The European Prospective Investigation Into Cancer in Norfolk Prospective Population Study (EPIC-Norfolk)

April 15, 2019 updated by: Kay-Tee Khaw, University of Cambridge
The European Prospective Investigation into Cancer and Nutrition in Norfolk is a population based prospective study of approximately 25,000 men and women resident in Norfolk United Kingdom. They were aged 39-79 years when first recruited from general practice age sex registers at baseline assessment 1993-1997. While part of a ten country half million participant European collaboration originally aimed to investigate diet and other lifestyle determinants of cancer, the objectives of the Norfolk cohort from inception were expanded to encompass the trajectory of health, ill health and mortality in a population over time and to examine the biological and lifestyle determinants of health and chronic disease.

Study Overview

Status

Active, not recruiting

Intervention / Treatment

Detailed Description

The European Prospective Investigation into Cancer and Nutrition in Norfolk is a population based prospective study of approximately 25,000 men and women resident in Norfolk United Kingdom. They were aged 39-79 years when first recruited from general practice age sex registers at baseline assessment 1993-1997. While part of a ten country half million participant European collaboration originally aimed to investigate diet and other lifestyle determinants of cancer, the objectives of the Norfolk cohort from inception were expanded to encompass the trajectory of health, ill health and mortality in a population over time and to examine the biological and lifestyle determinants of health and chronic disease. Detailed data on sociodemographic, lifestyle, medical and family history were collected and a biological sample bank including urine and blood samples established. Participants have been followed up through repeat examinations, mailed questionnaires as well as through record linkage with routine health records including death certification by cause, cancer registration and hospital admissions by cause till present.

Study Type

Observational

Enrollment (Actual)

25639

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

39 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Resident in Norfolk, United Kingdom on general practice age sex registers 1993-1997

Description

Inclusion Criteria:

  • Willing to participate
  • On general practice age sex registers in Norfolk, United Kingdom in 1993-1997

Exclusion Criteria:

  • Not willing to participate in study
  • terminal illness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
neoplasms
Time Frame: Through 25 years
cancer incidence
Through 25 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cardiovascular diseases
Time Frame: through 25 years
incidence of cardiovascular diseases
through 25 years
death
Time Frame: through 25 years
total mortality by cause
through 25 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
fractures
Time Frame: through 25 years
incident fractures
through 25 years
diabetes mellitus
Time Frame: through 25 years
incident diabetes
through 25 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Kay-Tee Khaw, MBBChir, University of Cambridge
  • Principal Investigator: Nicholas Wareham, MBBS, University of Cambridge

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 1992

Primary Completion (Anticipated)

December 31, 2040

Study Completion (Anticipated)

December 31, 2040

Study Registration Dates

First Submitted

January 25, 2018

First Submitted That Met QC Criteria

January 31, 2018

First Posted (Actual)

February 7, 2018

Study Record Updates

Last Update Posted (Actual)

April 16, 2019

Last Update Submitted That Met QC Criteria

April 15, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MR/N003284/1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

EPIC Norfolk follows Medical Research Council UK good practice for data sharing. Requests for data are submitted to the EPIC Norfolk management committee to assess scientific feasibility and avoid duplication and within the requirements of NHS Digital data protection rules.

IPD Sharing Time Frame

Data are available after collection, cleaning and quality control

IPD Sharing Access Criteria

Bonafide researchers

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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