Discovering Cancer Risks From Environmental Contaminants and Maternal/Child Health
- Conditions
- Cancer
- Interventions
- Other: Health QuestionnairesOther: Specimen sample collection
- Registration Number
- NCT05746169
- Lead Sponsor
- University of California, San Francisco
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10000
- 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.
- Women under the age of 18.
- Women expecting the birth of multiples (twins, triplets, etc.).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Pregnant women and their children Health Questionnaires 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. Pregnant women and their children Specimen sample collection 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.
- Primary Outcome Measures
Name Time Method Evaluation of endocrine system disruptions Up to 4 years Exposures 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 modulation Up to 4 years 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.
Frequency of oxidative stress biomarkers Up to 4 years 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.
Assessment of levels of consumer product-related chemicals Up to 4 years Consumer product related chemicals measured via biomonitoring of polyfluoroalkyl substances (PFAS), phthalates and other plasticizers, phenolic compounds, pesticides, and aromatic amines will be assessed.
Impact of geographical environmental pollutants Up to 4 years 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
University of California, Berkeley
🇺🇸Berkeley, California, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
Fresno Community Regional Medical Center
🇺🇸Fresno, California, United States