Blood Sample Collection to Evaluate Biomarkers for Hepatocellular Carcinoma
NCT ID: NCT03628651
Last Updated: 2020-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2150 participants
OBSERVATIONAL
2018-04-02
2020-03-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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HCC Surveillance
Approximately 1400 HCC surveillance subjects (controls) will be enrolled.
Blood Sample Collection
Surveillance subjects will have a blood sample collected and will be followed for up to 6 months. A second blood sample will be collected at the 6 month visit which will be scheduled no longer than 6 months from enrollment.
HCC
Approximately 700 subjects with untreated clinically diagnosed HCC will be enrolled.
Blood Sample Collection
HCC subjects will have one blood sample collected.
Interventions
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Blood Sample Collection
HCC subjects will have one blood sample collected.
Blood Sample Collection
Surveillance subjects will have a blood sample collected and will be followed for up to 6 months. A second blood sample will be collected at the 6 month visit which will be scheduled no longer than 6 months from enrollment.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Exact Sciences Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Laura Strong
Role: STUDY_DIRECTOR
Exact Sciences
Locations
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Cedars Sinai Medical Center
Los Angeles, California, United States
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
The Jackson Clinic
Jackson, Tennessee, United States
Methodist Healthcare University Hospital
Memphis, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
ARC Clinical Research at Wilson Parke
Austin, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
ADP Clinical Research
Magnolia, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Bon Secours Liver Institute of Hampton Roads
Newport News, Virginia, United States
Hunter Holmes McGuire Medical
Richmond, Virginia, United States
South Perry Endoscopy
Spokane, Washington, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
CHU de Besancon Hopital Jean Minjoz
Besançon, , France
CHU Caen
Caen, , France
Hopital Henri Mondor
Créteil, , France
Centre Hospitalier Universitaire de Grenoble
La Tronche, , France
CHRU de LILLE - Hospital HURIEZ
Lille, , France
Chru Brabois
Nancy, , France
CHU Reims, Hopital Robert Debre
Reims, , France
CHU Pontchaillou
Rennes, , France
Helios Klinikum Berlin-Buch
Berlin, , Germany
Universitätsklinikum Bonn
Bonn, , Germany
Gastroenterologische Studienambulanz
Cologne, , Germany
Universitat Leipzig
Leipzig, , Germany
Otto-von-Guericke-Universitaet Magdeburg
Magdeburg, , Germany
Medizinische Klinik und Poliklinik II
München, , Germany
Policlinico Sant' Orsola Malpighi
Bologna, , Italy
AOU Cagliary
Cagliari, , Italy
A.O.U. Policlinico G.Martino
Messina, , Italy
Ospedale San Gerardo
Monza, , Italy
Ospedale Sant'Andrea Hospital
Roma, , Italy
Hgu Alicante
Alicante, , Spain
Hospital de Mar - Parc de Salut Mar
Barcelona, , Spain
Hospital Reina Sofia
Córdoba, , Spain
Universidad Autonoma de Madrid - Hospital Universitario La Paz
Madrid, , Spain
Parc Tauli Hospital Universitari
Sabadell, , Spain
Hospital Universitario Marqués de Valdecilla
Santander, , Spain
Hospital Universitario de Rio Hortega
Valladolid, , Spain
Changhua Christian Hospital
Chang-hua, , Taiwan
Kaohsiung Medical University Hospital
Kaohsiung City, , Taiwan
Chang Gung Medical Foundation
Kaohsiung City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Liver DIS Center
Taichung, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
Chi Mei Medical Center - Liuying
Tainan City, , Taiwan
Chang Gung Medical Foundation
Taoyuan District, , Taiwan
Phramongkutklao Hospital
Bangkok, , Thailand
Sririraj Hospital
Bangkok, , Thailand
Chiang Mai University
Chiang Mai, , Thailand
Countries
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References
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Chalasani NP, Porter K, Bhattacharya A, Book AJ, Neis BM, Xiong KM, Ramasubramanian TS, Edwards DK 5th, Chen I, Johnson S, Roberts LR, Kisiel JB, Reddy KR, Singal AG, Olson MC, Bruinsma JJ. Validation of a Novel Multitarget Blood Test Shows High Sensitivity to Detect Early Stage Hepatocellular Carcinoma. Clin Gastroenterol Hepatol. 2022 Jan;20(1):173-182.e7. doi: 10.1016/j.cgh.2021.08.010. Epub 2021 Aug 13.
Chalasani NP, Ramasubramanian TS, Bhattacharya A, Olson MC, Edwards V DK, Roberts LR, Kisiel JB, Reddy KR, Lidgard GP, Johnson SC, Bruinsma JJ. A Novel Blood-Based Panel of Methylated DNA and Protein Markers for Detection of Early-Stage Hepatocellular Carcinoma. Clin Gastroenterol Hepatol. 2021 Dec;19(12):2597-2605.e4. doi: 10.1016/j.cgh.2020.08.065. Epub 2020 Sep 2.
Other Identifiers
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2017-01
Identifier Type: -
Identifier Source: org_study_id
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