Blood Sample Collection in Subjects With Pulmonary Nodules or CT Suspicion of Lung Cancer or Pathologically Diagnosed Lung Cancer
1 other identifier
observational
3,298
1 country
83
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2016
Longer than P75 for all trials
83 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 11, 2016
CompletedFirst Submitted
Initial submission to the registry
August 9, 2018
CompletedFirst Posted
Study publicly available on registry
August 16, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedFebruary 15, 2021
February 1, 2021
4.7 years
August 9, 2018
February 12, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Biomarker Identification
Screening subjects to find the appropriate methylation sites for the detection of lung cancer
Subjects could be followed for up to 27 months.
Study Arms (3)
Pulmonary Nodules
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
Subject with suspicion of lung cancer will provide a blood sample. Diagnostic information will be collected to confirm the final diagnosis.
Pathologically Confirmed Cancer
Subject has pathologically confirmed lung cancer and is treatment naïve. Subject will be enrolled and provide a blood sample.
Interventions
Subjects participating in the study will have blood drawn at enrollment. Additional blood samples may be collected at 12 months from enrollment.
Eligibility Criteria
Approximately 3,250 subjects will be enrolled in this study. Subjects will be men and women, 35 years of age or older, with a CT confirmed nodule measuring 6-30 mm. Subjects will be enrolled into one of three groups: CT suspicion of lung cancer who are scheduled for biopsy/other diagnostic procedure; pathologically confirmed lung cancer that are treatment naïve; or recent positive CT showing pulmonary nodule(s) without a scheduled biopsy/diagnostic procedure.
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (83)
Achieve Clinical Research
Birmingham, Alabama, 35216, United States
Phoenix Medical Group
Peoria, Arizona, 85381, United States
Newport NativeMD
Newport Beach, California, 92663, United States
Palmtree Clinical Research, Inc
Palm Springs, California, 92262, United States
Palo Alto Veterans Health Care
Palo Alto, California, 94304, United States
Premier Medical Group
Upland, California, 91786, United States
American Research Institute, Inc
Cutler Bay, Florida, 33157, United States
International Research Partners, LLC
Doral, Florida, 33122, United States
Jupiter Medical Center
Jupiter, Florida, 33458, United States
Pulmonary Disease Specialists
Kissimmee, Florida, 34741, United States
Medical Research of Central Florida, LLC
Leesburg, Florida, 34748, United States
Future Clinical Research
Miami, Florida, 33122, United States
University of Miami Miller School of Medicine
Miami, Florida, 33125, United States
Orcinova AMS Research
Miami, Florida, 33130, United States
Sunrise Research Institute, Inc
Miami, Florida, 33130, United States
American Research Medical Group
Miami, Florida, 33144, United States
Health and Life Research Institute, LLC
Miami, Florida, 33155, United States
Care Research Center
Miami, Florida, 33175, United States
Clinical Trials of Florida, LLC
Miami, Florida, 33186, United States
AMPM research Clinic
Miami Gardens, Florida, 33169, United States
Sarasota Memorial Hospital Clinical Research Center
Sarasota, Florida, 34239, United States
Coastal Pulmonary and Critical Care, PLC
St. Petersburg, Florida, 33704, United States
Pasadena Center for Medical Research, Inc
St. Petersburg, Florida, 33707, United States
Florida Pulmonary Research Institute, LLC
Winter Park, Florida, 32789, United States
Pulmonary Care Research Group, PA
Winter Park, Florida, 32789, United States
Piedmont Healthcare, Inc.
Atlanta, Georgia, 30309, United States
Gwinnett Research institute, LLC
Buford, Georgia, 30519, United States
Columbus Regional Research Institute
Columbus, Georgia, 60631, United States
Gwinnett Biomedical Research
Lawrenceville, Georgia, 30046, United States
DC Research Work
Marietta, Georgia, 30060, United States
Southeast Lung Associates Research
Rincon, Georgia, 31326, United States
Saltzer Medical Group
Nampa, Idaho, 83686, United States
PMG Research of Christie Clinic
Champaign, Illinois, 61820, United States
Medical and Procedural Specialists of Illinois, LLC
Chicago, Illinois, 60631, United States
Loyola University Chicago
Maywood, Illinois, 60153, United States
Community Hospital of Anderson and Madison County, Inc.
