Ignite Creation Date:
2025-12-24 @ 7:33 PM
Ignite Modification Date:
2026-01-27 @ 7:42 PM
Study NCT ID:
NCT03227003
Status:
COMPLETED
Last Update Posted:
2017-07-24
First Post:
2017-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DNA Methylation and 1-C Metabolism Nutrient Intake
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5983}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2015-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-21', 'studyFirstSubmitDate': '2017-07-21', 'studyFirstSubmitQcDate': '2017-07-21', 'lastUpdatePostDateStruct': {'date': '2017-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood DNA methylation', 'timeFrame': '2014-2015', 'description': 'Methylation of DNA from peripheral blood, HumanMethylation 450 Beadchip assay'}], 'secondaryOutcomes': [{'measure': 'Blood DNA methylation', 'timeFrame': '2014-2015', 'description': 'Methylation of DNA from peripheral blood, LINE-1, Alu, Sat2'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['DNA Methylation']}, 'referencesModule': {'references': [{'pmid': '30101351', 'type': 'DERIVED', 'citation': 'Chamberlain JA, Dugue PA, Bassett JK, Hodge AM, Brinkman MT, Joo JE, Jung CH, Makalic E, Schmidt DF, Hopper JL, Buchanan DD, English DR, Southey MC, Giles GG, Milne RL. Dietary intake of one-carbon metabolism nutrients and DNA methylation in peripheral blood. Am J Clin Nutr. 2018 Sep 1;108(3):611-621. doi: 10.1093/ajcn/nqy119.'}]}, 'descriptionModule': {'briefSummary': 'The present study used a sub-sample of the Melbourne Collaborative Cohort Study (MCCS) (Milne RL et al, Int J Epidemiol, 2017), who had valid data on dietary intakes (121-item food frequency questionnaire) and valid measures of DNA methylation using the HumanMethylation Infinium 450K Beadchip assay, or using LINE-1, Alu and Sat2 assays.\n\nThe investigators studied the association between nutrients involved in one-carbon metabolism and DNA methylation in peripheral blood.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '27 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The population is a sub-sample of the Melbourne Collaborative Cohort Study (MCCS), with non-random sampling based on selection into of six case-control studies nested within the MCCS. The MCCS is a prospective cohort study of 41,513 people (17,044 men and 24,469 women) recruited between 1990 and 1994. The age range at recruitment was 27-80 (99.3% being aged 40-69). Southern European migrants to Australia were over-sampled to extend the range of exposures, including dietary patterns.\n\nParticipants in this sub-study had valid dietary intake data and valid measures of DNA methylation.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Selected into one of six case-control studies nested in the Melbourne Collaborative Cohort Study\n* Completed a 121-item Food Frequency Questionnaire\n* Had a blood DNA sample with a measure of methylation\n\nExclusion Criteria:\n\n* Missing data in any of the outcome, exposure, or confounders (N=797 excluded)'}, 'identificationModule': {'nctId': 'NCT03227003', 'briefTitle': 'DNA Methylation and 1-C Metabolism Nutrient Intake', 'organization': {'class': 'OTHER', 'fullName': 'Cancer Council Victoria'}, 'officialTitle': 'Dietary Intake of One-carbon Metabolism Nutrients and DNA Methylation in Peripheral Blood', 'orgStudyIdInfo': {'id': 'CEID_methylation_1'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Graham G Giles, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cancer Council Victoria'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cancer Council Victoria', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head, Cancer Epidemiology & Intelligence Division', 'investigatorFullName': 'Roger Milne', 'investigatorAffiliation': 'Cancer Council Victoria'}}}}