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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03424668
Recruitment Status : Active, not recruiting
First Posted : February 7, 2018
Last Update Posted : April 16, 2019
Sponsor:
Collaborators:
Medical Research Council
Cancer Research UK
Information provided by (Responsible Party):
Kay-Tee Khaw, University of Cambridge

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Neoplasms Cardiovascular Diseases Death Behavioral: diet

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 Design
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Study Type : Observational
Actual Enrollment : 25639 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The European Prospective Investigation Into Cancer in Norfolk Prospective Population Study
Actual Study Start Date : January 1, 1992
Estimated Primary Completion Date : December 31, 2040
Estimated Study Completion Date : December 31, 2040
Groups and Cohorts
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Intervention Details:
  • Behavioral: diet
    lifestyle factors
    Other Name: physical activity

Outcome Measures
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Primary Outcome Measures :
  1. neoplasms [ Time Frame: Through 25 years ]
    cancer incidence


Secondary Outcome Measures :
  1. cardiovascular diseases [ Time Frame: through 25 years ]
    incidence of cardiovascular diseases

  2. death [ Time Frame: through 25 years ]
    total mortality by cause


Other Outcome Measures:
  1. fractures [ Time Frame: through 25 years ]
    incident fractures

  2. diabetes mellitus [ Time Frame: through 25 years ]
    incident diabetes


Biospecimen Retention:   Samples With DNA
Blood and urine samples

Eligibility Criteria
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Ages Eligible for Study:   39 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Resident in Norfolk, United Kingdom on general practice age sex registers 1993-1997
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03424668


Sponsors and Collaborators
University of Cambridge
Medical Research Council
Cancer Research UK
Investigators
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Principal Investigator: Nicholas Wareham, MBBS University of Cambridge
Principal Investigator: Kay-Tee Khaw, MBBChir University of Cambridge
More Information
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Publications:

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Responsible Party: Kay-Tee Khaw, Professor of Clinical Gerontology, University of Cambridge
ClinicalTrials.gov Identifier: NCT03424668    
Other Study ID Numbers: MR/N003284/1
First Posted: February 7, 2018    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data are available after collection, cleaning and quality control
Access Criteria: Bonafide researchers
URL: http://www.srl.cam.ac.uk/epic/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kay-Tee Khaw, University of Cambridge:
nutrition
physical activity
lifestyle
smoking
Additional relevant MeSH terms:
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Cardiovascular Diseases