Ignite Creation Date:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2025-12-28 @ 1:14 PM
Study NCT ID:
NCT01069835
Status:
COMPLETED
Last Update Posted:
2015-05-19
First Post:
2010-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epidemiological Study to Describe Non Small Cell Lung Cancer (NSCLC) Clinical Management Patterns in Central Eastern Europe and Russia (Lung-EPICLIN)
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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Paraffin embedded tumour tissue samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 840}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-18', 'studyFirstSubmitDate': '2010-02-15', 'studyFirstSubmitQcDate': '2010-02-16', 'lastUpdatePostDateStruct': {'date': '2015-05-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the differences in patient characteristics, disease stage (differentiating between non-advanced disease, locally advanced disease, metastatic disease), and in clinical management across Central Eastern European countries and Russia', 'timeFrame': '24 months'}], 'secondaryOutcomes': [{'measure': 'To detect differences in clinical outcomes and related factors among countries', 'timeFrame': '24 months'}, {'measure': 'To identify factors associated with clinical outcomes (patient, disease stage -see above- and clinical management related factors): predictive modelling for improved patient outcome', 'timeFrame': '24 months'}, {'measure': 'To identify factors associated with the different levels of functional status and quality of life', 'timeFrame': '24 months'}, {'measure': 'To compare the use of health care resources among countries', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Non small cell lung cancer', 'EGFR mutation', 'NSCLC'], 'conditions': ['Non Small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '25867537', 'type': 'DERIVED', 'citation': 'Tjulandin S, Imyanitov E, Moiseyenko V, Ponomarenko D, Gurina L, Koroleva I, Karaseva V. Prospective cohort study of clinical characteristics and management patterns for patients with non-small-cell lung cancer in the Russian Federation: EPICLIN-Lung. Curr Med Res Opin. 2015 Jun;31(6):1117-27. doi: 10.1185/03007995.2015.1036015. Epub 2015 May 8.'}], 'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1019&filename=CSR-NIS-ORU-IRE-2009-1.pdf', 'label': 'Related Info'}, {'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1019&filename=CSR-NIS-ORU-IRE-2009-1.pdf', 'label': 'CSR-NIS-ORU-IRE-2009-1.pdf'}, {'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1019&filename=NIS-ORU-IRE-20091EPICLIN-LUNG-FinalProtocol-CEERussia-08122009.pdf', 'label': 'NIS-ORU-IRE-20091EPICLIN-LUNG-FinalProtocol-CEERussia-08122009'}]}, 'descriptionModule': {'briefSummary': 'The overall aim of the study is:\n\nTo provide accurate and reliable information regarding NSCLC clinical management across Central Eastern European countries and Russia in order to detect unmet medical needs of this disease in terms of:\n\n* Patient and hospital characteristics.\n* Diagnostic and treatment approaches: initial and subsequent.\n* Follow-up patterns in clinical management.\n* Outcomes: symptoms, death, functionality, quality of life.\n* Use of resources and burden on patients and health care systems. Addendum objective is to collect epidemiological data on EGFR mutation status (M+, M-) in the Russian population'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cancer patients from Oncological Dispensaries and Cancer Research Institutes', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed NSCLC diagnosis (e.g.bronchoscopic biopsy or FNAB), all stages, men and women, attending the responsible department of treating this type of patients for the first time between January 1st, 2010 and March 31st, 2010\n* For Patient Reported Outcome (PRO) sub-sample: ability to read and write since they will be asked to participate in the PRO part of the study. Selection will not be based on the disease stage of each patient, in order to avoid a selection bias.\n* Tumour tissue samples (in paraffin-embedded blocks) suitable for EGFR mutation testing available.\n\nExclusion Criteria:\n\n* Mixed histology of small cell and non-small cell lung cancer.'}, 'identificationModule': {'nctId': 'NCT01069835', 'acronym': 'EPICLIN', 'briefTitle': 'Epidemiological Study to Describe Non Small Cell Lung Cancer (NSCLC) Clinical Management Patterns in Central Eastern Europe and Russia (Lung-EPICLIN)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Epidemiological Study to Describe NSCLC Clinical Management Patterns in Central Eastern Europe and Russia. Lung-EPICLIN', 'orgStudyIdInfo': {'id': 'NIS-ORU-IRE-2009/1'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Non-small cell lung cancer patients'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Barnaul', 'state': 'Altaiskiy Krai', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 53.36199, 'lon': 83.72786}}, {'city': 'Birobidzhan', 'state': 'EAO', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 48.793, 'lon': 132.92033}}, {'city': 'Khabarovsk', 'state': 'Khabarovskiy Krai', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 48.46204, 'lon': 135.0971}}, {'city': 'Khanty-Mansyisk', 'state': 'Khanty-Mansyiskyi AO', 'country': 'Russia', 'facility': 'Research Site'}, {'city': 'Krasnodar', 'state': 'Krasnodarskiy Krai', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 45.04534, 'lon': 38.98178}}, {'city': 'Vladivostok', 'state': 'Primorskiy Krai', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 43.10562, 'lon': 131.87353}}, {'city': "Kazan'", 'state': 'Resp. of Tatarstan', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 55.78874, 'lon': 49.12214}}, {'city': 'Yakutsk', 'state': 'Sakha', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 62.03114, 'lon': 129.72288}}, {'city': 'Arkhangelsk', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 64.5461, 'lon': 40.55183}}, {'city': 'Belgorod', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 50.60343, 'lon': 36.58091}}, {'city': 'Blagoveshchensk', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 50.27593, 'lon': 127.52637}}, {'city': 'Chita', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 52.04311, 'lon': 113.49171}}, {'city': "Engel's", 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 51.48389, 'lon': 46.10528}}, {'city': 'Irkutsk', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 52.29566, 'lon': 104.29076}}, {'city': 'Kemerovo', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 55.35417, 'lon': 86.10435}}, {'city': 'Khimki', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 55.9001, 'lon': 37.42848}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Nizhny Novgorod', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 56.32867, 'lon': 44.00205}}, {'city': 'Novosibirsk', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}, {'city': 'Obninsk', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 55.10993, 'lon': 36.61238}}, {'city': 'Omsk', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 54.99244, 'lon': 73.36859}}, {'city': 'Oryol', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 52.96879, 'lon': 36.0791}}, {'city': 'Perm', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 58.01046, 'lon': 56.25017}}, {'city': 'Pyatigorsk', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 44.05, 'lon': 43.05036}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Samara', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 53.20767, 'lon': 50.13553}}, {'city': 'Tomsk', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 56.50049, 'lon': 84.98216}}, {'city': 'Tula', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 54.19609, 'lon': 37.61822}}, {'city': 'Volgograd', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 48.71378, 'lon': 44.4976}}, {'city': 'Yuzno-Sakhalinsk', 'country': 'Russia', 'facility': 'Research Site'}, {'city': 'Zhukovsky', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 55.59528, 'lon': 38.12028}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}