ISRCTN ISRCTN52971746
DOI https://doi.org/10.1186/ISRCTN52971746
Secondary identifying numbers TROPGAN0005
Submission date
26/11/2012
Registration date
03/12/2012
Last edited
01/07/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Gastric cancer is a common cause of cancer death in Zambia as elsewhere. There are no interventions (treatment) available for prevention which can be applied to an African population. We have observed that over the last 30 years there appears to have been a trend towards diagnosis at a younger age. This study is designed to test the hypothesis that HIV and/or dietary factors (particularly antioxidant intake in the form of fruit and vegetables) might contribute to what appears to be a changing epidemiology.

Who can participate?
Patients presenting to the endoscopy unit of the University Teaching Hospital, Lusaka, Zambia.

What does the study involve?
Participants were recruited at the time of endoscopy which has been requested by their physician. If a lesion was seen which is suspicious for gastric cancer, they were recruited if the tests confirmed the diagnosis of gastric cancer. Controls were recruited from patients seen subsequently who have normal endoscopy and are the same sex and in the same age band.

What are the possible benefits and risks of participating?
The benefits to the individual are minimal except for the additional attention they will receive.
The risks are only the inconvenience of answering the questions and submitting blood and urine samples.

Where is the study run from?
The University Teaching Hospital, Lusaka, Zambia.

When is the study starting and how long is it expected to run for?
The study started in December 2010 and completed in January 2012.

Who is funding the study?
National Institutes of Health, USA.

Who is the main contact?
Dr Paul Kelly
m.p.kelly@qmul.ac.uk

Contact information

Dr Paul Kelly
Scientific

Blizard Institute
Barts & The London School of Medicine
Queen Mary University of London
Turner Street
London
E1 2AD
United Kingdom

Email m.p.kelly@qmul.ac.uk

Study information

Study designCase-control study
Primary study designObservational
Secondary study designCase-control study
Study setting(s)Hospital
Study typeScreening
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleGastric cancer in Zambian adults: a case-control study
Study objectivesThat gastric cancer epidemiology in Zambia is changing due to the emergence of Human immunodeficiency virus (HIV) and/or adverse dietary factors.
Ethics approval(s)University of Zambia Biomedical Research Ethics Committee, 15/04/2010, reference number 008-02-10
Health condition(s) or problem(s) studiedGastric adenocarcinoma
InterventionNo interventions are planned. The study is designed to assess HIV, socio-demographic and behavioural risk factors, dietary intakes, and urine isoprostane excretion. Socio-demographic and behavioural (smoking, alcohol use) factors are assessed by interview using a standard questionnaire at the time of enrolment. Blood samples are tested for HIV using Unigold and Determine rapid tests. Urine isoprostane excretion is assessed using Enzyme-linked immunosorbent assay (ELISA) and (in a subset) High-performance liquid chromatography (HPLC).

The study is a case-control study so all assessments are immediate or retrospective and no formal follow-up is planned. All patients are referred appropriately in the light of their pathology results.
Intervention typeOther
Primary outcome measure1. HIV status
2. Smoking and alcohol intake
3. Dietary intake assessed by food frequency questionnaire
4. Antioxidant status assessed by urinary isoprostane excretion
Secondary outcome measuresOther socio-demographic risk factors
1. Age
2. Sex
3. Wealth (measured on an asset scale)
4. Smoking
5. Alcohol use
Overall study start date01/12/2010
Completion date31/01/2012

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants180
Key inclusion criteriaCases: Histologically confirmed cases of gastric adenocarcinoma presenting to the endoscopy unit of the University Teaching Hospital (UTH), Lusaka, Zambia.

Controls:
1. Patients presenting to UTH endoscopy unit with no macroscopic abnormality on endoscopy
2. Age- and sex- matched to cases in a ratio of 2:1
Key exclusion criteriaPatients already receiving chemo- or radio- therapy
Date of first enrolment01/12/2010
Date of final enrolment31/01/2012

Locations

Countries of recruitment

  • England
  • United Kingdom
  • Zambia

Study participating centre

Blizard Institute
London
E1 2AD
United Kingdom

Sponsor information

Queen Mary, University of London (UK)
University/education

c/o Paul Kelly
Blizard Institute
Barts & the London School of Medcine
Turner Street
London
E1 2AD
England
United Kingdom

Email m.p.kelly@qmul.ac.uk
Website http://www.smd.qmul.ac.uk/
ROR logo "ROR" https://ror.org/026zzn846

Funders

Funder type

Government

National Institutes of Health (NIH) (USA) grant ref: R24TW007988

No information available

American Relief and Recovery Act (USA)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/05/2013 Yes No