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



Status:Recruiting
Conditions:Lung Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:35 - Any
Updated:3/2/2019
Start Date:April 11, 2016
End Date:August 2021
Contact:Alexandra Massoud
Email:amassoud@exactsciences.com

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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.

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.

Inclusion Criteria:

- All Subjects:

1. Subject is male or female, 35 years of age or older.

2. Subject has at least one CT confirmed 6-30 mm nodule.

3. 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:

4. Subject has CT suspicion of lung cancer and is scheduled for biopsy or other
diagnostic procedure.

Pathologically Confirmed Cancer Subjects:

4. Subject has pathologically confirmed lung cancer and is treatment naïve.

Pulmonary Nodule Subjects:

4. 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).

Exclusion Criteria:

- All Subjects

1. CT with IV contrast within 1 day [or 24 hours] of blood collection.

2. 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.

3. Prior removal of the lung, excluding percutaneous lung biopsy.

4. Treatment (e.g., surgical resection, radiofrequency ablation) for pulmonary
nodules prior to blood sample collection for this trial.

5. 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:

6. Biopsy within 7 days prior to blood collection.

7. Unresolved bleeding as a result of biopsy at the time of enrollment.
We found this trial at
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555 Old Norcross Road
Buford, Georgia 30519
Principal Investigator: Alexander Osowa
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2017 Canyon Road, Suite 41
Birmingham, Alabama 35216
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9500 Euclid Avenue
Cleveland, Ohio 44106
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301 University Blvd
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(409) 772-1011
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Jupiter, Florida 33458
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750 Highland Avenue
Madison, Wisconsin 53792
Principal Investigator: Scott Ferguson, MD
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1601 Northwest 12th Avenue
Miami, Florida 33136
(305) 243-6545
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5807 Needleleaf Drive
Milford, Ohio 45150
513-575-0863
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Albany, New York 12208
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Anderson, Indiana 46011
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Anderson, South Carolina 29621
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Atlanta, Georgia 30309
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733 North Broadway
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Bellevue, Washington 98004
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41 Mall Road
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171 Ashley Avenue
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Charleston, South Carolina 29401
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Charlotte, North Carolina 28207
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21216 Northwest Freeway
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120 North Bryant Avenue
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442 East Long Avenue
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1038 West North Boulevard
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180 Wingo Way
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Nampa, Idaho 83686
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2014 Washington St
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2500 California Plaza
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1615 Pasadena Avenue South
Saint Petersburg, Florida 33707
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759 Chestnut Street
Springfield, Massachusetts 01199
(413) 794 - 0000
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Baystate Medical Center Baystate Medical Center (BMC), in Springfield, Massachusetts, is an academic, research, and...
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The Woodlands, Texas 77380
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The Woodlands, Texas 77380
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Toms River, New Jersey 08755
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1907 Tradd Ct
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Winter Park, Florida 32789
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