Tobacco UseNCT03352635
Mechanisms of Ethnic/Racial Differences in Lung Cancer Due to Cigarette Smoking Clinical and Biomarkers Core
An observational study of Tobacco Use, run by University of Minnesota at 2 sites in United States.
Trial summary
The purpose of the study is to collect human biological samples and measurements from people of various ethnic and racial backgrounds for projects related to the "Mechanisms of Ethnic/Racial Differences in Lung Cancer Due to Cigarette Smoking" Program Project Grant. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Tobacco Use
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Sep 2017to 30 Aug 2022
- 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
- Adult, Older adult
Study population: Cigarette smokers who are Japanese American, Non-Hispanic Whites - two parents of non-Hispanic white descent or Native Hawaiians over the age of 18.
Who may be able to join
- One of the three targeted ethnic groups: 1)Japanese American - two parents of Japanese descent; 2) Non-Hispanic Whites - two parents of non-Hispanic white descent; 3) 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;
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Tobacco Research Programs University of Minnesota
Minneapolis, Minnesota, 55414
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Mechanisms of Ethnic/Racial Differences in Lung Cancer Due to Cigarette Smoking Clinical and Biomarkers Core: Observation Study
The purpose of the study is to collect human biological samples and measurements from people of various ethnic and racial backgrounds for projects related to the "Mechanisms of Ethnic/Racial Differences in Lung Cancer Due to Cigarette Smoking" Program Project Grant. These samples will be used to evaluate and compare biomarkers of tobacco exposure across Japanese Americans, Whites, and Native Hawaiians and to add to the Multiethnic Cohort (MEC) biorepository to develop or assess future biomarkers.
Read the detailed description
This cross-sectional, observational study will primarily recruit smokers from the MEC study. The biological samples from these smokers are being collected since they do not currently exist in the biorepository (e.g. buccal cells). Potential smokers from the three racial groups who meet specific inclusion criteria will be invited to participate in the study. Should recruitment from the MEC sample be insufficient, smokers who meet the criteria will be recruited from the general population. This study will involve one to two home visits where tobacco use and medical history and biological samples will be collected including blood, buccal cells and urine.
Approximately 300 smokers will be recruited from the Multiethnic Cohort (MEC) study or the general population in Hawai'i. 100 participants from each of the three designated ethnic/racial groups: Native Hawaiians, Japanese Americans and Non-Hispanic Whites. All participants will be recruited from Hawai'i to reduce variation due to geographical location and maximize ability to recruit the targeted ethnic/racial groups.
This study will involve one to two home visits where demographics, tobacco use and exposure history, medical history and medication use, questionnaires assessing tobacco dependence, alcohol use, and environmental exposures will be administered. and biological samples will be collected including blood, buccal cells and urine.
- Conditions
- Tobacco Use
- Keywords
- Ethnic Differences
- Medical subject headings
- Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Native Hawaiians | One parent of Hawaiian descent. | |
| Japanese Americans | Two parents of Japanese descent. | |
| Non-Hispanic Whites | Two parents of non-Hispanic white descent. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Project 3: Analysis of 1,3-butadiene DNA adducts
Ethnic differences in butadiene-DNA adducts across racial groups to determine the relationship of DNA adducts to lung cancer and the influence of carcinogen metabolizing genes on DNA adduct formation, repair, and toxicity/mutagenicity.
Measured: Baseline
Project 4: Correlation of DNA adducts of buccal cells and urinary markers and lung cancer risk
DNA adduct levels in oral cells, themselves or together with urinary biomarker levels, correlate with lung cancer risk across various ethnic/racial groups
Measured: Baseline
Project 2: NNK α-hydroxylation
Analysis of biomarkers of NNK α-hydroxylation (bioactivation) pathway and the effect of P450 2A6 activity on this process.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study start1 Sep 2017 (estimated)
- Primary completion30 Aug 2021 (estimated)
- Study completion30 Aug 2022 (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 Tobacco UseStudies of the same condition, open and under way.
- More trials run by 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dorothy Hatsukami, PHD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03352635
- Sponsor's protocol ID
- 5P01CA138388-06
- Status last verified
- Nov 2017
- First submitted
- 25 Jul 2017
- Last updated
- 24 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Intend to share findings from this research through publications and presentations. Institutions and individuals wishing to access any resources or data must contact the Principal Investigator (Hatsukami). Data will be available in two formats. One will be a summary of the data, with graphs and tables, posted as pdf files and as raw individual-level data for analysis. Data generated by this grant will be made to outside investigators, according to NIH Guidance. When data are shared, there will be no limits placed on how the data will be used, and co-authorship is not required as a condition for receiving data. Users will agree, however, that the recipient must not transfer the data to other users and that the data are only to be used for research purposes. A record of transfer of data and a copy of the dataset that was distributed will be kept by University of Minnesota.
