Blood Sample Collection to Evaluate Biomarkers for Hepatocellular Carcinoma

August 4, 2020 updated by: Exact Sciences Corporation

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

2150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besançon, France, 25030
        • CHU de Besancon Hopital Jean Minjoz
      • Caen, France, 14000
        • CHU Caen
      • Créteil, France, 94010
        • Hôpital Henri Mondor
      • La Tronche, France, 38700
        • Centre Hospitalier Universitaire de Grenoble
      • Lille, France, 59037
        • CHRU de LILLE - Hospital HURIEZ
      • Nancy, France, 54500
        • Chru Brabois
      • Reims, France, 51092
        • CHU Reims, Hopital Robert Debre
      • Rennes, France, 35000
        • CHU Pontchaillou
  • Germany
      • Berlin, Germany, 13125
        • Helios Klinikum Berlin-Buch
      • Bonn, Germany, 53105
        • Universitätsklinikum Bonn
      • Koln, Germany, 50937
        • Gastroenterologische Studienambulanz
      • Leipzig, Germany, 04103
        • Universität Leipzig
      • Magdeburg, Germany, 39120
        • Otto-von-Guericke-Universitaet Magdeburg
      • München, Germany, 81377
        • Medizinische klinik und Poliklinik II
  • Italy
      • Bologna, Italy, 40138
        • Policlinico Sant' Orsola Malpighi
      • Cagliari, Italy, 09042
        • AOU Cagliary
      • Messina, Italy, 98125
        • A.O.U. Policlinico G.Martino
      • Monza, Italy, 20052
        • Ospedale San Gerardo
      • Roma, Italy, 00189
        • Ospedale Sant'Andrea Hospital
  • Spain
      • Alicante, Spain, 03010
        • Hgu Alicante
      • Barcelona, Spain, 08003
        • Hospital de Mar - Parc de Salut Mar
      • Córdoba, Spain, 14014
        • Hospital Reina Sofia
      • Madrid, Spain, 28046
        • Universidad Autonoma de Madrid - Hospital Universitario La Paz
      • Sabadell, Spain, 08208
        • Parc Tauli Hospital Universitari
      • Santander, Spain, 39008
        • Hospital Universitario Marques de Valdecilla
      • Valladolid, Spain, 47012
        • Hospital Universitario De Rio Hortega
  • Taiwan
      • Chang Hua, Taiwan, 50006
        • Changhua Christian Hospital
      • Kaohsiung, Taiwan, 807
        • Kaohsiung Medical University Hospital
      • Kaohsiung, Taiwan, 83301
        • Chang Gung Medical Foundation
      • Taichung, Taiwan, 40447
        • China Medical University Hospital
      • Taichung, Taiwan, 40705
        • Taichung Veterans General Hospital
      • Taichung, Taiwan, 40705
        • Liver DIS Center
      • Tainan, Taiwan, 70403
        • National Cheng Kung University Hospital
      • Tainan, Taiwan, 736
        • Chi Mei Medical Center - Liuying
      • Taoyuan, Taiwan, 33305
        • Chang Gung Medical Foundation
  • Thailand
      • Bangkok, Thailand, 10400
        • Phramongkutklao Hospital
      • Bangkok, Thailand, 10700
        • Sririraj Hospital
      • Chiang Mai, Thailand, 50200
        • Chiang Mai University
  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Medical Center
      • Los Angeles, California, United States, 91345
        • FACEY Medical Foundation
      • Newport Beach, California, United States, 92663-3668
        • Office of Dr. John D. Homan MD
      • Orange, California, United States, 92868
        • UC Irvine Health
      • Oxnard, California, United States, 93030
        • Fomat Medical Research
      • Poway, California, United States, 92064
        • Alliance Clinical Research
    • Florida
      • Homestead, Florida, United States, 33030
        • Medical Center of Homestead
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinc
      • Lauderdale Lakes, Florida, United States, 33319
        • Precision Clinical Research, LLC
      • Tampa, Florida, United States, 33614
        • Guardian Angel Research Center, Inc.
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60637
        • University of Chicago
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Medical Center
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
    • Maryland
      • Baltimore, Maryland, United States, 21202
        • Mercy Medical Research
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
      • Detroit, Michigan, United States, 48202-2608
        • Henry Ford Hospital (HFH)
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • New York
      • Stony Brook, New York, United States, 11794
        • Stony Brook Cancer Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28226
        • OnSite Clinical Solutions
      • Charlotte, North Carolina, United States, 28210
        • CMC Center for Liver Disease
      • Winston-Salem, North Carolina, United States, 27103
        • PMG Research of Winston-Salem, LLC
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • UH Cleveland Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19141
        • Einstein Medical Center
    • Tennessee
      • Jackson, Tennessee, United States, 38301
        • The Jackson Clinic
      • Memphis, Tennessee, United States, 38104
        • Methodist Healthcare University Hospital
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt University Medical Center
    • Texas
      • Austin, Texas, United States, 78726
        • ARC Clinical Research at Wilson Parke
      • Dallas, Texas, United States, 75201
        • UT Southwestern Medical Center
      • Magnolia, Texas, United States, 77355
        • ADP Clinical Research
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia
      • Newport News, Virginia, United States, 23602
        • Bon Secours Liver Institute of Hampton Roads
      • Richmond, Virginia, United States, 23249
        • Hunter Holmes McGuire Medical
    • Washington
      • Spokane, Washington, United States, 99202
        • South Perry Endoscopy
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • University of Wisconsin Hospital and Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HCC Surveillance
Approximately 1400 HCC surveillance subjects (controls) will be enrolled.
Other: Blood Sample Collection
HCC subjects will have one blood sample collected.
Other: 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.
Other: Blood Sample Collection
HCC subjects will have one blood sample collected.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomarker Identification
Time Frame: 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)
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Exact Sciences Corporation

Investigators

  • Study Director: Laura Strong, Exact Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2018

Primary Completion (Actual)

March 11, 2020

Study Completion (Actual)

March 11, 2020

Study Registration Dates

First Submitted

August 9, 2018

First Submitted That Met QC Criteria

August 9, 2018

First Posted (Actual)

August 14, 2018

Study Record Updates

Last Update Posted (Actual)

August 6, 2020

Last Update Submitted That Met QC Criteria

August 4, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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