Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2026-02-24 @ 5:49 PM
Study NCT ID:
NCT01692951
Status:
COMPLETED
Last Update Posted:
2017-06-20
First Post:
2012-09-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Serum Free Fatty Acid Metabolite Biomarkers of Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sessled@ccf.org', 'phone': '216-444-4900', 'title': 'Daniel Sessler, MD', 'organization': 'Cleveland Clinic Foundation'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Lung Adenocarcinoma Patients', 'description': 'Serum samples were collected from patients with lung cancer at the time of their diagnosis, prior to the initiation of treatment. Diagnosis of lung adenocarcinoma was based on pathologic analysis.\n\nserum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 0, 'seriousNumAtRisk': 37, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Matched to Adenocarcinoma', 'description': 'Control subjects without known cancer and aged from 40 to 75 years should meet at least one of the following criteria: (1) current or ex-smoker with at least a 10 pack-year history, (2) a first-degree relative with a history of lung cancer, or (3) a clinical diagnosis of COPD.\n\nserum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank', 'otherNumAtRisk': 111, 'deathsNumAtRisk': 111, 'otherNumAffected': 0, 'seriousNumAtRisk': 111, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Lung Squamous Cell Carcinoma Patients', 'description': 'Serum samples were collected from patients with lung cancer at the time of their diagnosis, prior to the initiation of treatment. Diagnosis of lung squamous cell carcinoma was based on pathologic analysis.\n\nserum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Control Matched to Squamous Cell', 'description': 'Control subjects without known cancer and aged from 40 to 75 years should meet at least one of the following criteria: (1) current or ex-smoker with at least a 10 pack-year history, (2) a first-degree relative with a history of lung cancer, or (3) a clinical diagnosis of COPD.\n\nserum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank', 'otherNumAtRisk': 54, 'deathsNumAtRisk': 54, 'otherNumAffected': 0, 'seriousNumAtRisk': 54, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Compare Concentration of Fatty Acids and Their Metabolites', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Lung Adenocarcinoma Patients', 'description': 'Serum samples were collected from patients with lung cancer at the time of their diagnosis, prior to the initiation of treatment. Diagnosis of lung adenocarcinoma was based on pathologic analysis.\n\nserum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank'}, {'id': 'OG001', 'title': 'Control Matched to Adenocarcinoma', 'description': 'Control subjects without known cancer and aged from 40 to 75 years should meet at least one of the following criteria: (1) current or ex-smoker with at least a 10 pack-year history, (2) a first-degree relative with a history of lung cancer, or (3) a clinical diagnosis of COPD.\n\nserum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank'}, {'id': 'OG002', 'title': 'Lung Squamous Cell Carcinoma Patients', 'description': 'Serum samples were collected from patients with lung cancer at the time of their diagnosis, prior to the initiation of treatment. Diagnosis of lung squamous cell carcinoma was based on pathologic analysis.\n\nserum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank'}, {'id': 'OG003', 'title': 'Control Matched to Squamous Cell', 'description': 'Control subjects without known cancer and aged from 40 to 75 years should meet at least one of the following criteria: (1) current or ex-smoker with at least a 10 pack-year history, (2) a first-degree relative with a history of lung cancer, or (3) a clinical diagnosis of COPD.\n\nserum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank'}], 'classes': [{'title': 'Arachidonic Acid', 'categories': [{'measurements': [{'value': '5.70', 'groupId': 'OG000', 'lowerLimit': '4.62', 'upperLimit': '7.74'}, {'value': '2.95', 'groupId': 'OG001', 'lowerLimit': '2.26', 'upperLimit': '4.63'}, {'value': '4.24', 'groupId': 'OG002', 'lowerLimit': '3.65', 'upperLimit': '5.05'}, {'value': '3.18', 'groupId': 'OG003', 'lowerLimit': '2.43', 'upperLimit': '4.45'}]}]}, {'title': 'Linoleic Acid', 'categories': [{'measurements': [{'value': '0.59', 'groupId': 'OG000', 'lowerLimit': '0.46', 'upperLimit': '0.73'}, {'value': '0.34', 'groupId': 'OG001', 'lowerLimit': '0.22', 'upperLimit': '0.52'}, {'value': '0.44', 'groupId': 'OG002', 'lowerLimit': '0.33', 'upperLimit': '0.64'}, {'value': '0.32', 'groupId': 'OG003', 'lowerLimit': '0.23', 'upperLimit': '0.42'}]}]}, {'title': 'Hydroperoxyoctadecadienoyl