Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2026-01-02 @ 11:19 PM
Study NCT ID:
NCT05746169
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-06
First Post:
2023-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Discovering Cancer Risks From Environmental Contaminants and Maternal/Child Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013048', 'term': 'Specimen Handling'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '* Maternal urine will be collected at 2nd trimester, delivery, and 4-year visit.\n* Maternal blood will be collected at 2nd trimester, delivery, and 4-year visit. Self-collected maternal blood will be collected via finger stick.\n* Maternal hair and nail samples will be collected at 2nd trimester , 2.5-year assessment, and 4-year assessment. Toenail samples will be collected with standard, stainless steel toenail clippers.\n* Umbilical cord blood samples will be collected at time of delivery.\n* Child hair and nail samples will be collected at two timepoints: 2.5-year follow-up assessment and 4-year clinic visit.\n* Child urine will be collected from children at the 4-year clinic visit.\n* Child saliva will be collected from saliva samples from children at the 4-year clinic visit.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 179}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-02', 'studyFirstSubmitDate': '2023-02-17', 'studyFirstSubmitQcDate': '2023-02-17', 'lastUpdatePostDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of levels of consumer product-related chemicals', 'timeFrame': 'Up to 4 years', 'description': 'Consumer product related chemicals measured via biomonitoring of polyfluoroalkyl substances (PFAS), phthalates and other plasticizers, phenolic compounds, pesticides, and aromatic amines will be assessed.'}, {'measure': 'Evaluation of endocrine system disruptions', 'timeFrame': 'Up to 4 years', 'description': 'Exposures to environmental chemicals that disrupt endocrine and related biological systems during pregnancy which may predispose women and children to cancer will be evaluated.'}, {'measure': 'Assessment of Inflammation/Immune modulation', 'timeFrame': 'Up to 4 years', 'description': 'Measures of peripheral whole blood using a standard laboratory procedure for Complete Blood Count (CBC) panel will be calculated to assess shifts in immune cell profiles indicative of inflammation and immune modulation.'}, {'measure': 'Impact of geographical environmental pollutants', 'timeFrame': 'Up to 4 years', 'description': "The environmental pollutants found in air and water, as well as pesticide use, will be evaluated via geographic information system analyses of participants' residential history."}, {'measure': 'Frequency of oxidative stress biomarkers', 'timeFrame': 'Up to 4 years', 'description': 'Oxidative Stress/DNA damage will be measured by seven oxidative stress biomarkers which reflect oxidative damage to DNA will be measured to determine overall assessment of oxidative damage to DNA: proteins and lipids (OSBs): (o,o -dityrosine (diY), 8-hydroxy-2 -deoxyguanosine (8-OHdG), malondialdehyde (MDA), and four F2-isoprostane isomers (i.e., 8-isoprostaglandinF2α \\[8-PGF2α\\], 11β-prostaglandinF2α \\[11-PGF2α\\], 15(R)-prostaglandinF2α \\[15-PGF2α\\], and 8-iso,15(R)-prostaglandinF2α \\[8,15-PGF2α\\]) in maternal urine.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cancer Risk', 'Environmental Cancer Risk', 'Maternal-Child Cancer Risk', 'Environmental Contaminants'], 'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': 'The DREAM Cohort is a longitudinal observational study developed to enhance our understanding of how multiple exposures to environmental chemicals and pollutants across a diverse population of pregnant women and their offspring are linked to cancer risks. Because pregnancy induces multiple maternal hormonal and physiological changes that can increase cancer susceptibility to environmental chemical exposures, this study will focus on pregnancy as a period of particular vulnerability to toxic agents.', 'detailedDescription': "The environmental exposures will focus on two major components: Consumer product related chemicals (including per- and polyfluoroalkyl substances (PFAS), phthalates and plasticizers, phenolic compounds, pesticides, and aromatic amines) measured via biomonitoring and prioritized based on widespread public exposure; and environmental pollutants in air and water, evaluated via geographic information system analyses of participants' residential histories.\n\nThe study team will collect questionnaire data and biospecimen samples starting at the second trimester of pregnancy up until the child reaches four years of age. A Cohort Ambassador Program will also be established to invite participants across our three sites to provide continuous feedback which will be integrated into the research priorities."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women and their children', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women, over the age of 18 years.\n* English or Spanish-speaking.\n* Children born of participants enrolled during pregnancy will be enrolled in the DREAM cohort.\n* Inclusion criterion for the DREAM Cohort Ambassador Program is limited to research participants in the DREAM Cohort.\n\nExclusion Criteria:\n\n* Women under the age of 18.\n* Women expecting the birth of multiples (twins, triplets, etc.).'}, 'identificationModule': {'nctId': 'NCT05746169', 'briefTitle': 'Discovering Cancer Risks From Environmental Contaminants and Maternal/Child Health', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'DREAM: Discovering Cancer Risks From Environmental Contaminants And Maternal/Child Health', 'orgStudyIdInfo': {'id': '21621'}, 'secondaryIdInfos': [{'id': 'NCI-2022-10633', 'type': 'REGISTRY', 'domain': 'NCI Clinical Trials Reporting Program (CTRP)'}, {'id': 'UG3CA265845', 'link': 'https://reporter.nih.gov/quickSearch/UG3CA265845', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pregnant women and their children', 'description': 'The DREAM cohort will recruit from University of California, San Francisco (UCSF) Mission Bay, Zuckerberg San Francisco General Hospital, and Fresno Community Medical Center locations to enroll an economically, geographically, ethnically and racially diverse cohort of pregnant women and their children for long term follow-up.', 'interventionNames': ['Other: Health Questionnaires', 'Other: Specimen sample collection']}], 'interventions': [{'name': 'Health Questionnaires', 'type': 'OTHER', 'description': "A questionnaire with content developed and tested in the investigator's previous reproductive and cancer epidemiology studies as part of the NIH Environmental Influences on Child Health Outcomes (ECHO) consortium will be used to collect information on primary established and hypothesized risk factors for cancer and additional covariates.", 'armGroupLabels': ['Pregnant women and their children']}, {'name': 'Specimen sample collection', 'type': 'OTHER', 'otherNames': ['Biospecimen sample collection', 'Specimen collection'], 'description': 'Collection of blood, urine, nails, hair, and saliva samples will be obtained during the participant encounters.', 'armGroupLabels': ['Pregnant women and their children']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94720', 'city': 'Berkeley', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Berkeley', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}, {'zip': '93721', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Fresno Community Regional Medical Center', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Peggy Reynolds, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'California Office of Environmental Health Hazard Assessment (OEHHA)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}