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Trial Title:
Discovering Cancer Risks From Environmental Contaminants and Maternal/Child Health
NCT ID:
NCT05746169
Condition:
Cancer
Conditions: Keywords:
Cancer Risk
Environmental Cancer Risk
Maternal-Child Cancer Risk
Environmental Contaminants
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Health Questionnaires
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.
Arm group label:
Pregnant women and their children
Intervention type:
Other
Intervention name:
Specimen sample collection
Description:
Collection of blood, urine, nails, hair, and saliva samples will be obtained during the
participant encounters.
Arm group label:
Pregnant women and their children
Other name:
Biospecimen sample collection
Other name:
Specimen collection
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.
Criteria for eligibility:
Study pop:
Pregnant women and their children
Sampling method:
Non-Probability Sample
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.).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
University of California, Berkeley
Address:
City:
Berkeley
Zip:
94720
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Rachel Morello-Frosch, PhD
Email:
Principal Investigator
Facility:
Name:
Fresno Community Regional Medical Center
Address:
City:
Fresno
Zip:
93721
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Amy (Meg) Autry, MD
Email:
Principal Investigator
Facility:
Name:
University of California, San Francisco
Address:
City:
San Francisco
Zip:
94143
Country:
United States
Status:
Recruiting
Contact:
Last name:
Erin DeMicco
Phone:
415-476-3220
Email:
Erin.DeMicco@ucsf.edu
Investigator:
Last name:
Peggy Reynolds, PhD
Email:
Principal Investigator
Investigator:
Last name:
Tracey Woodruff, PhD, MPH
Email:
Sub-Investigator
Start date:
September 1, 2021
Completion date:
August 31, 2027
Lead sponsor:
Agency:
University of California, San Francisco
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Collaborator:
Agency:
California Office of Environmental Health Hazard Assessment (OEHHA)
Agency class:
Other
Source:
University of California, San Francisco
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05746169
