Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03694600 |
| Other study ID # |
LAM-2018-01 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 4, 2019 |
| Est. completion date |
June 30, 2024 |
Study information
| Verified date |
September 2023 |
| Source |
Helio Genomics |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
This is a clinical trial designed to evaluate the performance of a multi-analyte blood test
alone to ultrasound alone for the detection of HCC within a population that is at high risk
for HCC due to liver cirrhosis.
Description:
This multi-site, prospective study is designed to compare the sensitivity and specificity of
a multi-analyte blood test alone to ultrasound alone for the detection of HCC within a
population at high risk of HCC due to liver cirrhosis. Subjects will be enrolled until the
pre-determined number of subjects are enrolled.
Subjects at high risk for developing HCC due to liver cirrhosis and who are eligible for
liver cancer surveillance as determined by the patient's physician and who meet all inclusion
and exclusion eligibility criteria as described in this protocol, will be invited to
participate in this study. Subjects will then read, understand and sign the Informed Consent
Form and the HIPAA Authorization Agreement for Medical Records Form.
For each subject upon enrollment, the following blood analytes will also be determined:
creatinine, prothrombin time, bilirubin, blood platelet count, ALT, AST and ALP. The results
of all clinical laboratory tests will be recorded by use of the subject's Case Report Form.
Whole blood samples drawn for the multi-analyte blood test will be collected (according to
the instructions provided with each sample collection kit) by using the multi-analyte Sample
Collection, Stabilization and Shipping Kit, and shipped to a central LAM laboratory for
testing. Samples will be assayed by laboratory technicians blinded to the results of any
other testing. Within the same clinical visit as the blood draws (when possible), subjects
will undergo conventional ultrasound to examine the liver. Every subject will then go on to
diagnostic imaging by multiphasic MRI. The results of diagnostic imaging will primarily be
scored by LI-RADS score and the number and size of any malignant lesions identified will be
recorded. The images of all MRI, CT, or ultrasound will be saved and uploaded for evaluation
by a blinded, centralized team of radiologists to confirm diagnosis. Any biopsy results or
surgical pathology results that are generated for study subjects as part of current clinical
practice will also be recorded.
Study procedures will consist of conventional ultrasound to examine the liver, providing
blood samples for testing with the multi-analyte blood test and other conventional blood
analytes, and diagnostic imaging by multiphasic MRI.
Upon enrolling in the study, subjects will commence the Initial Surveillance Visit (t=0
months). During the Initial Surveillance Visit, all enrolled subjects will undergo ultrasound
to examine the liver and provide blood samples for the multi-analyte blood test and for
determining conventional blood analytes. Every subject will then go on to diagnostic imaging
by multiphasic MRI. The results of diagnostic imaging will primarily be scored by a Liver
Reporting and Data System (LI-RADS) score. The data of all diagnostic imaging by MRI will be
saved and uploaded for evaluation by a blinded, centralized team of radiologists, which will
be used as the basis of the clinical truth for all subjects.
After the Initial Surveillance Visit (t=0 months), subjects with an indeterminant HCC finding
by MRI (LI-RADS 3) will be recommended to up to three Follow-Up Visits (t=6 months, t=12
months, and t=18 months) to attempt to resolve the clinical truth for these subjects. Each
Follow-Up Visit will consist of an ultrasound to examine the liver, providing blood samples
for the multi-analyte blood test , as well as diagnostic imaging by multiphasic MRI.
Although not required by this clinical protocol, any biopsy or surgical pathology results, or
any additional imaging (such as multiphasic CT) that are generated for study subjects as part
of current clinical practice will also be recorded for each subject and the results shall be
made available to the Sponsor if performed within 6 months of a scheduled Visit. Biopsy and
surgical pathology results that indicate a malignancy will be used in place of diagnostic
imaging as the clinical truth for each subject if performed within 6 months of a scheduled
visit and prior to database lock.
All study-related procedures will occur during the Study Duration Period, which consists of
the Initial Surveillance Visit for all subjects and up to three Follow-Up Visits for subjects
with an initial indeterminant HCC finding (LI-RADS 3) by diagnostic imaging. After this Study
Duration Period, no study related blood draws, imaging or procedures will occur for these
subjects.
