kingdom
Londonderry
BT47 6SB
United Kingdom
Edinburgh
Lothian
EH4 2XU
United Kingdom
Old Dalkeith Road
Edinburgh
Lothian
EH16 4SA
United Kingdom
Dundonald
Belfast
BT16 1RH
United Kingdom
Dundee
DD1 9SY
United Kingdom
Sponsor information
Hospital/treatment centre
UCL Institute of Clinical Trials and Methodology
2nd Floor 90 High Holborn
London
WC1V 6LJ
England
United Kingdom
| Phone | +44 (0)203 108 5146 |
|---|---|
| cctu.aspect_xl@ucl.ac.uk |
Funders
Funder type
Charity
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 29/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | 1. Peer-reviewed scientific journals 2. Conference presentation 3. Publication on website 4. Other publication A summary of the study protocol will be made available for public access throughout the duration of the study. At the end of the study and following the publication of the final reports, applications for access to the study dataset will be submitted in writing to UCL CCTU. Access will only be granted after formal consideration by the study's Chief Investigator and the oversight committees. Appropriate data-sharing agreements will be in place. The results of the study will be published after completing the final statistical analysis within 12 months of study completion. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from (Chief Investigator: Prof. Janusz Jankowski, j.jankowski@ucl.ac.uk). Anonymised data will be shared. The results of the study will be published after completing the final statistical analysis within 12 months of study completion. A summary of the AspECT EXceL study protocol will be made available for public access throughout the duration of the study. At the end of the study and following the publication of the final reports, applications for access to the study dataset will be submitted in writing to UCL CCTU. Access will only be granted after formal consideration by the study's Chief Investigator and the oversight committees. Appropriate data-sharing agreements will be in place. The results of the trial will be disseminated regardless of the direction of effect. The publication of results will comply with the UCL and UCL CCTU Publication Policies and will include submission to open-access journals. Types of analyses: All analyses will be performed using the intention-to-treat (ITT) population. All patients will be analysed according to their randomised treatment arm irrespective of whether the treatment (or absence of treatment) was received. A mediation analysis will be considered as to the effect of trial adherence to randomised treatment, with a focus on changes in the interim period in terms of drugs taken (PPI + aspirin) via a retrospective review of patient notes. Separately, a further analysis using Restricted Mean Survival Time will be used should there be a clear departure from the constant hazard assumption. Informed consent will be obtained from alive patients who participated in the original AspECT trial and CAG and equivalents approvals will be sought to access the clinical information of deceased patients who participated in the original AspECT trial. |
Editorial Notes
01/05/2025: The overall study end date was changed from 31/07/2025 to 30/04/2025.
24/01/2025: The following changes were made to the study record:
1. Contact details updated.
2. The recruitment end date was changed from 31/01/2025 to 14/10/2024.
3. The overall study end date was changed from 29/05/2025 to 31/07/2025.
4. Total final enrolment added.
24/01/2024: The following changes have been made:
1. The recruitment end date has been changed from 01/01/2024 to 31/01/2025.
2. The overall study end date was changed from 29/05/2024 to 29/05/2025.
3. The intention to publish date was changed from 29/12/2024 to 29/12/2025.
01/11/2023: Cancer Research UK plain English summary link added to plain English summary field.
16/06/2023: The following changes have been made:
1. The recruitment start date has been changed from 01/06/2023 to 01/07/2023.
2. Ethics approval was added.
05/06/2023: Internal review.
20/05/2023: ISRCTN received notification of combined HRA/MHRA approval for this trial on 20/05/2023.
08/12/2022: Trial's existence confirmed by the HRA.
