DREAM: Discovering Cancer Risks From Environmental Contaminants And Maternal/Child Health
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1,576
- 试验地点
- 3
- 主要终点
- Evaluation of endocrine system disruptions
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Women under the age of
- •Women expecting the birth of multiples (twins, triplets, etc.).
结局指标
主要结局
Evaluation of endocrine system disruptions
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点