Ignite Creation Date:
2025-12-24 @ 6:58 PM
Ignite Modification Date:
2025-12-28 @ 6:38 PM
Study NCT ID:
NCT01700257
Status:
COMPLETED
Last Update Posted:
2020-12-31
First Post:
2012-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lung Cancer Screening Study With Low-dose CT Scan and Blood Biomarker
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1361}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-12-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-29', 'studyFirstSubmitDate': '2012-10-02', 'studyFirstSubmitQcDate': '2012-10-02', 'lastUpdatePostDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-10-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Health Economics', 'timeFrame': 'One Year', 'description': 'Comparison of the health economic costs of Early CDT-Lung test and CT scan when each is used individually or in combination.'}], 'primaryOutcomes': [{'measure': 'CT alone vs. both Early CDT-Lung test and CT scan.', 'timeFrame': 'One year', 'description': 'Assess the number of lung cancers detected with CT alone vs. with both Early CDT-Lung test and CT scan. Compare positive CT results with positive/negative Early CDT Lung test results and assess ability of the combination to detect earlier stage lung cancer.'}], 'secondaryOutcomes': [{'measure': 'Value of Early CDT-lung test in detecting cancer', 'timeFrame': 'One year', 'description': 'Assess the value of Early CDT-lung test in detecting lung cancer in individuals who are CT scan negative but positive for Early CDT-lung.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Lung cancer screening', 'Smokers or former smokers', 'Family history of lung cancer'], 'conditions': ['High Risk of Developing Lung Cancer']}, 'descriptionModule': {'briefSummary': 'Lung cancer is the number one cancer killer in the USA. Early stage lung cancer is asymptomatic. Most patients with lung cancer are usually symptomatic at diagnosis and already have advanced stage disease. Low dose CT screening (LDCT) for high risk individuals has recently been shown to decrease lung cancer mortality by 20%. However, 4 out of 5 lung cancer deaths are not prevented with LDCT screening alone.', 'detailedDescription': 'In this trial, the addition of a blood biomarker test is being combined with early LDCT to determine if screening with combination may result in detection of more lung cancer at an earlier stage of disease.The study will also assess if the blood test is able to detect lung cancers in high risk individuals when the LDCT is negative for cancer. There will be health-economic costs included in the final analysis of study data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Smokers or former smokers\n* At least 20 pack year history of smoking\n* Ages 50 - 75\n\nExclusion Criteria:\n\n* Had a CT scan of chest within last 24 months\n* History of any cancer within 10 yrs (except skin cancer or cervical cancer)\n* A serious illness that decreases life expectancy to less than 5 years\n* Any current use of Oxygen\n* Uncontrolled congestive heart failure or cardiac arrhythmia that would prevent surgery for a lung lesion\n* Severe COPD or dyspnea that would prevent lung surgery or stereotactic body radiotherapy'}, 'identificationModule': {'nctId': 'NCT01700257', 'briefTitle': 'Lung Cancer Screening Study With Low-dose CT Scan and Blood Biomarker', 'organization': {'class': 'OTHER', 'fullName': 'National Jewish Health'}, 'officialTitle': 'Different Strategies Using Autoantibodies and/or CT Scan Detection of Lung Cancer', 'orgStudyIdInfo': {'id': 'Oncimmune-2550'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'CT scan & Early CDT Lung test', 'description': 'Every study participant receives a CT scan \\& Early CDT-Lung test (biomarker blood test) for lung cancer screening purposes.', 'interventionNames': ['Radiation: CT scan & Early CDT Lung test', 'Other: CT scan & Early CDT Lung test']}], 'interventions': [{'name': 'CT scan & Early CDT Lung test', 'type': 'RADIATION', 'otherNames': ['Every study participant receives a CT scan & Early CDT-Lung test (biomarker blood test)', 'for lung cancer screening purposes'], 'armGroupLabels': ['CT scan & Early CDT Lung test']}, {'name': 'CT scan & Early CDT Lung test', 'type': 'OTHER', 'otherNames': ['CT scan & Early CDT-Lung test (biomarker blood test)for lung cancer screening.'], 'armGroupLabels': ['CT scan & Early CDT Lung test']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80206', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'National Jewish Health', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}], 'overallOfficials': [{'name': 'James R Jett, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Jewish Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Jewish Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}