Condition category
Cancer
Date applied
09/03/2011
Date assigned
09/05/2011
Last edited
04/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 2021

Who is funding the study?
1. Cancer Research UK (CRUK) (UK)
2. Bupa Foundation (UK)

Who is the main contact?
Prof. Nicholas Wald

Trial website

Contact information

Type

Scientific

Primary contact

Prof Nicholas Wald

ORCID ID

Contact details

Centre for Environmental and Preventive Medicine
Wolfson Institute of Preventive Medicine
Barts and The London School of Medicine and Dentistry
Queen Mary
University of London
Charterhouse Square
London
EC1M 6BQ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

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

Study information

Scientific title

A randomised trial of the effects of screening for and treating Helicobacter pylori

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

The Clinical Research Ethics Committee of the Royal College of General Practitioners, 28/11/1995, ref: CREC/1995/33(28)

Study design

Cluster randomised open controlled multi-centre trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

07/04/1997

Overall trial end date

13/01/2021

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

56,000

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

13/01/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Centre for Environmental and Preventive Medicine
London
EC1M 6BQ
United Kingdom

Sponsor information

Organisation

Queen Mary University of London (UK)

Sponsor details

Research and Development
Joint Research Office
24-26 Walden Street
Whitechapel
London
E1 2AN
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK) (UK) (ref no C5070/A5429)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

Bupa Foundation (UK) (Award letter 08/12/1997)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

04/03/2016: Plain English summary added.