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.|
|ClinicalTrials.gov Identifier: NCT03628651|
Recruitment Status : Completed
First Posted : August 14, 2018
Last Update Posted : August 6, 2020
- Study Details
- Tabular View
- Results Submitted
- How to Read a Study Record
|Condition or disease||Intervention/treatment|
|Hepatocellular Carcinoma Hepatocellular Carcinoma Surveillance||Other: Blood Sample Collection|
|Study Type :||Observational|
|Actual Enrollment :||2150 participants|
|Official Title:||2017-01: Blood Sample Collection to Evaluate Biomarkers for Hepatocellular Carcinoma|
|Actual Study Start Date :||April 2, 2018|
|Actual Primary Completion Date :||March 11, 2020|
|Actual Study Completion Date :||March 11, 2020|
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.
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Sampling Method:||Non-Probability Sample|
- 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
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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT03628651
|Study Director:||Laura Strong||Exact Sciences|
|Responsible Party:||Exact Sciences Corporation|
|Other Study ID Numbers:||
|First Posted:||August 14, 2018 Key Record Dates|
|Last Update Posted:||August 6, 2020|
|Last Verified:||August 2020|
|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.|
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 email@example.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.|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases