Discovering Cancer Risks From Environmental Contaminants and Maternal/Child Health

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05746169
• Other study ID #: 21621
• Secondary ID: NCI-2022-10633UG
• Status: Recruiting
• Start date: September 1, 2021
• Est. completion date: August 31, 2027

Study information

• Verified date: February 2023
• Source: University of California, San Francisco
• Contact: Erin DeMicco
• Phone: 415-476-3220
• Email: Erin.DeMicco[@]ucsf.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: August 31, 2027
• Est. primary completion date: August 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.).

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• Health Questionnaires
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.
• Specimen sample collection
Collection of blood, urine, nails, hair, and saliva samples will be obtained during the participant encounters.

Locations

Country	Name	City	State
United States	Fresno Community Regional Medical Center	Fresno	California
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of levels of consumer product-related chemicals	Consumer product related chemicals measured via biomonitoring of polyfluoroalkyl substances (PFAS), phthalates and other plasticizers, phenolic compounds, pesticides, and aromatic amines will be assessed.	Up to 4 years
Primary	Evaluation of endocrine system disruptions	Exposures to environmental chemicals that disrupt endocrine and related biological systems during pregnancy which may predispose women and children to cancer will be evaluated.	Up to 4 years
Primary	Assessment of Inflammation/Immune modulation	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.	Up to 4 years
Primary	Impact of geographical environmental pollutants	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.	Up to 4 years
Primary	Assessment of Oxidative Stress/DNA damage	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-isoprostaglandinF2a [8-PGF2a], 11ß-prostaglandinF2a [11-PGF2a], 15(R)-prostaglandinF2a [15-PGF2a], and 8-iso,15(R)-prostaglandinF2a [8,15-PGF2a]) in maternal urine.	Up to 4 years