- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03424668
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
Conditions
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.
Sponsor
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.
General Publications
- Day N, Oakes S, Luben R, Khaw KT, Bingham S, Welch A, Wareham N. EPIC-Norfolk: study design and characteristics of the cohort. European Prospective Investigation of Cancer. Br J Cancer. 1999 Jul;80 Suppl 1:95-103. No abstract available.
- Bingham SA, Welch AA, McTaggart A, Mulligan AA, Runswick SA, Luben R, Oakes S, Khaw KT, Wareham N, Day NE. Nutritional methods in the European Prospective Investigation of Cancer in Norfolk. Public Health Nutr. 2001 Jun;4(3):847-58. doi: 10.1079/phn2000102.
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
Keywords
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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