Lung CancerNCT03421678
Ethnic/Racial Differences in Metabolism and DNA Adduct Formation
An observational study of Lung Cancer, run by Masonic Cancer Center, University of Minnesota.
Trial summary
The study will investigate the role of 1,3-butadiene metabolic activation and deactivation in lung cancer risk among various ethnic/racial groups. This project will require urine samples from smokers and nonsmokers from the three ethnic/racial groups recruited by the Clinical and Biomarker Core for the analysis of… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Urine Sample
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2020to Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Approximately 300 smokers will be recruited from the Multiethnic Cohort (MEC) study or the general population in Hawai'i
Who may be able to join
- One of the three targeted ethnic groups:
- Japanese American - two parents of Japanese descent
- Non-Hispanic Whites - two parents of non-Hispanic white descent
- Native Hawaiians will include individuals with at least one parent of Hawaiian descent;
- Smoke 5 cigarettes per day over the past three months;
- >21 years of age;
Show all 9Show fewer
- Consumes 14 or fewer drinks of alcohol per week;
- Generally stable and good health (determined by review of medical history);
- Able to provide written voluntary consent before performance of any study related procedure.
Who cannot join
- Current use of other nicotine containing products for > 4 times per month (and no use of any nicotine-containing products except cigarettes for 2 weeks prior to their study visits);
- Acute or uncontrolled medical or psychiatric conditions;
- Currently taking any medications that affect relevant metabolic enzymes or anti- inflammatory medications such as ibuprofen (this will be reviewed by study investigators on a case-by-case basis);
- Active infection (e.g., influenza, cold, respiratory infection, sinus infection) at the time of the visit;
- Pregnant or nursing or planning on becoming pregnant during the study;
- Unable to read and understand English.
About this study
Official title: Ethnic/Racial Differences in Metabolism and DNA Adduct Formation by 1,3-butadiene
The study will investigate the role of 1,3-butadiene metabolic activation and deactivation in lung cancer risk among various ethnic/racial groups. This project will require urine samples from smokers and nonsmokers from the three ethnic/racial groups recruited by the Clinical and Biomarker Core for the analysis of 1,3-butadiene DNA adducts. Data on nicotine intake (urinary TNE) in these subjects as well as in 400 lung cancer cases and 400 controls from Project 1 will be also required for this project.
- Conditions
- Lung Cancer
- Being tested
- Urine Sample
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urine SampleDiagnostic test
One to two home visits where tobacco use and medical history and biological samples will be collected including blood, buccal cells and urine
| Study group | Role | What they receive |
|---|---|---|
| Japanese American | Two parents of Japanese descent Receives: Diagnostic Test: Urine Sample | |
| Non-Hispanic Whites | Two parents of non-Hispanic white descent Receives: Diagnostic Test: Urine Sample | |
| Native Hawaiians | At least one parent of Hawaiian descent Receives: Diagnostic Test: Urine Sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Butadiene-DNA adducts in different ethnic groups
Investigate ethnic differences in butadiene-DNA adducts in smokers belonging to different ethnic groups.
Measured: Day 1 & 2
Butadiene-DNA adduct load in smokers with lung cancer
Investigate the association between butadiene-DNA adduct load and lung cancer development in smokers.
Measured: Day 1 & 2
Polymorphisms of carnicogen metabolizing genes
Examine how polymorphisms of carcinogen metabolizing genes influence metabolic inactivation, DNA adduct formation/repair, and toxicity of butadiene-derived epoxides.
Measured: Day 1 & 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study startOct 2020 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Why it stopped: Study was completed at other sites
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Dorothy Hatsukami, Ph.D., Principal investigator, University of Minnesota, Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03421678
- Sponsor's protocol ID
- 2017NTLS019
- Status last verified
- Sep 2020
- First submitted
- 23 Jan 2018
- Last updated
- 5 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ethnic/Racial Differences in Metabolism and DNA Adduct Formation by 1,3-butadiene
- ClinicalTrials.gov ID
- NCT03421678
- Acronym / sponsor ID
- 2017NTLS019
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study was completed at other sites
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Oct 2020 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 5 Feb 2018 (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 study will investigate the role of 1,3-butadiene metabolic activation and deactivation in lung cancer risk among various ethnic/racial groups. This project will require urine samples from smokers and nonsmokers from the three ethnic/racial groups recruited by the Clinical and Biomarker Core for the analysis of 1,3-butadiene DNA adducts. Data on nicotine intake (urinary TNE) in these subjects as well as in 400 lung cancer cases and 400 controls from Project 1 will be also required for this project.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Japanese American | – | Diagnostic Test: Urine SampleTwo parents of Japanese descent |
| Non-Hispanic Whites | – | Diagnostic Test: Urine SampleTwo parents of non-Hispanic white descent |
| Native Hawaiians | – | Diagnostic Test: Urine SampleAt least one parent of Hawaiian descent |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 300 smokers will be recruited from the Multiethnic Cohort (MEC) study or the general population in Hawai'i
Key inclusion criteria (9 listed)
- One of the three targeted ethnic groups:
- Smoke 5 cigarettes per day over the past three months;
- >21 years of age;
- Consumes 14 or fewer drinks of alcohol per week;
- Generally stable and good health (determined by review of medical history);
Key exclusion criteria (6 listed)
- Current use of other nicotine containing products for > 4 times per month (and no use of any nicotine-containing products except cigarettes for 2 weeks prior to their study visits);
- Acute or uncontrolled medical or psychiatric conditions;
- Currently taking any medications that affect relevant metabolic enzymes or anti- inflammatory medications such as ibuprofen (this will be reviewed by study investigators on a case-by-case basis);
- Active infection (e.g., influenza, cold, respiratory infection, sinus infection) at the time of the visit;
- Pregnant or nursing or planning on becoming pregnant during the study;
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 |
|---|---|---|
| Urine SampleOne to two home visits where tobacco use and medical history and biological samples will be collected including blood, buccal cells and urine | Diagnostic test | Japanese American, Native Hawaiians, Non-Hispanic Whites |
Primary outcome
Butadiene-DNA adducts in different ethnic groups
Time frame: Day 1 & 2
Investigate ethnic differences in butadiene-DNA adducts in smokers belonging to different ethnic groups.
Butadiene-DNA adduct load in smokers with lung cancer
Time frame: Day 1 & 2
Investigate the association between butadiene-DNA adduct load and lung cancer development in smokers.
Polymorphisms of carnicogen metabolizing genes
Time frame: Day 1 & 2
Examine how polymorphisms of carcinogen metabolizing genes influence metabolic inactivation, DNA adduct formation/repair, and toxicity of butadiene-derived epoxides.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
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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.
Dorothy Hatsukami, Ph.D. principal investigator
University of Minnesota, Department of Psychiatry
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Masonic Cancer Center, University of Minnesota.
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 9 inclusion and 6 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: withdrawn, as of the sponsor's last update on 5 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Butadiene-DNA adducts in different ethnic groups (time frame: Day 1 & 2). 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 5 Oct 2020.