Blood Sample Collection in Subjects Participating in a Lung Cancer Screening Program
- Conditions
- Healthy
- Interventions
- Other: Blood Sample Collection
- Registration Number
- NCT03628638
- Lead Sponsor
- Exact Sciences Corporation
- Brief Summary
The primary objective of this study is to establish a control population to assess performance of an investigational diagnostic test targeting lung neoplasms.
- Detailed Description
Subjects will be participating in a lung cancer screening program at enrollment. Subjects will have a blood sample collected within 60 days of a low-dose CT scan (LDCT). Subjects with nodules present on the LDCT or subjects with a clean LDCT scheduled for a 12-month follow-up may have another blood draw at 12 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1718
-
Subject is male or female, 50 years of age or older.
-
Subject meets one of two lung cancer screening criteria below.
- Subject is a candidate for LDCT lung cancer screening and is scheduled for a baseline LDCT scan. There may be circumstances when a patient cannot have an LDCT scan (e.g., due to insurance issues). In these cases, it is allowable for a patient to have a CT scan in order to meet the inclusion criteria. OR
- 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).
-
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.
- Subjects with pulmonary nodules on the most recent LDCT scan prior to enrollment (Lung-RADS category 1 nodules with specific calcifications such as complete, central, popcorn, concentric rings and fat containing nodules are excluded).
- Prior history of cancer within the past 5 years except for non-melanoma skin cancer.
- Prior removal of the lung, excluding percutaneous lung biopsy.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Lung Cancer Screening Patients - No Nodules Blood Sample Collection Subjects in an low dose CT screening program that present no nodules. Lung Cancer Screening Patients - Nodules Blood Sample Collection 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
- Primary Outcome Measures
Name Time Method Biomarker Identification 27 months Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in blood to detect lung cancer
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (31)
International Research Partners, LLC
🇺🇸Doral, Florida, United States
ProHealth Care
🇺🇸Waukesha, Wisconsin, United States
Achieve Clinical Research
🇺🇸Birmingham, Alabama, United States
Highlands Oncology Group
🇺🇸Springdale, Arkansas, United States
Sarasota Memorial Hospital
🇺🇸Sarasota, Florida, United States
Phoenix Medical Group
🇺🇸Peoria, Arizona, United States
Lahey Clinic, Inc.
🇺🇸Burlington, Massachusetts, United States
Boone Hospital Center
🇺🇸Columbia, Missouri, United States
Creighton University
🇺🇸Omaha, Nebraska, United States
Clinical Trials of Florida, LLC
🇺🇸Miami, Florida, United States
Pulmonary Associates of Richmond, Inc.
🇺🇸Richmond, Virginia, United States
UnityPoint Health - St. Luke's Hospital
🇺🇸Cedar Rapids, Iowa, United States
NewportNativeMD, Inc.
🇺🇸Newport Beach, California, United States
Palmtree Clinical Research, Inc.
🇺🇸Palm Springs, California, United States
Pulmonary Ultimate Research Experience, LLC
🇺🇸Toms River, New Jersey, United States
Safe Harbor Clinical Research
🇺🇸East Providence, Rhode Island, United States
Pasadena Center for Medical Research, Inc.
🇺🇸Saint Petersburg, Florida, United States
Sarkis Clinical Trials
🇺🇸Ocala, Florida, United States
Clinical Research of Charleston
🇺🇸Mount Pleasant, South Carolina, United States
Meritus Center for Clinical Research
🇺🇸Hagerstown, Maryland, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Research Protocol Management Specialists
🇺🇸Pittsburgh, Pennsylvania, United States
Northwell Health Physicians Pulmonary Medicine
🇺🇸Manhasset, New York, United States
Anderson Pharmaceutical Research, LLC
🇺🇸Anderson, South Carolina, United States
Gotham Cardiovascular Research, PC
🇺🇸New York, New York, United States
Chest Diseases of Northwestern PA
🇺🇸Erie, Pennsylvania, United States
Allegheny Health Network
🇺🇸Pittsburgh, Pennsylvania, United States
Charleston Research Institution
🇺🇸Charleston, South Carolina, United States
Union Pharmaceutical Research
🇺🇸Union, South Carolina, United States
South Carolina Pharmaceutical Research
🇺🇸Spartanburg, South Carolina, United States
Clinical Trials Developers, Inc.
🇺🇸Milford, Ohio, United States