Development of a Urine Test for the Early Detection of Liver Cancer

DESCRIPTION provided by applicant Development of a urine test for the early detection of liver cancer The need to develop an effective method of detecting hepatocellular carcinoma HCC is urgent HCC is the third leading cause of cancer deaths and has a year survival rate of less than If HCC is identified early the survival rate can be as high as The survival rate drops significantly however to as low as if the cancer has spread to other organs The goal of this project is to develop a noninvasive urine based diagnostic test that would allow for early detection of liver cancer Such a test if applied to high risk populations o surveyed patients could significantly increase survival rates and could contribute to improved quality and duration of life Conventional diagnostic methods such as ultrasound imaging and the AFP blood test are either expensive ultrasound or relatively insensitive AFP blood test sensitivity to early stage I II HCC We propose a new diagnostic method based on our phase I marker urine test for detecting small fractions of HCC derived genetically and epigenetically modified DNA present in the urine of patients with liver cancer JBS Science Inc has successfully accomplished the phase I study that demonstrates feasibility in several key areas of this proposal Encouragingly the JBS phase I HCC urine test had a sensitivity of and a specificity of and was able to detect of AFP negative HCC which represents of HCC in a well controlled open labeled study using archived urine DNA samples The goal of this phase II study is to further develop the urine test to detect at least of the urin samples from patients with early stage stages I II HCC in a blinded pre validation study and obtain sufficient information to prepare for a large multicenter validation study PUBLIC HEALTH RELEVANCE The need is urgent to have an effective method for noninvasive detection of early stage liver cancer which is the third leading cause of cancer death worldwide and has one of the highest recurrence rates The current standard methods for screening rely on the serum level of alpha fetoprotein which has only sensitivity The goal of this project is to develop a urine DNA test to detect early stages of liver cancer by analyzing liver cancer associated genetic and epigenetic modifications