Condition category
Cancer
Date applied
01/08/2017
Date assigned
11/09/2017
Last edited
12/04/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Antonio Agudo

ORCID ID

Contact details

Av. Gran Via de l'Hospitalet
199-203
2nd floor
Barcelona
08908
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PI15_0639_1

Study information

Scientific title

Inflammatory potential of the diet and risk of gastric cancer in the European Prospective Investigation into Cancer and Nutrition (EPIC) study

Acronym

Study hypothesis

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

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

Study design

Prospective cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Community

Trial type

Other

Patient information sheet

No participant information sheet available

Condition

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

Phase

Drug names

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 trial start date

01/10/2015

Overall trial end date

31/12/2016

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

500000 overall for 10 European countries. variable number by country/center

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/09/1992

Recruitment end date

31/12/2000

Locations

Countries of recruitment

Denmark, France, Germany, Greece, Italy, Netherlands, Norway, Spain, Sweden, United Kingdom

Trial participating centre

Paris
94076
France

Trial participating centre

Athens
10679
Greece

Trial participating centre

Aarhus
8000
Denmark

Trial participating centre

Copenhagen
2100
Denmark

Trial participating centre

Tromso
9019
Norway

Trial participating centre

Malmo
21119
Sweden

Trial participating centre

Umea
90187
Sweden

Trial participating centre

Utrecht
3584
Netherlands

Trial participating centre

Bilthoven
3721
Netherlands

Trial participating centre

Oxford
OX1 2JD
United Kingdom

Trial participating centre

Norfolk
NR31 0ED
United Kingdom

Trial participating centre

Heidelberg
69120
Germany

Trial participating centre

Potsdam
14558
Germany

Trial participating centre

Asturias
33005
Spain

Trial participating centre

Guipúzcoa
20013
Spain

Trial participating centre

Navarra
31003
Spain

Trial participating centre

Murcia
30003
Spain

Trial participating centre

Granada
18011
Spain

Trial participating centre

Turin
10126
Italy

Trial participating centre

Milan
20133
Italy

Trial participating centre

Florence
50139
Italy

Trial participating centre

Naples
80138
Italy

Trial participating centre

Ragusa
97100
Italy

Trial participating centre

IARC
Lyon
69372
France

Trial participating centre

Imperial College London
SW7 2AZ
United Kingdom

Sponsor information

Organisation

Catalan Institute of Oncology

Sponsor details

Av. Gran Via de l'Hospitalet
199-203
2nd floor
Barcelona
08908
Spain

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Health Research Fund (FIS)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

European Commission (DG-SANCO)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Bundesministerium für Bildung und Forschung

Alternative name(s)

Federal Ministry of Education and Research, BMBF

Funding Body Type

government organisation

Funding Body Subtype

federal

Location

Germany

Funder name

Hellenic Health Foundation (Greece)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Associazione Italiana per la Ricerca sul Cancro

Alternative name(s)

Italian Association for Cancer Research, AIRC

Funding Body Type

private sector organisation

Funding Body Subtype

professional associations and societies

Location

Italy

Funder name

Consiglio Nazionale delle Ricerche

Alternative name(s)

National Research Council, CNR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Italy

Funder name

Ministerie van Volksgezondheid, Welzijn en Sport

Alternative name(s)

Dutch Ministry of Health, Welfare and Sport, VWS

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Netherlands

Funder name

Netherlands Cancer Registry (NKR)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

World Cancer Research Fund

Alternative name(s)

WCRF UK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

Red Temática de Investigación Cooperativa en Cáncer of the Instituto de Salud Carlos III

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

FEDER funds/European Regional Development Fund (ERDF)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Swedish Research Council and County Councils of Skåne and Västerbotten (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Cancer Research UK

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Publication in peer reviewed journal.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/08/2017

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29635497

Publication citations

Additional files

Editorial Notes

12/04/2018: Publication reference added.