Blood Sample Collection to Evaluate Biomarkers for Hepatocellular Carcinoma

Completed

Conditions studied: Hepatocellular Carcinoma, Hepatocellular Carcinoma Surveillance

In brief

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).

Key facts

Study ID

NCT03628651

Run by

Exact Sciences Corporation

People needed

2150

Starts

2018-04-02

Expected to finish

2020-03-11

Last updated by the study team

2020-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All Subjects:
• Subject is 18 years of age or older
• 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:
• 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:
• Non-cancer subject undergoing routine imaging surveillance for HCC
• Definitive lack of HCC within 3 months prior to enrollment as defined by negative imaging, for HCC.
• Control Group 1 - negative by ultrasound
• Control Group 2 - negative by CT or MRI

You may not qualify if…

• Known cancer diagnosis within the past 5 years (with the exceptions of basal cell or squamous cell skin cancers).
• Chemotherapy and/or radiation therapy within 5 years prior to enrollment/sample collection.
• Prior or current treatment with sorafenib, regorafenib, or other treatment indicated for HCC.
• Any HCC treatment prior to enrollment/blood sample collection (e.g., surgery, ablation, embolization, pharmacotherapy, radiotherapy, liver transplant or other treatment indicated for HCC).
• IV contrast (e.g. CT and MRI) within 1 day [or 24 hours] of blood collection.
• Less than 3 days between fine needle aspiration (FNA) of target pathology and blood collection.
• Less than 7 days between biopsy (other than FNA) of target pathology and blood collection.
• 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.

Where it is running

• Facey Medical Foundation — Los Angeles, California, United States
• Office of Dr. John D. Homan MD — Newport Beach, California, United States
• UC Irvine Health — Orange, California, United States
• FOMAT Medical Research — Oxnard, California, United States
• Alliance Clinical Research — Poway, California, United States
• Medical Center of Homestead — Homestead, Florida, United States
• Mayo Clinc — Jacksonville, Florida, United States
• Precision Clinical Research, LLC — Lauderdale Lakes, Florida, United States
• Guardian Angel Research Center, Inc. — Tampa, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• Indiana University Medical Center — Indianapolis, Indiana, United States
• University of Iowa — Iowa City, Iowa, United States
• Mercy Medical Research — Baltimore, Maryland, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Henry Ford Hospital (HFH) — Detroit, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Stony Brook Cancer Center — Stony Brook, New York, United States
• CMC Center for Liver Disease — Charlotte, North Carolina, United States
• OnSite Clinical Solutions — Charlotte, North Carolina, United States
• PMG Research of Winston-Salem, LLC — Winston-Salem, North Carolina, United States
• UH Cleveland Medical Center — Cleveland, Ohio, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Einstein Medical Center — Philadelphia, Pennsylvania, United States
• Cedars Sinai Medical Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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