Lewis R. Roberts, M.B., Ch.B., Ph.D.

The primary objective of this study is to assess overall sensitivity and specificity of Oncoguard™ Liver for hepatocellular cancer (HCC) detection in a surveillance population.

Secondary objectives for this study are to assess performance of Oncoguard Liver in confirmed HCC and non-HCC population, and to assess early-stage sensitivity of Oncoguard Liver for HCC detection in a surveillance population.

This study is being done to:

1. Create a registry of patients having or at risk for cancer of the liver or bile ducts (also known as hepatocellular carcinoma or cholangiocarcinoma), or gallbladder cancer, and those individuals who have normal risk factors in order to improve the ability to diagnose and treat these cancers. We will use information in the medical record in this registry including how far advanced the cancer is (stage) and what treatments are used to treat the cancer.

2. A second purpose of this study is to obtain blood and tissue samples from participants having or at risk for developing cancer of the liver or bile ducts or gallbladder cancer to be used for future research testing. Future testing may include searching for changes in the genetic material (DNA and other molecules).

The purpose of this study is to validate an NMR-based (Nuclear magnetic resonance) serum metabolite constellation for detection of early Hepatocellular carcinoma (HCC) lesions in liver cirrhosis.

Group 1: The primary purpose of this study is to evaluate the safety and tolerability of an autologous dendritic cells (DC) vaccine delivered by intra-tumoral injection in patients with primary liver cancer treated with high-dose conformal external beam radiotherapy (EBRT).

Group 2: The primary purpose of this study is to estimate the progression-free survival rate at 2 years post-registration to see if treatment is efficacious compared to historical data

Cholangiocarcinoma (CCA) has key similarities with HCC, therefore, we hypothesize that Sulf1 and Sulf2 may also play roles in promotion of CCA progression.

TARGET-HCC is a longitudinal, observational study of patients being managed for HCC in usual clinical practice. TARGET-HCC will create a research registry of participants with HCC within academic and community real-world practices in order to assess the safety and effectiveness of the entire spectrum of current and future therapies across diverse populations.

The safety and effectiveness of TheraSphere will be evaluated in patients with unresectable hepatocellular carcinoma in whom treatment with standard-of-care sorafenib is planned. All patients receive the standard-of-care sorafenib with or without the addition of TheraSphere.

The primary objective of this study is to obtain de-identified, clinically-characterized whole blood specimens for use in developing and evaluating the performance of new biomarker assays for detection of hepatocellular carcinoma (HCC).

The purpose of this study is to compare the use of the Glycotest HCC Panel vs. the serum protein biomarker alpha-fetoprotein (AFP) for the early detection of Hepatocellular Carcinoma (HCC).

The purpose of this study is to develop a better understanding of the carcinogenetic progression in cholangiocarcinoma and also to develop more accurate diagnostic tests.

The overall goal of this research is to measure the circulating tumor cell in the peripheral blood and investigate the association between circulating tumor cell level and tumor characteristics and prognosis.

This clinical trial compares the efficacy of peginterferon plus tenofovir for 24 weeks followed by monotherapy with tenofovir for a further 3.5 years to the efficacy of tenofovir alone given for 4 years in patients with chronic hepatitis B. The primary measure of outcome will be HBsAg loss in serum at 48 weeks after stopping all antiviral therapy (sustained off-treatment response).

The purpose of this study is to investigate the usefulness of identifying DNA mutations in circulating tumor cells and cfDNA from the peripheral blood of patients with cholangiocarcinoma. The future plan is to compare DNA mutations detected from peripheral blood (the research) with clinical results from tumor tissue.

The purpose of this study is to investigate the feasibility of isolating circulating tumor cells (CTCs) and cfDNA from patients with CCA for molecular characterization and compare the mutation results between peripheral blood and tumor tissue.

The purpose of this study is to investigate means to identify circulating tumor cells from the portal vein and hepatic vein blood of patients with liver cancer at the time of liver transplantation.

This study is being done to investigate if we can identify circulating tumor cell from the peripheral blood of patients with hepatocellular carcinoma using an investigational device, RareCyte system. The results of this test will be compared to the results of the FDA-approved CellSearch Test.

The main objective of this study is to identify minimally invasive, blood-based methylomic markers by comparing blood cfDNA methylation patterns among HIV-infected and uninfected HCC patients, and in HIV-infected but HCC-free patients. 
 

The purpose of this study is to find the rate of Hepatitis B, Hepatitis C, and Hepatocellular Carcinoma in individual populations of African descendants living in Minnesota, and to see what the current knowledge, attitudes and practices of these immigrants are towards screening, vaccination, and disease management.

Fluorescence in situ hybridization (FISH) has improved the diagnostic performance of cytology for evaluation of malignant biliary strictures in the US and Europe. The utility of FISH for diagnosis of biliary strictures in Asia is currently unknown. The investigators conducted a prospective study in 2 university hospitals to determine diagnostic performance of FISH for the diagnosis of malignant biliary strictures in Thai patients.

This is an ancillary to the NIDDK-sponsored Hepatitis B Research Network (HBRN) Study Cohort Study NCT01263587. This study will examine the balance between immune regulatory and effector responses in hepatitis B-infected participants enrolled in the HBRN study (NCT01263587).

The prevalence of hepatitis B virus (HBV) and hepatitis C virus (HCV) in the United States (US) is relatively low. However, immigrant populations in the US from Asia and sub-Saharan Africa have substantially higher prevalence than the general population and are consequently at a significant risk for hepatocellular carcinoma (HCC).

The purpose of this study is to evaluate the usefulness of new markers found in blood that might help to diagnose of liver cancer (HCC) early among people with cirrhosis. We hope that this study will show that these new markers could identify HCC at an earlier stage where better treatment options are available.

The goal of the study is to identify immune responses (immune cell activation and suppression) following local ablation of liver tumors.

The primary purpose of this study is to describe participants with hepatitis B virus (HBV) infection and identify factors that may cause the disease to activate or worsen.

The purpose of this study is to determine whether INO-8000 alone or in combination with INO-9012 (IL-12) is safe and induces a Hepatitis C virus-specific immune response.

This pilot clinical trial studies the best dose of erlotinib hydrochloride and to see how well it works in preventing liver cancer in patients with scarring (cirrhosis) of the liver undergoing surgery. Erlotinib hydrochloride may help to inhibit the development of fibrous tissue and prevent liver cancer from forming in patients with cirrhosis of the liver.

The purpose of this observational study is to describe the safety and effectiveness of regorafenib in patients with uHCC under real world practice conditions.

The goal of this study is to develop a resource (bank) of biospecimens (blood, tissue) from patients having cancers that metastasis to the liver. The purpose of the resource bank is to facilitate studies on the pathogenesis of cancers metastasizing to the liver and also in order to assess the ability of new tests to detect early cancer in the cohort of patients undergoing routine surveillance for cancer. The biospecimens will include cultures of tumor cells and tumor-associated non-malignant cells, as well as xenografts established from freshly isolated metastatic cancers in immunodeficient mice. We plan to administer a risk factor questionnaire to facilitate identification of risk factors for development of metastatic liver cancer. The study will also  determine survival of patients from time of diagnosis.