Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Exact Sciences Corporation
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
Clareo Health | Blood Sample Collection to Evaluate Biomarkers for Hepatocellular Carcinoma
