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Blood Sample Collection to Evaluate Biomarkers for Hepatocellular Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03628651
Recruitment Status : Active, not recruiting
First Posted : August 14, 2018
Last Update Posted : October 30, 2019
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment
Hepatocellular Carcinoma Hepatocellular Carcinoma Surveillance Other: Blood Sample Collection

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.

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Study Type : Observational
Estimated Enrollment : 2100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 2017-01: Blood Sample Collection to Evaluate Biomarkers for Hepatocellular Carcinoma
Actual Study Start Date : April 2, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Group/Cohort Intervention/treatment
HCC Surveillance
Approximately 1400 HCC surveillance subjects (controls) will be enrolled.
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.

Approximately 700 subjects with untreated clinically diagnosed HCC will be enrolled.
Other: Blood Sample Collection
HCC subjects will have one blood sample collected.

Primary Outcome Measures :
  1. 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)

Biospecimen Retention:   Samples With DNA
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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03628651

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Sponsors and Collaborators
Exact Sciences Corporation
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Study Director: Laura Strong Exact Sciences

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Responsible Party: Exact Sciences Corporation Identifier: NCT03628651     History of Changes
Other Study ID Numbers: 2017-01
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: October 30, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Informed Consent Form (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 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases