Cigarette Smoking-Related CarcinomaNCT04972513
Impact of E-cigarette Use on the Body
An observational study of Cigarette Smoking-Related Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This study examines how electronic (e)-cigarette use impacts the body, by studying both users and non-users of e-cigarettes. Early evidence indicates that e-cig users experience adverse health effects. Results of this study may help policy-makers develop standards for different types of tobacco. Read more about this study
- Who is it for?
- Ages 15 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking-Related Carcinoma
- What is being tested?
- Biospecimen Collection, Nitric Oxide Breath Test and Oscillometry
- Type of treatment
- Surgery or procedure
- How many people
- 182 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2021to 31 Dec 2026
- Phase
- Observational
- 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 15 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: E-cig (cigarette) users and non-users in Ohio
Who may be able to join
- 75 e-cig users and 75 never-users
- No self-reported diagnosis of lung disease (e.g., coronavirus disease-2019 [COVID-19], pneumonia, cystic fibrosis)
- No history of cardiac event or distress
- Not currently breastfeeding, pregnant, or planning to become pregnant (e-cig users only; will be confirmed via pregnancy test)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: The Emerging Adulthood Health Project
This study examines how electronic (e)-cigarette use impacts the body, by studying both users and non-users of e-cigarettes. Early evidence indicates that e-cig users experience adverse health effects. Results of this study may help policy-makers develop standards for different types of tobacco.
Read the detailed description
PRIMARY OBJECTIVE:
Examine the short-term impacts of vaping on pulmonary and respiratory outcomes.
OUTLINE:
Current e-cigarette users will vape their own e-cigarette device ad libitum for 30 minutes; non-users will watch a neutral video for 30 minutes. Before and after the 30 minute vaping [video] session, participants will undergo the following assessments: computer-based spirometry testing, nitric oxide breath testing, airwave oscillometry, and an assessment of endothelial function. Participants will also undergo collection of blood.
- Conditions
- Cigarette Smoking-Related Carcinoma
- Being tested
- Biospecimen Collection, Nitric Oxide Breath Test, Oscillometry, Spirometry, Survey Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Undergo collection of blood
Nitric Oxide Breath TestProcedure or surgery
Undergo nitric oxide breath testing
OscillometryProcedure or surgery
Undergo airwave oscillometry
SpirometryProcedure or surgery
Undergo spirometry
Survey AdministrationOther
Complete survey
Endothelial functionProcedure or surgery
Endothelial function will be assessed with the EndoPAT device, which measures changes in pressure from sensors placed on the fingertip
| Study group | Role | What they receive |
|---|---|---|
| Prevention (survey, breathe tests, biospecimen collection) | Participants undergo computer-based spirometry testing, nitric oxide breath testing, airwave oscillometry, and an assessment of endothelial function. Participants will undergo collection of blood. Current e-cigarette users also vape their own e-cigarette device for 30 minutes. Receives: Procedure: Biospecimen Collection; Procedure: Nitric Oxide Breath Test; Procedure: Oscillometry; Procedure: Spirometry; Other: Survey Administration; Procedure: Endothelial function |
What is being measured
The primary outcome is the main question the study is designed to answer.
Airway inflammation as assessed by exhaled nitric oxide
Exhaled nitric oxide will be measured in parts per billion (ppb)
Measured: Procedure will last approximately 3 minutes; the procedure will occur twice during the laboratory session (separated by approximately 60 minutes)
Airway reactivity as assessed by airwave oscillometry
Airway reactivity will be measured via Tremoflo, which is a well validated measurement of airway reactivity and provides curves of Resistance (R) and Reactance (X)
Measured: Procedure will last approximately 3 minutes; the procedure will occur twice during the laboratory session (separated by approximately 60 minutes)
Respiratory functioning as assessed by a mobile Spirometry device
Spirometry will collect daily data from participants on the relationship between their forced expiratory volume and forced vital capacity (measured as FEV1/FVC).
Measured: Procedure will last approximately 3 minutes; the procedure will occur twice during the laboratory session (separated by approximately 60 minutes)
Endothelial function
Endothelial function will be assessed with the EndoPAT device (unit of measurement = LnRHI).
Measured: Procedure will last approximately 20 minutes; the procedure will occur twice during the laboratory session (separated by approximately 90 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start22 Jul 2021
- Primary completion29 Jun 2022
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarette Smoking-Related CarcinomaStudies of the same condition, open and under way.
