跳至主要内容
临床试验/NCT06357845
NCT06357845招募中不适用

Healthy Futures Research Study: Linking Somatic Mutation Rate With Baseline Exposure in East Palestine

Case Comprehensive Cancer Center1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2024年8月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
500
试验地点
1
主要终点
Geographic Association of Somatic Mutation Rates

研究概览

简要总结

The goal of this study is to This research team is conducting this study to develop methods to measure the biological impact of exposure to the chemicals released following the February 3, 2023 train derailment on residents of East Palestine, Ohio, and surrounding communities. The main question it aims to answer is:

  • What biological impact will be measured based on DNA damage?
  • In participants who provide a biospecimen, how are biomarker changes related to proximity to the derailment and variations in residents' health histories and behaviors?

Participants will:

  • Complete a brief survey asking about experiences related to the February 3, 2023 train derailment, health experiences, and concerns following the derailment, and background information regarding health history.
  • Possibly contribute biospecimens such as blood, spit, hair, and/or toenail clippings.
  • Receive communication about study updates and future research opportunities.
  • A total of 40 study participants will be recruited to participate in a 90-minute interview. The interviews will be video and audio recorded.

详细描述

On February 3, 2023, at 8:55 pm EST, over 30 train cars from a Norfolk Southern train carrying hazardous chemicals derailed in the village of East Palestine, Ohio. In a few hours, residents within a 1- mile radius were ordered to evacuate, followed by several shelter-in-place orders. By February 6, the evacuation zone was expanded, and a controlled burn was implemented in the hopes of preventing an explosion. A week later, the Environmental Protection Agency (EPA) announced vinyl chloride, butyl acrylate, ethylhexyl acrylate, and ethylene glycol monobutyl ether were released into the air, surface soil, and surface waters. Although the EPA failed to detect contaminants at concerning levels for human health in the East Palestine region on February 12, East Palestine residents with private wells were recommended to use bottled water only four days later, and subsequent testing has detected elevated chemical levels in the region. The EPA instructed Norfolk Southern to expand testing and include dioxin testing on March 2. Four days later seven members of a 15-person CDC/ATSDR team reported sore throats, headaches, coughing and nausea after conducting Assessment of Chemical Exposure (ACE) surveys. The inconsistent messaging from the EPA and other governmental agencies have frustrated East Palestine and surrounding community (EPSC) residents, and generated concerns regarding long-term health effects.

This study has several aims:

  • Establish the Healthy Futures Pilot Cohort utilizing a community-engaged research approach
  • Compare genotoxicity levels arising from chemical exposure by geographical proximity and direction from the train derailment epicenter utilizing the somatic mutation rate in DNA among residents
  • Understand experiences during and post-disaster with respect to effects on quality of life, perceived stressors, future prospects, and overall health-and how acute disasters shape risk perception, coping strategies, and access to health-protective resources through semi-structured interviews.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

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

  • •Residence on February 3rd, 2023 in Columbiana County, Ohio, Mahoning County, Ohio, Beaver County, PA, or Lawrence County, PA.
  • •Current residence in the United States.

排除标准

  • •Address provided for February 3rd, 2023 not in Columbiana County, Ohio, Mahoning County, Ohio, Beaver County, PA, or Lawrence County, PA
  • •Invalid address provided for February 3rd, 2023 residence.

研究组 & 干预措施

Residents effected by the Derailment event

Other

Eligible residents must be adult participants from Columbiana County, Ohio, Mahoning County, Ohio, Beaver County, Pennsylvania, or Lawrence County, Pennsylvania.

干预措施: Survey (Other)

Residents effected by the Derailment event

Other

Eligible residents must be adult participants from Columbiana County, Ohio, Mahoning County, Ohio, Beaver County, Pennsylvania, or Lawrence County, Pennsylvania.

干预措施: Biological specimen collection (Other)

Residents effected by the Derailment event

Other

Eligible residents must be adult participants from Columbiana County, Ohio, Mahoning County, Ohio, Beaver County, Pennsylvania, or Lawrence County, Pennsylvania.

干预措施: Communications about study updates and future research opportunities (Other)

Residents effected by the Derailment event

Other

Eligible residents must be adult participants from Columbiana County, Ohio, Mahoning County, Ohio, Beaver County, Pennsylvania, or Lawrence County, Pennsylvania.

干预措施: Qualitative interview (Other)

结局指标

主要结局

Geographic Association of Somatic Mutation Rates

时间窗: Up to 24 months

The primary outcome measure is somatic mutation rates in association with geographical distance from the train derailment epicenter.

次要结局

  • Self-reported Symptomology Association of Somatic Mutation Rates(Up to 24 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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