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| ID | Type | Description | Link |
|---|---|---|---|
| STU00001887 | Other Identifier | Northwestern University IRB |
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Studying samples of blood in the laboratory from patients receiving erlotinib may help doctors learn more about the effects of erlotinib on hormone levels.
This clinical trial is looking at hormone changes in women with stage IIIB or stage IV non-small cell lung cancer receiving erlotinib.
Patients undergo a dermatology evaluation and complete the Polycystic Ovarian Syndrome (PCOS) research study questionnaire once. Blood samples are collected after an overnight fast. Samples are analyzed for circulating levels of total and bioavailable testosterone, dehydroepiandrosterone sulfate, and sex hormone binding globulin. Serum luteinizing hormone, follicle stimulating hormone, fasting glucose, and insulin levels are also assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| questionnaire and laboratory biomarker analysis | Subjects with advanced non-small cell lung cancer and take erlotinib as part of their anticancer therapy for at least 3 months. Subjects have had some changes in hair growth, acne or menses (periods) that might be a side effect of erlotinib. Subjects will complete a questionnaire and blood collected for biomarker analysis. |
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| Measure | Description | Time Frame |
|---|---|---|
| Presence of hyperandrogenemia | We will determine if hyperandrogenemia is present in women with nonsmall cell lung cancer who are taking erlotinib. | One approximate 30 minute visit |
| Measure | Description | Time Frame |
|---|---|---|
| Dermatologic manifestations | We will describe the dermatologic manifestations of erlotinib in women | One approximate 30 minute visit |
| Changes in body habitus and patterns of hair loss | We will describe changes in body habitus and patterns of hair loss from women on erlotinib. |
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Histologically confirmed non-small cell lung cancer
Must be receiving daily erlotinib hydrochloride for more than 3 months
Must have hirsutism, acne, androgenic alopecia, amenorrhea, truncal weight gain, or other clinical phenotype associated with syndrome of androgen excess
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Subjects have advanced nonsmall cell lung cancer and have been taking erlotinib as part of anticancer therapy for at least 3 months.
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| Name | Affiliation | Role |
|---|---|---|
| Jyoti D. Patel, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University, Northwestern Medical Faculty Foundation | Chicago | Illinois | 60611-3013 | United States |
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blood will be tested for different sex hormones as well as glucose metabolism
| One approximate 30 minute visit |