Blood Sample Collection to Evaluate Biomarkers for Hepatocellular Carcinoma



Status:Recruiting
Conditions:Liver Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:April 2, 2018
End Date:January 19, 2020
Contact:Alexandra Massoud
Email:amassoud@exactsciences.com
Phone:608-957-5652

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2017-01: Blood Sample Collection to Evaluate Biomarkers for Hepatocellular Carcinoma

The primary objective of this study is to obtain de-identified, clinically-characterized
whole blood specimens for use in developing and evaluating the performance of new biomarker
assays for detection of hepatocellular carcinoma (HCC).

Subjects with untreated Hepatocellular Carcinoma (HCC) and subjects undergoing HCC
surveillance will be enrolled and have blood samples collected. Subjects undergoing HCC
surveillance will be followed for up to 6 months. Another blood sample will be collected at
the 6 month visit which will be scheduled no longer than 6 months from enrollment.

Inclusion Criteria:

- All Subjects:

1. Subject is 18 years of age or older

2. Subject understands the study procedures and is able to provide informed consent
to participate in the study and authorization for release of data, including
personal health data, to the study investigator and sponsor

HCC Subjects:

1. Subject has a recent (within 6 months of enrollment) untreated clinically diagnosed
hepatocellular carcinoma as defined by ≥1 cm lesion exhibiting arterial phase
hyperenhancement in combination with washout appearance and/or capsule by 4 phase CT scan
or multiphase contrast enhanced MRI or biopsy is positive for HCC.

Control Subjects:

1. Non-cancer subject undergoing routine imaging surveillance for HCC

2. Definitive lack of HCC within 3 months prior to enrollment as defined by negative
imaging, for HCC.

1. Control Group 1 - negative by ultrasound

2. Control Group 2 - negative by CT or MRI

Exclusion Criteria:

1. Known cancer diagnosis within the past 5 years (with the exceptions of basal cell or
squamous cell skin cancers).

2. Chemotherapy and/or radiation therapy within 5 years prior to enrollment/sample
collection.

3. Prior or current treatment with sorafenib, regorafenib, or other treatment indicated
for HCC.

4. Any HCC treatment prior to enrollment/blood sample collection (e.g., surgery,
ablation, embolization, pharmacotherapy, radiotherapy, liver transplant or other
treatment indicated for HCC).

5. IV contrast (e.g. CT and MRI) within 1 day [or 24 hours] of blood collection.

6. Less than 3 days between fine needle aspiration (FNA) of target pathology and blood
collection.

7. Less than 7 days between biopsy (other than FNA) of target pathology and blood
collection.

8. 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
35
sites
1901 S Hawthorne Rd #306
Winston-Salem, North Carolina 27103
(336) 768-8062
Principal Investigator: Brian Smith
PMG Research of Winston-Salem PMG Research of Winston-Salem, founded in 1979, occupies a 10,000 square...
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Principal Investigator: Anjana Pillai
Phone: 773-702-2788
University of Chicago One of the world's premier academic and research institutions, the University of...
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Andrew Scanga
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Principal Investigator: Rajender K. Reddy
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Neehar Parikh
Phone: 734-764-7987
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Annapolis, Maryland 21401
Phone: 410-224-4887
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11714 Wilson Parke Avenue
Austin, Texas 78726
Principal Investigator: Anurekha Chadha
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Baltimore, Maryland 21202
Principal Investigator: Paul Thuluvath
Phone: 410-843-2075
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Besançon, 25030
Principal Investigator: Stefano Kim
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Charlotte, North Carolina 28210
Principal Investigator: Andrew deLemos
Phone: 704-355-9636
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Charlotte, North Carolina 28210
Principal Investigator: Avinash Shah
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Charlottesville, Virginia 22903
(434) 924-0311
Principal Investigator: Matthew Reilley
Phone: 434-297-5726
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
Principal Investigator: Amit Singal
Phone: 214-645-9748
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Detroit, Michigan 48202
Principal Investigator: Reena Salgia
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Homestead, Florida 33030
Principal Investigator: Michael Feldman
Phone: 786-339-8454
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545 Barnhill Dr
Indianapolis, Indiana 46201
(317) 274-8157
Principal Investigator: Naga Chalasani
Phone: 917-278-9207
Indiana University Medical Center Indiana University Health is Indiana
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Jackson, Tennessee 38301
Principal Investigator: James Egan
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Jacksonville, Florida 32224
Principal Investigator: Tushar Patel
Phone: 904-953-3464
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4700 North State Road 7
Lauderdale Lakes, Florida 33319
Principal Investigator: Robert Campitelli
Phone: 954-915-9991
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600 Highland Ave
Madison, Wisconsin 53792
(608) 263-6400
Principal Investigator: Adnan Said
Phone: 608-262-5404
University of Wisconsin Hospital and Clinics UW Health strives to meet the health needs of...
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Magnolia, Texas 77355
Principal Investigator: Najamuddin Karimjee
Phone: 832-847-9187
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7691 Poplar Avenue
Memphis, Tennessee 38104
Principal Investigator: Sanjaya Satapathy
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Newport Beach, California 92663
Principal Investigator: John Homan
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Newport News, Virginia 23602
Principal Investigator: Mitchell Shiffman
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Orange, California
Principal Investigator: David Imagawa
Phone: 714-456-7242
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Oxnard, California 93030
Principal Investigator: Karen Simon
Phone: 805-483-1185
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Palo Alto, California 94304
Phone: 650-721-8712
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Philadelphia, Pennsylvania 19141
Principal Investigator: Richard Kalman
Phone: 215-456-7534
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Poway, California 92064
Principal Investigator: Kevin Merkes
Phone: 949-973-7304
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Richmond, Virginia 23249
Principal Investigator: Binu John
Phone: 804-675-6407
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Rochester, Minnesota 55905
Principal Investigator: Lewis Roberts
Phone: 507-538-0097
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Spokane, Washington 99202
Principal Investigator: Harold Preiksaitis
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3 Edmund D. Pellegrino Road
Stony Brook, New York 11794
Principal Investigator: Yue Zhang
Phone: 631-638-0837
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Tampa, Florida 33614
Principal Investigator: Sadaf Bazargan
Phone: 813-512-7479
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