Blood Sample Collection in Subjects With Pulmonary Nodules or CT Suspicion of Lung Cancer or Pathologically Diagnosed Lung Cancer

Completed

Conditions studied: Lung Cancer (Diagnosis)

In brief

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.

Key facts

Study ID

NCT03633006

Run by

Exact Sciences Corporation

People needed

3298

Starts

2016-04-11

Expected to finish

2020-12-31

Last updated by the study team

2021-02-15

Who can join

Age: 35 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Phoenix Medical Group — Peoria, Arizona, United States
• Newport NativeMD — Newport Beach, California, United States
• Palmtree Clinical Research, Inc — Palm Springs, California, United States
• Palo Alto Veterans Health Care — Palo Alto, California, United States
• Premier Medical Group — Upland, California, United States
• American Research Institute, Inc — Cutler Bay, Florida, United States
• International Research Partners, LLC — Doral, Florida, United States
• Jupiter Medical Center — Jupiter, Florida, United States
• Pulmonary Disease Specialists — Kissimmee, Florida, United States
• Medical Research of Central Florida, LLC — Leesburg, Florida, 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
• AMPM research Clinic — Miami Gardens, Florida, United States
• Sarasota Memorial Hospital Clinical Research Center — Sarasota, Florida, United States
• Coastal Pulmonary and Critical Care, PLC — St. Petersburg, Florida, United States
• Pasadena Center for Medical Research, Inc — St. Petersburg, Florida, United States
• Florida Pulmonary Research Institute, LLC — Winter Park, Florida, United States
• Pulmonary Care Research Group, PA — Winter Park, Florida, United States
• Achieve Clinical Research — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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