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Gastric cancer in Zambian adults
ISRCTN ISRCTN52971746
DOI 10.1186/ISRCTN52971746
ClinicalTrials.gov identifier
EudraCT number
Public title Gastric cancer in Zambian adults
Scientific title Gastric cancer in Zambian adults: a case-control study
Acronym N/A
Serial number at source TROPGAN0005
Study hypothesis That gastric cancer epidemiology in Zambia is changing due to the emergence of Human immunodeficiency virus (HIV) and/or adverse dietary factors.
Lay 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
Ethics approval University of Zambia Biomedical Research Ethics Committee, 15/04/2010, reference number 008-02-10
Study design Case-control study
Countries of recruitment Zambia
Disease/condition/study domain Gastric adenocarcinoma
Participants - 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
Participants - exclusion criteria Patients already receiving chemo- or radio- therapy
Anticipated start date 01/12/2010
Anticipated end date 31/01/2012
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 180
Interventions 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.
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
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
Sources of funding 1. National Institutes of Health (NIH) (USA) grant ref: R24TW007988
2. American Relief and Recovery Act (USA)
Trial website
Publications 1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23535107
Contact name Dr  Paul  Kelly
  Address Blizard Institute
Barts & The London School of Medicine
Queen Mary University of London
Turner Street
  City/town London
  Zip/Postcode E1 2AD
  Country United Kingdom
  Email m.p.kelly@qmul.ac.uk
Sponsor Queen Mary, University of London (UK)
  Address c/o Paul Kelly
Blizard Institute
Barts & the London School of Medcine
Turner Street
  City/town London
  Zip/Postcode E1 2AD
  Country United Kingdom
  Email m.p.kelly@qmul.ac.uk
  Sponsor website: http://www.smd.qmul.ac.uk/
Date applied 26/11/2012
Last edited 01/07/2013
Date ISRCTN assigned 03/12/2012
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