Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2026-02-26 @ 12:03 PM
Study NCT ID:
NCT00899535
Status:
COMPLETED
Last Update Posted:
2016-06-29
First Post:
2009-05-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cancer Genome Study Using Samples From Patients With Stage I or Stage II Non-Small Cell Lung Cancer Treated on Clinical Trial ACOSOG-Z0030
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': 'D046228', 'term': 'Microarray Analysis'}, {'id': 'D054458', 'term': 'Amplified Fragment Length Polymorphism Analysis'}], 'ancestors': [{'id': 'D046208', 'term': 'Microchip Analytical Procedures'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D016172', 'term': 'DNA Fingerprinting'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D016133', 'term': 'Polymerase Chain Reaction'}, {'id': 'D021141', 'term': 'Nucleic Acid Amplification Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Tumor samples from patients enrolled on Z0030.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-27', 'studyFirstSubmitDate': '2009-05-09', 'studyFirstSubmitQcDate': '2009-05-09', 'lastUpdatePostDateStruct': {'date': '2016-06-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical relevance of conducting comprehensive molecular analyses on clinically annotated high-quality tumor biospecimens', 'timeFrame': 'Up to 3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['adenocarcinoma of the lung', 'large cell lung cancer', 'squamous cell lung cancer', 'stage I non-small cell lung cancer', 'stage II non-small cell lung cancer'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Studying samples of tumor 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 study is looking at the cancer genome using tumor samples from patients with stage I or stage II non-small cell lung cancer treated on clinical trial ACOSOG-Z0030.', 'detailedDescription': 'OBJECTIVES:\n\n* To investigate the clinical relevance of conducting comprehensive molecular analyses on clinically annotated high-quality tumor biospecimens from patients with stage I or II, N0 or N1 (less than hilar) non-small cell lung cancer.\n\nOUTLINE: This is a multicenter study.\n\nBiological specimens are collected from participating clinical sites and analyzed by transcription profiling of RNA and microRNA; detection of DNA copy number changes and chromosomal rearrangements; epigenetic modifications analyses; and sequencing of genomic segments, genes, and regulatory regions to assess sequence variation. Clinical information associated with each specimen donor is also collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with non-small cell carcinoma previously registered on ACOSOG-Z0030.', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of non-small cell carcinoma\n\n * Primary, untreated disease\n * Stage I or II (T1 or T2, N0 or non-hilar N1, M0) disease\n * Any of the following histologies allowed:\n\n * Squamous cell carcinoma\n * Adenocarcinoma (\\< 10%)\n * Large cell carcinoma (high-grade)\n* Available tumor tissue samples collected on clinical trial ACOSOG-Z0030 and meeting the following criteria:\n\n * Snap-frozen and stored at a temperature of -80°C or lower\n * Specimens may come from any site within the lung or one that is involved by direct regional extension of tumor from the originating site in the lung\n* No regional lymph node or distant metastases\n* No recurrent or persistent disease after prior neoadjuvant or adjuvant treatment for lung cancer\n* Must have matching frozen samples of normal tissue and blood'}, 'identificationModule': {'nctId': 'NCT00899535', 'briefTitle': 'Cancer Genome Study Using Samples From Patients With Stage I or Stage II Non-Small Cell Lung Cancer Treated on Clinical Trial ACOSOG-Z0030', 'organization': {'class': 'OTHER', 'fullName': 'Alliance for Clinical Trials in Oncology'}, 'officialTitle': 'The Cancer Genome Atlas (TCGA) Utilizing Z0030 NSCLC Patient Samples', 'orgStudyIdInfo': {'id': 'ACOSOG-Z4082'}, 'secondaryIdInfos': [{'id': 'ACOSOG-Z4082'}, {'id': 'CDR0000617514', 'type': 'REGISTRY', 'domain': 'NCI Physician Reference Desk'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'This research study is looking at the cancer genome using tumor samples from patients with stage I or stage II non-small cell lung cancer treated on clinical trial ACOSOG-Z0030. Studying samples of tumor 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.', 'interventionNames': ['Genetic: DNA analysis', 'Genetic: RNA analysis', 'Genetic: microarray analysis', 'Genetic: mutation analysis', 'Genetic: polymorphism analysis']}], 'interventions': [{'name': 'DNA analysis', 'type': 'GENETIC', 'armGroupLabels': ['Group 1']}, {'name': 'RNA analysis', 'type': 'GENETIC', 'armGroupLabels': ['Group 1']}, {'name': 'microarray analysis', 'type': 'GENETIC', 'armGroupLabels': ['Group 1']}, {'name': 'mutation analysis', 'type': 'GENETIC', 'armGroupLabels': ['Group 1']}, {'name': 'polymorphism analysis', 'type': 'GENETIC', 'armGroupLabels': ['Group 1']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Mark Allen, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alliance for Clinical Trials in Oncology', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}