Recruiting

Biological Impact

Sponsor:

Case Comprehensive Cancer Center

Code:

NCT06357845

Conditions

Somatic Mutation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Survey

Biological specimen collection

Communications about study updates and future research opportunities

Qualitative interview

Study Details

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.

Conditions

Somatic Mutation

Study ID

NCT06357845

Start date

Aug 16, 2024

Status verified date

Mar, 2026

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: 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.

Study Design

Enrollment

500 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Geographic Association of Somatic Mutation Rates [ Time Frame: Up to 24 months ]

Central Contacts and Locations

Central contacts

Fredrick R Schumacher, PhD

216-368-0351healthyfutures@case.edu

Locations

Case Western Reserve University, Case Comprehensive Cancer Center

Recruiting

Cleveland, Ohio, United States, 44195

More Information

Sponsor

Case Comprehensive Cancer Center

Last update posted

Mar 16, 2026

Last verified

Mar, 2026

Keywords

  • East Palestine
  • Train Derailment
  • Healthy Futures Research Study
  • Environmental Impact

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Case Comprehensive Cancer Center on 2026-03-16.