Linking Somatic Mutation Rate With Baseline Exposure in East Palestine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-16

Study Completion Date

2026-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Implications of Maternal 45,X Mosaicism as a Secondary Genomic Finding Following Cell-Free DNA Sequencing During Pregnancy: A Deep Phenotype Study

NCT05548881

Cardiovascular Phenotype Metabolic Phenotype Hypertensive Disease +2 more

WITHDRAWN

Exome and Genome Analysis to Elucidate Genetic Etiologies and Population Characteristics in the Plain Community

NCT02927158

Undiagnosed Disease

RECRUITING

Natural History Study of GEMIN-5 Related Neurodevelopmental Disorder

NCT06776341

SMN Complex Proteins GEMIN5 Protein, Human Neurodevelopmental Disorders

RECRUITING

Next Generation to Identify Genetic Causes of Disease in Patients Participating in NICHD Clinical Protocols

NCT01375543

Genetic Predisposition

COMPLETED

Genetic Studies to Identify Stroke Subtypes and Outcome

NCT00357513

Cerebrovascular Disease Stroke

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Somatic Mutation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

A cross-sectional study design will be implemented.

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type OTHER

Survey

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes