Vapors; InhalationNCT05819996
Addressing Tetrachloroethylene Exposure in an Impacted Community
A study testing Environmental educational campaign in people with Vapors; Inhalation and Cancer, run by Purdue University at 1 site in United States.
Trial summary
Groundwater in Martinsville, IN, is contaminated by volatile organic compounds (VOCs), tetrachloroethylene (PCE) and trichloroethylene (TCE). Indoor air in some residential and commercial buildings is also contaminated with PCE and TCE. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Vapors; Inhalation, Cancer, Volatile Organic Compounds
- What is being tested?
- Environmental educational campaign
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 510 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2023to 31 May 2028
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Residents of Martinsville, Indiana
- 18 years or older
Who cannot join
None listed.
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
Purdue University
West Lafayette, Indiana, 47907
Sa Liu, PhD, 7654966240, saliu@purdue.edu
Monica M Bozymski, MS, 765-496-4823, mbozymsk@purdue.edu
About this study
Official title: Addressing Tetrachloroethylene Exposure in an Impacted Community: Residents' Concerns, Neurotoxic Effects, and Exposure Reduction
Groundwater in Martinsville, IN, is contaminated by volatile organic compounds (VOCs), tetrachloroethylene (PCE) and trichloroethylene (TCE). Indoor air in some residential and commercial buildings is also contaminated with PCE and TCE. This study is being conducted to better understand the impact of low-level exposures to these compounds on community members' health. Data collected in this study will be used to help the community identify a course of action.
Read the detailed description
Martinsville, IN, is a community of 11,000 people that overlays four groundwater contamination sites, including a U.S. Environmental Protection Agency (EPA)-designated Superfund site. The total area of groundwater contamination is over 60 acres and lies within a single aquifer. The contaminates are chlorinated volatile organic compounds (VOCs), primarily tetrachloroethylene (PCE) and trichloroethylene (TCE). These contaminants are thought to originate from several dry cleaning and metal degreasing operations. An activated carbon filtration system has been in operation since 2005 to remove PCE and chlorinated VOCs from the municipal water, which now meets EPA drinking water standards. However, a recent report from the Agency for Toxic Substances and Disease Registry concludes that people's health may be harmed by breathing indoor air contaminated via vapor intrusion, the migration of volatile compounds from contaminated groundwater and soil into buildings above. The long-term goal of this research is to understand how PCE exposure in communities affects health and to empower community members' participation in environmental health decision-making. In this project researchers will work with the community of Martinsville, IN to:
- Determine the extent and exposure levels to the contaminants by measuring the contamination in residents and at their homes.
- Assess the community's concern and perceptions about the contamination and associated health risks.
- Study the impact of the contaminants on visual and neurocognitive functions.
- Compare cancer rates in Martinsville to county and state rates.
The above information will help researchers and community partners co-design a targeted educational campaign to reduce community members' exposure to the contaminants.
- Conditions
- Vapors; Inhalation, Cancer, Volatile Organic Compounds
- Being tested
- Environmental educational campaign
- Keywords
- Tetrachloroethylene, Trichloroethylene, PCE, TCE, Community environmental contamination, Chlorinated volatile organic compounds
- Medical subject headings
- Respiratory Aspiration, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Environmental educational campaignBehavioural
Educational campaign will be conducted to promote participation in indoor air testing.
| Study group | Role | What they receive |
|---|---|---|
| Martinsville Residents | Other | Residents of Martinsville, Indiana, will receive educational campaign promoting participation in environmental testing Receives: Behavioral: Environmental educational campaign |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in concerns about environmental chemical contamination in Martinsville.
This measure is based on the differences between the percentage of "Yes" responses to a close-ended, not scaled question at 3 different time points, administered via repeated surveys to the same sample of respondents.
Are participants concerned about environmental chemical contamination in Martinsville? Yes / Somewhat / No / Refuse
1a. Changes in concerns about environmental chemical contamination in Martinsville from Year 1 to Year 3. This is based on the differences in percentage of yes responses to this question in surveys administered in Year 1 (Main survey, baseline) and Year 3 (online survey administered at the beginning of Year 3).
1b. Changes in concerns about environmental chemical contamination in Martinsville from Year 1 to Year 5. This is based on the differences in percentage of yes responses to this question in surveys administered in Year 1 (Main survey, baseline) and Year 5 (Online survey, post intervention).
Measured: For Measure 1a, Time frame is from year 1 to year 3; for Measure 1b, Time frame is from year 1 to year 5.
Changes in awareness of possible exposure to chemicals from soil or groundwater in Martinsville.
This measure is based on the differences between the percentage of "Yes" responses to a close-ended, not scaled question at 3 different time points, administered via repeated surveys to the same sample of respondents.
Are participants aware of possible exposure to chemicals from soil or groundwater in Martinsville? Yes / No / Refuse
2a. Changes in awareness of possible exposure to chemicals from soil or groundwater in Martinsville from Year 1 to Year 3. This is based on the differences in percentage of yes responses to this question in surveys administered in Year 1 (Main survey, baseline) and Year 3 (Online survey administered at the beginning of Year 3).
2b. Changes in awareness of available resources for exposure reduction from Year 1 to Year 5. This is based on the differences in surveys administered in Year 1 (Main survey, baseline) and Year 5 (Online survey, post intervention)
Measured: For Measure 2a, Time frame is from year 1 to year 3; for Measure 2b, Time frame is from year 1 to year 5.
Change in willingness to have respondent's homes tested for chemical contamination from contaminated soil or groundwater.
This measure is based on the difference between the percentage of "Yes" responses to a close-ended, not scaled question at 3 different time points, administered via repeated surveys to the same sample of respondents.
Are participants willing to have their home tested for chemical contamination from contaminated soil or groundwater? Yes / No / Refuse / Don't know
3a. Changes in willingness to have respondents' homes tested for the chemical contamination from Year 1 to Year 3. This is based on the differences in percentage of yes responses to this question in surveys administered in Year 1 (Main survey, baseline) and Year 3 (Online survey at the beginning of Year 3)
3b. Changes in willingness to have respondents' homes tested for the chemical contamination from Year 1 to Year 5. This is based on the differences in differences in percentage of yes responses to this question in surveys administered in Year 1 (Main survey, baseline) and Year 5 (Online survey, post intervention)
Measured: For Measure 3a, Time frame is from year 1 to year 3; for Measure 3b, Time frame is from year 1 to year 5.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start17 Feb 2023
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vapors; InhalationStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- An educational campaign targeting the community
- Masking
- None (open label)
- Enrolment
- 510 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Illinois Chicago, Indiana University, Mackey Children's Cancer Foundation
- Responsible party
- Principal investigator, Sa Liu, Purdue University
- Investigators
- Sa Liu, MPH, PhD, Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05819996
- Sponsor's protocol ID
- 20211507
- Status last verified
- May 2024
- First submitted
- 5 Dec 2022
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Tetrachloroethylene Exposure in an Impacted Community: Residents' Concerns, Neurotoxic Effects, and Exposure Reduction
- ClinicalTrials.gov ID
- NCT05819996
- Acronym / sponsor ID
- 20211507
- Conditions
- Vapors; Inhalation, Cancer, Volatile Organic Compounds
- Keywords
- Tetrachloroethylene, Trichloroethylene, PCE, TCE, Community environmental contamination, Chlorinated volatile organic compounds
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 510 participants (estimated)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Collaborators
- University of Illinois Chicago, Indiana University, Mackey Children's Cancer Foundation
- Study start
- 17 Feb 2023 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 19 Apr 2023 (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.
Groundwater in Martinsville, IN, is contaminated by volatile organic compounds (VOCs), tetrachloroethylene (PCE) and trichloroethylene (TCE). Indoor air in some residential and commercial buildings is also contaminated with PCE and TCE. This study is being conducted to better understand the impact of low-level exposures to these compounds on community members' health. Data collected in this study will be used to help the community identify a course of action.
Detailed description
Martinsville, IN, is a community of 11,000 people that overlays four groundwater contamination sites, including a U.S. Environmental Protection Agency (EPA)-designated Superfund site. The total area of groundwater contamination is over 60 acres and lies within a single aquifer. The contaminates are chlorinated volatile organic compounds (VOCs), primarily tetrachloroethylene (PCE) and trichloroethylene (TCE). These contaminants are thought to originate from several dry cleaning and metal degreasing operations. An activated carbon filtration system has been in operation since 2005 to remove PCE and chlorinated VOCs from the municipal water, which now meets EPA drinking water standards. However, a recent report from the Agency for Toxic Substances and Disease Registry concludes that people's health may be harmed by breathing indoor air contaminated via vapor intrusion, the migration of volatile compounds from contaminated groundwater and soil into buildings above. The long-term goal of this research is to understand how PCE exposure in communities affects health and to empower community members' participation in environmental health decision-making. In this project researchers will work with the community of Martinsville, IN to:
- Determine the extent and exposure levels to the contaminants by measuring the contamination in residents and at their homes.
- Assess the community's concern and perceptions about the contamination and associated health risks.
- Study the impact of the contaminants on visual and neurocognitive functions.
- Compare cancer rates in Martinsville to county and state rates.
The above information will help researchers and community partners co-design a targeted educational campaign to reduce community members' exposure to the contaminants.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- An educational campaign targeting the community
| Arm | Type | Receives |
|---|---|---|
| Martinsville Residents | Other | Behavioral: Environmental educational campaignResidents of Martinsville, Indiana, will receive educational campaign promoting participation in environmental testing |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Residents of Martinsville, Indiana
- 18 years or older
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Environmental educational campaignEducational campaign will be conducted to promote participation in indoor air testing. | Behavioural | Martinsville Residents |
Primary outcome
Change in concerns about environmental chemical contamination in Martinsville.
Time frame: For Measure 1a, Time frame is from year 1 to year 3; for Measure 1b, Time frame is from year 1 to year 5.
This measure is based on the differences between the percentage of "Yes" responses to a close-ended, not scaled question at 3 different time points, administered via repeated surveys to the same sample of respondents. Are participants concerned about environmental chemical contamination in Martinsville? Yes / Somewhat / No / Refuse 1a. Changes in concerns about environmental chemical contamination in Martinsville from Year 1 to Year 3. This is based on the differences in percentage of yes responses to this question in surveys administered in Year 1 (Main survey, baseline) and Year 3 (online survey administered at the beginning of Year 3). 1b. Changes in concerns about environmental chemical contamination in Martinsville from Year 1 to Year 5. This is based on the differences in percentage of yes responses to this question in surveys administered in Year 1 (Main survey, baseline) and Year 5 (Online survey, post intervention).
Changes in awareness of possible exposure to chemicals from soil or groundwater in Martinsville.
Time frame: For Measure 2a, Time frame is from year 1 to year 3; for Measure 2b, Time frame is from year 1 to year 5.
This measure is based on the differences between the percentage of "Yes" responses to a close-ended, not scaled question at 3 different time points, administered via repeated surveys to the same sample of respondents. Are participants aware of possible exposure to chemicals from soil or groundwater in Martinsville? Yes / No / Refuse 2a. Changes in awareness of possible exposure to chemicals from soil or groundwater in Martinsville from Year 1 to Year 3. This is based on the differences in percentage of yes responses to this question in surveys administered in Year 1 (Main survey, baseline) and Year 3 (Online survey administered at the beginning of Year 3). 2b. Changes in awareness of available resources for exposure reduction from Year 1 to Year 5. This is based on the differences in surveys administered in Year 1 (Main survey, baseline) and Year 5 (Online survey, post intervention)
Change in willingness to have respondent's homes tested for chemical contamination from contaminated soil or groundwater.
Time frame: For Measure 3a, Time frame is from year 1 to year 3; for Measure 3b, Time frame is from year 1 to year 5.
This measure is based on the difference between the percentage of "Yes" responses to a close-ended, not scaled question at 3 different time points, administered via repeated surveys to the same sample of respondents. Are participants willing to have their home tested for chemical contamination from contaminated soil or groundwater? Yes / No / Refuse / Don't know 3a. Changes in willingness to have respondents' homes tested for the chemical contamination from Year 1 to Year 3. This is based on the differences in percentage of yes responses to this question in surveys administered in Year 1 (Main survey, baseline) and Year 3 (Online survey at the beginning of Year 3) 3b. Changes in willingness to have respondents' homes tested for the chemical contamination from Year 1 to Year 5. This is based on the differences in differences in percentage of yes responses to this question in surveys administered in Year 1 (Main survey, baseline) and Year 5 (Online survey, post intervention)
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 18 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Sa Liu, MPH, PhD principal investigator
Purdue University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Environmental educational campaign in people with Vapors; Inhalation and Cancer, run by Purdue University 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 0 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 18 Mar 2025. 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 Sa Liu, MPH, PhD (765-496-6240, saliu@purdue.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in concerns about environmental chemical contamination in Martinsville. (time frame: For Measure 1a, Time frame is from year 1 to year 3; for Measure 1b, Time frame is from year 1 to year 5.). The study lists 3 primary outcomes in all. 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 18 Mar 2025.