Blood Sample Collection in Subjects With Pulmonary Nodules or CT Suspicion of Lung Cancer or Pathologically Diagnosed Lung Cancer
- Conditions
- Lung Cancer (Diagnosis)
- Interventions
- Other: Blood Sample Collection
- Registration Number
- NCT03633006
- Lead Sponsor
- Exact Sciences Corporation
- Brief Summary
The primary objective of this study is to obtain de-identified, clinically characterized, whole blood specimens for use in assessing new biomarkers for the detection of neoplasms of the lung. Subjects will be men and women, 35 years of age and older, with a CT confirmed nodule measuring 6-30 mm.
- Detailed Description
Subjects with pulmonary nodules, a suspicion of lung cancer or pathologically confirmed, untreated lung cancer will be enrolled. Blood samples will be collected at enrollment and may be collected at 12 months for subjects with pulmonary nodules. Radiological and pathological data will be collected to confirm a cancer diagnosis or up to 2 years to assess nodule resolution.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3298
-
All Subjects:
-
Subject is male or female, 35 years of age or older.
-
Subject has at least one CT confirmed 6-30 mm nodule.
-
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.
Suspicion of Cancer Subjects:
-
Subject has CT suspicion of lung cancer and is scheduled for biopsy or other diagnostic procedure.
-
Pathologically Confirmed Cancer Subjects:
- Subject has pathologically confirmed lung cancer and is treatment naïve.
Pulmonary Nodule Subjects:
- Subject has a recent (within 90 days of enrollment) CT radiological diagnosis of pulmonary nodule(s) without a scheduled biopsy/diagnostic procedure (other than CT or PET/CT).
-
All Subjects
-
CT with IV contrast within 1 day [or 24 hours] of blood collection.
-
Prior history of cancer within the past 5 years except for non-melanoma skin cancer. For subjects with suspicion of lung cancer who may have a concurrent work-up for another primary cancer, the non-lung cancer primary must be ruled out prior to enrollment.
-
Prior removal of the lung, excluding percutaneous lung biopsy.
-
Treatment (e.g., surgical resection, radiofrequency ablation) for pulmonary nodules prior to blood sample collection for this trial.
-
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.
Pathologically Confirmed Cancer Subjects:
-
Biopsy within 7 days prior to blood collection.
-
Unresolved bleeding as a result of biopsy at the time of enrollment.
-
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Pathologically Confirmed Cancer Blood Sample Collection Subject has pathologically confirmed lung cancer and is treatment naïve. Subject will be enrolled and provide a blood sample. Pulmonary Nodules Blood Sample Collection Subject with pulmonary nodules will be enrolled, provide a blood sample and may be followed up to 2 years for nodule resolution. A second blood draw will be collected at 12 months. CT Suspicion of Cancer Blood Sample Collection Subject with suspicion of lung cancer will provide a blood sample. Diagnostic information will be collected to confirm the final diagnosis.
- Primary Outcome Measures
Name Time Method Biomarker Identification Subjects could be followed for up to 27 months. Screening subjects to find the appropriate methylation sites for the detection of lung cancer
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (83)
Sarasota Memorial Hospital Clinical Research Center
🇺🇸Sarasota, Florida, United States
Florida Pulmonary Research Institute, LLC
🇺🇸Winter Park, Florida, United States
Piedmont Healthcare, Inc.
🇺🇸Atlanta, Georgia, United States
Medical and Procedural Specialists of Illinois, LLC
🇺🇸Chicago, Illinois, United States
Loyola University Chicago
🇺🇸Maywood, Illinois, United States
Meritus Center for Clinical Research
🇺🇸Hagerstown, Maryland, United States
Lahey Clinic, Inc
🇺🇸Burlington, Massachusetts, United States
Somnos Laboratories
🇺🇸Lincoln, Nebraska, United States
Albany Medical College MC-91
🇺🇸Albany, New York, United States
Pulmonix, LLC
🇺🇸Greensboro, North Carolina, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Research Protocol Management Specialists
🇺🇸Pittsburgh, Pennsylvania, United States
Anderson Pharmaceutical Research, LLC
🇺🇸Anderson, South Carolina, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
Renovatio Clinical
🇺🇸The Woodlands, Texas, United States
Future Clinical Research
🇺🇸Miami, Florida, United States
University of Miami Miller School of Medicine
🇺🇸Miami, Florida, United States
Orcinova AMS Research
🇺🇸Miami, Florida, United States
Sunrise Research Institute, Inc
🇺🇸Miami, Florida, United States
American Research Medical Group
🇺🇸Miami, Florida, United States
Health and Life Research Institute, LLC
🇺🇸Miami, Florida, United States
Care Research Center
🇺🇸Miami, Florida, United States
Clinical Trials of Florida, LLC
🇺🇸Miami, Florida, United States
International Research Partners, LLC
🇺🇸Doral, Florida, United States
Pulmonary Disease Specialists
🇺🇸Kissimmee, Florida, United States
Heartland Research Associates, LLC-An AMR Company
🇺🇸Augusta, Kansas, United States
Premier Medical Group
🇺🇸Upland, California, United States
Jupiter Medical Center
🇺🇸Jupiter, Florida, United States
Pulmonary Ultimate Research Experience, LLC (PURE, LLC)
🇺🇸Toms River, New Jersey, United States
Hickory Research Center DBA Research Carolina of Hickory
🇺🇸Hickory, North Carolina, United States
Medical Research of Central Florida, LLC
🇺🇸Leesburg, Florida, United States
AMPM research Clinic
🇺🇸Miami Gardens, Florida, United States
Safe Harbor Clinical Research
🇺🇸East Providence, Rhode Island, United States
Newport NativeMD
🇺🇸Newport Beach, California, United States
Northwell Health
🇺🇸New Hyde Park, New York, United States
Charletson Research Institute
🇺🇸Charleston, South Carolina, United States
Southeast Lung Associates Research
🇺🇸Rincon, Georgia, United States
Phoenix Medical Group
🇺🇸Peoria, Arizona, United States
Palo Alto Veterans Health Care
🇺🇸Palo Alto, California, United States
American Research Institute, Inc
🇺🇸Cutler Bay, Florida, United States
Pasadena Center for Medical Research, Inc
🇺🇸Saint Petersburg, Florida, United States
Palmtree Clinical Research, Inc
🇺🇸Palm Springs, California, United States
Coastal Pulmonary and Critical Care, PLC
🇺🇸Saint Petersburg, Florida, United States
MedStar Shah Medical Group
🇺🇸Hollywood, Maryland, United States
Saltzer Medical Group
🇺🇸Nampa, Idaho, United States
Johns Hopkins University School of Medicine
🇺🇸Baltimore, Maryland, United States
Virtua Health, Inc
🇺🇸Marlton, New Jersey, United States
Gastonia Pharmaceutical Research
🇺🇸Gastonia, North Carolina, United States
PMG Research of Rocky Mount, LLC
🇺🇸Rocky Mount, North Carolina, United States
DC Research Work
🇺🇸Marietta, Georgia, United States
Columbus Regional Research Institute
🇺🇸Columbus, Georgia, United States
PMG Research of Christie Clinic
🇺🇸Champaign, Illinois, United States
Baystate Medical Center
🇺🇸Springfield, Massachusetts, United States
American Health Research, LLC
🇺🇸Charlotte, North Carolina, United States
Clinical Research of Gastonia
🇺🇸Gastonia, North Carolina, United States
The Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Gwinnett Biomedical Research
🇺🇸Lawrenceville, Georgia, United States
Pulmonary Care Research Group, PA
🇺🇸Winter Park, Florida, United States
Community Hospital of Anderson and Madison County, Inc.
🇺🇸Anderson, Indiana, United States
Newton-Wellesley Hospital
🇺🇸Newton, Massachusetts, United States
PMG Research of Wilmington, LLC
🇺🇸Wilmington, North Carolina, United States
OK Clinical Research, LLC
🇺🇸Edmond, Oklahoma, United States
Clinical Research of Charleston
🇺🇸Mount Pleasant, South Carolina, United States
Gwinnett Research institute, LLC
🇺🇸Buford, Georgia, United States
Jamaica Hospital Medical Center
🇺🇸Jamaica, New York, United States
Coastal Carolina Health Care
🇺🇸New Bern, North Carolina, United States
VitaLink Research--Gaffney (Gaffney Pharmaceutical Research, LLC)
🇺🇸Gaffney, South Carolina, United States
VitaLink Research-Rock Hill
🇺🇸Rock Hill, South Carolina, United States
Renovatio Clinical Consultants, LLC
🇺🇸The Woodlands, Texas, United States
Clinical Trial Developers, Inc.
🇺🇸Milford, Ohio, United States
Chest Diseases of Northwestern PA
🇺🇸Erie, Pennsylvania, United States
William S. Middleton Memorial Veterans Hospital
🇺🇸Madison, Wisconsin, United States
South Carolina Pharmaceutical Research, LLC
🇺🇸Spartanburg, South Carolina, United States
Union Pharmaceutical Research
🇺🇸Union, South Carolina, United States
Pulmonary Associates of Richmond
🇺🇸Richmond, Virginia, United States
Overlake Hospital Medical Center
🇺🇸Bellevue, Washington, United States
Clinical Research of Rock HIll
🇺🇸Rock Hill, South Carolina, United States
Houston Pulmonary Sleep and Allergy Associates
🇺🇸Cypress, Texas, United States
Envision Cancer Care, LLC
🇺🇸Laredo, Texas, United States
University of Wisconsin School of Medicine and Public Health
🇺🇸Madison, Wisconsin, United States
Achieve Clinical Research
🇺🇸Birmingham, Alabama, United States
The Oregon Clinic, PC
🇺🇸Portland, Oregon, United States
Creighton University
🇺🇸Omaha, Nebraska, United States