- More trials run by Ohio State University 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Megan Roberts, Ohio State University Comprehensive Cancer Center
- Investigators
- Megan E Roberts, PhD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04972513
- Sponsor's protocol ID
- OSU-20320
- Other IDs
- NCI-2021-06438
- Status last verified
- Mar 2026
- First submitted
- 29 Jun 2021
- Last updated
- 23 Mar 2026
- 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 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Emerging Adulthood Health Project
- ClinicalTrials.gov ID
- NCT04972513
- Acronym / sponsor ID
- OSU-20320
- Conditions
- Cigarette Smoking-Related Carcinoma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 22 Jul 2021 (actual)
- Primary completion
- 29 Jun 2022 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Jul 2021 (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.
This study examines how electronic (e)-cigarette use impacts the body, by studying both users and non-users of e-cigarettes. Early evidence indicates that e-cig users experience adverse health effects. Results of this study may help policy-makers develop standards for different types of tobacco.
Detailed description
PRIMARY OBJECTIVE:
Examine the short-term impacts of vaping on pulmonary and respiratory outcomes.
OUTLINE:
Current e-cigarette users will vape their own e-cigarette device ad libitum for 30 minutes; non-users will watch a neutral video for 30 minutes. Before and after the 30 minute vaping [video] session, participants will undergo the following assessments: computer-based spirometry testing, nitric oxide breath testing, airwave oscillometry, and an assessment of endothelial function. Participants will also undergo collection of blood.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prevention (survey, breathe tests, biospecimen collection) | – | Procedure: Biospecimen Collection, Procedure: Nitric Oxide Breath Test, Procedure: Oscillometry, Procedure: Spirometry, Other: Survey Administration, Procedure: Endothelial functionParticipants undergo computer-based spirometry testing, nitric oxide breath testing, airwave oscillometry, and an assessment of endothelial function. Participants will undergo collection of blood. Current e-cigarette users also vape their own e-cigarette device for 30 minutes. |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- E-cig (cigarette) users and non-users in Ohio
Key inclusion criteria (4 listed)
- 75 e-cig users and 75 never-users
- No self-reported diagnosis of lung disease (e.g., coronavirus disease-2019 [COVID-19], pneumonia, cystic fibrosis)
- No history of cardiac event or distress
- Not currently breastfeeding, pregnant, or planning to become pregnant (e-cig users only; will be confirmed via pregnancy test)
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 |
|---|---|---|
| Biospecimen CollectionUndergo collection of blood | Procedure or surgery | Prevention (survey, breathe tests, biospecimen collection) |
| Nitric Oxide Breath TestUndergo nitric oxide breath testing | Procedure or surgery | Prevention (survey, breathe tests, biospecimen collection) |
| OscillometryUndergo airwave oscillometry | Procedure or surgery | Prevention (survey, breathe tests, biospecimen collection) |
| SpirometryUndergo spirometry | Procedure or surgery | Prevention (survey, breathe tests, biospecimen collection) |
| Survey AdministrationComplete survey | Other | Prevention (survey, breathe tests, biospecimen collection) |
| Endothelial functionEndothelial function will be assessed with the EndoPAT device, which measures changes in pressure from sensors placed on the fingertip | Procedure or surgery | Prevention (survey, breathe tests, biospecimen collection) |
Primary outcome
Airway inflammation as assessed by exhaled nitric oxide
Time frame: Procedure will last approximately 3 minutes; the procedure will occur twice during the laboratory session (separated by approximately 60 minutes)
Exhaled nitric oxide will be measured in parts per billion (ppb)
Airway reactivity as assessed by airwave oscillometry
Time frame: Procedure will last approximately 3 minutes; the procedure will occur twice during the laboratory session (separated by approximately 60 minutes)
Airway reactivity will be measured via Tremoflo, which is a well validated measurement of airway reactivity and provides curves of Resistance (R) and Reactance (X)
Respiratory functioning as assessed by a mobile Spirometry device
Time frame: Procedure will last approximately 3 minutes; the procedure will occur twice during the laboratory session (separated by approximately 60 minutes)
Spirometry will collect daily data from participants on the relationship between their forced expiratory volume and forced vital capacity (measured as FEV1/FVC).
Endothelial function
Time frame: Procedure will last approximately 20 minutes; the procedure will occur twice during the laboratory session (separated by approximately 90 minutes)
Endothelial function will be assessed with the EndoPAT device (unit of measurement = LnRHI).
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 23 Mar 2026.
- The JameslineLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
Megan E Roberts, PhD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cigarette Smoking-Related Carcinoma, run by Ohio State University 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 4 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: under way, not looking for participants, as of the sponsor's last update on 23 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Airway inflammation as assessed by exhaled nitric oxide (time frame: Procedure will last approximately 3 minutes; the procedure will occur twice during the laboratory session (separated by approximately 60 minutes)). The study lists 4 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 23 Mar 2026.