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
m.p.kelly@qmul.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Paul Kelly
ORCID ID
Contact details
Blizard Institute
Barts & The London School of Medicine
Queen Mary University of London
Turner Street
London
E1 2AD
United Kingdom
m.p.kelly@qmul.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
TROPGAN0005
Study information
Scientific title
Gastric cancer in Zambian adults: a case-control study
Acronym
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
Observational
Secondary study design
Case-control study
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
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
01/12/2010
Overall trial end date
31/01/2012
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
180
Participant exclusion criteria
Patients already receiving chemo- or radio- therapy
Recruitment start date
01/12/2010
Recruitment end date
31/01/2012
Locations
Countries of recruitment
Zambia
Trial participating centre
Blizard Institute
London
E1 2AD
United Kingdom
Sponsor information
Organisation
Queen Mary, University of London (UK)
Sponsor details
c/o Paul Kelly
Blizard Institute
Barts & the London School of Medcine
Turner Street
London
E1 2AD
United Kingdom
m.p.kelly@qmul.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Institutes of Health (NIH) (USA) grant ref: R24TW007988
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
American Relief and Recovery Act (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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 http://www.ncbi.nlm.nih.gov/pubmed/23535107
Publication citations
-
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.