Ignite Creation Date:
2025-12-24 @ 11:21 PM
Ignite Modification Date:
2026-01-01 @ 7:34 AM
Study NCT ID:
NCT03269656
Status:
COMPLETED
Last Update Posted:
2017-09-01
First Post:
2017-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Age Gene/Environment Susceptibility Reykjavik Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5764}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2014-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-30', 'studyFirstSubmitDate': '2017-08-30', 'studyFirstSubmitQcDate': '2017-08-30', 'lastUpdatePostDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2006-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'From date of diagnosis until death or censored at end of the follow-up (December 31, 2014)', 'description': 'The association between pre-diagnostic 25(OH)D levels in cancer patients and overall survival'}, {'measure': 'Cancer survival', 'timeFrame': 'From date of diagnosis until cancer death or censored at the end of the follow-up (December 31, 2014)', 'description': 'The association between pre-diagnostic 25(OH)D levels in cancer patients and cancer survival'}], 'secondaryOutcomes': [{'measure': 'Cancer diagnosis', 'timeFrame': 'From date of blood draw (study entry) until cancer diagnosis, death or end of the observation period (December 31, 2014) whichever occurred first', 'description': 'The association between pre-diagnostic 25(OH)D levels and cancer risk'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vitamin D', 'Cancer', 'Survival'], 'conditions': ['Neoplasms']}, 'referencesModule': {'references': [{'pmid': '17351290', 'type': 'BACKGROUND', 'citation': 'Harris TB, Launer LJ, Eiriksdottir G, Kjartansson O, Jonsson PV, Sigurdsson G, Thorgeirsson G, Aspelund T, Garcia ME, Cotch MF, Hoffman HJ, Gudnason V. Age, Gene/Environment Susceptibility-Reykjavik Study: multidisciplinary applied phenomics. Am J Epidemiol. 2007 May 1;165(9):1076-87. doi: 10.1093/aje/kwk115. Epub 2007 Mar 10.'}], 'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2723948/', 'label': 'Age, Gene/Environment Susceptibility-Reykjavik Study: Multidisciplinary Applied Phenomics'}]}, 'descriptionModule': {'briefSummary': '5764 men and women in Iceland, aged 66 to 96 years entered the Ages Gene/Environment Susceptibility (AGES) - Reykjavik Study. Serum 25(OH)D was measured in 5,519 of all 5,764 (96%) participants at study entry in year 2002 through 2006. The main emphasis was on exploring whether pre-diagnostic serum levels of 25(OH)D were associated with survival after cancer diagnosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '98 Years', 'minimumAge': '66 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'In 1967, all 30,795 men and women living in the capital area of Iceland and born between 1907 and 1935 were invited by the Icelandic Heart Association to join a prospective cohort study. Approximately 19,000 attended the clinic at least once and became participants of the Reykjavik Study. Subsequently, in 2002, a random sample of the cohort comprising 5,764 men and women who were still alive in Iceland and aged 66 to 96 years entered the Ages Gene/Environment Susceptibility (AGES) - Reykjavik Study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* To participate in the AGES-Reykjavik study\n\nExclusion Criteria:\n\n* To be diagnosed with cancer before study entry'}, 'identificationModule': {'nctId': 'NCT03269656', 'acronym': 'AGES', 'briefTitle': 'Age Gene/Environment Susceptibility Reykjavik Study', 'organization': {'class': 'OTHER', 'fullName': 'Icelandic Heart Association'}, 'officialTitle': 'Association of Pre-diagnostic Vitamin D Levels and Survival in Older Individuals With Cancer', 'orgStudyIdInfo': {'id': 'IHA'}, 'secondaryIdInfos': [{'id': 'NO1-AG-1-2100', 'type': 'OTHER_GRANT', 'domain': 'National Institute on Aging'}, {'id': 'ZIAEY000401', 'link': 'https://reporter.nih.gov/quickSearch/ZIAEY000401', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'AGES-Reykjavik participants', 'description': 'Exploring whether pre-diagnostic serum levels of 25(OH)D among older individuals living in Iceland were associated with survival after cancer diagnosis. We also assessed the risk of being diagnosed with cancer in association with 25(OH)D levels.'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Johanna Torfadottir, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Iceland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Icelandic Heart Association', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Iceland', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}