Linking Somatic Mutation Rate With Baseline Exposure in East Palestine

Healthy Futures Research Study: 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.

Study Overview

• Status: Recruiting
• Conditions: Somatic Mutation
• Intervention / Treatment: Other: Survey; Other: Biological specimen collection; Other: Communications about study updates and future research opportunities; Other: Qualitative interview

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.

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fredrick R Schumacher, PhD; Phone Number: 216-368-0351; Email: healthyfutures@case.edu

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Case Western Reserve University, Case Comprehensive Cancer Center
      • Contact: Fredrick Schumacher, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Residents effected by the Derailment event; Eligible residents must be adult participants from Columbiana County, Ohio, Mahoning County, Ohio, Beaver County, Pennsylvania, or Lawrence County, Pennsylvania.

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 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geographic Association of Somatic Mutation Rates	The primary outcome measure is somatic mutation rates in association with geographical distance from the train derailment epicenter.	Up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported Symptomology Association of Somatic Mutation Rates	The secondary outcome measure is somatic mutation rates in association with self-reported symptomology at time of exposure.	Up to 24 months

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Collaborators: National Institutes of Health (NIH); National Institute of Environmental Health Sciences (NIEHS)
• Investigators: Principal Investigator: Fredrick R Schumacher, PhD, Case Western Reserve University, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: April 5, 2024
• First Submitted That Met QC Criteria: April 5, 2024
• First Posted (Actual): April 10, 2024

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Environmental Impact; East Palestine; Train Derailment; Healthy Futures Research Study
• Additional Relevant MeSH Terms: Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires
• Other Study ID Numbers: CASE5Z24; 1R21ES036031-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Questionnaire data will be captured by usage of REDCap and Qualtrix data bases. Genomic data, low pass sequencing measuring the somatic mutation rate (SMR), will be individual level data.
• IPD Sharing Time Frame: Genomic data will be uploaded to dbGAP within three months of data generation and released within six months to individuals with approved protocols.
• IPD Sharing Access Criteria: Submitted proposal and approved by the study data access committee. All proposals need to be related to the primary and secondary hypotheses.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No