phosphatidylcholine', 'categories': [{'measurements': [{'value': '22.3', 'groupId': 'OG000', 'lowerLimit': '13.1', 'upperLimit': '33.3'}, {'value': '17.9', 'groupId': 'OG001', 'lowerLimit': '12.3', 'upperLimit': '23.6'}, {'value': '18', 'groupId': 'OG002', 'lowerLimit': '16', 'upperLimit': '29'}, {'value': '18', 'groupId': 'OG003', 'lowerLimit': '14', 'upperLimit': '24'}]}]}, {'title': 'Hydroxyoctadecadienoylphosphatidylcholine', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '5.5'}, {'value': '7.1', 'groupId': 'OG001', 'lowerLimit': '3.2', 'upperLimit': '13.1'}, {'value': '4', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '18'}, {'value': '9', 'groupId': 'OG003', 'lowerLimit': '4', 'upperLimit': '16'}]}]}, {'title': 'Azelaoyl platelet activating factor', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '0.5'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '0.8'}, {'value': '0.5', 'groupId': 'OG002', 'lowerLimit': '0.3', 'upperLimit': '0.8'}, {'value': '0.5', 'groupId': 'OG003', 'lowerLimit': '0.3', 'upperLimit': '0.8'}]}]}, {'title': 'Azelaoyl phosphatidylcholine', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '0.3'}, {'value': '0.2', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '0.3'}, {'value': '0.2', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '0.3'}, {'value': '0.2', 'groupId': 'OG003', 'lowerLimit': '0.2', 'upperLimit': '0.2'}]}]}, {'title': 'C18-lysophospholipid platelet activating factor', 'categories': [{'measurements': [{'value': '12.7', 'groupId': 'OG000', 'lowerLimit': '8.6', 'upperLimit': '15.7'}, {'value': '16.5', 'groupId': 'OG001', 'lowerLimit': '13.1', 'upperLimit': '19.8'}, {'value': '13', 'groupId': 'OG002', 'lowerLimit': '11', 'upperLimit': '14'}, {'value': '17', 'groupId': 'OG003', 'lowerLimit': '13', 'upperLimit': '20'}]}]}, {'title': 'C16-lyso-phosphatidylcholine', 'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000', 'lowerLimit': '6.2', 'upperLimit': '17.8'}, {'value': '9.8', 'groupId': 'OG001', 'lowerLimit': '6.6', 'upperLimit': '30.6'}, {'value': '12', 'groupId': 'OG002', 'lowerLimit': '6', 'upperLimit': '52'}, {'value': '13', 'groupId': 'OG003', 'lowerLimit': '7', 'upperLimit': '42'}]}]}, {'title': 'C16-lysophospholipid platelet activating factor', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.1'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '0.1'}, {'value': '0.1', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '0.1'}]}]}, {'title': '5-hydroxyeicosatetraenoic acid', 'categories': [{'measurements': [{'value': '0.05', 'groupId': 'OG000', 'lowerLimit': '0.04', 'upperLimit': '0.07'}, {'value': '0.03', 'groupId': 'OG001', 'lowerLimit': '0.02', 'upperLimit': '0.05'}, {'value': '0.04', 'groupId': 'OG002', 'lowerLimit': '0.03', 'upperLimit': '0.05'}, {'value': '0.03', 'groupId': 'OG003', 'lowerLimit': '0.02', 'upperLimit': '0.04'}]}]}, {'title': '11-hydroxyeicosatetraenoic acid', 'categories': [{'measurements': [{'value': '0.07', 'groupId': 'OG000', 'lowerLimit': '0.03', 'upperLimit': '0.11'}, {'value': '0.03', 'groupId': 'OG001', 'lowerLimit': '0.02', 'upperLimit': '0.05'}, {'value': '0.04', 'groupId': 'OG002', 'lowerLimit': '0.04', 'upperLimit': '0.06'}, {'value': '0.03', 'groupId': 'OG003', 'lowerLimit': '0.02', 'upperLimit': '0.04'}]}]}, {'title': '12-hydroxyeicosatetraenoic acid', 'categories': [{'measurements': [{'value': '0.94', 'groupId': 'OG000', 'lowerLimit': '0.44', 'upperLimit': '1.73'}, {'value': '0.23', 'groupId': 'OG001', 'lowerLimit': '0.13', 'upperLimit': '0.57'}, {'value': '0.42', 'groupId': 'OG002', 'lowerLimit': '0.18', 'upperLimit': '0.95'}, {'value': '0.22', 'groupId': 'OG003', 'lowerLimit': '0.13', 'upperLimit': '0.51'}]}]}, {'title': '15-hydroxyeicosatetraenoic acid', 'categories': [{'measurements': [{'value': '0.02', 'groupId': 'OG000', 'lowerLimit': '0.01', 'upperLimit': '0.02'}, {'value': '0.01', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.01'}, {'value': '0.01', 'groupId': 'OG002', 'lowerLimit': '0.01', 'upperLimit': '0.02'}, {'value': '0.01', 'groupId': 'OG003', 'lowerLimit': '0.01', 'upperLimit': '0.01'}]}]}, {'title': '9-hydroxyoctadecadienoic acid', 'categories': [{'measurements': [{'value': '0.56', 'groupId': 'OG000', 'lowerLimit': '0.30', 'upperLimit': '0.97'}, {'value': '0.58', 'groupId': 'OG001', 'lowerLimit': '0.32', 'upperLimit': '0.87'}, {'value': '0.52', 'groupId': 'OG002', 'lowerLimit': '0.36', 'upperLimit': '0.68'}, {'value': '0.51', 'groupId': 'OG003', 'lowerLimit': '0.34', 'upperLimit': '0.76'}]}]}, {'title': '13-hydroxyoctadecadienoic acid', 'categories': [{'measurements': [{'value': '0.43', 'groupId': 'OG000', 'lowerLimit': '0.27', 'upperLimit': '0.62'}, {'value': '0.48', 'groupId': 'OG001', 'lowerLimit': '0.30', 