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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-01148 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Basic Science (deuterated phenanthrene tetraol) | Patients receive deuterated phenanthrene tetraol PO and collect urine for 6 hours after dosing. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| deuterated phenanthrene tetraol | Drug | Given PO |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Up to 6 hours |
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Healthy current and former smokers
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| Name | Affiliation | Role |
|---|---|---|
| Stephen S Hecht, PhD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States | ||
| Roswell Park Cancer Institute |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C031181 | phenanthrene |
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Urine, blood, buccal swab
| pharmacological study | Drug | Correlative studies |
|
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| laboratory biomarker analysis | Drug | Correlative studies |
|
| Buffalo |
| New York |
| 14263 |
| United States |
| BC Cancer Agency | Vancouver | British Columbia | V5Z 4E6 | Canada |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |