Ignite Creation Date:
2024-05-06 @ 12:54 PM
Last Modification Date:
2024-10-26 @ 1:05 PM
Study NCT ID:
NCT03878550
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-11-15
First Post:
2019-03-15
Brief Title:
Case-Control Study of the Glycotest HCC Panel vs AFP for the Detection of Early-stage Hepatocellular Carcinoma
Sponsor:
Glycotest Inc
Organization:
Glycotest Inc
Study Overview
Official Title:
Case-Control Study of the Glycotest HCC Panel vs AFP for the Detection of Early-stage Hepatocellular Carcinoma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Study Rationale
This study is designed to compare the ability of the Glycotest HCC Panel with that of AFP to differentiate between patients with early-stage Hepatocellular Carcinoma HCC against a background of cirrhosis from cirrhotic patients without HCC at risk
Primary Objective
The primary objective of this study is to determine whether the Glycotest HCC Panel outperforms AFP in terms of area under the receiver operating characteristic curve AUROC for the differentiation of patients with early-stage HCC from those without HCC in the at-risk population
Secondary Objective
The secondary objective of this study is to determine whether the Glycotest HCC Panel outperforms AFP in terms of clinical sensitivity as estimated using the 90 specificity estimate as the decision threshold for the detection of patients with early-stage HCC
Study Design
This is a phase 2 multicenter laboratory-blinded case-control study of the Glycotest HCC Panel vs AFP for the discrimination of patients with early-stage HCC from those at risk Case and control samples will be obtained from multiple institutions using prospective collection The study will consist of a screeningbaseline visit for all patients controls initially assessed by abdominal US will also undergo a 6-month follow-up visit to confirm absence of HCC at enrollment Assays will be performed by Glycotest with analysts blinded to clinical data
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
Number of Subjects
Maximum of 388 cases and 378 controls
150 cases and 140 controls training set
Maximum of 238 cases and 238 controls validation set
Study Duration
30 months approximately 24 months accrual 6 month follow up
Study Phases Patients potentially eligible for the study population will undergo informed consent prior to screeningbaseline visits
Screening Once consented a subjects demographics medical record laboratory data and imaging will be reviewed Patients are considered eligible for enrollment once they meet all study enrollment criteria
Enrollment Screening data will be re-reviewed if necessary and recorded Serum from blood samples 5 mL will be obtained for measurement of Glycotest HCC Panel score which includes AFP
Follow up Medical record reviewimaging at 6 months from enrollment for control patients originally assessed using abdominal US
This study is designed to compare the ability of the Glycotest HCC Panel with that of AFP to differentiate between patients with early-stage Hepatocellular Carcinoma HCC against a background of cirrhosis from cirrhotic patients without HCC at risk
Primary Objective
The primary objective of this study is to determine whether the Glycotest HCC Panel outperforms AFP in terms of area under the receiver operating characteristic curve AUROC for the differentiation of patients with early-stage HCC from those without HCC in the at-risk population
Secondary Objective
The secondary objective of this study is to determine whether the Glycotest HCC Panel outperforms AFP in terms of clinical sensitivity as estimated using the 90 specificity estimate as the decision threshold for the detection of patients with early-stage HCC
Study Design
This is a phase 2 multicenter laboratory-blinded case-control study of the Glycotest HCC Panel vs AFP for the discrimination of patients with early-stage HCC from those at risk Case and control samples will be obtained from multiple institutions using prospective collection The study will consist of a screeningbaseline visit for all patients controls initially assessed by abdominal US will also undergo a 6-month follow-up visit to confirm absence of HCC at enrollment Assays will be performed by Glycotest with analysts blinded to clinical data
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
Number of Subjects
Maximum of 388 cases and 378 controls
150 cases and 140 controls training set
Maximum of 238 cases and 238 controls validation set
Study Duration
30 months approximately 24 months accrual 6 month follow up
Study Phases Patients potentially eligible for the study population will undergo informed consent prior to screeningbaseline visits
Screening Once consented a subjects demographics medical record laboratory data and imaging will be reviewed Patients are considered eligible for enrollment once they meet all study enrollment criteria
Enrollment Screening data will be re-reviewed if necessary and recorded Serum from blood samples 5 mL will be obtained for measurement of Glycotest HCC Panel score which includes AFP
Follow up Medical record reviewimaging at 6 months from enrollment for control patients originally assessed using abdominal US
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None