'upperLimit': '0.69'}, {'value': '0.49', 'groupId': 'OG002', 'lowerLimit': '0.38', 'upperLimit': '0.73'}, {'value': '0.44', 'groupId': 'OG003', 'lowerLimit': '0.33', 'upperLimit': '0.63'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At the time of diagnosis, prior to the initiation of lung cancer treatment', 'description': 'Biochemical analysis of serum sample was conducted by an investigator who was strictly blinded to cancer status and patient characteristics.', 'unitOfMeasure': 'mg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lung Adenocarcinoma Patients', 'description': 'Serum samples were collected from patients with lung cancer at the time of their diagnosis, prior to the initiation of treatment. Diagnosis of lung adenocarcinoma was based on pathologic analysis.\n\nserum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank'}, {'id': 'FG001', 'title': 'Control Matched to Adenocarcinoma', 'description': 'Control subjects without known cancer and aged from 40 to 75 years should meet at least one of the following criteria: (1) current or ex-smoker with at least a 10 pack-year history, (2) a first-degree relative with a history of lung cancer, or (3) a clinical diagnosis of COPD.\n\nserum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank'}, {'id': 'FG002', 'title': 'Lung Squamous Cell Carcinoma Patients', 'description': 'Serum samples were collected from patients with lung cancer at the time of their diagnosis, prior to the initiation of treatment. Diagnosis of lung squamous cell carcinoma was based on pathologic analysis.\n\nserum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank'}, {'id': 'FG003', 'title': 'Control Matched to Squamous Cell', 'description': 'Control subjects without known cancer and aged from 40 to 75 years should meet at least one of the following criteria: (1) current or ex-smoker with at least a 10 pack-year history, (2) a first-degree relative with a history of lung cancer, or (3) a clinical diagnosis of COPD.\n\nserum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '111'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '54'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '111'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '54'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}, {'value': '220', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Lung Adenocarcinoma Patients', 'description': 'Serum samples were collected from patients with lung cancer at the time of their diagnosis, prior to the initiation of treatment. Diagnosis of lung adenocarcinoma was based on pathologic analysis.\n\nserum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank'}, {'id': 'BG001', 'title': 'Control Matched to Adenocarcinoma', 'description': 'Control subjects without known cancer and aged from 40 to 75 years should meet at least one of the following criteria: (1) current or ex-smoker with at least a 10 pack-year history, (2) a first-degree relative with a history of lung cancer, or (3) a clinical diagnosis of COPD.\n\nserum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank'}, {'id': 'BG002', 'title': 'Lung Squamous Cell Carcinoma Patients', 'description': 'Serum samples were collected from patients with lung cancer at the time of their diagnosis, prior to the initiation of treatment. Diagnosis of lung squamous cell carcinoma was based on pathologic analysis.\n\nserum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank'}, {'id': 'BG003', 'title': 'Control Matched to Squamous Cell', 'description': 'Control subjects without known cancer and aged from 40 to 75 years should meet at least one of the following criteria: (1) current or ex-smoker with at least a 10 pack-year history, (2) a first-degree relative with a history of lung cancer, or (3) a clinical diagnosis of COPD.\n\nserum sample: Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66', 'spread': '11', 'groupId': 'BG000'}, {'value': '65', 'spread': '6', 'groupId': 'BG001'}, {'value': '70', 'spread': '9', 'groupId': 'BG002'}, {'value': '68', 'spread': '6', 'groupId': 'BG003'}, {'value': '66', 'spread': '7', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '84', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '136', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Smoking status', 'classes': [{'title': 'Never', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}]}, {'title': 'Former', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}, {'value': '157', 'groupId': 'BG004'}]}]}, {'title': 'Current', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '56', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Family history of lung cancer', 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '48', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'COPD', 