Ignite Creation Date:
2025-12-24 @ 1:29 PM
Ignite Modification Date:
2025-12-28 @ 7:24 AM
Study NCT ID:
NCT01414595
Status:
COMPLETED
Last Update Posted:
2017-06-27
First Post:
2011-08-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Tissue Samples From Patients With Non-Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D000077192', 'term': 'Adenocarcinoma of Lung'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], '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': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019175', 'term': 'DNA Methylation'}, {'id': 'D020869', 'term': 'Gene Expression Profiling'}, {'id': 'D054458', 'term': 'Amplified Fragment Length Polymorphism Analysis'}], 'ancestors': [{'id': 'D008745', 'term': 'Methylation'}, {'id': 'D000478', 'term': 'Alkylation'}, {'id': 'D001669', 'term': 'Biochemical Phenomena'}, {'id': 'D055598', 'term': 'Chemical Phenomena'}, {'id': 'D008660', 'term': 'Metabolism'}, {'id': 'D055614', 'term': 'Genetic Phenomena'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D016172', 'term': 'DNA Fingerprinting'}, {'id': 'D016133', 'term': 'Polymerase Chain Reaction'}, {'id': 'D021141', 'term': 'Nucleic Acid Amplification Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Tumor and blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 248}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'lastUpdateSubmitDate': '2017-06-26', 'studyFirstSubmitDate': '2011-08-10', 'studyFirstSubmitQcDate': '2011-08-10', 'lastUpdatePostDateStruct': {'date': '2017-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identification and characterization of SNVs in primary adenocarcinoma of the lung or squamous cell carcinoma of the lung', 'timeFrame': 'up to 5 years'}, {'measure': 'Identification and characterization of structural variations in the genomes of NSCLC', 'timeFrame': 'up to 5 years'}, {'measure': 'Identification and characterization of other genomic alterations including, but not limited to, gene expression profiling and methylation', 'timeFrame': 'up to 5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['adenocarcinoma of the lung', 'adenosquamous cell lung cancer', 'non-small cell lung cancer', 'squamous cell lung cancer'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.\n\nPURPOSE: This research trial studies tissue samples from patients with non-small cell lung cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* To identify and characterize single nucleotide variations (SNVs) in non-small cell lung cancer (NSCLC) specimens.\n* To identify and characterize structural variations in the genomes of NSCLC specimens.\n* To identify and characterize other genomic alterations including, but not limited to, expression profiling and methylation.\n\nOUTLINE: DNA and RNA extracted from archived specimens are analyzed for single nucleotide variations, structural variations in the genomes, and other genomic alterations including, but not limited to, gene expression profiling and methylation. Clinical data related to disease, treatment, and recurrence from each patient sample is also collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with lung cancer who are registered to CALGB-140202.', 'healthyVolunteers': False, 'eligibilityCriteria': '* Patient must have been registered to CALGB 140202.\n* Tumor histology should be either primary adenocarcinoma or squamous cell carcinoma of the lung.\n* Patients are eligible for this study if their samples from CALGB 140202 are available.\n* All living patients must sign the CALGB 151107 consent form to be eligible for this trial.'}, 'identificationModule': {'nctId': 'NCT01414595', 'briefTitle': 'Study of Tissue Samples From Patients With Non-Small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Alliance for Clinical Trials in Oncology'}, 'officialTitle': 'Molecular Characterization of Lung Cancer: A Collaboration With the Cancer Genome Atlas Project (TGCA)', 'orgStudyIdInfo': {'id': 'CALGB-151107'}, 'secondaryIdInfos': [{'id': 'CALGB-151107'}, {'id': 'CDR0000706375', 'type': 'REGISTRY', 'domain': 'NCI Physician Reference Desk'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': "CALGB 140202 outlines the standard procedures for sample procurement. Samples to be used for this project have already been obtained and are currently banked at the CALGB Pathology Coordinating Office (PCO) and the Lung Cancer Tissue Bank at Brigham and Women's Hospital.", 'interventionNames': ['Genetic: DNA analysis', 'Genetic: DNA methylation analysis', 'Genetic: RNA analysis', 'Genetic: gene expression analysis', 'Genetic: polymorphism analysis', 'Other: laboratory biomarker analysis', 'Other: medical chart review']}], 'interventions': [{'name': 'DNA analysis', 'type': 'GENETIC', 'armGroupLabels': ['Group 1']}, {'name': 'DNA methylation analysis', 'type': 'GENETIC', 'armGroupLabels': ['Group 1']}, {'name': 'RNA analysis', 'type': 'GENETIC', 'armGroupLabels': ['Group 1']}, {'name': 'gene expression analysis', 'type': 'GENETIC', 'armGroupLabels': ['Group 1']}, {'name': 'polymorphism analysis', 'type': 'GENETIC', 'armGroupLabels': ['Group 1']}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'armGroupLabels': ['Group 1']}, {'name': 'medical chart review', 'type': 'OTHER', 'armGroupLabels': ['Group 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '19958', 'city': 'Lewes', 'state': 'Delaware', 'country': 'United States', 'facility': 'Tunnell Cancer Center at Beebe Medical Center', 'geoPoint': {'lat': 38.77456, 'lon': -75.13935}}, {'zip': '19713', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'CCOP - Christiana Care Health Services', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Greenebaum Cancer Center at University of Maryland Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21921', 'city': 'Elkton', 'state': 'Maryland', 'country': 'United States', 'facility': 'Union Hospital of Cecil County', 'geoPoint': {'lat': 39.60678, 'lon': -75.83327}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '08043', 'city': 'Voorhees Township', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Cancer Institute of New Jersey at Cooper - Voorhees', 'geoPoint': {'lat': 40.4795, 'lon': -74.49062}}, {'zip': '14263-0001', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Roswell Park Cancer Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Cancer Institute', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Rhode Island Hospital Comprehensive Cancer Center', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '02906', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Miriam Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'overallOfficials': [{'name': 'Ramaswamy Govindan, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Washington University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alliance for Clinical Trials in Oncology', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}