CLiMB
This is a clinical trial designed to evaluate the performance of a multi-analyte blood test alone, ultrasound alone and the combination of both the multi-analyte blood test and ultrasound for the detection of HCC within a population that is at high risk for HCC due to liver cirrhosis.
Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.
The study population will consist of men and women age 21 to 84 (inclusive) who are at a high risk for HCC due to liver cirrhosis. This study population will be drawn from subjects that currently meet AASLD recommendations for HCC surveillance every 6 months by ultrasound. Subjects may be enrolled in an existing HCC surveillance program at the time of enrollment.
Primary disease category: Liver
Secondary disease categories: Cancer, Liver Cancer
This study is enrolling healthy volunteers.
Sponsor: Helio Health, Inc.
Protocol number: LAM-2018-01
Projected enrollment dates: February 2019 to August 2022
Official study title: Prospective Clinical Trial to Detect Liver Cancer Through Quantification of cfDNA Methylation in Blood Samples: A LAM Insight Trial Study
ClinicalTrials.gov page:
http://www.clinicaltrials.gov/show/NCT03694600