A Study to Compare of the Glycotest™ HCC Panel vs AFP for the Detection of Early-stage Hepatocellular Carcinoma

Overview

About this study

The purpose of this study is to compare the use of the Glycotest HCC Panel vs. the serum protein biomarker alpha-fetoprotein (AFP) for the early detection of Hepatocellular Carcinoma (HCC).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Cases

1) Males and females ages 18 years or older.

2) Treatment-naïve HCC as defined by LI-RADS LR-5 or OPTN 5 CT or MRI criteria (all lesions must exhibit arterial phase hyper-enhancement), or histologic evidence.

3) Early-stage HCC defined by single lesion ≤5 cm or ≤ 3 lesions ≤3 cm determined at enrollment or within 100 days prior without vascular invasion.

4) Cirrhosis based on serum biomarkers (FibroSure®/FibroTest > 0.74, APRI > 2, or FIB-4 > 3.25), histology, imaging, elastography, or clinical evidence of portal hypertension in the setting of known chronic liver disease.

5) Child-Pugh score A–B8.

6) Subject must be able to understand and provide informed consent.

Controls

1) Males and females ages 18 or older.

2) Cirrhosis based on serum biomarkers (FibroSure®/FibroTest > 0.74, APRI > 2, or FIB-4 > 3.25), histology, imaging, elastography, or clinical evidence of portal hypertension in the setting of known chronic liver disease.
3) Evidence of the absence of a solid hepatic mass, suspicious for HCC, at enrollment or within 100 days prior based on one of the following:
a. Negative multiphase CT scan or MRI with contrast at screening/baseline visit, OR
b. Negative abdominal US at both screening/baseline visit AND 6-month follow-up visit, OR
c. Negative abdominal US at screening/baseline visit AND negative multiphase CT scan or MRI with contrast at 6-month or earlier follow-up visit.
4) Child-Pugh score A–B8.
5) Subject must be able to understand and provide informed consent

Exclusion Criteria:

Cases

1) Uncontrolled ascites.

2) Uncontrolled encephalopathy.

3) History of liver transplant.

4) Diagnosis of active malignancy or history of active malignancy within 5 years prior to enrollment, including mixed HCC-CCA (if diagnosed with previous malignancy, subject must be in remission for at least 5 years prior to enrollment). Prior history of HCC, including resection of HCC at any time, is excluded.

5) Prior treatment of tumor.

6) Any significant non-liver-related medical condition in which expected survival is less than 1 year.

Controls

1) Imaging evidence of solid hepatic mass, suspicious for HCC, including lesions meeting LI-RADS LR-3 or LR-4, OPTN-3 or OPTN-4, or LI-RADS LR-M criteria.

2) Uncontrolled ascites.

3) Uncontrolled encephalopathy.

4) History of liver transplant.

5) Diagnosis of active malignancy or history of active malignancy within 5 years prior to enrollment (if diagnosed with previous malignancy, subject must be in remission for at least 5 years prior to enrollment). History of HCC, including resection of HCC at any time, is excluded.

6) Any significant non-liver-related medical condition in which expected survival is less than 1 year.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Lewis Roberts, M.B., Ch.B., Ph.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

  • Hepatocellular carcinoma (HCC) has the greatest increase in mortality among all solids tumors in the United States related to low rates of early tumor detection. Development of noninvasive biomarkers for the early detection of HCC may reduce HCC-related mortality. We have developed an algorithm that combines routinely observed clinical values into a single equation that in a study of >3,000 patients from 5 independent sites improved detection of HCC as compared with the currently used biomarker, alpha-fetoprotein (AFP), by 4% to 20%. However, this algorithm had limited benefit in those with AFP <20 ng/mL. To that end, we have developed a secondary algorithm that incorporates a marker, fucosylated kininogen, to improve the detection of HCC, especially in those with AFP <20 ng/mL and early-stage disease. The ability to detect early-stage AFP-negative (AFP <20 ng/mL) HCC increased from 0% (AFP alone) to 89% (for the new algorithm). Glycan analysis revealed that kininogen has several glycan modifications that have been associated with HCC, but often not with specific proteins, including increased levels of core and outer-arm fucosylation and increased branching. An algorithm combining fucosylated kininogen, AFP, and clinical characteristics is highly accurate for early HCC detection. Our biomarker algorithm could significantly improve early HCC detection and curative treatment eligibility in patients with cirrhosis. . Read More on PubMed

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

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