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NCT Number: NCT06357845

Linking Somatic Mutation Rate With Baseline Exposure in East Palestine

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.

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Key information

Conditions

Somatic Mutation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Case Western Reserve University, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location status: Recruiting

Location contact

Fredrick Schumacher, PhD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Survey

Other

Participants will complete a brief web-based survey asking about their experiences related to the February 3, 2023 train derailment, health experiences and concerns following the derailment, and background information regarding their health history. The survey will last approximately 15 minutes.

Biological specimen collection

Other

Participants may possibly contribute biospecimens such as blood, spit, hair, and/or toenail clippings. Participants will be asked which samples they are interested in providing. Participants will receive a specific sample collection kit based on their selection. For blood samples, participants will receive a mailed collection kit at their mailing address. A member of the research team will reach out to schedule blood sample collection, which may take place at home with a trained phlebotomist or at a designated collection site. A total of 1-2 teaspoons of blood (5-10 milliliters) will be collected at a one-time blood draw. For either saliva, hair, and/or toenail clippings, participants will be sent a sample collection kit and receive instructions at their mailing address. This kit also includes a return mailing envelope. Participants will provide the selected samples in the collection kits, place them in the return mailing envelope, and send them back to the research team.

Communications about study updates and future research opportunities

Other

By consenting to participate in this study, the research team will send updates about the research results and any additional study opportunities to participants.

Qualitative interview

Other

A total of 40 study participants will be recruited to participate in a 90-minute interview with open-ended questions. The interviews will be video and audio-recorded.

Primary outcomes

  1. Geographic Association of Somatic Mutation Rates

    Time frame: Up to 24 months

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

Secondary outcomes

  1. Self-reported Symptomology Association of Somatic Mutation Rates

    Time frame: Up to 24 months

    The secondary outcome measure is somatic mutation rates in association with self-reported symptomology at time of exposure.

Study contacts

Contact information is provided by the study sponsor or research team.

Fredrick R Schumacher, PhD

CONTACT

[email protected]

216-368-0351

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Collaborators

  • National Institute of Environmental Health Sciences (NIEHS)
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 10, 2024
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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