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
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Principal Investigator: Kevin Merkes
Phone: 949-973-7304
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
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Phone: 773-702-2788
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
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3400 Spruce St
Philadelphia, Pennsylvania 19104
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500 S State St
Ann Arbor, Michigan 48109
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Annapolis, Maryland 21401
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11714 Wilson Parke Avenue
Austin, Texas 78726
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Baltimore, Maryland 21202
Principal Investigator: Paul Thuluvath
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Besançon, 25030
Principal Investigator: Stefano Kim
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(434) 924-0311
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Phone: 434-297-5726
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2201 Inwood Rd
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2799 W Grand Blvd
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(313) 916-2600
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Principal Investigator: Michael Feldman
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545 Barnhill Dr
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(317) 274-8157
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Phone: 917-278-9207
Indiana University Medical Center Indiana University Health is Indiana
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Jacksonville, Florida 32224
Principal Investigator: Tushar Patel
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4700 North State Road 7
Lauderdale Lakes, Florida 33319
Principal Investigator: Robert Campitelli
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600 Highland Ave
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(608) 263-6400
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Phone: 608-262-5404
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Magnolia, Texas 77355
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Newport Beach, California 92663
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Phone: 805-483-1185
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Palo Alto, California 94304
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Principal Investigator: Richard Kalman
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Richmond, Virginia 23249
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1901 S Hawthorne Rd #306
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