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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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The study will examine and evaluate the use of extracellular RNA in blood as markers for the diagnosis of liver disease or cancer, and as markers for prediction of response to treatment or recurrence of cancer after surgery
The goal is to identify an extracellular RNA candidate for the detection and diagnosis of liver cancers such as hepatocellular cancer or biliary cancer, and chronic liver diseases. The use of selected exRNA biomarkers for diagnosis of hepatocellular cancer (HCC) or biliary tract cancers in patients with cirrhosis will be evaluated in a prospective case-control study. The study will create a registry of patients who have chronic liver disease, cirrhosis, liver and biliary tract cancers. A risk factor questionnaire will be administered to facilitate identification of risk factors for development of liver cancer. Patient information will be obtained from the medical record, and include demographics, medical history, liver disease, smoking and alcohol history, etiology, family history, and clinical laboratory data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hepatocellular Carcinoma | Blood samples will be collected at entry into the study and at varying intervals over a two to three year period. |
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| Biliary Tract Cancer | Blood samples will be collected at entry into the system and at varying intervals over a two to three year period. |
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| Cirrhosis | Blood samples will be collected during regular intervals over a three year period. |
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| Chronic Liver Disease without Cirrhosis | A single blood sample will be collected at entry into the study |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood samples | Other | Blood samples collected at varying intervals over a two to three year period. |
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| Measure | Description | Time Frame |
|---|---|---|
| Diagnosis of liver cancer based on tumor markers and imaging studies. | The exRNA biomarker levels in the HCC and biliary tract cancer groups will be evaluated and compared to the exRNA biomarker levels present in the other groups, cirrhosis and chronic liver disease. Statistical analysis will be used to evaluate the sensitivity and specificity of these markers for the diagnosis of cancers based on findings of liver mass, imaging characteristics, size, and extent of viable tumor on imaging, or on elevated levels of tumor markers such as alpha-fetoprotein. | Five years |
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Inclusion Criteria:
Exclusion Criteria for the HCC/biliary tract cancer group:
Exclusion criteria for the cirrhosis and chronic liver disease groups:
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Patients undergoing evaluation at Mayo Clinic Florida Liver Transplant, Surgery, Oncology or Radiology clinics who have hepatocellular carcinoma (HCC) or biliary tract cancers, cirrhosis without HCC, or chronic liver disease without cirrhosis.
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| Name | Affiliation | Role |
|---|---|---|
| Tushar Patel, MBChB | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | United States | ||
| The University of Chicago Medical Center |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D001661 | Biliary Tract Neoplasms |
| D005355 | Fibrosis |
| D008107 | Liver Diseases |
| D008113 | Liver Neoplasms |
| D018281 | Cholangiocarcinoma |
| D006505 | Hepatitis |
| D001650 | Bile Duct Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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whole blood
| Chicago |
| Illinois |
| 60637 |
| United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| McGuire VA Medical Center | Richmond | Virginia | 23249 | United States |
| D009369 | Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D001660 | Biliary Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001649 | Bile Duct Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |