Somatic MutationNCT06357845
Linking Somatic Mutation Rate With Baseline Exposure in East Palestine
A study testing Survey, Biological specimen collection and Communications about study updates and future research opportunities in people with Somatic Mutation, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Somatic Mutation
- What is being tested?
- Survey, Biological specimen collection and Communications about study updates and future research opportunities
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2024to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Case Western Reserve University, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
Fredrick Schumacher, PhD
About this study
Official title: Healthy Futures Research Study: Linking Somatic Mutation Rate With Baseline Exposure in East Palestine
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?
Read more
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.
Read the detailed description
On February 3, 2023, at 8:55 pm EST, over 30 train cars from a Norfolk Southern train carrying hazardous chemicals derailed in the village of East Palestine, Ohio. In a few hours, residents within a 1- mile radius were ordered to evacuate, followed by several shelter-in-place orders. By February 6, the evacuation zone was expanded, and a controlled burn was implemented in the hopes of preventing an explosion. A week later, the Environmental Protection Agency (EPA) announced vinyl chloride, butyl acrylate, ethylhexyl acrylate, and ethylene glycol monobutyl ether were released into the air, surface soil, and surface waters. Although the EPA failed to detect contaminants at concerning levels for human health in the East Palestine region on February 12, East Palestine residents with private wells were recommended to use bottled water only four days later, and subsequent testing has detected elevated chemical levels in the region. The EPA instructed Norfolk Southern to expand testing and include dioxin testing on March 2. Four days later seven members of a 15-person CDC/ATSDR team reported sore throats, headaches, coughing and nausea after conducting Assessment of Chemical Exposure (ACE) surveys. The inconsistent messaging from the EPA and other governmental agencies have frustrated East Palestine and surrounding community (EPSC) residents, and generated concerns regarding long-term health effects.
This study has several aims:
- Establish the Healthy Futures Pilot Cohort utilizing a community-engaged research approach
- Compare genotoxicity levels arising from chemical exposure by geographical proximity and direction from the train derailment epicenter utilizing the somatic mutation rate in DNA among residents
- Understand experiences during and post-disaster with respect to effects on quality of life, perceived stressors, future prospects, and overall health-and how acute disasters shape risk perception, coping strategies, and access to health-protective resources through semi-structured interviews.
- Conditions
- Somatic Mutation
- Being tested
- Survey, Biological specimen collection, Communications about study updates and future research opportunities, Qualitative interview
- Keywords
- East Palestine, Train Derailment, Healthy Futures Research Study, Environmental Impact
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
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 collectionOther
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 opportunitiesOther
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 interviewOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Survey; Other: Biological specimen collection; Other: Communications about study updates and future research opportunities; Other: Qualitative interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geographic Association of Somatic Mutation Rates
The primary outcome measure is somatic mutation rates in association with geographical distance from the train derailment epicenter.
Measured: Up to 24 months
Secondary outcomes (1)
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.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start16 Aug 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Somatic MutationStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A cross-sectional study design will be implemented.
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Environmental Health Sciences (NIEHS)
- Responsible party
- Sponsor
- Investigators
- Fredrick R Schumacher, PhD, Principal investigator, Case Western Reserve University, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06357845
- Sponsor's protocol ID
- CASE5Z24
- Other IDs
- 1R21ES036031-01
- Status last verified
- Mar 2026
- First submitted
- 5 Apr 2024
- Last updated
- 16 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Questionnaire data will be captured by usage of REDCap and Qualtrix data bases. Genomic data, low pass sequencing measuring the somatic mutation rate (SMR), will be individual level data.
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Futures Research Study: Linking Somatic Mutation Rate With Baseline Exposure in East Palestine
- ClinicalTrials.gov ID
- NCT06357845
- Acronym / sponsor ID
- CASE5Z24
- Conditions
- Somatic Mutation
- Keywords
- East Palestine, Train Derailment, Healthy Futures Research Study, Environmental Impact
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Environmental Health Sciences (NIEHS)
- Study start
- 16 Aug 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 10 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
On February 3, 2023, at 8:55 pm EST, over 30 train cars from a Norfolk Southern train carrying hazardous chemicals derailed in the village of East Palestine, Ohio. In a few hours, residents within a 1- mile radius were ordered to evacuate, followed by several shelter-in-place orders. By February 6, the evacuation zone was expanded, and a controlled burn was implemented in the hopes of preventing an explosion. A week later, the Environmental Protection Agency (EPA) announced vinyl chloride, butyl acrylate, ethylhexyl acrylate, and ethylene glycol monobutyl ether were released into the air, surface soil, and surface waters. Although the EPA failed to detect contaminants at concerning levels for human health in the East Palestine region on February 12, East Palestine residents with private wells were recommended to use bottled water only four days later, and subsequent testing has detected elevated chemical levels in the region. The EPA instructed Norfolk Southern to expand testing and include dioxin testing on March 2. Four days later seven members of a 15-person CDC/ATSDR team reported sore throats, headaches, coughing and nausea after conducting Assessment of Chemical Exposure (ACE) surveys. The inconsistent messaging from the EPA and other governmental agencies have frustrated East Palestine and surrounding community (EPSC) residents, and generated concerns regarding long-term health effects.
This study has several aims:
- Establish the Healthy Futures Pilot Cohort utilizing a community-engaged research approach
- Compare genotoxicity levels arising from chemical exposure by geographical proximity and direction from the train derailment epicenter utilizing the somatic mutation rate in DNA among residents
- Understand experiences during and post-disaster with respect to effects on quality of life, perceived stressors, future prospects, and overall health-and how acute disasters shape risk perception, coping strategies, and access to health-protective resources through semi-structured interviews.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A cross-sectional study design will be implemented.
| Arm | Type | Receives |
|---|---|---|
| Residents effected by the Derailment event | Other | Other: Survey, Other: Biological specimen collection, Other: Communications about study updates and future research opportunities, Other: Qualitative interviewEligible residents must be adult participants from Columbiana County, Ohio, Mahoning County, Ohio, Beaver County, Pennsylvania, or Lawrence County, Pennsylvania. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveyParticipants 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. | Other | Residents effected by the Derailment event |
| Biological specimen collectionParticipants 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. | Other | Residents effected by the Derailment event |
| Communications about study updates and future research opportunitiesBy consenting to participate in this study, the research team will send updates about the research results and any additional study opportunities to participants. | Other | Residents effected by the Derailment event |
| Qualitative interviewA 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. | Other | Residents effected by the Derailment event |
Primary outcome
Geographic Association of Somatic Mutation Rates
Time frame: Up to 24 months
The primary outcome measure is somatic mutation rates in association with geographical distance from the train derailment epicenter.
1 secondary outcome
Self-reported Symptomology Association of Somatic Mutation Rates
Time frame: Up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: Yes. Questionnaire data will be captured by usage of REDCap and Qualtrix data bases. Genomic data, low pass sequencing measuring the somatic mutation rate (SMR), will be individual level data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fredrick R Schumacher, PhD principal investigator
Case Western Reserve University, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Survey, Biological specimen collection and Communications about study updates and future research opportunities in people with Somatic Mutation, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fredrick R Schumacher, PhD (216-368-0351, healthyfutures@case.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geographic Association of Somatic Mutation Rates (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.