Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2026-02-20 @ 11:49 PM
Study NCT ID:
NCT00897650
Status:
COMPLETED
Last Update Posted:
2017-07-19
First Post:
2009-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Protein and RNA Expression Patterns in Predicting Response to Treatment in Patients With Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007150', 'term': 'Immunohistochemistry'}, {'id': 'D015153', 'term': 'Blotting, Western'}, {'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D006651', 'term': 'Histocytochemistry'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006652', 'term': 'Histological Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D004586', 'term': 'Electrophoresis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D055664', 'term': 'Electrochemical Techniques'}, {'id': 'D015151', 'term': 'Immunoblotting'}, {'id': 'D007118', 'term': 'Immunoassay'}, {'id': 'D015336', 'term': 'Molecular Probe Techniques'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Lung tumor tissue and blood samples will be collected.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 204}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-18', 'studyFirstSubmitDate': '2009-05-09', 'studyFirstSubmitQcDate': '2009-05-09', 'lastUpdatePostDateStruct': {'date': '2017-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DNA, RNA, and Protein expression patterns and mutational analysis', 'timeFrame': 'After lung tumor tissue and blood collection.', 'description': 'DNA, RNA, and Protein expression patterns and mutation status in lung tumor tissue that are capable of predicting tumor response to therapy'}], 'secondaryOutcomes': [{'measure': 'Characterization of genes and proteins predictive of response to therapy', 'timeFrame': 'After lung tumor tissue and blood collection', 'description': 'Identify genes and proteins predictive of response to therapy and that can be used to identify novel mechanisms underlying lung cancer behavior'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['lung cancer'], 'conditions': ['Lung Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.vicc.org/ct/', 'label': 'Vanderbilt-Ingram Cancer Center, Find a Clinical Trial'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Studying samples of tumor tissue and blood in the laboratory from patients with cancer may help doctors learn more about changes that occur in genetic material (DNA and RNA) and may also identify protein expression patterns related to cancer. It may also help doctors predict how patients will respond to treatment.\n\nPURPOSE: This research study evaluates changes in DNA, RNA, and proteins with the goal of predicting response to treatment in patients with lung cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* To determine protein and/or RNA expression patterns capable of predicting tumor response to therapy in tumor tissue samples from patients with lung cancer or suspected of having lung cancer.\n* To characterize the genes and proteins found to be predictive of response in order to help elucidate the molecular biology underlying cancer chemosensitivity.\n* To evaluate DNA mutations found within the lung cancer sample which may be predictive of response or resistance to certain therapeutic agents.\n\nOUTLINE: Patients undergo collection of tumor tissue by percutaneous fine needle aspiration, core biopsy, thoracentesis, or during any medically indicated procedure involving removal of lung cancer tissue. Tissue samples are analyzed by a variety of techniques, including DNA sequencing, RNA sequencing and expression levels, protein assessment \\[by immunohistochemistry, western blot, Matrix-assisted laser desorption/ionization time of flight mass spectrometry (MALDI-MS\\]). The goal of these studies is to identify of gene mutations, gene expression levels, and proteins predictive of treatment response. Blood samples are also collected to obtain normal DNA for analysis.\n\nAfter completion of study, patients will be followed until their death.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'People who have or may have lung cancer.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* Diagnosis of suspected lung cancer or lung cancer\n\nExclusion criteria\n\n* Inability to undergo therapy'}, 'identificationModule': {'nctId': 'NCT00897650', 'briefTitle': 'Protein and RNA Expression Patterns in Predicting Response to Treatment in Patients With Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt-Ingram Cancer Center'}, 'officialTitle': 'Molecular Fingerprints in Lung Cancer: Predicting Tumor Response to Therapy', 'orgStudyIdInfo': {'id': 'VICC THO 0547'}, 'secondaryIdInfos': [{'id': 'P30CA068485', 'link': 'https://reporter.nih.gov/quickSearch/P30CA068485', 'type': 'NIH'}, {'id': 'VU-VICC-THO-0547', 'type': 'OTHER', 'domain': 'VICC'}, {'id': 'P50CA090949', 'link': 'https://reporter.nih.gov/quickSearch/P50CA090949', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Lung cancer', 'description': 'Patients with a diagnosis of invasive lung cancer.', 'interventionNames': ['Genetic: DNA/RNA sequencing and expression levels', 'Genetic: Protein expression analysis', 'Procedure: Lung tumor biopsy', 'Procedure: Blood sample']}], 'interventions': [{'name': 'DNA/RNA sequencing and expression levels', 'type': 'GENETIC', 'description': 'Lung tumor tissue will be collected.', 'armGroupLabels': ['Lung cancer']}, {'name': 'Protein expression analysis', 'type': 'GENETIC', 'otherNames': ['Matrix-assisted laser desorption/ionization time of flight mass spectrometry (MALDI)', 'Immunohistochemistry', 'Western blot', 'RPPA'], 'description': 'Lung tumor tissue will be collected.', 'armGroupLabels': ['Lung cancer']}, {'name': 'Lung tumor biopsy', 'type': 'PROCEDURE', 'description': 'Tissue will be collected by percutaneous fine needle aspiration, a percutaneous core biopsy, or during a medically indicated procedure during which lung tumor tissue will be removed', 'armGroupLabels': ['Lung cancer']}, {'name': 'Blood sample', 'type': 'PROCEDURE', 'description': 'Patients will be asked for a venous blood sample', 'armGroupLabels': ['Lung cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232-6838', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt-Ingram Cancer Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Christine Lovly, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Vanderbilt-Ingram Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt-Ingram Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine and Cancer Biology', 'investigatorFullName': 'Christine Lovly, MD, PhD', 'investigatorAffiliation': 'Vanderbilt-Ingram Cancer Center'}}}}