Blood Sample Collection in Subjects Participating in a Lung Cancer Screening Program

Completed

Conditions studied: Healthy

In brief

The primary objective of this study is to establish a control population to assess performance of an investigational diagnostic test targeting lung neoplasms.

Key facts

Study ID

NCT03628638

Run by

Exact Sciences Corporation

People needed

1718

Starts

2017-04-06

Expected to finish

2021-01-31

Last updated by the study team

2021-02-15

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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