Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-27 @ 7:12 AM
Study NCT ID:
NCT00897234
Status:
COMPLETED
Last Update Posted:
2014-08-22
First Post:
2009-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Blood Samples From Patients With Non-Small Cell Lung Cancer and From Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'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': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013058', 'term': 'Mass Spectrometry'}], 'ancestors': [{'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood sample collection, one 10 ml purple top EDTA tube, will be collected from each patient and control via venipuncture or from a central line.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-21', 'studyFirstSubmitDate': '2009-05-09', 'studyFirstSubmitQcDate': '2009-05-09', 'lastUpdatePostDateStruct': {'date': '2014-08-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Levels of cathepsin D', 'timeFrame': 'At Routine Follow-Up', 'description': 'Measure plasma CD levels in patients with non-small cell lung cancer and non-smoker healthy controls using mass spectrometry.'}], 'secondaryOutcomes': [{'measure': 'Levels of fatty acid synthase (FAS)', 'timeFrame': 'At Routine Follow-Up', 'description': 'Measure FAS levels in patients with non-small cell lung cancer and non-smoker healthy controls using mass spectrometry.'}, {'measure': 'Global microRNA expression', 'timeFrame': 'At Routine Follow-Up', 'description': 'Measure global microRNA expression by microarray analysis using Illumina probes.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['recurrent non-small cell lung cancer', 'stage I non-small cell lung cancer', 'stage II non-small cell lung cancer', 'stage IIIA non-small cell lung cancer', 'stage IIIB non-small cell lung cancer', 'stage IV non-small cell lung cancer'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Studying samples of blood 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 blood samples from patients with non-small cell lung cancer and from healthy volunteers.', 'detailedDescription': 'OBJECTIVES:\n\n* Measure plasma cathepsin D levels in patients with non-small cell lung cancer and in healthy volunteers using mass spectometry.\n* Measure fatty acid synthase levels in these patients and healthy volunteers using mass spectometry.\n\nOUTLINE: Blood samples are collected from patients and healthy volunteers to measure the levels of cathepsin D and fatty acid synthase by proteomic profiling and mass spectrometry.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects who have non-small cell lung cancer (NSCLC) will be recruited from the Masonic Cancer Center at the University of Minnesota. Controls will be non-smoking individuals, age matched to the NSCLC subjects recruited through advertising. Normal controls should not be regularly exposed to second hand smoke.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nNon-Small Cell Lung Cancer Patients\n\n* Documented diagnosis of non-small cell lung cancer, any stage and any time point in the course of treatment (i.e., at diagnosis, during any treatment, and during post treatment surveillance)\n* Measurable disease by CT scan within the past 4 weeks\n\nHealthy volunteer\n\n* Non-smoking, defined as \\< 5 packs/year history of smoking and cessation of smoking ≥ 6 months ago OR a never smoker\n\n * Not regularly exposed (i.e., daily) to second-hand smoke\n\nExclusion Criteria:\n\n* Severe underlying lung disease (i.e., chronic obstructive pulmonary disease with FEV\\_1 \\< 1.0 L, pulmonary fibrosis, bronchiectasis, cystic fibrosis, etc.) as determined by enrolling researcher.\n\nWritten consent must be given for both subjects and controls.'}, 'identificationModule': {'nctId': 'NCT00897234', 'briefTitle': 'Blood Samples From Patients With Non-Small Cell Lung Cancer and From Healthy Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Plasma Quantification of Cathepsin D and FAS in Non-Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': '2008NTLS094'}, 'secondaryIdInfos': [{'id': '0809M47482', 'type': 'OTHER', 'domain': 'IRB, University of Minnesota'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy Volunteers', 'description': 'Non-smoking healthy volunteers', 'interventionNames': ['Other: Mass Spectrometry']}, {'label': 'Non-Small Cell Lung Cancer', 'description': 'Patients with non-small cell lung cancer.', 'interventionNames': ['Other: Mass Spectrometry']}], 'interventions': [{'name': 'Mass Spectrometry', 'type': 'OTHER', 'description': 'Levels of Cathepsin D (CD) and fatty acid synthase (FAS) will be measured using isobaric tag labeling coupled with mass spectrometry. RNA concentration will be measured using spectrophometer and purity will be analyzed.', 'armGroupLabels': ['Healthy Volunteers', 'Non-Small Cell Lung Cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Masonic Cancer Center at University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Robert A. Kratzke, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Masonic Cancer Center, University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}