Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2026-02-28 @ 1:08 AM
Study NCT ID:
NCT00252759
Status:
COMPLETED
Last Update Posted:
2011-01-28
First Post:
2005-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Iressa Case Control Study in Japan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2006-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-27', 'studyFirstSubmitDate': '2005-11-14', 'studyFirstSubmitQcDate': '2005-11-14', 'lastUpdatePostDateStruct': {'date': '2011-01-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-11-15', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Non-small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '30762084', 'type': 'DERIVED', 'citation': 'Kawata T, Higashimori M, Itoh Y, Tomkinson H, Johnson MG, Tang W, Nyberg F, Jiang H, Tanigawara Y. Gefitinib exposure and occurrence of interstitial lung disease in Japanese patients with non-small-cell lung cancer. Cancer Chemother Pharmacol. 2019 May;83(5):849-858. doi: 10.1007/s00280-019-03788-4. Epub 2019 Feb 14.'}]}, 'descriptionModule': {'briefSummary': 'The purposes of this study are:\n\n* To estimate the relative risk of ILD in advanced/recurrence NSCLC patients treated with gefitinib as compared to other chemotherapy treatment, and to assess the risk factors for ILD in advanced/recurrence NSCLC patients undergoing treatment\n* To provide an estimate of the incidence of ILD in a group of advanced/recurrence NSCLC patients undergoing treatment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Advanced/recurrence NSCLC patients who have had one or more chemotherapy regimens.\n* Patients who are to be treated with gefitinib or chemotherapy\n* Cohort: All advanced/recurrence NSCLC patients participating in this post-marketing clinical study\n\nExclusion Criteria:\n\n* Patients judged by the investigator(s) to have ILD (provisional cases) among those registered in the cohort OR Randomly selected patients without ILD (controls) for each provisional case\n* Case-control study: Patients enrolled in the case-control study; all consenting patients with ILD as cases and approximately 4 times as many consenting patients without ILD as controls randomly selected from the cohort'}, 'identificationModule': {'nctId': 'NCT00252759', 'briefTitle': 'Iressa Case Control Study in Japan', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Nested Case-control Study to Determine the Relative Risk of and Risk Factors for Interstitial Lung Disease in a Cohort of NSCLC Patients Treated With and Without Gefitinib', 'orgStudyIdInfo': {'id': 'D791AL00002'}, 'secondaryIdInfos': [{'id': 'V-15-33'}, {'id': 'OZV1533'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'city': 'Okazaki', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.95, 'lon': 137.16667}}, {'city': 'Toyoake', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.038, 'lon': 136.99931}}, {'city': 'Imba-gun', 'state': 'Chiba', 'country': 'Japan', 'facility': 'Research Site'}, {'city': 'Kashiwa', 'state': 'Chiba', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.86224, 'lon': 139.97732}}, {'city': 'Matsuyama', 'state': 'Ehime', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 33.83916, 'lon': 132.76574}}, {'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Kitakyushu', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 33.85181, 'lon': 130.85034}}, {'city': 'Gifu', 'state': 'Gifu', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.42291, 'lon': 136.76039}}, {'city': 'Hiroshima', 'state': 'Hiroshima', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'city': 'Asahikawa', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 43.77063, 'lon': 142.36489}}, {'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Akashi', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.65524, 'lon': 135.00687}}, {'city': 'Kobe', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}, {'city': 'Kanazawa', 'state': 'Ishikawa-ken', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 36.6, 'lon': 136.61667}}, {'city': 'Isehara', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.39932, 'lon': 139.31019}}, {'city': 'Sagamihara', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.56707, 'lon': 139.24167}}, {'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'city': 'Kumamoto', 'state': 'Kumamoto', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'city': 'Kyoto', 'state': 'Kyoto', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'city': 'Sendai', 'state': 'Miyagi', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'city': 'Nagasaki', 'state': 'Nagasaki', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 32.75, 'lon': 129.88333}}, {'city': 'Ōmura', 'state': 'Nagasaki', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 32.92139, 'lon': 129.95389}}, {'city': 'Tenri', 'state': 'Nara', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.58333, 'lon': 135.83333}}, {'city': 'Niigata', 'state': 'Niigata', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 37.92259, 'lon': 139.04125}}, {'city': 'Okayama', 'state': 'Okayama-ken', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'city': 'Ginowan', 'state': 'Okinawa', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 26.26265, 'lon': 127.76147}}, {'city': 'Habikino', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.55276, 'lon': 135.59097}}, {'city': 'Izumisano', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.41667, 'lon': 135.31667}}, {'city': 'Osaka', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Sakai', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.58216, 'lon': 135.46653}}, {'city': 'Sayama', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.51685, 'lon': 135.56298}}, {'city': 'Toyonaka', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.78244, 'lon': 135.46932}}, {'city': 'Tokyo', 'state': 'Ota', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Ōtsu', 'state': 'Shiga', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.0, 'lon': 135.86667}}, {'city': 'Sunto-gun', 'state': 'Shizuoka', 'country': 'Japan', 'facility': 'Research Site'}, {'city': 'Bunkyo-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Research Site'}, {'city': 'Bunkyo', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Research Site'}, {'city': 'Kiyose', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.77952, 'lon': 139.53014}}, {'city': 'Minato-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Research Site'}, {'city': 'Mitaka', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.68361, 'lon': 139.56002}}, {'city': 'Shinjuku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.69115, 'lon': 139.70854}}, {'city': 'Toshima-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Research Site'}, {'city': 'Toyama', 'state': 'Toyama', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 36.7, 'lon': 137.21667}}], 'overallOfficials': [{'name': 'AstraZeneca Japan Medical Director, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}}}}