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '58', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Amount of Cigarette Smoking as Pack-year', 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000', 'lowerLimit': '25', 'upperLimit': '56'}, {'value': '40', 'groupId': 'BG001', 'lowerLimit': '26', 'upperLimit': '56'}, {'value': '38', 'groupId': 'BG002', 'lowerLimit': '25', 'upperLimit': '50'}, {'value': '39', 'groupId': 'BG003', 'lowerLimit': '24', 'upperLimit': '60'}, {'value': '40', 'groupId': 'BG004', 'lowerLimit': '25', 'upperLimit': '56'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'pack-year', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood will be sampled for FFA metabolites'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-06', 'studyFirstSubmitDate': '2012-09-21', 'resultsFirstSubmitDate': '2017-02-21', 'studyFirstSubmitQcDate': '2012-09-21', 'lastUpdatePostDateStruct': {'date': '2017-06-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-06', 'studyFirstPostDateStruct': {'date': '2012-09-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare Concentration of Fatty Acids and Their Metabolites', 'timeFrame': 'At the time of diagnosis, prior to the initiation of lung cancer treatment', 'description': 'Biochemical analysis of serum sample was conducted by an investigator who was strictly blinded to cancer status and patient characteristics.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Lung Cancer', 'Biomarkers', 'Fatty Acids']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the performance of serum free fatty acids as biomarkers for the identification of lung cancer.', 'detailedDescription': 'We will compare the concentration of free fatty acids and their metabolites between patients with lung cancer and control pulmonary patients without known cancer. The diagnostic accuracy will be assessed for potential predictors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patient samples are retrieved from the Cleveland Clinic Biobank.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age from 40 to 80\n* Lung adenocarcinoma with pathological diagnosis\n* Lung squamous cell carcinoma with pathological diagnosis\n* Control patients should have at least one of the following criteria: (1) current or ex-smoker with at least a 10 pack-year history, (2) a first-degree relative with a history of lung cancer, or (3) a clinical diagnosis of COPD.\n\nExclusion Criteria:\n\n\\- Lung cancer patient without serum sample before the initiation of treatment'}, 'identificationModule': {'nctId': 'NCT01692951', 'briefTitle': 'Serum Free Fatty Acid Metabolite Biomarkers of Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'Serum Free Fatty Acid Metabolite Biomarkers of Lung Cancer', 'orgStudyIdInfo': {'id': '12-306'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Lung adenocarcinoma patients', 'description': 'Serum samples were collected from patients with lung cancer at the time of their diagnosis, prior to the initiation of treatment. Diagnosis of lung adenocarcinoma was based on pathologic analysis.', 'interventionNames': ['Other: serum sample']}, {'label': 'Control matched to adenocarcinoma', 'description': 'Control subjects without known cancer and aged from 40 to 75 years should meet at least one of the following criteria: (1) current or ex-smoker with at least a 10 pack-year history, (2) a first-degree relative with a history of lung cancer, or (3) a clinical diagnosis of COPD.', 'interventionNames': ['Other: serum sample']}, {'label': 'Lung squamous cell carcinoma patients', 'description': 'Serum samples were collected from patients with lung cancer at the time of their diagnosis, prior to the initiation of treatment. Diagnosis of lung squamous cell carcinoma was based on pathologic analysis.', 'interventionNames': ['Other: serum sample']}, {'label': 'Control matched to squamous cell', 'description': 'Control subjects without known cancer and aged from 40 to 75 years should meet at least one of the following criteria: (1) current or ex-smoker with at least a 10 pack-year history, (2) a first-degree relative with a history of lung cancer, or (3) a clinical diagnosis of COPD.', 'interventionNames': ['Other: serum sample']}], 'interventions': [{'name': 'serum sample', 'type': 'OTHER', 'description': 'Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank', 'armGroupLabels': ['Control matched to adenocarcinoma', 'Control matched to squamous cell', 'Lung adenocarcinoma patients', 'Lung squamous cell carcinoma patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Daniel Sessler, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'd sessler', 'investigatorAffiliation': 'Outcomes Research Consortium'}}}}