Helicobacter pylori Screening Study
| ISRCTN | ISRCTN71557037 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71557037 |
| Secondary identifying numbers | SP/1793/0501 from 1/7/97, SP/1793/0502 from 1/7/99, SP/1793/0503 from 1/7/00, SP/1793/0504 from 1/3/01, SP/1793/0505 from 1/7/01, C5070/A3021 from 1/7/02, C5070/A5429 from 1/7/04, C5070/A11090 1/1/09 |
- Submission date
- 09/03/2011
- Registration date
- 09/05/2011
- Last edited
- 18/01/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English Summary
Background and study aims
Helicobacter pylori is a bacterial infection that increases the risk of stomach cancer. The aim of this study is to find out whether screening for and eradicating H. pylori infection in healthy middle aged people can reduce the subsequent incidence of stomach cancer.
Who can participate?
Men aged 35-69 and women aged 45-69 attending a Bupa Wellness Centre for a health screen.
What does the study involve?
Participants are randomly allocated to one of two groups. Participants in one group are tested for H. pylori and, if found to be infected, are offered a one-week course of drug treatment to eradicate the infection (oral metronidazole, clarithromycin and lansoprazole). Participants in the other group do not receive any screening or treatment. All participants are followed up for 15 years or more to assess the incidence of deaths from stomach cancer.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Queen Mary, University of London (UK)
When is the study starting and how long is it expected to run for?
April 1997 to January 2025
Who is funding the study?
1. Cancer Research UK (CRUK) (UK)
2. Bupa Foundation (UK)
Who is the main contact?
1. Prof. Nicholas Wald
2. Prof. Joan Morris
jmorris@sgul.ac.uk
Contact information
Scientific
Professor of Preventive Medicine
UCL Institute of Health Informatics
29/30 Newbury Street
London
EC1A 7HZ
United Kingdom
Scientific
St George’s, University of London
London
SW17 0RE
United Kingdom
 ORCID ID |
0000-0002-7164-612X |
|---|---|
| Phone | +44(0)20 8725 1324 |
| jmorris@sgul.ac.uk |
Study information
| Study design | Cluster randomized open controlled multi-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A randomised trial of the effects of screening for and treating Helicobacter pylori |
| Study acronym | HPSS |
| Study hypothesis | HPSS was designed to assess whether screening for and eradicating H. pylori infection in healthy middle aged people can reduce the subsequent incidence of stomach cancer |
| Ethics approval(s) | The Clinical Research Ethics Committee of the Royal College of General Practitioners, 28/11/1995, ref: CREC/1995/33(28) |
| Condition | Prevention of stomach cancer |
| Intervention | Participants seen in treatment weeks, if H. pylori positive, were offered a one week course of eradication therapy comprising twice-daily oral metronidazole 400 mg, clarithromycin 250 mg and lansoprazole 30 mg. No screening or treatment was offered to control participants. Follow-up is for all participants, for 15 years or more after recruitment, with notifications of all cancers and of deaths by cause from the Information Centre for Health and Social Care and the General Register Office for Scotland. |
| Intervention type | Other |
| Primary outcome measure | Incidence of and death from stomach cancer |
| Secondary outcome measures | 1. Incidence of and death from oesophageal cancer 2. Death from ischaemic heart disease 3. Death from gastric bleed or peptic ulcer |
| Overall study start date | 07/04/1997 |
| Overall study end date | 01/01/2025 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 35 Years |
| Upper age limit | 69 Years |
| Sex | Both |
| Target number of participants | 56,000 |
| Total final enrolment | 62454 |
| Participant inclusion criteria | 1. Healthy NHS-registered UK residents 2. Male participants aged 35-69 3. Female participants aged 45-69 4. Patients attending a Bupa Wellness Centre for a health screen |
| Participant exclusion criteria | 1. On medication which may interact dangerously with metronidazole, clarithromycin or lansoprazole (according to Appendix 1 of the British National Formulary) 2. A history of intolerance or allergy to metronidazole, clarithromycin or lansoprazole or other drugs of the same class as any of these three drugs 3. Currently being treated for an ulcer 4. On a proton-pump inhibitor or H2 antagonist 5. Having been tested or treated for H. pylori infection in the previous three years 6. Pregnancy or breastfeeding 7. Past history of or current gastric cancer 8. Life-threatening illness 9. Porphyria 10. Prolongation of QT interval 11. Current clinical liver disease or a history of severe liver disease |
| Recruitment start date | 07/04/1997 |
| Recruitment end date | 31/01/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
EC1M 6BQ
United Kingdom
Sponsor information
University/education
Research and Development
Joint Research Office
24-26 Walden Street
Whitechapel
London
E1 2AN
England
United Kingdom
"ROR" |
https://ror.org/026zzn846 |
|---|
Funders
Funder type
Charity
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Private sector organisation / Trusts, charities, foundations (both public and private)
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/04/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
18/01/2024: The following changes were made to the study record:
1. The overall end date was changed from 01/01/2024 to 01/01/2025.
2. The intention to publish date was changed from 01/01/2025 to 01/04/2026.
31/01/2023: The following changes were made to the trial record:
1. The overall end date was changed from 01/01/2023 to 01/01/2024.
2. The intention to publish date was changed from 01/01/2024 to 01/01/2025.
3. Total final enrolment and IPD sharing statement added.
12/12/2019: One of the scientific contact's details have been updated.
24/07/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 13/01/2021 to 31/01/2006.
2. The overall end date was changed from 13/01/2021 to 01/01/2023.
3. The intention to publish date was added.
4. A scientific contact was added.
5. The plain English summary was updated to reflect these changes.
04/03/2016: Plain English summary added.
