Linking Somatic Mutation Rate With Baseline Exposure in East Palestine

NCT06357845 | Recruiting

• 2 other identifiers: CASE5Z241R21ES036031-01
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Geographic Association of Somatic Mutation Rates

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

  Up to 24 months

Secondary Outcomes (1)

• Self-reported Symptomology Association of Somatic Mutation Rates

  Up to 24 months

Study Arms (1)

Residents effected by the Derailment event

OTHER

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

Other: Survey; Other: Biological specimen collection; Other: Communications about study updates and future research opportunities; Other: Qualitative interview

Interventions

Biological specimen collection 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.

Residents effected by the Derailment event

Communications about study updates and future research opportunities 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.

Residents effected by the Derailment event

Qualitative interview 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.

Residents effected by the Derailment event

Survey 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.

Residents effected by the Derailment event

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Environmental Health Sciences (NIEHS): collaborator

Study Sites (1)

Case Western Reserve University, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Fredrick R Schumacher, PhD

  Case Western Reserve University, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fredrick R Schumacher, PhD

CONTACT

216-368-0351; healthyfutures@case.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A cross-sectional study design will be implemented.

Study Record Dates

• First Submitted: April 5, 2024
• First Posted: April 10, 2024
• Study Start: August 16, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: Genomic data will be uploaded to dbGAP within three months of data generation and released within six months to individuals with approved protocols.
• Access Criteria: Submitted proposal and approved by the study data access committee. All proposals need to be related to the primary and secondary hypotheses.

Locations

US (1)