Lung CancerOCDNANCT03285893
Oral Cell DNA Adducts in Smokers
An observational study of Lung Cancer, run by University of Minnesota at 1 site in United States.
Trial summary
DNA adducts in the oral mucosa cells of 100 smokers from 3 ethnic groups - Native Hawaiians, Whites, and Japanese Americans with differing risks for lung cancer upon cigarette smoking will be quantified. DNA adducts of tobacco smoke carcinogens will be quantified using both targeted and untargeted approaches. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- oral cell DNA adducts
- Type of treatment
- Pill or oral medicine
- How many people
- 281 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2018to 1 Aug 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adult, Older adult
Study population: 100 each of three ethnic groups: Native Hawaiians, Japanese Americans, whites
Who may be able to join
- currently smoke at least 5 cigarettes per day, self-identified Japanese Americans, European Americans, or Native Hawaiians.
Who cannot join
- no current use of other nicotine containing products, no acute or uncontrolled medical or psychiatric conditions, no greater than 14 alcoholic drinks per week, not pregnant, not breastfeeding, not currently taking any medications that affect relevant metabolic enzymes, no active infection.
Trial locations and contacts
1 site in 1 country.
United States1 site
Tobacco Use Research Center
Minneapolis, Minnesota, 55455
About this study
Official title: Quantitation of Oral Cell DNA Adducts in Smokers
DNA adducts in the oral mucosa cells of 100 smokers from 3 ethnic groups - Native Hawaiians, Whites, and Japanese Americans with differing risks for lung cancer upon cigarette smoking will be quantified. DNA adducts of tobacco smoke carcinogens will be quantified using both targeted and untargeted approaches.
Read the detailed description
Using high resolution mass spectrometry, quantify known DNA adducts in oral mucosa cells of 100 smokers from each ethnic group - Native Hawaiians, Whites, and Japanese Americans. DNA adducts of tobacco-specific compounds, formaldehyde, and acrolein will be quantified.
- Analyze the urine of 100 smokers and 100 non-smokers from each of these groups for mercapturic acids of acrolein and crotonaldehyde, as well as total nicotine equivalents and total NNAL (smokers only). These data will provide critical information relevant to the high risk of Native Hawaiians for lung cancer, and in relationship to the DNA adduct measurements of Specific Aim 1.
- Conditions
- Lung Cancer
- Being tested
- oral cell DNA adducts
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral cell DNA adductsOther
oral cells will be collected, DNA isolated, and analyzed for adducts
| Study group | Role | What they receive |
|---|---|---|
| Native Hawaiian cigarette smokers | oral cell DNA adducts Receives: Other: oral cell DNA adducts | |
| White (European Americans) cigarette smokers | oral cell DNA adducts Receives: Other: oral cell DNA adducts | |
| Japanese American cigarette smokers | oral cell DNA adducts Receives: Other: oral cell DNA adducts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of γ-OH-Acr-dGuo, a Major Acrolein-DNA Adduct
Acrolein-DNA adduct (8R/S)-3-(2'-deoxyribos-1'-yl)-5,6,7,8-tetrahy- dro-8-hydroxypyrimido[1,2-a]purine-10(3H)-one. Model adjusted for age, sex and race/ethnicity
Measured: Baseline
Secondary outcomes (1)
εdAdo, Per 10^9 Nucleotides
Lipid peroxidation-related adduct 1,N6-etheno-dAdo etheno-DNA adducts from peroxidation of lipids. Model adjusted for age, sex and race/ethnicity
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study start1 Feb 2018
- Primary completion1 Aug 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 281 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- University of Hawaii
- Responsible party
- Sponsor
- Investigators
- Stepehn Hecht, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03285893
- Sponsor's protocol ID
- 2017NTLS019
- Acronym
- OCDNA
- Status last verified
- Sep 2024
- First submitted
- 1 Sep 2017
- Last updated
- 12 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Only unidentified data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitation of Oral Cell DNA Adducts in Smokers
- ClinicalTrials.gov ID
- NCT03285893
- Acronym / sponsor ID
- OCDNA / 2017NTLS019
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 281 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- University of Hawaii
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 18 Sep 2017 (actual)
- Results
- Posted 12 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
DNA adducts in the oral mucosa cells of 100 smokers from 3 ethnic groups - Native Hawaiians, Whites, and Japanese Americans with differing risks for lung cancer upon cigarette smoking will be quantified. DNA adducts of tobacco smoke carcinogens will be quantified using both targeted and untargeted approaches.
Detailed description
Using high resolution mass spectrometry, quantify known DNA adducts in oral mucosa cells of 100 smokers from each ethnic group - Native Hawaiians, Whites, and Japanese Americans. DNA adducts of tobacco-specific compounds, formaldehyde, and acrolein will be quantified.
- Analyze the urine of 100 smokers and 100 non-smokers from each of these groups for mercapturic acids of acrolein and crotonaldehyde, as well as total nicotine equivalents and total NNAL (smokers only). These data will provide critical information relevant to the high risk of Native Hawaiians for lung cancer, and in relationship to the DNA adduct measurements of Specific Aim 1.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Native Hawaiian cigarette smokers | – | Other: oral cell DNA adductsoral cell DNA adducts |
| White (European Americans) cigarette smokers | – | Other: oral cell DNA adductsoral cell DNA adducts |
| Japanese American cigarette smokers | – | Other: oral cell DNA adductsoral cell DNA adducts |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 100 each of three ethnic groups: Native Hawaiians, Japanese Americans, whites
Key inclusion criteria (1 listed)
- currently smoke at least 5 cigarettes per day, self-identified Japanese Americans, European Americans, or Native Hawaiians.
Key exclusion criteria (1 listed)
- no current use of other nicotine containing products, no acute or uncontrolled medical or psychiatric conditions, no greater than 14 alcoholic drinks per week, not pregnant, not breastfeeding, not currently taking any medications that affect relevant metabolic enzymes, no active infection.
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 |
|---|---|---|
| oral cell DNA adductsoral cells will be collected, DNA isolated, and analyzed for adducts | Other | Japanese American cigarette smokers, Native Hawaiian cigarette smokers, White (European Americans) cigarette smokers |
Primary outcome
Concentration of γ-OH-Acr-dGuo, a Major Acrolein-DNA Adduct
Time frame: Baseline
Acrolein-DNA adduct (8R/S)-3-(2'-deoxyribos-1'-yl)-5,6,7,8-tetrahy- dro-8-hydroxypyrimido[1,2-a]purine-10(3H)-one. Model adjusted for age, sex and race/ethnicity
1 secondary outcome
εdAdo, Per 10^9 Nucleotides
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. Only unidentified data will be shared.
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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.
Stepehn Hecht, PhD principal investigator
University of Minnesota
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 Lung Cancer, run by University of Minnesota 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 12 Nov 2024. 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?
Yes. Results are posted in the registry (first posted 12 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Concentration of γ-OH-Acr-dGuo, a Major Acrolein-DNA Adduct (time frame: Baseline). 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 12 Nov 2024.