rine mass spectrometry in patients with hepatocellular carcinoma, liver cirrhosis and healthy persons

Recruiting

Conditions: hepatocellular carcinoma
liver cancer
10019654

Registration Number: NL-OMON35069

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 180

Inclusion Criteria

1. Subjects with age above 18 years
2. Informed consent
3. Diagnosed hepatocellular carcinoma in patients with CT or MRI-scan
or
4. Running the surveillance program (patients with cirrhosis or those positive for HBV and older than 40 years) without hepatocellular carcinoma in patients with CT or MRI-scan
or
5. Healthy persons (kidney donors)

Exclusion Criteria

1. Patients diagnosed with other malignant tumours
2. Patients who received prior chemotherapy (transarterial chemo-embolization)

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To determine metabolites and natural occurring peptides in urine by mass<br /><br>spectrometry in patients with hepatocellular carcinoma. This study is designed<br /><br>as a validation study; in a smaller study a spectrum of metabolites and natural<br /><br>occurring peptides have been identified in urine of patients with HCC and<br /><br>without HCC. However, with the data from the pilot study we cannot discriminate<br /><br>between biomarkers related to cirrhosis and to hepatocellular carcinoma. As<br /><br>identification of biomarkers predicting the early presence of hepatocellular<br /><br>carcinoma in cirrhotic livers would be of great clinical relevance additional<br /><br>urine analysis using mass spectrometry is indicated to determine a potential<br /><br>successful test of a new biomarker signature. </p><br>

Secondary Outcome Measures