Gastric cancer in Zambian adults
| 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
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
Scientific
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 |
Study information
| Study design | Case-control study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/12/2010 |
| Completion date | 31/01/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
- Zambia
Study participating centre
E1 2AD
United Kingdom
Sponsor information
University/education
c/o Paul Kelly
Blizard Institute
Barts & the London School of Medcine
Turner Street
London
E1 2AD
England
United Kingdom
| m.p.kelly@qmul.ac.uk | |
| Website | http://www.smd.qmul.ac.uk/ |
"ROR" |
https://ror.org/026zzn846 |
Funders
Funder type
Government
No information available
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
