Linking Somatic Mutation Rate With Baseline Exposure in East Palestine

ConditionSomatic Mutation

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorCase Comprehensive Cancer Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

Survey
Other intervention
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
Other intervention
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
Other intervention
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
Other intervention
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.

Treatment groups

500 Participants

are divided into 1 treatment group

Group A: Residents effected by the Derailment eventOther 4 interventions

Trial outcomes

Primary outcomes

Geographic Association of Somatic Mutation Rates

The primary outcome measure is somatic mutation rates in association with geographical distance from the train derailment epicenter.

Time frame

Up to 24 months

Secondary outcomes

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.

Time frame

Up to 24 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Case Comprehensive Cancer Center

Lead sponsor

National Institutes of Health (NIH)

Collaborator

National Institute of Environmental Health Sciences (NIEHS)