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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON35069

Enrollment

180

Registered

2010-06-15

Start date

2010-08-02

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hepatocellular carcinoma liver cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Measure

Time frame

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

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Secondary

Measure	Time frame
nvt	—

Countries

Netherlands

Outcome results