Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2025-12-28 @ 2:43 AM
Study NCT ID:
NCT00997061
Status:
COMPLETED
Last Update Posted:
2014-02-03
First Post:
2009-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SCOT Registry: Small Cell Lung Cancer Treatment and Outcome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019772', 'term': 'Topotecan'}], 'ancestors': [{'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-30', 'studyFirstSubmitDate': '2009-10-15', 'studyFirstSubmitQcDate': '2009-10-15', 'lastUpdatePostDateStruct': {'date': '2014-02-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Registry with disease, treatment and outcome data collected.', 'timeFrame': '6-9mth recruitment period, 18mth study duration.'}], 'secondaryOutcomes': [{'measure': 'survival rates', 'timeFrame': '18 month period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Lung Cancer, Small Cell']}, 'descriptionModule': {'briefSummary': 'The registry is an international, multicenter, observational registry of newly diagnosed patients with SCLC.\n\nData will be entered into an electronic CRF (eCRF) via Internet access. Treatment plan remains the responsibility of the patient\'s physician and data collected in this registry will reflect a "real world" approach of the diagnosis and treatment of patients with SCLC.\n\nApproximately 60 centres in 13 countries will take part in this registry. It is expected that about 500 patients will be recruited during a period of 6 to 9 months according to the feasibility.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Newly Diagnosed SCLC patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or Female \\>/= 18 years\n* Diagnosis of small cell lung cancer\n* Patient newly diagnosed with SCLC\n* Has given written informed consent (if applicable)\n\nExclusion Criteria:\n\n* Concurrent history of other neoplasm, except curatively treated basal cell skin cancer or adequately treated in-situ carcinoma of the cervix.\n* Patient presenting with recurrence of SCLC.\n* Patients who has received any chemotherapy for the SCLC.'}, 'identificationModule': {'nctId': 'NCT00997061', 'acronym': 'SCOT', 'briefTitle': 'SCOT Registry: Small Cell Lung Cancer Treatment and Outcome', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'SCOT Registry: Small Cell Lung Cancer Treatment and Outcome', 'orgStudyIdInfo': {'id': '112791'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HYCAMTIN', 'interventionNames': ['Drug: HYCAMTIN']}], 'interventions': [{'name': 'HYCAMTIN', 'type': 'DRUG', 'description': 'Observing patients on HYCAMTIN and other drugs for SCLC.', 'armGroupLabels': ['HYCAMTIN']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'A-8036', 'city': 'Graz', 'country': 'Austria', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': 'A-6020', 'city': 'Innsbruck', 'country': 'Austria', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': '5020', 'city': 'Salzburg', 'country': 'Austria', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}, {'zip': '1130', 'city': 'Vienna', 'country': 'Austria', 'facility': 'GSK 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