Lung CancerNCT01673711
Deuterated Phenanthrene Tetraol in Smokers Who Are at High Risk For Lung Cancer
An observational study of Lung Cancer and Squamous Lung Dysplasia, run by University of Minnesota at 3 sites in 2 countries.
Trial summary
This clinical trial studies deuterated phenanthrene tetraol in smokers who are at high risk for lung cancer. Studying samples of urine in the laboratory from smokers who are at high risk for lung cancer may help doctors learn more about biomarkers related to cancer. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer, Squamous Lung Dysplasia, Tobacco Use Disorder
- What is being tested?
- deuterated phenanthrene tetraol, pharmacological study and laboratory biomarker analysis
- How many people
- 350 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jul 2012to 30 Sep 2019
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy current and former smokers
- Current or former smoker
- 18 years of age or older
- Documentation of a diagnosis of no dysplasia, dysplasia, or metaplasia on bronchoscopy (white light and/or autofluorescence) conducted less than or equal to 10 years prior to registration
- Not pregnant or breastfeeding
- Able to provide written informed consent indicating an understanding of the nature of the study
- Willing to comply with study requirements, including taking [D10]phenanthrene in water with 20% ethanol
- No previous history of aerodigestive cancer
- Not currently undergoing treatment for any cancers. Exception: basal cell or squamous cell skin cancer
- Not currently taking any other investigational agents
- No history of allergic reaction to [D10]phenanthrene or similar compounds
- No major medical comorbidities, for example, renal dysfunction, heart function, and diabetes, to be adjudicated by study physicians
- Not a former or recovering alcoholic
- No use of metronidazole or antabuse less than or equal to 7 days prior to [D10]phenanthrene dosing, as they could potentially interact with ethanol
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Roswell Park Cancer Institute
Buffalo, New York, 14263
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: Correlation of [D10] Phenanthrene Metabolism With Bronchoepithelial Dysplasia and Metaplasia in Smokers at High Risk for Lung Cancer
This clinical trial studies deuterated phenanthrene tetraol in smokers who are at high risk for lung cancer. Studying samples of urine in the laboratory from smokers who are at high risk for lung cancer may help doctors learn more about biomarkers related to cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the relationship between urinary deuterated ([D10]) phenanthrene tetraol (PheT) level, PheT:phenanthrols (HOPhe) ratio, and the presence of bronchoepithelial metaplasia and/or dysplasia in smokers who have undergone screening bronchoscopy at Roswell Park Cancer Institute (RPCI).
OUTLINE:
Patients receive deuterated phenanthrene tetraol orally (PO). Urine samples are collected for laboratory studies for 6 hours after dosing.
- Conditions
- Lung Cancer, Squamous Lung Dysplasia, Tobacco Use Disorder
- Being tested
- deuterated phenanthrene tetraol, pharmacological study, laboratory biomarker analysis
- Medical subject headings
- Lung Neoplasms, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deuterated phenanthrene tetraolDrug
Also called [D10] phenanthrene, phenanthrene-D10
Given PO
Also called pharmacological studies
Correlative studies
laboratory biomarker analysisDrug
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Basic Science (deuterated phenanthrene tetraol) | Patients receive deuterated phenanthrene tetraol PO and collect urine for 6 hours after dosing. Receives: Drug: deuterated phenanthrene tetraol; Drug: pharmacological study; Drug: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary deuterated phenanthrene tetraol level
A multiple regression analysis will be performed including explanatory variables such as lesion status, presence/absence of chronic obstructive pulmonary disease (COPD) or asbestos, duration of smoking, smoking intensity, age, and gender.
Measured: Up to 6 hours
PheT:HOPhe ratio
A multiple regression analysis will be performed including explanatory variables such as lesion status, presence/absence of COPD or asbestos, duration of smoking, smoking intensity, age, and gender.
Measured: Up to 6 hours
Correlation of deuterated phenanthrene tetraol level and PheT:HOPhe ratio with the presence of bronchoepithelial metaplasia and/or dysplasia
A multiple regression analysis will be performed including explanatory variables such as lesion status, presence/absence of COPD or asbestos, duration of smoking, smoking intensity, age, and gender.
Measured: Up to 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2012 (estimated)
- Study startJul 2012
- Primary completion31 Mar 2019
- Study completion30 Sep 2019
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 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
- Other
- Time perspective
- Prospective
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Stephen S Hecht, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01673711
- Sponsor's protocol ID
- 2011NTUC092
- Other IDs
- NCI-2012-01148
- Status last verified
- Oct 2019
- First submitted
- 2 Aug 2012
- Last updated
- 9 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of [D10] Phenanthrene Metabolism With Bronchoepithelial Dysplasia and Metaplasia in Smokers at High Risk for Lung Cancer
- ClinicalTrials.gov ID
- NCT01673711
- Acronym / sponsor ID
- 2011NTUC092
- Conditions
- Lung Cancer, Squamous Lung Dysplasia, Tobacco Use Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2012 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 28 Aug 2012 (estimated)
- 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 clinical trial studies deuterated phenanthrene tetraol in smokers who are at high risk for lung cancer. Studying samples of urine in the laboratory from smokers who are at high risk for lung cancer may help doctors learn more about biomarkers related to cancer.
Detailed description
PRIMARY OBJECTIVES:
- To determine the relationship between urinary deuterated ([D10]) phenanthrene tetraol (PheT) level, PheT:phenanthrols (HOPhe) ratio, and the presence of bronchoepithelial metaplasia and/or dysplasia in smokers who have undergone screening bronchoscopy at Roswell Park Cancer Institute (RPCI).
OUTLINE:
Patients receive deuterated phenanthrene tetraol orally (PO). Urine samples are collected for laboratory studies for 6 hours after dosing.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Basic Science (deuterated phenanthrene tetraol) | – | Drug: deuterated phenanthrene tetraol, Drug: pharmacological study, Drug: laboratory biomarker analysisPatients receive deuterated phenanthrene tetraol PO and collect urine for 6 hours after dosing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy current and former smokers
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 |
|---|---|---|
| deuterated phenanthrene tetraolAlso: [D10] phenanthrene, phenanthrene-D10Given PO | Drug | Basic Science (deuterated phenanthrene tetraol) |
| pharmacological studyAlso: pharmacological studiesCorrelative studies | Drug | Basic Science (deuterated phenanthrene tetraol) |
| laboratory biomarker analysisCorrelative studies | Drug | Basic Science (deuterated phenanthrene tetraol) |
Primary outcome
Urinary deuterated phenanthrene tetraol level
Time frame: Up to 6 hours
A multiple regression analysis will be performed including explanatory variables such as lesion status, presence/absence of chronic obstructive pulmonary disease (COPD) or asbestos, duration of smoking, smoking intensity, age, and gender.
PheT:HOPhe ratio
Time frame: Up to 6 hours
A multiple regression analysis will be performed including explanatory variables such as lesion status, presence/absence of COPD or asbestos, duration of smoking, smoking intensity, age, and gender.
Correlation of deuterated phenanthrene tetraol level and PheT:HOPhe ratio with the presence of bronchoepithelial metaplasia and/or dysplasia
Time frame: Up to 6 hours
A multiple regression analysis will be performed including explanatory variables such as lesion status, presence/absence of COPD or asbestos, duration of smoking, smoking intensity, age, and gender.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2019.
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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.
Stephen S Hecht, PhD principal investigator
University of Minnesota
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Squamous Lung Dysplasia, run by University of Minnesota at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 9 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Canada. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Urinary deuterated phenanthrene tetraol level (time frame: Up to 6 hours). 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 9 Oct 2019.