Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information



Primary contact

Dr Paul Kelly


Contact details

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

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Gastric cancer in Zambian adults: a case-control study


Study hypothesis

That gastric cancer epidemiology in Zambia is changing due to the emergence of Human immunodeficiency virus (HIV) and/or adverse dietary factors.

Ethics approval

University of Zambia Biomedical Research Ethics Committee, 15/04/2010, reference number 008-02-10

Study design

Case-control study

Primary study design


Secondary study design

Case-control study

Trial setting


Trial type


Patient information sheet

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


Gastric adenocarcinoma


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



Not Applicable

Drug names

Primary outcome measures

1. 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 measures

Other socio-demographic risk factors
1. Age
2. Sex
3. Wealth (measured on an asset scale)
4. Smoking
5. Alcohol use

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

Cases: Histologically confirmed cases of gastric adenocarcinoma presenting to the endoscopy unit of the University Teaching Hospital (UTH), Lusaka, Zambia.

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

Participant type


Age group




Target number of participants


Participant exclusion criteria

Patients already receiving chemo- or radio- therapy

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Blizard Institute
E1 2AD
United Kingdom

Sponsor information


Queen Mary, University of London (UK)

Sponsor details

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

Sponsor type




Funder type


Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

American Relief and Recovery Act (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

1. 2013 results in

Publication citations

  1. Results

    Asombang AW, Kayamba V, Mwanza-Lisulo M, Colditz G, Mudenda V, Yarasheski K, Chott R, Rubin DC, Gyawali CP, Sinkala E, Mwanamakondo S, Anderson-Spearie C, Kelly P, Gastric cancer in Zambian adults: a prospective case-control study that assessed dietary intake and antioxidant status by using urinary isoprostane excretion., Am. J. Clin. Nutr., 2013, 97, 5, 1029-1035, doi: 10.3945/ajcn.112.051284.

Additional files

Editorial Notes