MiRNA as a Diagnostic and Prognostic Biomarker of Hepatocellular Carcinoma

NCT02448056 | Unknown

• 1 other identifier: 201504020RINC
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Carcinoma, Hepatocellular; Marker, Biological

Outcome Measures

Primary Outcomes (1)

• Patient survival

  5 years

Study Arms (3)

Pre-treatment

All enrolled HCC patients.

Post-treatment one week

All enrolled HCC patients.

Post-treatment one month

All enrolled HCC patients.

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HCC receive surgery, RFA, TACE or Sorafenib tx.

You may qualify if:

• HCC, diagnosed by AASLD image criteriae or histopathologically.

You may not qualify if:

• Nil

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Far Eastern Memorial Hospital: collaborator

Study Sites (1)

National Taiwn University Hospital

Taipei, Taiwan, 100, Taiwan

Location

Biospecimen

Retention: SAMPLES WITH DNA

serum; tissue: tumor/ non-tumor part.

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Ja-Der Liang, Master

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ja-Der Liang, Master

CONTACT

886-2-23123456; jdliangntu@ntu.edu.tw

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2015
• First Posted: May 19, 2015
• Study Start: June 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2025
• Last Updated: May 19, 2015

Record last verified: 2015-05

Locations

TW (1)