Blood Sample Collection to Evaluate Biomarkers for Hepatocellular Carcinoma
2017-01: Blood Sample Collection to Evaluate Biomarkers for Hepatocellular Carcinoma
1 other identifier
observational
2,150
7 countries
74
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2018
74 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 2, 2018
CompletedFirst Submitted
Initial submission to the registry
August 9, 2018
CompletedFirst Posted
Study publicly available on registry
August 14, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 11, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 11, 2020
CompletedAugust 6, 2020
August 1, 2020
1.9 years
August 9, 2018
August 4, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Biomarker Identification
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)
1 year
Study Arms (2)
HCC Surveillance
Approximately 1400 HCC surveillance subjects (controls) will be enrolled.
HCC
Approximately 700 subjects with untreated clinically diagnosed HCC will be enrolled.
Interventions
Eligibility Criteria
Subjects 18 years of age and older who have clinically diagnosed HCC or are negative for HCC following disease surveillance will be enrolled. Approximately 2100 subjects will be enrolled into the two groups, HCC subjects and control subjects.
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (74)
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
Facey Medical Foundation
Los Angeles, California, 91345, United States
Office of Dr. John D. Homan MD
Newport Beach, California, 92663-3668, United States
UC Irvine Health
Orange, California, 92868, United States
FOMAT Medical Research
Oxnard, California, 93030, United States
Alliance Clinical Research
Poway, California, 92064, United States
Medical Center of Homestead
Homestead, Florida, 33030, United States
Mayo Clinc
Jacksonville, Florida, 32224, United States
Precision Clinical Research, LLC
Lauderdale Lakes, Florida, 33319, United States
Guardian Angel Research Center, Inc.
Tampa, Florida, 33614, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Chicago
Chicago, Illinois, 60637, United States
Indiana University Medical Center
Indianapolis, Indiana, 46202, United States
University of Iowa
Iowa City, Iowa, 52242, United States
Mercy Medical Research
Baltimore, Maryland, 21202, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Henry Ford Hospital (HFH)
Detroit, Michigan, 48202-2608, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Stony Brook Cancer Center
Stony Brook, New York, 11794, United States
CMC Center for Liver Disease
Charlotte, North Carolina, 28210, United States
OnSite Clinical Solutions
Charlotte, North Carolina, 28226, United States
PMG Research of Winston-Salem, LLC
Winston-Salem, North Carolina, 27103, United States
UH Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Einstein Medical Center
Philadelphia, Pennsylvania, 19141, United States
The Jackson Clinic
Jackson, Tennessee, 38301, United States
Methodist Healthcare University Hospital
Memphis, Tennessee, 38104, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37212, United States
ARC Clinical Research at Wilson Parke
Austin, Texas, 78726, United States
UT Southwestern Medical Center
Dallas, Texas, 75201, United States
ADP Clinical Research
Magnolia, Texas, 77355, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Bon Secours Liver Institute of Hampton Roads
Newport News, Virginia, 23602, United States
Hunter Holmes McGuire Medical
Richmond, Virginia, 23249, United States
South Perry Endoscopy
Spokane, Washington, 99202, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53705, United States
CHU de Besancon Hopital Jean Minjoz
Besançon, 25030, France
CHU Caen
Caen, 14000, France
Hopital Henri Mondor
Créteil, 94010, France
Centre Hospitalier Universitaire de Grenoble
La Tronche, 38700, France
CHRU de LILLE - Hospital HURIEZ
Lille, 59037, France
Chru Brabois
Nancy, 54500, France
CHU Reims, Hopital Robert Debre
Reims, 51092, France
CHU Pontchaillou
Rennes, 35000, France
Helios Klinikum Berlin-Buch
Berlin, 13125, Germany
Universitätsklinikum Bonn
Bonn, 53105, Germany
Gastroenterologische Studienambulanz
Cologne, 50937, Germany
Universitat Leipzig
Leipzig, 04103, Germany
Otto-von-Guericke-Universitaet Magdeburg
Magdeburg, 39120, Germany
Medizinische Klinik und Poliklinik II
München, 81377, Germany
Policlinico Sant' Orsola Malpighi
Bologna, 40138, Italy
AOU Cagliary
Cagliari, 09042, Italy
A.O.U. Policlinico G.Martino
Messina, 98125, Italy
Ospedale San Gerardo
Monza, 20052, Italy
Ospedale Sant'Andrea Hospital
Roma, 00189, Italy
Hgu Alicante
Alicante, 03010, Spain
Hospital de Mar - Parc de Salut Mar
Barcelona, 08003, Spain
Hospital Reina Sofia
Córdoba, 14014, Spain
Universidad Autonoma de Madrid - Hospital Universitario La Paz
Madrid, 28046, Spain
Parc Tauli Hospital Universitari
Sabadell, 08208, Spain
Hospital Universitario Marqués de Valdecilla
Santander, 39008, Spain
Hospital Universitario de Rio Hortega
Valladolid, 47012, Spain
Changhua Christian Hospital
Chang-hua, 50006, Taiwan
Kaohsiung Medical University Hospital
Kaohsiung City, 807, Taiwan
Chang Gung Medical Foundation
Kaohsiung City, 83301, Taiwan
China Medical University Hospital
Taichung, 40447, Taiwan
Liver DIS Center
Taichung, 40705, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
National Cheng Kung University Hospital
Tainan, 70403, Taiwan
Chi Mei Medical Center - Liuying
Tainan, 736, Taiwan
Chang Gung Medical Foundation
Taoyuan District, 33305, Taiwan
Phramongkutklao Hospital
Bangkok, 10400, Thailand
Sririraj Hospital
Bangkok, 10700, Thailand
Chiang Mai University
Chiang Mai, 50200, Thailand
Related Publications (2)
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.
PMID: 34391922DERIVEDChalasani 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.
PMID: 32889146DERIVED
Biospecimen
Blood samples will not be used other than to develop and evaluate the performance of blood-based biomarker assays to detect cancer. Samples may be stored for up to 10 years.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Laura Strong
Exact Sciences
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2018
First Posted
August 14, 2018
Study Start
April 2, 2018
Primary Completion
March 11, 2020
Study Completion
March 11, 2020
Last Updated
August 6, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Data will be available from 2 years and ending 4 years after publication. Data will be shared with researchers who provide a methodologically sound proposal to achieve the aims outlined in the approved proposal.
- Access Criteria
- Proposals for access to data should be directed to clinicaltrials@exactsciences.com. To gain access, data requestors will need to provide a methodologically sound proposal and sign a data access agreement. Researchers are required to obtain necessary IRB/EC approvals or waivers as applicable to conduct research. Data will be available between 2 and 4 years after publication through the Sponsor.
Individual participant data that underlie the results reported in publications of the study will be shared after deidentification. This may include text, tables, figures, and appendices. The study protocol, statistical analysis plan, informed consent form, and clinical study report will also be shared.