Clinical trial NCT05746169: Discovering Cancer Risks From Environmental Contaminants and Maternal/Child Health
Official title: DREAM: Discovering Cancer Risks From Environmental Contaminants And Maternal/Child Health
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Keywords: Cancer Risk
Environmental Cancer Risk
Maternal-Child Cancer Risk
Environmental Contaminants
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: California Office of Environmental Health Hazard Assessment (OEHHA)
First posted: 2023-02-27
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women and their children

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.

Eligibility criteria: 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.).

Primary outcomes:
measure: Assessment of levels of consumer product-related chemicals
timeFrame: Up to 4 years
measure: Evaluation of endocrine system disruptions
timeFrame: Up to 4 years
measure: Assessment of Inflammation/Immune modulation
timeFrame: Up to 4 years
measure: Impact of geographical environmental pollutants
timeFrame: Up to 4 years
measure: Frequency of oxidative stress biomarkers
timeFrame: Up to 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: University of California, Berkeley
state: California
city: Fresno
country: United States
facility: Fresno Community Regional Medical Center
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Peggy Reynolds, PhD
role: PRINCIPAL_INVESTIGATOR
References: