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Sponsor study identifier
observational
150
1 country
1
Study Start
June 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Hepatocellular carcinoma (HCC) is the most common primary liver cancer and the third leading cause of cancer-related death worldwide. Treatments of HCC include surgical resection, local therapies such as radiofrequency ablation and ethanol injection, transarterial chemoembolization, sorafenib and best supportive care. However, even after successful treatment such as surgical resection, most patients suffered from recurrence or progression of the tumor. Because clinical staging systems cannot precisely predict the outcome of patients with HCC, it's of great interest to search serum biomarkers for HCC. Among them, alpha-fetoprotein (AFP) is the most well-studied. However, the applicability of AFP for HCC after surgical resection of tumor or after local therapy is still uncertain. MicroRNAs (miRNAs), 17- to 25-nucleotide non-coding RNAs, are frequently dysregulated in cancer and emerging as novel non-invasive biomarker for cancer screening, diagnosis, monitor therapy efficacy and predict prognosis. MiRNAs are stably expression in serum as their resistance to endogenous RNase and easily storage with high stability. Several studies have shown abnormal expression of human serum miRNAs in many cancers such as liver, colorectal, and pancreatic cancer. The sensitivity of miRNA as a diagnostic biomarker of HCC could be upto 80%. Using miRNA arrays can generate miRNA signatures and improve the sensitivity and specificity of biomarker for tumor diagnosis and prognosis prediction. In this study, the investigators will establish an miRNA platform as biomarkers for diagnostic or prognostic tools of HCC. The investigators will also compare the miRNA expression level before and after treatment in the serum and correlate the miRNA expression between serum and tumor tissue.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 10, 2015
Actual (reported)May 19, 2015
Actual (reported)June 2015
Date type not reportedThis date has not been verified as actual or estimated.
May 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Patient survival
5 years
All enrolled HCC patients.
All enrolled HCC patients.
All enrolled HCC patients.
HCC receive surgery, RFA, TACE or Sorafenib tx.
National Taiwn University Hospital
Taipei, Taiwan, 100, Taiwan
serum; tissue: tumor/ non-tumor part.
Ja-Der Liang, Master
National Taiwan University Hospital
First Submitted
May 10, 2015
First Posted
May 19, 2015
Study Start
June 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2017
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 19, 2015
Record last verified: 2015-05
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Source: ClinicalTrials.gov.
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