Linking Somatic Mutation Rate With Baseline Exposure in East Palestine

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Other Survey
  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.
• Other Biological specimen collection
  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
• Other Communications about study updates and future research opportunities
  By consenting to participate in this study, the research team will send updates about the research results and any additional study opportunities to participants.
• Other Qualitative interview
  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 outcome measures

• Geographic Association of Somatic Mutation Rates [Time frame: Up to 24 months]

Secondary outcome measures (1)

• Self-reported Symptomology Association of Somatic Mutation Rates [Time frame: Up to 24 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Screening

Study locations

United States · 1 center

• Case Western Reserve University, Case Comprehensive Cancer Center — Cleveland

Identifiers

NCT: NCT06357845 · CASE5Z24 · 1R21ES036031-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