Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-26 @ 1:35 AM
Study NCT ID:
NCT00602433
Status:
COMPLETED
Last Update Posted:
2011-04-15
First Post:
2008-01-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hormone Changes in Women With Stage IIIB or Stage IV Non-Small Cell Lung Cancer Receiving Erlotinib
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'blood will be tested for different sex hormones as well as glucose metabolism'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-14', 'studyFirstSubmitDate': '2008-01-17', 'studyFirstSubmitQcDate': '2008-01-24', 'lastUpdatePostDateStruct': {'date': '2011-04-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of hyperandrogenemia', 'timeFrame': 'One approximate 30 minute visit', 'description': 'We will determine if hyperandrogenemia is present in women with nonsmall cell lung cancer who are taking erlotinib.'}], 'secondaryOutcomes': [{'measure': 'Dermatologic manifestations', 'timeFrame': 'One approximate 30 minute visit', 'description': 'We will describe the dermatologic manifestations of erlotinib in women'}, {'measure': 'Changes in body habitus and patterns of hair loss', 'timeFrame': 'One approximate 30 minute visit', 'description': 'We will describe changes in body habitus and patterns of hair loss from women on erlotinib.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['advanced nonsmall cell lung cancer'], 'conditions': ['Advanced Nonsmall Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'Studying samples of blood in the laboratory from patients receiving erlotinib may help doctors learn more about the effects of erlotinib on hormone levels.\n\nThis clinical trial is looking at hormone changes in women with stage IIIB or stage IV non-small cell lung cancer receiving erlotinib.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects have advanced nonsmall cell lung cancer and have been taking erlotinib as part of anticancer therapy for at least 3 months.', 'healthyVolunteers': False, 'eligibilityCriteria': '* Histologically confirmed non-small cell lung cancer\n\n * Stage IIIB (effusion) or stage IV disease\n* Must be receiving daily erlotinib hydrochloride for more than 3 months\n* Must have hirsutism, acne, androgenic alopecia, amenorrhea, truncal weight gain, or other clinical phenotype associated with syndrome of androgen excess'}, 'identificationModule': {'nctId': 'NCT00602433', 'briefTitle': 'Hormone Changes in Women With Stage IIIB or Stage IV Non-Small Cell Lung Cancer Receiving Erlotinib', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Evaluation of Hormonal Changes in Women on Erlotinib Therapy', 'orgStudyIdInfo': {'id': 'NU 07CC4'}, 'secondaryIdInfos': [{'id': 'STU00001887', 'type': 'OTHER', 'domain': 'Northwestern University IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'questionnaire and laboratory biomarker analysis', 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611-3013', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University, Northwestern Medical Faculty Foundation', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Jyoti D. Patel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Jyoti Patel, MD', 'oldOrganization': 'Northwestern University'}}}}