Anderson, Indiana, 46011, United States
Heartland Research Associates, LLC-An AMR Company
Augusta, Kansas, 67010, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287, United States
Meritus Center for Clinical Research
Hagerstown, Maryland, 21742, United States
MedStar Shah Medical Group
Hollywood, Maryland, 20636, United States
Lahey Clinic, Inc
Burlington, Massachusetts, 01805, United States
Newton-Wellesley Hospital
Newton, Massachusetts, 02462, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
Somnos Laboratories
Lincoln, Nebraska, 68510, United States
Creighton University
Omaha, Nebraska, 68178, United States
Virtua Health, Inc
Marlton, New Jersey, 08053, United States
Pulmonary Ultimate Research Experience, LLC (PURE, LLC)
Toms River, New Jersey, 08755, United States
Albany Medical College MC-91
Albany, New York, 12208, United States
Jamaica Hospital Medical Center
Jamaica, New York, 11418, United States
Northwell Health
New Hyde Park, New York, 11040, United States
American Health Research, LLC
Charlotte, North Carolina, 28277, United States
Clinical Research of Gastonia
Gastonia, North Carolina, 28054, United States
Gastonia Pharmaceutical Research
Gastonia, North Carolina, 28054, United States
Pulmonix, LLC
Greensboro, North Carolina, 27403, United States
Hickory Research Center DBA Research Carolina of Hickory
Hickory, North Carolina, 28601, United States
Coastal Carolina Health Care
New Bern, North Carolina, 28562, United States
PMG Research of Rocky Mount, LLC
Rocky Mount, North Carolina, 27804, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28401, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Clinical Trial Developers, Inc.
Milford, Ohio, 45150, United States
OK Clinical Research, LLC
Edmond, Oklahoma, 73034, United States
The Oregon Clinic, PC
Portland, Oregon, 97220, United States
Chest Diseases of Northwestern PA
Erie, Pennsylvania, 16508, United States
Research Protocol Management Specialists
Pittsburgh, Pennsylvania, United States
Safe Harbor Clinical Research
East Providence, Rhode Island, 02914, United States
Anderson Pharmaceutical Research, LLC
Anderson, South Carolina, 29621, United States
Charletson Research Institute
Charleston, South Carolina, 29401, United States
The Medical University of South Carolina
Charleston, South Carolina, 29425, United States
VitaLink Research--Gaffney (Gaffney Pharmaceutical Research, LLC)
Gaffney, South Carolina, 29340, United States
Clinical Research of Charleston
Mt. Pleasant, South Carolina, 29464, United States
Clinical Research of Rock HIll
Rock Hill, South Carolina, 29732, United States
VitaLink Research-Rock Hill
Rock Hill, South Carolina, 29732, United States
South Carolina Pharmaceutical Research, LLC
Spartanburg, South Carolina, 29303, United States
Union Pharmaceutical Research
Union, South Carolina, 29379, United States
Houston Pulmonary Sleep and Allergy Associates
Cypress, Texas, 77429, United States
University of Texas Medical Branch
Galveston, Texas, 77555, United States
Envision Cancer Care, LLC
Laredo, Texas, 78041, United States
Renovatio Clinical Consultants, LLC
The Woodlands, Texas, 77380, United States
Renovatio Clinical
The Woodlands, Texas, 77380, United States
Pulmonary Associates of Richmond
Richmond, Virginia, 23225, United States
Overlake Hospital Medical Center
Bellevue, Washington, 98004, United States
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, 53705, United States
William S. Middleton Memorial Veterans Hospital
Madison, Wisconsin, 53705, United States
Biospecimen
Residual blood samples may be used for further analysis and future research. Samples may be stored for up to 20 years. These blood samples will be de-identified.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Laura Strong
Exact Sciences
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2018
First Posted
August 16, 2018
Study Start
April 11, 2016
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
February 15, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, CSR
- Time Frame
- Data will be available from 2 years and ending 4 years after publication. Data will be shared with researchers who provide a methodologically sound proposal to achieve the aims outlined in the approved proposal.
- Access Criteria
- Proposals for access to data should be directed to clinicaltrials@exactsciences.com. To gain access, data requesors will need to provide a methodologically sound proposal and sign a data access agreement. Researchers are required to obtain necessary IRB/EC approvals or waivers as applicable to conduct research. Data will be available between 2 and 4 years after publication through the Sponsor.
Individual participant data that underlie the results reported in publications of the study will be shared after deidentification. This may include text, tables, figures, and appendices. The study protocol, informed consent form, and clinical study report will also be shared.