Linking Somatic Mutation Rate With Baseline Exposure in East Palestine

Somatic Mutation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06357845
• Other study ID #: CASE5Z24
• Secondary ID: 1R21ES036031-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: January 31, 2026

Study information

• Verified date: June 2024
• Source: Case Comprehensive Cancer Center
• Contact: Fredrick R Schumacher, PhD
• Phone: 216-368-0351
• Email: healthyfutures[@]case.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: January 31, 2026
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Somatic Mutation

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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