Inflammatory potential of the diet and risk of gastric cancer in the European Prospective Investigation into Cancer and Nutrition (EPIC) study
| ISRCTN | ISRCTN12136108 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12136108 |
| Secondary identifying numbers | PI15_0639_1 |
- Submission date
- 01/08/2017
- Registration date
- 11/09/2017
- Last edited
- 12/04/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Chronic (long-term) inflammation plays a critical role in the development of the two major types of gastric (stomach) cancer. Several foods, nutrients, and non-nutrient food components seem to be involved in chronic inflammation. The aim of this study is to assess the link between the inflammatory potential of the diet and the risk of gastric cancer, overall and for the two major types of gastric cancer: cardia cancers and non-cardia cancers.
Who can participate?
People aged 30-70 who participated in the European Investigation into Cancer and Nutrition (EPIC) study
What does the study involve?
Dietary information is collected using questionnaires and the inflammatory potential of the diet is assessed. Gastric cancer incidence is assessed using population cancer registries and national or regional mortality registries in most of the participating countries. In France, Germany and Greece a combination of approaches are used, including cancer and pathology registries, health insurance records, and active follow-up contacting the participants or their next-of-kin.
What are the possible benefits and risks of participating?
There are no direct benefits for the patient, but they will contribute to the general advance in knowledge for the prevention of diseases. No risks are involved other than minor incidents due to blood sampling.
Where is the study run from?
1. International Agency for Research on Cancer (France)
2. Imperial College London (UK)
When is the study starting and how long is it expected to run for?
October 2015 to December 2016
Who is funding the study?
1. Health Research Fund (FIS)
2. European Commission (DG-SANCO)
3. Bundesministerium für Bildung und Forschung
4. Hellenic Health Foundation (Greece)
5. Associazione Italiana per la Ricerca sul Cancro
6. Consiglio Nazionale delle Ricerche
7. Ministerie van Volksgezondheid, Welzijn en Sport
8. Netherlands Cancer Registry (NKR)
9. World Cancer Research Fund
10. Red Temática de Investigación Cooperativa en Cáncer of the Instituto de Salud Carlos III
11. FEDER funds/European Regional Development Fund (ERDF)
12. Swedish Research Council and County Councils of Skåne and Västerbotten (Sweden)
13. Cancer Research UK
Who is the main contact?
Dr Antonio Agudo
Contact information
Scientific
Av. Gran Via de l'Hospitalet, 199-203
2nd floor
Barcelona
08908
Spain
Study information
| Study design | Prospective cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Community |
| Study type | Other |
| Participant information sheet | No participant information sheet available |
| Scientific title | Inflammatory potential of the diet and risk of gastric cancer in the European Prospective Investigation into Cancer and Nutrition (EPIC) study |
| Study objectives | Inflammation is related to carcinogenesis, and specially to tumors from the GI tract. Diet modulates inflammation and many dietary components have been related with levels of circulating inflammatory markers. Therefore, the inflammatory potential of diet can be associated with the risk of gastric cancer. |
| Ethics approval(s) | Clinical Research Ethics Committee (Comité de Investigación Clínica) of the Bellvitge University Hospital, L’Hospitalet de Llobregat (Barcelona), Spain, 23/03/2015, ref. PR102/15 All other centres received ethics approval before recruitment of the first participant |
| Health condition(s) or problem(s) studied | Gastric cancer (malignant carcinoma) |
| Intervention | Dietary information collected by means of dietary history questionnaire or food-frequency questionnaires. The dietary inflammatory potential was assessed by means of an inflammatory score of the diet (ISD), calculated using 28 dietary components and their corresponding inflammatory scores. Outcomes assessed by record linkage with population cancer registries and national or regional mortality registries in most of the participating countries. In France, Germany and Greece an active follow-up used a combination of approaches, including cancer and pathology registries, health insurance records, and active follow-up contacting the participants or their next-of-kin. Updates of the endpoints (as well as vital status) were done approximately every two years. The association between the ISD and gastric cancer risk was estimated by hazard ratios (HR) and 95%-confidence intervals (CI) calculated by multivariate Cox regression models adjusted for confounders. |
| Intervention type | Other |
| Primary outcome measure | Gastric cancer incidence, assessed by record linkage with population cancer registries and national or regional mortality registries approximately every two years during the study |
| Secondary outcome measures | Gastric cancers according to anatomical site: cardia or non-cardia, assessed by record linkage with population cancer registries and national or regional mortality registries approximately every two years during the study |
| Overall study start date | 01/10/2015 |
| Completion date | 31/12/2016 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 500000 overall for 10 European countries. variable number by country/center |
| Key inclusion criteria | 1. Healthy volunteers resident in each study centre. Different settings by centre: general population, blood donors, participants in screening programs 2. Aged 30-70 |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/09/1992 |
| Date of final enrolment | 31/12/2000 |
Locations
Countries of recruitment
- Denmark
- England
- France
- Germany
- Greece
- Italy
- Netherlands
- Norway
- Spain
- Sweden
- United Kingdom
Study participating centres
France
Greece
Denmark
Denmark
Norway
Sweden
Sweden
Netherlands
Netherlands
United Kingdom
United Kingdom
Germany
Germany
Spain
Spain
Spain
Spain
Spain
Italy
Italy
Italy
Italy
Italy
69372
France
United Kingdom
Sponsor information
Hospital/treatment centre
Av. Gran Via de l'Hospitalet, 199-203
2nd floor
Barcelona
08908
Spain
"ROR" |
https://ror.org/01j1eb875 |
|---|
Funders
Funder type
Government
No information available
No information available
Government organisation / National government
- Alternative name(s)
- Federal Ministry of Education and Research, BMBF
- Location
- Germany
No information available
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- Italian Association for Cancer Research, The Italian Association for Cancer Research, AIRC
- Location
- Italy
Government organisation / National government
- Alternative name(s)
- National Research Council, Consiglio Nazionale delle Ricerche (IT), National Research Council of Italy, National Research Council (Italy), Italy, Consiglio Nazionale delle Ricerche, CNR
- Location
- Italy
Government organisation / National government
- Alternative name(s)
- Dutch Ministry of Health, Welfare and Sport, VWS
- Location
- Netherlands
No information available
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- World Cancer Research Fund UK, WCRF, WCRF UK
- Location
- United Kingdom
No information available
No information available
No information available
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/08/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Publication in peer reviewed journal. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2018 | Yes | No |
Editorial Notes
12/04/2018: Publication reference added.
