Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-25 @ 9:27 PM
Study NCT ID:
NCT03413956
Status:
COMPLETED
Last Update Posted:
2018-05-21
First Post:
2018-01-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Observational Study to Explore Clinical Characteristics of the Patients With T1 Non-small Cell Lung Cancer
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10885}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-18', 'studyFirstSubmitDate': '2018-01-15', 'studyFirstSubmitQcDate': '2018-01-22', 'lastUpdatePostDateStruct': {'date': '2018-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percentage of N2 patients with lymph nodes', 'timeFrame': '2015 - 2017', 'description': 'Percentages of N2 patients with lymph nodes in N2 population'}, {'measure': 'Percentage of patients with lymph metastases categorised by tumor baseline characteristics', 'timeFrame': '2015 - 2017', 'description': 'Percentage of patients with lymph metastases categorised by tumor baseline characteristics'}, {'measure': 'Number of lymph nodes in N2 patients', 'timeFrame': '2015 - 2017', 'description': 'Number of lymph nodes in N2 patients categorised by tumor baseline characteristics'}, {'measure': 'Percentage of patients with N2 skip metastases', 'timeFrame': '2015 - 2017', 'description': 'Percentage of patients with N2 skip metastases categorised by tumor baseline characteristics'}], 'primaryOutcomes': [{'measure': 'Percentage of the patients with lymph metastases', 'timeFrame': '2015 - 2017', 'description': 'Percentages of the patients with lymph metastases categorised by patient demographic and tumor biological characteristics'}], 'secondaryOutcomes': [{'measure': 'Percentages of N0/N1/N2/N3 patients', 'timeFrame': '2015 - 2017', 'description': 'Percentages of N0/N1/N2/N3 patients in the target population'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chinese', 'T1 non-small cell lung cancer', 'Lymph metastases'], 'conditions': ['Non Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The real-world observational study was designed to explore the odd factors of lymph metastases in the patients with T1 non-small cell lung cancer, the effects of clinical characteristics on lymph metastases, and compare the differences in lymph metastases in the subgroups.', 'detailedDescription': 'The trial is a multi-centre, real-world non-interventional observational study. In the study, the patients with T1 non-small cell lung cancer enrolled in clinics from 2015 to 2017 were included via a retrospectively review method and the study data on patient demographic/tumor biological characteristics, and clinical treatments were collected to explore the clinical odd factors of lymph metastases, evaluate the effects of clinical characteristics on lymph metastases, and compare the differences in lymph metastases in the subgroups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The eligible subjects are the Chinese T1 patients with non-small cell lung cancer complicated with lymph metastases', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who received surgeries from 2015 to 2017;\n* Pathologically diagnosed patients with T1 non-small cell lung cancer;\n\nExclusion Criteria:\n\n\\- Patients with tumor treatments (including chemotherapies, radiotherapies, biological therapies, intervention therapies)'}, 'identificationModule': {'nctId': 'NCT03413956', 'briefTitle': 'An Observational Study to Explore Clinical Characteristics of the Patients With T1 Non-small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Jiangsu Cancer Institute & Hospital'}, 'officialTitle': 'A Multi-centre Real-world Non-interventional Observational Study to Explore Clinical Characteristics of the Chinese Patients With T1 Non-small Cell Lung Cancer Complicated With Lymph Metastases', 'orgStudyIdInfo': {'id': 'JS-LC-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'NSCLC patients with lymph metastases', 'description': 'Pathologically diagnosed patients with T1 non-small cell lung cancer complicated with lymph metastases after surgeries', 'interventionNames': ['Procedure: Surgeries']}], 'interventions': [{'name': 'Surgeries', 'type': 'PROCEDURE', 'description': 'Surgeries', 'armGroupLabels': ['NSCLC patients with lymph metastases']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100029', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'China-Japan Friendship Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100853', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': "China People's Liberation Army Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '450003', 'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': 'Henan cancer hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': 'Henan Cancer Hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Tongji Hospital Affiliated to Tongji Medical College, Huaxi Technology University', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '210009', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Jiangsu Cancer Institute and Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '710000', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': "Xi'an Tangdu Hospital", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'zip': '200030', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Chest Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'West China Hospital', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '310006', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'First Hospital Affiliated to Medical College, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Lin Xu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jiangsu Cancer Institute and Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu Cancer Institute & Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Feng Jiang', 'investigatorAffiliation': 'Jiangsu Cancer Institute & Hospital'}}}}