Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2025-12-26 @ 12:43 AM
Study NCT ID:
NCT00745160
Status:
COMPLETED
Last Update Posted:
2011-03-30
First Post:
2008-09-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Survey and Blood Sample Collection for Patients With Lung Cancer Who Never Smoked Cigarettes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood sample for DNA analysis'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 115}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-29', 'studyFirstSubmitDate': '2008-09-02', 'studyFirstSubmitQcDate': '2008-09-02', 'lastUpdatePostDateStruct': {'date': '2011-03-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the feasibility of an internet-based protocol to collect clinical information and biological specimens from 2,000 never smokers with lung cancer.', 'timeFrame': 'conclusion of the study'}]}, 'conditionsModule': {'keywords': ['Questionaires'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine if collecting information and blood from a group of people who never smoked but who have lung cancer, is possible across the US. The investigators will collect information on each patient's diagnosis and treatments. If the collection is successful, blood samples will be used to try to identify new genes (which are the basic elements of heredity, passed from parents to their offspring), which may explain and predict why certain patients develop lung cancer without having smoked tobacco."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Never-smokers with lung cancer\n\nInternet recruitment The study will be advertised through a specifically designed website linked to the MSKCC Lung Cancer webpage. The website will be designed after approval of the study. The website will be accordingly reviewed by the IRB. We plan to advertise this study by word-of mouth at scientific meetings and on patient associations' websites and/or bulletins, with permission. The website will post a description of the study and an invitation to participate.\n\nInterested patients will be given an email or mail address and/or phone number 866-854-4652 to contact MSKCC investigators about the study.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18 years or older\n* histologically and/or cytologically proven diagnosis of non-small cell lung cancer\n* never smoker, defined as having smoked less than 100 cigarettes over one's life-time\n* completed survey and inclusion form\n* signed informed consent\n\nExclusion Criteria:\n\n* previous history of cancer (other than lung cancer)\n* living outside the United States\n* patients who cannot read English (as website and questionnaires will only be written in English)\n* unable to understand the protocol or to give informed consent"}, 'identificationModule': {'nctId': 'NCT00745160', 'briefTitle': 'Survey and Blood Sample Collection for Patients With Lung Cancer Who Never Smoked Cigarettes', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Survey and Blood Sample Collection for Patients With Lung Cancer Who Never Smoked Cigarettes', 'orgStudyIdInfo': {'id': '08-104'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Never-smokers with lung cancer', 'interventionNames': ['Other: blood sample and questionnaire']}], 'interventions': [{'name': 'blood sample and questionnaire', 'type': 'OTHER', 'description': 'After giving informed consent, all patients will be asked to complete questionnaire and will be asked to provide a blood sample for DNA analysis. The questionnaire will consist of a detailed smoking questionnaire, based on the most recent Centers for Disease Control and Prevention (CDC) Behavioral Risk Factor Surveillance System Survey Questionnaire.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Basking Ridge', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Memoral Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.70621, 'lon': -74.54932}}, {'zip': '11725', 'city': 'Commack', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center @ Suffolk', 'geoPoint': {'lat': 40.84288, 'lon': -73.29289}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11570', 'city': 'Rockville Centre', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center at Mercy Medical Center', 'geoPoint': {'lat': 40.65871, 'lon': -73.64124}}, {'city': 'Sleepy Hollow', 'state': 'New York', 'country': 'United States', 'facility': 'Memoral Sloan Kettering Cancer Center@Phelps', 'geoPoint': {'lat': 41.08565, 'lon': -73.85847}}], 'overallOfficials': [{'name': 'Vincent Miller, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Vincent Miller, MD', 'oldOrganization': 'Memorial Sloan-Kettering Cancer Center'}}}}