NeoplasmsEPIC-NorfolkNCT03424668
The European Prospective Investigation Into Cancer in Norfolk Prospective Population Study
An observational study of Neoplasms and Cardiovascular Diseases, run by University of Cambridge.
Trial 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. Read more about this study
- Who is it for?
- Ages 39 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Neoplasms, Cardiovascular Diseases, Death
- What is being tested?
- diet
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 25,639 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 1992to 31 Dec 2040
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 39 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Resident in Norfolk, United Kingdom on general practice age sex registers 1993-1997
Who may be able to join
- Willing to participate
- On general practice age sex registers in Norfolk, United Kingdom in 1993-1997
Who cannot join
- Not willing to participate in study
- terminal illness
About this study
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.
Read the 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.
- Conditions
- Neoplasms, Cardiovascular Diseases, Death
- Being tested
- diet
- Keywords
- nutrition, physical activity, lifestyle, smoking
- Medical subject headings
- Neoplasms, Cardiovascular Diseases, Death, Motor Activity, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietBehavioural
Also called physical activity
lifestyle factors
What is being measured
The primary outcome is the main question the study is designed to answer.
neoplasms
cancer incidence
Measured: Through 25 years
Secondary outcomes (2)
cardiovascular diseases
incidence of cardiovascular diseases
Measured: through 25 years
death
total mortality by cause
Measured: through 25 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2018
- Study start1 Jan 1992
- Primary completion31 Dec 2040 (estimated)
- Study completion31 Dec 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25,639 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cambridge
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council, Cancer Research UK
- Responsible party
- Principal investigator, Kay-Tee Khaw, University of Cambridge
- Investigators
- Nicholas Wareham, MBBS, Principal investigator, University of CambridgeKay-Tee Khaw, MBBChir, Principal investigator, University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03424668
- Sponsor's protocol ID
- MR/N003284/1
- Acronym
- EPIC-Norfolk
- Status last verified
- Apr 2019
- First submitted
- 25 Jan 2018
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 10466767Bingham 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.
PubMed 11415493
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The European Prospective Investigation Into Cancer in Norfolk Prospective Population Study
- ClinicalTrials.gov ID
- NCT03424668
- Acronym / sponsor ID
- EPIC-Norfolk / MR/N003284/1
- Conditions
- Neoplasms, Cardiovascular Diseases, Death
- Keywords
- nutrition, physical activity, lifestyle, smoking
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 25,639 participants (actual)
- Lead sponsor
- University of CambridgeUniversity, hospital or other
- Collaborators
- Medical Research Council, Cancer Research UK
- Study start
- 1 Jan 1992 (actual)
- Primary completion
- 31 Dec 2040 (estimated)
- Study completion
- 31 Dec 2040 (estimated)
- First posted
- 7 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 39 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Resident in Norfolk, United Kingdom on general practice age sex registers 1993-1997
Key inclusion criteria (2 listed)
- Willing to participate
- On general practice age sex registers in Norfolk, United Kingdom in 1993-1997
Key exclusion criteria (2 listed)
- Not willing to participate in study
- terminal illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dietAlso: physical activitylifestyle factors | Behavioural | – |
Primary outcome
neoplasms
Time frame: Through 25 years
cancer incidence
2 secondary outcomes
cardiovascular diseases
Time frame: through 25 years
death
Time frame: through 25 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Background: PubMed 10466767Day 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.
- Background: PubMed 11415493Bingham 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas Wareham, MBBS principal investigator
University of Cambridge
Kay-Tee Khaw, MBBChir principal investigator
University of Cambridge
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasms and Cardiovascular Diseases, run by University of Cambridge.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neoplasms (time frame: Through 25 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03424668, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.