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Ethnic/Racial Differences in Lung Cancer Due to Cigarette Smoking Clinical and Biomarkers Core: Observation Study
- ClinicalTrials.gov ID
- NCT03352635
- Acronym / sponsor ID
- 5P01CA138388-06
- Conditions
- Tobacco Use
- Keywords
- Ethnic Differences
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study was completed at other sites
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Sep 2017 (estimated)
- Primary completion
- 30 Aug 2021 (estimated)
- Study completion
- 30 Aug 2022 (estimated)
- First posted
- 24 Nov 2017 (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 purpose of the study is to collect human biological samples and measurements from people of various ethnic and racial backgrounds for projects related to the "Mechanisms of Ethnic/Racial Differences in Lung Cancer Due to Cigarette Smoking" Program Project Grant. These samples will be used to evaluate and compare biomarkers of tobacco exposure across Japanese Americans, Whites, and Native Hawaiians and to add to the Multiethnic Cohort (MEC) biorepository to develop or assess future biomarkers.
Detailed description
This cross-sectional, observational study will primarily recruit smokers from the MEC study. The biological samples from these smokers are being collected since they do not currently exist in the biorepository (e.g. buccal cells). Potential smokers from the three racial groups who meet specific inclusion criteria will be invited to participate in the study. Should recruitment from the MEC sample be insufficient, smokers who meet the criteria will be recruited from the general population. This study will involve one to two home visits where tobacco use and medical history and biological samples will be collected including blood, buccal cells and urine.
Approximately 300 smokers will be recruited from the Multiethnic Cohort (MEC) study or the general population in Hawai'i. 100 participants from each of the three designated ethnic/racial groups: Native Hawaiians, Japanese Americans and Non-Hispanic Whites. All participants will be recruited from Hawai'i to reduce variation due to geographical location and maximize ability to recruit the targeted ethnic/racial groups.
This study will involve one to two home visits where demographics, tobacco use and exposure history, medical history and medication use, questionnaires assessing tobacco dependence, alcohol use, and environmental exposures will be administered. and biological samples will be collected including blood, buccal cells and urine.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Native Hawaiians | – | –One parent of Hawaiian descent. |
| Japanese Americans | – | –Two parents of Japanese descent. |
| Non-Hispanic Whites | – | –Two parents of non-Hispanic white descent. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Cigarette smokers who are Japanese American, Non-Hispanic Whites - two parents of non-Hispanic white descent or Native Hawaiians over the age of 18.
Key inclusion criteria (6 listed)
- One of the three targeted ethnic groups: 1)Japanese American - two parents of Japanese descent; 2) Non-Hispanic Whites - two parents of non-Hispanic white descent; 3) 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;
- 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.
Primary outcome
Project 3: Analysis of 1,3-butadiene DNA adducts
Time frame: Baseline
Ethnic differences in butadiene-DNA adducts across racial groups to determine the relationship of DNA adducts to lung cancer and the influence of carcinogen metabolizing genes on DNA adduct formation, repair, and toxicity/mutagenicity.
Project 4: Correlation of DNA adducts of buccal cells and urinary markers and lung cancer risk
Time frame: Baseline
DNA adduct levels in oral cells, themselves or together with urinary biomarker levels, correlate with lung cancer risk across various ethnic/racial groups
Project 2: NNK α-hydroxylation
Time frame: Baseline
Analysis of biomarkers of NNK α-hydroxylation (bioactivation) pathway and the effect of P450 2A6 activity on this process.
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 24 Nov 2017.
- Individual participant dataSharing planned: Yes. Intend to share findings from this research through publications and presentations. Institutions and individuals wishing to access any resources or data must contact the Principal Investigator (Hatsukami). Data will be available in two formats. One will be a summary of the data, with graphs and tables, posted as pdf files and as raw individual-level data for analysis. Data generated by this grant will be made to outside investigators, according to NIH Guidance. When data are shared, there will be no limits placed on how the data will be used, and co-authorship is not required as a condition for receiving data. Users will agree, however, that the recipient must not transfer the data to other users and that the data are only to be used for research purposes. A record of transfer of data and a copy of the dataset that was distributed will be kept by University of Minnesota.
Related trials for Tobacco Use
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Recruiting
Effectiveness of Volitional Help Sheets as an Adjunct to Treatment to Promote Behavior Change: A Pilot Study on Smoking
Tobacco Dependence
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Active, not recruiting
Vaping Cessation Using the Ottawa Model for Smoking Cessation Among E-Cigarette Users
Tobacco Smoking, Vaping
Not yet recruitingEarly Phase 1
Lung Health and Breath Biomarkers: Acute Effects of Inhaled Cannabis
Cannabis Use, Tobacco
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, PHD principal investigator
University of Minnesota
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tobacco Use, run by University of Minnesota at 2 sites 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 6 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 24 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Project 3: Analysis of 1,3-butadiene DNA adducts (time frame: Baseline). 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 24 Nov 2017.