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Discovering Cancer Risks From Environmental Contaminants and Maternal/Child Health

DREAM: Discovering Cancer Risks From Environmental Contaminants And Maternal/Child Health

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05746169
Enrollment
1576
Registered
2023-02-27
Start date
2021-09-01
Completion date
2025-07-21
Last updated
2025-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

Cancer Risk, Environmental Cancer Risk, Maternal-Child Cancer Risk, Environmental Contaminants

Brief summary

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.

Detailed description

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. The 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.

Interventions

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.

Collection of blood, urine, nails, hair, and saliva samples will be obtained during the participant encounters.

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
California Office of Environmental Health Hazard Assessment (OEHHA)
CollaboratorUNKNOWN
University of California, San Francisco
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Pregnant women, over the age of 18 years. * English or Spanish-speaking. * Children born of participants enrolled during pregnancy will be enrolled in the DREAM cohort. * Inclusion criterion for the DREAM Cohort Ambassador Program is limited to research participants in the DREAM Cohort.

Exclusion criteria

* Women under the age of 18. * Women expecting the birth of multiples (twins, triplets, etc.).

Design outcomes

Primary

MeasureTime frameDescription
Assessment of levels of consumer product-related chemicalsUp to 4 yearsConsumer product related chemicals measured via biomonitoring of polyfluoroalkyl substances (PFAS), phthalates and other plasticizers, phenolic compounds, pesticides, and aromatic amines will be assessed.
Evaluation of endocrine system disruptionsUp to 4 yearsExposures to environmental chemicals that disrupt endocrine and related biological systems during pregnancy which may predispose women and children to cancer will be evaluated.
Assessment of Inflammation/Immune modulationUp to 4 yearsMeasures 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.
Impact of geographical environmental pollutantsUp to 4 yearsThe environmental pollutants found in air and water, as well as pesticide use, will be evaluated via geographic information system analyses of participants' residential history.
Frequency of oxidative stress biomarkersUp to 4 yearsOxidative 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026