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Case-Control Study of the Glycotest™ HCC Panel vs AFP for the Detection of Early-stage Hepatocellular Carcinoma

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ClinicalTrials.gov Identifier: NCT03878550
Recruitment Status : Recruiting
First Posted : March 18, 2019
Last Update Posted : September 4, 2020
Sponsor:
Information provided by (Responsible Party):
Glycotest, Inc.

Brief Summary:
Clinical guidelines (AASLD) recommend the use of abdominal ultrasound (US) for surveillance testing for the early detection of Hepatocellular Carcinoma (HCC). The serum protein biomarker alpha-fetoprotein (AFP) is commonly used to augment US but its use alone is not recommended by clinical guidelines. Despite evidence that HCC surveillance improves early detection and reduces mortality from HCC, current HCC surveillance tests lack sensitivity, leaving a significant proportion of patients to present with late-stage disease. The Glycotest HCC Panel has shown better sensitivity than AFP, which is ineffective for the detection of early-stage HCC. This clinical study seeks to validate the Glycotest HCC Panel using a large multicenter cohort of cases and controls that includes patients diagnosed with early-stage HCC against a background of cirrhosis and cirrhotic patients without HCC (at risk) undergoing an established surveillance protocol.

Condition or disease
Carcinoma, Hepatocellular Cirrhosis, Liver

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Study Type : Observational
Estimated Enrollment : 766 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Case-Control Study of the Glycotest™ HCC Panel vs AFP for the Detection of Early-stage Hepatocellular Carcinoma
Actual Study Start Date : May 22, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Group/Cohort
Cases
Male and female adult patients with early-stage hepatocellular carcinoma against a background of liver cirrhosis.
Controls
Male and female adult patients with liver cirrhosis at risk for hepatocellular carcinoma.



Primary Outcome Measures :
  1. AUROC [ Time Frame: At enrollment ]
    Area under the receiver operating characteristics curve


Secondary Outcome Measures :
  1. Sensitivity [ Time Frame: At enrollment ]
    Clinical sensitivity for the detection of early-stage hepatocellular carcinoma as estimated using the 90% specificity estimate as the decision threshold


Biospecimen Retention:   Samples Without DNA
serum


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
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will comprise male and female adult patients with early-stage HCC against a background of cirrhosis (cases) as well as at-risk cirrhotic patients (controls). Enrollment of the aggregate of HCC cases with single lesions ≥ 3 cm and with multiple lesions will be capped at 50% of total cases. Enrollment of Chronic Hepatitis C cases and controls with sustained virologic response (SVR) to therapy will be matched. Cases and controls will be matched based on age, sex and etiology.
Criteria

Inclusion Criteria:

Cases

  1. Males and females ages 18 years or older.
  2. Treatment-naïve HCC as defined by LI-RADS (Liver Imaging Reporting and Data System) LR-5 or OPTN (Organ Procurement and Transplantation Network) 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 (AST to Platelet Ratio Index) > 2, or FIB-4 (Fibrosis-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:

    1. Negative multiphase CT scan or MRI with contrast at screening/baseline visit, OR
    2. Negative abdominal US at both screening/baseline visit AND 6-month follow-up visit, OR
    3. 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 (cholangiocarcinoma). If previously diagnosed with 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. History of liver transplantation.
  4. Uncontrolled encephalopathy.
  5. Diagnosis of active malignancy or history of active malignancy within 5 years prior to enrollment (if previously diagnosed with 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.

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 ClinicalTrials.gov identifier (NCT number): NCT03878550


Contacts
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Contact: Charles S Swindell, PhD 484-431-3483 charles@glycotest.com

Locations
Show Show 18 study locations
Sponsors and Collaborators
Glycotest, Inc.
Investigators
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Principal Investigator: Josep Llovet, MD Icahn School of Medicine at Mount Sinai
Principal Investigator: Jorge Marrero, MD UT Southwestern Medical Center
Principal Investigator: Amit Singal, MD UT Southwestern Medical Center
Publications:
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Responsible Party: Glycotest, Inc.
ClinicalTrials.gov Identifier: NCT03878550    
Other Study ID Numbers: G-1001
First Posted: March 18, 2019    Key Record Dates
Last Update Posted: September 4, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Carcinoma, Hepatocellular
Liver Cirrhosis
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases