Clinical trial NCT06357845: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Somatic Mutation
Keywords: East Palestine
Train Derailment
Healthy Futures Research Study
Environmental Impact
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Environmental Health Sciences (NIEHS)
First posted: 2024-04-10
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A cross-sectional study design will be implemented.
Primary purpose: SCREENING

Brief summary: 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.

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.

Primary outcomes:
measure: Geographic Association of Somatic Mutation Rates
timeFrame: Up to 24 months
Secondary outcomes:
measure: Self-reported Symptomology Association of Somatic Mutation Rates
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Western Reserve University, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Case Western Reserve University, Case Comprehensive Cancer Center
name: Fredrick R Schumacher, PhD
role: PRINCIPAL_INVESTIGATOR
References: