Discovering Cancer Risks From Environmental Contaminants and Maternal/Child Health

NCT05746169 | Terminated

• 3 other identifiers: 21621NCI-2022-10633UG3CA265845
• Study Type: observational
• Target: 1,576
• Locations: 1 country
• Sites: 3

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.

Conditions

Cancer

Keywords

Cancer Risk; Environmental Cancer Risk; Maternal-Child Cancer Risk; Environmental Contaminants

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• Frequency of oxidative stress biomarkers

  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.

  Up to 4 years

Study Arms (1)

Pregnant women and their children

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.

Other: Health Questionnaires; Other: Specimen sample collection

Interventions

Health Questionnaires OTHER

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.

Pregnant women and their children

Specimen sample collection OTHER

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

Also known as: Biospecimen sample collection, Specimen collection

Pregnant women and their children

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women and their children

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Cancer Institute (NCI): collaborator
• California Office of Environmental Health Hazard Assessment (OEHHA): collaborator

Study Sites (3)

University of California, Berkeley

Berkeley, California, 94720, United States

Location

Fresno Community Regional Medical Center

Fresno, California, 93721, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

* Maternal urine will be collected at 2nd trimester, delivery, and 4-year visit. * Maternal blood will be collected at 2nd trimester, delivery, and 4-year visit. Self-collected maternal blood will be collected via finger stick. * Maternal hair and nail samples will be collected at 2nd trimester , 2.5-year assessment, and 4-year assessment. Toenail samples will be collected with standard, stainless steel toenail clippers. * Umbilical cord blood samples will be collected at time of delivery. * Child hair and nail samples will be collected at two timepoints: 2.5-year follow-up assessment and 4-year clinic visit. * Child urine will be collected from children at the 4-year clinic visit. * Child saliva will be collected from saliva samples from children at the 4-year clinic visit.

MeSH Terms

Conditions

Neoplasms

Interventions

Specimen Handling

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Peggy Reynolds, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2023
• First Posted: February 27, 2023
• Study Start: September 1, 2021
• Primary Completion: July 21, 2025
• Study Completion: July 21, 2025
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)