Blood Sample Collection to Evaluate Biomarkers for Hepatocellular Carcinoma
- Conditions
- Hepatocellular CarcinomaHepatocellular Carcinoma Surveillance
- Interventions
- Other: Blood Sample Collection
- Registration Number
- NCT03628651
- Lead Sponsor
- Exact Sciences Corporation
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2150
-
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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description HCC Surveillance Blood Sample Collection Approximately 1400 HCC surveillance subjects (controls) will be enrolled. HCC Blood Sample Collection Approximately 700 subjects with untreated clinically diagnosed HCC will be enrolled.
- Primary Outcome Measures
Name Time Method Biomarker Identification 1 year Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in blood from subjects with HCC compared to those without (but are at risk of developing the disease so are under surveillance)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (73)
Einstein Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Office of Dr. John D. Homan MD
🇺🇸Newport Beach, California, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Mercy Medical Research
🇺🇸Baltimore, Maryland, 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
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Henry Ford Hospital (HFH)
🇺🇸Detroit, Michigan, United States
Helios Klinikum Berlin-Buch
🇩🇪Berlin, Germany
Centre Hospitalier Universitaire de Grenoble
🇫🇷La Tronche, France
CHRU de LILLE - Hospital HURIEZ
🇫🇷Lille, France
CHU Pontchaillou
🇫🇷Rennes, France
Gastroenterologische Studienambulanz
🇩🇪Koln, Germany
Universitätsklinikum Bonn
🇩🇪Bonn, Germany
Ospedale San Gerardo
🇮🇹Monza, Italy
Universidad Autonoma de Madrid - Hospital Universitario La Paz
🇪🇸Madrid, Spain
Parc Tauli Hospital Universitari
🇪🇸Sabadell, Spain
Kaohsiung Medical University Hospital
🇨🇳Kaohsiung, Taiwan
Chi Mei Medical Center - Liuying
🇨🇳Tainan, Taiwan
Sririraj Hospital
🇹🇭Bangkok, Thailand
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Guardian Angel Research Center, Inc.
🇺🇸Tampa, Florida, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
PMG Research of Winston-Salem, LLC
🇺🇸Winston-Salem, North Carolina, United States
Chru Brabois
🇫🇷Nancy, France
CHU Reims, Hopital Robert Debre
🇫🇷Reims, France
Cedars Sinai Medical Center
🇺🇸Los Angeles, California, United States
Universitat Leipzig
🇩🇪Leipzig, Germany
Otto-von-Guericke-Universitaet Magdeburg
🇩🇪Magdeburg, Germany
Liver DIS Center
🇨🇳Taichung, Taiwan
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
FOMAT Medical Research
🇺🇸Oxnard, California, United States
Mayo Clinc
🇺🇸Jacksonville, Florida, United States
CHU Caen
🇫🇷Caen, France
UH Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
UC Irvine Health
🇺🇸Orange, California, United States
Medical Center of Homestead
🇺🇸Homestead, Florida, United States
Precision Clinical Research, LLC
🇺🇸Lauderdale Lakes, Florida, United States
OnSite Clinical Solutions
🇺🇸Charlotte, North Carolina, United States
Methodist Healthcare University Hospital
🇺🇸Memphis, Tennessee, United States
CHU de Besancon Hopital Jean Minjoz
🇫🇷Besançon, France
Medizinische Klinik und Poliklinik II
🇩🇪München, Germany
A.O.U. Policlinico G.Martino
🇮🇹Messina, Italy
Hgu Alicante
🇪🇸Alicante, Spain
Hospital Universitario de Rio Hortega
🇪🇸Valladolid, Spain
Changhua Christian Hospital
🇨🇳Chang Hua, Taiwan
University of Iowa
🇺🇸Iowa City, Iowa, United States
Bon Secours Liver Institute of Hampton Roads
🇺🇸Newport News, Virginia, United States
Hospital de Mar - Parc de Salut Mar
🇪🇸Barcelona, Spain
Facey Medical Foundation
🇺🇸Los Angeles, California, United States
Policlinico Sant' Orsola Malpighi
🇮🇹Bologna, Italy
AOU Cagliary
🇮🇹Cagliari, Italy
Hospital Reina Sofia
🇪🇸Córdoba, Spain
Hospital Universitario Marqués de Valdecilla
🇪🇸Santander, Spain
Chang Gung Medical Foundation
🇨🇳Taoyuan, Taiwan
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
Chiang Mai University
🇹🇭Chiang Mai, Thailand
Stony Brook Cancer Center
🇺🇸Stony Brook, New York, United States
Alliance Clinical Research
🇺🇸Poway, California, United States
CMC Center for Liver Disease
🇺🇸Charlotte, North Carolina, United States
The Jackson Clinic
🇺🇸Jackson, Tennessee, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Hopital Henri Mondor
🇫🇷Créteil, France
China Medical University Hospital
🇨🇳Taichung, Taiwan
Phramongkutklao Hospital
🇹🇭Bangkok, Thailand
South Perry Endoscopy
🇺🇸Spokane, Washington, United States
University of Wisconsin Hospital and Clinics
🇺🇸Madison, Wisconsin, United States
Ospedale Sant'Andrea Hospital
🇮🇹Roma, Italy
ARC Clinical Research at Wilson Parke
🇺🇸Austin, Texas, United States
ADP Clinical Research
🇺🇸Magnolia, Texas, United States
Hunter Holmes McGuire Medical
🇺🇸Richmond, Virginia, United States