500 Participants Needed

Chemical Exposure Impact on Mutations

FR
Overseen ByFredrick R Schumacher, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Case Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how the February 3, 2023, train derailment in East Palestine, Ohio, might have affected the DNA of local residents. Researchers aim to measure DNA damage and determine if changes in biomarkers (indicators of health in the body) relate to residents' proximity to the derailment and their health history. Participants will complete surveys about their experiences and may provide samples like blood or hair (biological specimen collection). This trial is open to individuals who lived in certain counties of Ohio or Pennsylvania during the derailment. As an unphased study, it offers a unique opportunity to contribute to understanding the environmental impact on health.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to ask the research team for guidance.

What prior data suggests that this method is safe for measuring biological impact?

In this study, researchers collect samples such as blood and hair to examine DNA changes after a train accident. Since the study involves only sample collection, it does not include any new treatments or drugs, ensuring safety for participants. Participants provide samples like blood, saliva, or hair, which are common and low-risk. No known side effects result from giving these types of samples. The study aims to determine if proximity to the accident affects DNA, without introducing any new health risks.

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to uncover how chemical exposure affects genetic mutations in residents impacted by a specific environmental event. Unlike typical treatment trials, this study focuses on collecting biological specimens to understand the impact of environmental factors on genetic changes. By analyzing samples from residents in affected areas, the trial hopes to provide insights into how chemical spills can influence mutations, which could lead to better safety standards and health interventions in the future.

What evidence suggests that this method is effective for measuring the biological impact of chemical exposure?

This study examines how chemical exposure affects DNA, particularly following the train accident in East Palestine, Ohio. Research has shown that exposure to certain chemicals can damage DNA, potentially leading to changes or health problems over time. Although this study does not test a specific treatment, it aims to track changes in the bodies of those near the accident. Participants, specifically residents affected by the derailment, will provide biological specimens like blood or hair for analysis. Researchers aim to identify signs of chemical exposure in the body. This study is crucial for understanding the long-term health effects of chemical exposure on the community.

Who Is on the Research Team?

FR

Fredrick R Schumacher, PhD

Principal Investigator

Case Western Reserve University, Case Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

  • Biological specimen collection
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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Residents effected by the Derailment eventExperimental Treatment4 Interventions

Find a Clinic Near You

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+
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