Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2025-12-27 @ 1:12 AM
Study NCT ID:
NCT03424668
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2019-04-16
First Post:
2018-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The European Prospective Investigation Into Cancer in Norfolk Prospective Population Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004032', 'term': 'Diet'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood and urine samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25639}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '1992-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2040-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-15', 'studyFirstSubmitDate': '2018-01-25', 'studyFirstSubmitQcDate': '2018-01-31', 'lastUpdatePostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2040-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'fractures', 'timeFrame': 'through 25 years', 'description': 'incident fractures'}, {'measure': 'diabetes mellitus', 'timeFrame': 'through 25 years', 'description': 'incident diabetes'}], 'primaryOutcomes': [{'measure': 'neoplasms', 'timeFrame': 'Through 25 years', 'description': 'cancer incidence'}], 'secondaryOutcomes': [{'measure': 'cardiovascular diseases', 'timeFrame': 'through 25 years', 'description': 'incidence of cardiovascular diseases'}, {'measure': 'death', 'timeFrame': 'through 25 years', 'description': 'total mortality by cause'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nutrition', 'physical activity', 'lifestyle', 'smoking'], 'conditions': ['Neoplasms', 'Cardiovascular Diseases', 'Death']}, 'referencesModule': {'references': [{'pmid': '10466767', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '11415493', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '39 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Resident in Norfolk, United Kingdom on general practice age sex registers 1993-1997', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willing to participate\n* On general practice age sex registers in Norfolk, United Kingdom in 1993-1997\n\nExclusion Criteria:\n\n* Not willing to participate in study\n* terminal illness'}, 'identificationModule': {'nctId': 'NCT03424668', 'acronym': 'EPIC-Norfolk', 'briefTitle': 'The European Prospective Investigation Into Cancer in Norfolk Prospective Population Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Cambridge'}, 'officialTitle': 'The European Prospective Investigation Into Cancer in Norfolk Prospective Population Study', 'orgStudyIdInfo': {'id': 'MR/N003284/1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'diet', 'type': 'BEHAVIORAL', 'otherNames': ['physical activity'], 'description': 'lifestyle factors'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Nicholas Wareham, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cambridge'}, {'name': 'Kay-Tee Khaw, MBBChir', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cambridge'}]}, 'ipdSharingStatementModule': {'url': 'http://www.srl.cam.ac.uk/epic/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Data are available after collection, cleaning and quality control', 'ipdSharing': 'YES', '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.', 'accessCriteria': 'Bonafide researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cambridge', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medical Research Council', 'class': 'OTHER_GOV'}, {'name': 'Cancer Research UK', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Clinical Gerontology', 'investigatorFullName': 'Kay-Tee Khaw', 'investigatorAffiliation': 'University of Cambridge'}}}}