Blood Sample Collection in Subjects Participating in a Lung Cancer Screening Program
NCT ID: NCT03628638
Last Updated: 2021-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1718 participants
OBSERVATIONAL
2017-04-06
2021-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Lung Cancer Screening Patients - No Nodules
Subjects in an low dose CT screening program that present no nodules.
Blood Sample Collection
Subjects participating in the study will have blood sample collected at enrollment. . For any subjects scheduled for a 12 month follow-up, additional blood samples will be collected at 12 months from enrollment.
Lung Cancer Screening Patients - Nodules
Subjects in an low dose CT screening program that present nodules. Additional follow-up data will be collected for up to 12 months and an additional blood sample collected
Blood Sample Collection
Subjects participating in the study will have blood sample collected at enrollment. . For any subjects scheduled for a 12 month follow-up, additional blood samples will be collected at 12 months from enrollment.
Interventions
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Blood Sample Collection
Subjects participating in the study will have blood sample collected at enrollment. . For any subjects scheduled for a 12 month follow-up, additional blood samples will be collected at 12 months from enrollment.
Eligibility Criteria
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Inclusion Criteria
2. Subject meets one of two lung cancer screening criteria below.
2. Subject has had previous LDCT scan(s) for lung cancer screening and the most recent LDCT scan prior to enrollment is negative for pulmonary nodules (Lung-RADS category 1, no nodules).
3. Subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.
Exclusion Criteria
2. Prior history of cancer within the past 5 years except for non-melanoma skin cancer.
3. Prior removal of the lung, excluding percutaneous lung biopsy.
4. Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.
50 Years
ALL
Yes
Sponsors
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Exact Sciences Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Laura Strong
Role: STUDY_DIRECTOR
Exact Sciences
Locations
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Achieve Clinical Research
Birmingham, Alabama, United States
Phoenix Medical Group
Peoria, Arizona, United States
Highlands Oncology Group
Springdale, Arkansas, United States
NewportNativeMD, Inc.
Newport Beach, California, United States
Palmtree Clinical Research, Inc.
Palm Springs, California, United States
International Research Partners, LLC
Doral, Florida, United States
Clinical Trials of Florida, LLC
Miami, Florida, United States
Sarkis Clinical Trials
Ocala, Florida, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
Pasadena Center for Medical Research, Inc.
St. Petersburg, Florida, United States
UnityPoint Health - St. Luke's Hospital
Cedar Rapids, Iowa, United States
Meritus Center for Clinical Research
Hagerstown, Maryland, United States
Lahey Clinic, Inc.
Burlington, Massachusetts, United States
Boone Hospital Center
Columbia, Missouri, United States
Creighton University
Omaha, Nebraska, United States
Pulmonary Ultimate Research Experience, LLC
Toms River, New Jersey, United States
Northwell Health Physicians Pulmonary Medicine
Manhasset, New York, United States
Gotham Cardiovascular Research, PC
New York, New York, United States
Clinical Trials Developers, Inc.
Milford, Ohio, United States
Chest Diseases of Northwestern PA
Erie, Pennsylvania, United States
Allegheny Health Network
Pittsburgh, Pennsylvania, United States
Research Protocol Management Specialists
Pittsburgh, Pennsylvania, United States
Safe Harbor Clinical Research
East Providence, Rhode Island, United States
Anderson Pharmaceutical Research, LLC
Anderson, South Carolina, United States
Charleston Research Institution
Charleston, South Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Clinical Research of Charleston
Mt. Pleasant, South Carolina, United States
South Carolina Pharmaceutical Research
Spartanburg, South Carolina, United States
Union Pharmaceutical Research
Union, South Carolina, United States
Pulmonary Associates of Richmond, Inc.
Richmond, Virginia, United States
ProHealth Care
Waukesha, Wisconsin, United States
Countries
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Other Identifiers
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2016-11
Identifier Type: -
Identifier Source: org_study_id
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