Family-Based Intervention Study of the Effects of Environmental Exposures on Breast Tissue Composition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Feasibility of measuring pre/post-intervention change in participants' breast tissue concentration of oxygenated hemoglobin (%) measured using an Optical Spectroscopy machine.
研究概览
简要总结
This research study is being conducted to find out whether changes in household and personal behavior aimed at reducing exposure to environmental chemicals in dust (increased house dust removal efforts/cleaning and hand washing) and consumer products (increased us of personal care and beauty products that are free of chemicals including phthalates, parabens, and phenols) results in lower exposure to environmental chemicals including polycyclic aromatic hydrocarbons (PAHs) and endocrine disrupting chemicals including phthalates, parabens and phenols. These chemicals may have harmful health effects, as they can interfere with normal functions of the body. This study will also assess changes in breast tissue composition to understand the role of environmental exposures in breast cancer risk.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participant of Columbia's Breast Cancer Research and the Environment (BCERP) Study that recruited from the Columbia Children's Center for Environmental Health (CCCEH) Mothers and Newborns cohort.
- •Mother did not smoke or use illicit drugs prior to or during pregnancy (referring to pregnancy for participating daughter).
- •Mother was 18-35 years at time of daughter's delivery.
- •Mother registered in the prenatal clinics by the 20th week of pregnancy.
- •Mother free of diabetes, hypertension and reported HIV infection.
- •Mother resided in northern Manhattan or the South Bronx neighborhoods of New York City for at least one year prior to pregnancy.
- •Mother self-identified as African-American or Dominican.
- •Only participants in the CCCEH birth cohort who answered in the affirmative to the question "I would like to be contacted about future studies" on the consent form of the Mothers and Newborns Study will be contacted to participate in this intervention.
排除标准
- 未提供
结局指标
主要结局
Feasibility of measuring pre/post-intervention change in participants' breast tissue concentration of oxygenated hemoglobin (%) measured using an Optical Spectroscopy machine.
时间窗: Baseline, 6 months
Breast tissue composition will be assessed at each clinic visit using an Optical Breast Spectroscopy machine, a minimally invasive procedure that is investigational and not currently FDA-approved. This machine places a light source on 4 different locations of the breast (at 12, 3, 6, and 9 o'clock) and reads the reflected light through the breast tissue. The OS exam will be completed twice on each side of the chest so that 8 measures are taken from the left breast and 8 measures will be taken from the right breast (with each measurement taking no more than a minute). A Monte-Carlo light propagation simulation technique (FullMonte) will be used to extract breast tissue concentration of oxygenated hemoglobin (%).
Feasibility of measuring pre/post-intervention change in participants' breast tissue concentration of lipid (mg/cm^3) measured using an Optical Spectroscopy machine.
时间窗: Baseline, 6 months
Breast tissue composition will be assessed at each clinic visit using an Optical Breast Spectroscopy machine, a minimally invasive procedure that is investigational and not currently FDA-approved. This machine places a light source on 4 different locations of the breast (at 12, 3, 6, and 9 o'clock) and reads the reflected light through the breast tissue. The OS exam will be completed twice on each side of the chest so that 8 measures are taken from the left breast and 8 measures will be taken from the right breast (with each measurement taking no more than a minute). A Monte-Carlo light propagation simulation technique (FullMonte) will be used to extract breast tissue concentration of lipid (mg/cm\^3).
Feasibility of measuring pre/post-intervention change in participants' breast tissue concentration of water (mg/cm^3) measured using an Optical Spectroscopy machine.
时间窗: Baseline, 6 months
Breast tissue composition will be assessed at each clinic visit using an Optical Breast Spectroscopy machine, a minimally invasive procedure that is investigational and not currently FDA-approved. This machine places a light source on 4 different locations of the breast (at 12, 3, 6, and 9 o'clock) and reads the reflected light through the breast tissue. The OS exam will be completed twice on each side of the chest so that 8 measures are taken from the left breast and 8 measures will be taken from the right breast (with each measurement taking no more than a minute). A Monte-Carlo light propagation simulation technique (FullMonte) will be used to extract breast tissue concentration of water (mg/cm\^3).
Feasibility of measuring pre/post-intervention change in participants' breast tissue concentration of collagen (mg/cm^3) measured using an Optical Spectroscopy machine.
时间窗: Baseline, 6 months
Breast tissue composition will be assessed at each clinic visit using an Optical Breast Spectroscopy machine, a minimally invasive procedure that is investigational and not currently FDA-approved. This machine places a light source on 4 different locations of the breast (at 12, 3, 6, and 9 o'clock) and reads the reflected light through the breast tissue. The OS exam will be completed twice on each side of the chest so that 8 measures are taken from the left breast and 8 measures will be taken from the right breast (with each measurement taking no more than a minute). A Monte-Carlo light propagation simulation technique (FullMonte) will be used to extract breast tissue concentration of collagen (mg/cm\^3).
Feasibility of measuring pre/post-intervention change in participants' breast tissue concentration of total hemoglobin (μM) measured using an Optical Spectroscopy machine.
时间窗: Baseline, 6 months
Breast tissue composition will be assessed at each clinic visit using an Optical Breast Spectroscopy machine, a minimally invasive procedure that is investigational and not currently FDA-approved. This machine places a light source on 4 different locations of the breast (at 12, 3, 6, and 9 o'clock) and reads the reflected light through the breast tissue. The OS exam will be completed twice on each side of the chest so that 8 measures are taken from the left breast and 8 measures will be taken from the right breast (with each measurement taking no more than a minute). A Monte-Carlo light propagation simulation technique (FullMonte) will be used to extract breast tissue concentration of total hemoglobin (μM).
Feasibility of measuring pre/post-intervention change in urinary metabolites of endocrine disrupting chemicals, including polycyclic aromatic hydrocarbons (PAH), phthalates, and parabens (all measured in μg/L units) .
时间窗: Baseline, 6 months
Spot urines will be collected from mothers and daughters in each study arm at the pre-intervention and post-intervention clinic visits. Samples will be processed, aliquoted, and stored at -80°C within two hours of collection. Urinary concentrations of metabolites (μg/L) of PAH, phthalates and parabens will be measured in urine samples using commercially available ELISA kits. Blood samples will also be collected at pre- and post-intervention clinic visits using standard protocol, with the buffy coat of white blood cells, packed red blood cells, and plasma separated and stored in multiple aliquots at -80°C for future analyses. Each urine and blood sample will receive a unique barcode, blinding the lab technician to the study arms.
次要结局
未报告次要终点
研究者
Mary B. Terry
Professor of Epidemiology
Columbia University