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



Status:Recruiting
Conditions:Lung Cancer, Healthy Studies
Therapuetic Areas:Oncology, Other
Healthy:No
Age Range:50 - Any
Updated:2/13/2019
Start Date:April 6, 2017
End Date:December 2021
Contact:Alexandra Massoud
Email:amassoud@exactsciences.com
Phone:608-957-5652

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2016-11: Blood Sample Collection in Subjects Participating in a Lung Cancer Screening Program

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

Subjects will be participating in a lung cancer screening program at enrollment. Subjects
will have a blood sample collected within 60 days of a low-dose CT scan (LDCT). Subjects with
nodules present on the LDCT or subjects with a clean LDCT scheduled for a 12-month follow-up
may have another blood draw at 12 months.

Inclusion Criteria:

1. Subject is male or female, 50 years of age or older.

2. Subject meets one of two lung cancer screening criteria below.

1. 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

2. 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).

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.

Exclusion Criteria:

1. 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).

2. Prior history of cancer within the past 5 years except for non-melanoma skin cancer.

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

4. 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.
We found this trial at
31
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180 Wingo Way
Mount Pleasant, South Carolina 29464
Phone: 843-971-9789
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2017 Canyon Road, Suite 41
Birmingham, Alabama 35216
(205) 757-8208
Phone: 205-757-8212
Site Overview Achieve has two clinical research sites in Birmingham, AL. Our Birmingham sites are conveniently located...
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Anderson, South Carolina 29621
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41 Mall Road
Burlington, Massachusetts 1805
781-744-5100
Phone: 781-744-3714
Lahey Clinic When Frank Lahey, MD, founded a group practice in 1923, his vision was...
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Cedar Rapids, Iowa 52402
Phone: 319-369-7775
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Phone: 843-792-8233
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charleston, South Carolina 29401
Phone: 843-792-9873
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Columbia, Missouri 65201
Phone: 573-815-5132
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Doral, Florida 33166
Phone: 305-468-9455
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East Providence, Rhode Island 02914
Phone: 401-431-6611
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3580 Peach Street
Erie, Pennsylvania 16508
Phone: 814-838-8724
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Fayetteville, Arkansas 72703
Phone: 479-695-4207
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Hagerstown, Maryland 21740
Phone: 301-665-4682
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Manhasset, New York 11030
Principal Investigator: Jason Karp
Phone: 516-562-2082
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Miami, Florida 33186
Phone: 305-255-7452
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Milford, Ohio 45150
Phone: 330-705-7545
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New York, New York 10001
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1501 Superior Avenue
Newport Beach, California 92663
Phone: 949-791-8599
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611 Northwest 60 Street
Ocala, Florida 34474
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2500 California Plaza
Omaha, Nebraska 68102
(402) 280-2700
Creighton University Creighton University, located in Omaha, Neb., offers a top-ranked education in the Jesuit...
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Palm Springs, California 92262
Phone: 760-296-0020
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Peoria, Arizona 85381
Phone: 623-583-6549
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PIttsburgh, Pennsylvania 15212
Phone: 412-389-3059
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Pittsburgh, Pennsylvania 15243
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Richmond, Virginia 23225
Phone: 804-288-5945
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1615 Pasadena Avenue South
Saint Petersburg, Florida 33707
Phone: 727-347-5242
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1700 S Tamiami Trail
Sarasota, Florida 34239
(941) 917-9000
Phone: 941-917-3614
Sarasota Memorial Hospital Sarasota Memorial Health Care System, an 806-bed regional medical center, is among...
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Spartanburg, South Carolina 29303
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Toms River, New Jersey 08755
Phone: 917-446-1139
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1005 Thompson Boulevard
Union, South Carolina 29379
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Waukesha, Wisconsin 53188
Phone: 262-928-5539
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