Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2026-03-01 @ 6:01 AM
Study NCT ID:
NCT02917369
Status:
RECRUITING
Last Update Posted:
2016-09-28
First Post:
2016-09-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Integrative Analysis of Large-cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], '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'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-09-27', 'studyFirstSubmitDate': '2016-09-27', 'studyFirstSubmitQcDate': '2016-09-27', 'lastUpdatePostDateStruct': {'date': '2016-09-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '5 years overall survival', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'measure': '5 years disease-free survival', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['LCLC; Integrative Analysis; Metastasis'], 'conditions': ['Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '25651787', 'type': 'RESULT', 'citation': 'Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4.'}]}, 'descriptionModule': {'briefSummary': 'Integrative analysis of LCLC', 'detailedDescription': 'The investigators will analyzed proteomes of paired normal lung tissues and LCLC with or without liver metastasis, sequenced transcriptomes, perform whole exome sequencing, and single nucleotide polymorphism (SNP) array profiling for triplets, each comprising normal lung tissue, primary LCLC carcinoma, and its synchronous matched metastasis, as well as analyzed genomics of lung cancer characterized previously by The Cancer Genome Atlas (TCGA) to conduct integrated proteogenomic analyses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with large-cell lung cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≤ 75 years with histologically proven LCLC\n* No severe major organ dysfunction\n* World Health Organization (WHO) performance status of 0 or 1\n* No prior cancer chemotherapy\n\nExclusion Criteria:\n\n* Age ≥ 76\n* Severe major organ dysfunction\n* WHO performance status of \\>1\n* Prior cancer chemotherapy'}, 'identificationModule': {'nctId': 'NCT02917369', 'acronym': 'LCLC', 'briefTitle': 'Integrative Analysis of Large-cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': "Shanghai 10th People's Hospital"}, 'officialTitle': 'Integrative Analysis of Large-cell Lung Carcinoma', 'orgStudyIdInfo': {'id': '2016-52-Rainy'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal lung tissue', 'description': 'Normal lung tissue from LCLC patients', 'interventionNames': ['Other: Normal lung tissue']}, {'label': 'LCLC tissues', 'description': 'LCLC tissues from LCLC patients', 'interventionNames': ['Other: Normal lung tissue']}, {'label': 'Metastasis tissues', 'description': 'Metastasis tissues from LCLC patients', 'interventionNames': ['Other: Normal lung tissue']}], 'interventions': [{'name': 'Normal lung tissue', 'type': 'OTHER', 'description': 'The investigators will extract total protein, DNA and RNA from LCLC patients.', 'armGroupLabels': ['LCLC tissues', 'Metastasis tissues', 'Normal lung tissue']}]}, 'contactsLocationsModule': {'locations': [{'zip': '341000', 'city': 'Ganzhou', 'state': 'Jiangxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaoming Zhong, MD', 'role': 'CONTACT', 'email': '15979192617@163.com', 'phone': '00-86-797-8356156'}, {'name': 'Xiaoming Zhong, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Ganzhou City People's Hospital", 'geoPoint': {'lat': 25.84664, 'lon': 114.9326}}, {'zip': '200072', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Da Fu, PhD', 'role': 'CONTACT', 'email': 'fu800da900@126.com', 'phone': '00-86-21-66301604'}, {'name': 'Yushui Ma, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Shanghai Tenth People's Hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200433', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Likun Hou, MD', 'role': 'CONTACT', 'email': 'hlk9575@163.com', 'phone': '00-86-21-65115006', 'phoneExt': '3030'}, {'name': 'Likun Hou, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shanghai Pulmonary Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Da Fu, PhD', 'role': 'CONTACT', 'email': 'fu800da900@126.com', 'phone': '00-86-21-66301604'}], 'overallOfficials': [{'name': 'Da Fu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Shanghai 10th People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'The investigators are willing to share data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Shanghai 10th People's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Shanghai Pulmonary Hospital, Shanghai, China', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Da Fu', 'investigatorAffiliation': "Shanghai 10th People's Hospital"}}}}