Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2026-01-24 @ 6:46 AM
Study NCT ID:
NCT06526169
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-09
First Post:
2024-07-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Human Exposure to Chemical Hazards
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Plasma and serum samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-02', 'studyFirstSubmitDate': '2024-07-24', 'studyFirstSubmitQcDate': '2024-07-24', 'lastUpdatePostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Chemical hazards occurrence', 'timeFrame': '3 years', 'description': 'To evaluate the occurrence of chemical hazards exposure in the Singapore population and assess their association with food consumption.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dietary Exposure']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the occurrence of chemical hazards exposure in the Singapore population and assess their association with food consumption.', 'detailedDescription': "Human biomonitoring is an exposure assessment approach with the potential value-add supplementation to existing sources of information for regulatory risk assessments and for supporting food safety policies. The collaboration involving academic partners from the sciences and public health disciplines to quantify the in vivo chemical exposure of chemicals will take reference from the findings in the Singapore's total diet study on the prioritised chemical hazards of interest for a more precise assessment of the distribution of risk in the population. Direct measurement of chemicals and/or metabolites in biological specimens obtained from study subjects will be conducted to provide a more comprehensive understanding on the baseline dietary chemical exposure in the local population. Dietary assessment using food frequency questionnaire will be administered to the same group of study subjects to associate human exposure to chemical hazards with food consumption across the different population groups in Singapore."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '21 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy adults in the Singapore population', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be English-literate and able to give informed consent in English\n* 21 to 60 years of age (inclusive) at screening\n* Healthy adults\n* Race must be Chinese or Indian or Malay\n* Reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures\n\nExclusion Criteria:\n\n* Known or ongoing psychiatric disorders within 3 years\n* Being diagnosed with cancer, heart disease, stroke, renal failure, serious mental or physical illnesses at the time of recruitment\n* Have donated blood of more than 500 mL within 4 weeks of study enrolment'}, 'identificationModule': {'nctId': 'NCT06526169', 'briefTitle': 'Assessment of Human Exposure to Chemical Hazards', 'organization': {'class': 'OTHER', 'fullName': 'National University of Singapore'}, 'officialTitle': 'Assessment of Human Exposure to Chemical Hazards and Their Association With Food Consumption in the Singapore Population', 'orgStudyIdInfo': {'id': 'NUS-IRB-2024-128'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ethnicity: Chinese', 'interventionNames': ['Other: Food Frequency, Social, Lifestyle, Demographic Questionnaires and Blood Collection']}, {'label': 'Ethnicity: Malay', 'interventionNames': ['Other: Food Frequency, Social, Lifestyle, Demographic Questionnaires and Blood Collection']}, {'label': 'Ethnicity: Indian', 'interventionNames': ['Other: Food Frequency, Social, Lifestyle, Demographic Questionnaires and Blood Collection']}], 'interventions': [{'name': 'Food Frequency, Social, Lifestyle, Demographic Questionnaires and Blood Collection', 'type': 'OTHER', 'description': "Questionnaires on food frequency, social, lifestyle, and demographics will be administered to participants and will be correlated with the presence of chemical hazards in the blood. The chemical hazards analyzed will be referenced from Singapore's Total Diet Study, based on the prioritized chemical hazards of interest to investigate the distribution of risk in the population.", 'armGroupLabels': ['Ethnicity: Chinese', 'Ethnicity: Indian', 'Ethnicity: Malay']}]}, 'contactsLocationsModule': {'locations': [{'zip': '118177', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'National University of Singapore', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'city': 'Singapore', 'country': 'Singapore', 'facility': 'National University of Singapore, Department of Food Science & Technology', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Mei Hui Liu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National University of Singapore'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National University of Singapore', 'class': 'OTHER'}, 'collaborators': [{'name': 'Singapore Food Agency', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Lecturer', 'investigatorFullName': 'Mei Hui Liu', 'investigatorAffiliation': 'National University of Singapore'}}}}