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Liver cancer (HCC) is the second cause of death related to cancer worldwide, with about 750,000 deaths from this cause in 2012. Although the early diagnosis of liver cancer increases the available treatment options, the methods currently used for screening are not sufficiently sensitive for this purpose.
The investigators provide a high-performance and highly reliable in vitro platform that allows the identification and quantification of autoantibodies in serum for use as biomarkers of liver cancer, using an ELISA test (Yliver).
The aim of the study is to demonstrate whether the Yliver test can be used as a biomarker for the early diagnosis of hepatocellular carcinoma with a collection of samples from 58 patients diagnosed with HCC, 42 cirrhosis, 40 normal controls and the inclusion of 25-50 patients with chronic liver disease without cirrhosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HCC | Patients with diagnosis of Hepatocellular carcinoma |
| |
| Cirrhosis | Patients with the diagnosis of cirrhosis who is following a screening program for diagnosis of HCC |
| |
| Chronic liver diseases | Patients with the diagnosis of Chronic liver diseases without cirrhosis |
| |
| Control | Normal human serum from donors without liver disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test Yliver | Diagnostic Test | Test Yliver is used to detect autoantibodies against alpha fetoprotein in serum by an ELISA technique |
|
| Measure | Description | Time Frame |
|---|---|---|
| Yliver | Titer of autoantibodies against alpha fetoprotein applying Taby Technology | October 2018-February 2019 |
| Measure | Description | Time Frame |
|---|---|---|
| AFP | Levels of alpha fetoprotein in serum | October 2018-February 2019 |
| Ultrasound | Results of the ultrasound examination | October 2018-February 2019 |
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Inclusion Criteria:
EASL Clinical Practice Guidelines & Practice Guidance by the American Association for the Study of Liver Diseases for diagnosis of HCC, liver cirrhosis, chronic hepatitis without cirrhosis
Exclusion Criteria:
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HCC: patients with HCC diagnosis Cirrhosis: patients with liver cirrhosis diagnosis Chronic liver disease: patients with chronic liver diasease without cirrhosis Control: normal human serum from donors without liver disease
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Corporacion Parc TaulĂ | Sabadell | Barcelona | 08208 | Spain |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D004194 | Disease |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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Serum
| AAb AFP | Titer of autoantibodies against alpha fetoprotein with standard protocol | October 2018-February 2019 |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |