Chemical Exposure Impact on Mutations

Overseen By Fredrick R Schumacher, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Case Comprehensive Cancer Center

Disqualifiers: Invalid address, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

500 Participants Needed

Trial Summary

What is the purpose of 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.

Research Team

Fredrick R Schumacher, PhD

Principal Investigator

Case Western Reserve University, Case Comprehensive Cancer Center

Eligibility Criteria

This study is for people who lived in Columbiana County, Ohio; Mahoning County, Ohio; Beaver County, PA; or Lawrence County, PA on February 3rd, 2023. Participants must currently reside in the United States.

Inclusion Criteria

I lived in Columbiana, Mahoning, Beaver, or Lawrence County on February 3rd, 2023.

I currently live in the United States.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Data Collection

Participants complete a survey and possibly contribute biospecimens such as blood, spit, hair, and/or toenail clippings. Interviews are conducted and recorded.

4-8 weeks

1 visit (in-person) for biospecimen collection, 1 interview (virtual or in-person)

Analysis

Analysis of somatic mutation rates in association with geographical distance and self-reported symptomology.

Up to 24 months

Follow-up

Participants are monitored for any long-term health effects and receive communication about study updates and future research opportunities.

Up to 24 months

Treatment Details

Trial Overview The study measures DNA damage to understand the biological impact of chemical exposure from the East Palestine train derailment. It involves surveys about health and derailment experiences, collection of biospecimens like blood and hair, and interviews with some participants.

Participant Groups

Group I: Residents effected by the Derailment event Experimental Treatment 4 Interventions

Eligible residents must be adult participants from Columbiana County, Ohio, Mahoning County, Ohio, Beaver County, Pennsylvania, or Lawrence County, Pennsylvania.

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

National Institute of Environmental Health Sciences (NIEHS)

Collaborator

Trials

294

Recruited

1,233,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+