Trial record 18 of 135 for:
Open Studies | "Tobacco Use Disorder"
Deuterated Phenanthrene Tetraol in Smokers Who Are at High Risk For Lung Cancer
This study is currently recruiting participants.
Verified March 2013 by Roswell Park Cancer Institute
Sponsor:
Roswell Park Cancer Institute
Collaborator:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT01673711
First received: August 2, 2012
Last updated: March 13, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Lung Cancer Squamous Lung Dysplasia Tobacco Use Disorder |
Radiation: deuterated phenanthrene tetraol Other: pharmacological study Other: laboratory biomarker analysis |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Correlation of [D10] Phenanthrene Metabolism With Bronchoepitheial Dysplasia and Metaplasia in Smokers at High Risk for Lung Cancer |
Resource links provided by NLM:
Further study details as provided by Roswell Park Cancer Institute:
Primary Outcome Measures:
- Urinary deuterated phenanthrene tetraol level [ Time Frame: Up to 6 hours ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 350 |
| Study Start Date: | July 2012 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Basic Science (deuterated phenanthrene tetraol)
Patients receive deuterated phenanthrene tetraol PO. Urine samples are collected for laboratory studies for 6 hours after dosing.
|
Radiation: deuterated phenanthrene tetraol
Given PO
Other Names:
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Other: laboratory biomarker analysis
Correlative studies
|
Detailed Description:
PRIMARY OBJECTIVES:
I. 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Enrolled in the High Risk Lung Cancer (HRLC) Screening Program
- Eligible for bronchoscopy or have undergone screening bronchoscopy in the past
- Current smoker of at least 10 cigarettes daily
- Able to provide written consent indicating an understanding of the investigational nature of the study
- Willing to take [D10]phenanthrene in water with 20% ethanol
Exclusion Criteria:
- Previous aerodigestive tract cancer
- Currently attempting to cut down or quit smoking
- Major medical co-morbidities, for example, renal dysfunction, heart failure, and diabetes, to be adjudicated by study physicians
- Pregnant women, women intending to become pregnant, or women who are breastfeeding
- Former or recovering alcoholics
- Those needing to take medications such as metronidazole, chlorpromazine, Antabuse or benzodiazepines within 7 days of the deuterated phenanthrene dosing, as they could potentially interact with ethanol; ineligibility based on use of other medications is at the discretion of the study physicians
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01673711
Locations
| United States, New York | |
| Roswell Park Cancer Institute | Recruiting |
| Buffalo, New York, United States, 14263 | |
| Contact: Roswell Park 877-275-7724 AKSRPCI@roswellpark.org | |
| Principal Investigator: Alex A. Adjei | |
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
| Principal Investigator: | Alex Adjei | Roswell Park Cancer Institute |
More Information
No publications provided
| Responsible Party: | Roswell Park Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT01673711 History of Changes |
| Other Study ID Numbers: | I 194611, NCI-2012-01148 |
| Study First Received: | August 2, 2012 |
| Last Updated: | March 13, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Lung Neoplasms Tobacco Use Disorder Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases Substance-Related Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013