Gastric cancer in Zambian adults

ISRCTN	ISRCTN52971746
DOI	https://doi.org/10.1186/ISRCTN52971746
Protocol serial number	TROPGAN0005
Sponsor	Queen Mary, University of London (UK)
Funders	National Institutes of Health (NIH) (USA) grant ref: R24TW007988, American Relief and Recovery Act (USA)

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

Primary study design	Observational
Study design	Case-control study
Secondary study design	Case-control study
Study type	Participant information sheet
Scientific title	Gastric cancer in Zambian adults: a case-control study
Study objectives	That 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) studied	Gastric adenocarcinoma
Intervention	No 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 type	Other
Primary outcome measure(s)	1. HIV status 2. Smoking and alcohol intake 3. Dietary intake assessed by food frequency questionnaire 4. Antioxidant status assessed by urinary isoprostane excretion
Key secondary outcome measure(s)	Other socio-demographic risk factors 1. Age 2. Sex 3. Wealth (measured on an asset scale) 4. Smoking 5. Alcohol use
Completion date	31/01/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	180
Key inclusion criteria	Cases: 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 criteria	Patients already receiving chemo- or radio- therapy
Date of first enrolment	01/12/2010
Date of final enrolment	31/01/2012

Locations

Countries of recruitment

United Kingdom
England
Zambia

Study participating centre

Blizard Institute

London
E1 2AD
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not 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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes