Identification of Biomarkers Associated With Human Hepatocellular Carcinoma by SELDI

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2003 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00154531
First received: September 9, 2005
Last updated: December 19, 2005
Last verified: December 2003
  Purpose

Hepatocellular carcinoma (HCC) has been the leading cause of cancer death in Taiwan. Though Alpha-fetoprotein (AFP) and des-γ-carboxy prothrombin(DCP) are used as the tumor markers for diagnosis of HCCs. Thus, these two markers are not good enough for the early detection of small HCCs. To improve the survival, further investigations of the early diagnostic markers are still needed.

SELDI is a proteomic profiling techniques in biomarker discovery. Its approach has been successfully used to identify biomarkers of various cancers, such as prostate cancer, bladder cancer, ovarian cancer, lung cancer, colon cancer, breast cancer and pancreatic cancer.

In this current project we will apply the SELDI technique to identify the HCC biomarkers. Sera samples from the HCC patients and relevant controls will be collected. We hope that we can find the new HCC biomarkers. If biomarkers of HCC are identified, this can be used to clinical application for the possible early detection of HCCs.


Condition
Hepatocellular Carcinoma
Hepatitis B
Hepatitis C

Study Type: Observational
Study Design: Observational Model: Case Control
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Official Title: Identification of Biomarkers Associated With Human Hepatocellular Carcinoma by Surface-Enhanced Laser Desorption/Ionization (SELDI)

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Estimated Enrollment: 230
Study Start Date: August 2004
Estimated Study Completion Date: May 2005
Detailed Description:

Hepatocellular carcinoma (HCC) has been the leading cause of cancer death in Taiwan. Above 6000-8000 people died of this cancer every year in Taiwan. Though regular sonographic examination can early detect small HCC and there are many therapeutic modalities for HCC, the therapeutic results remains unsatisfactory. Though Alpha-fetoprotein (AFP) and des-γ-carboxy prothrombin(DCP) are used as the tumor markers for diagnosis of HCCs, AFP is normal in around one third of small(<3cm) HCC patients. Elevated DCP activities were present in 44%-47.6% with HCCs less than 3cm. Thus, these two markers are not good enough for the early detection of small HCCs. To improve the survival, further investigations of the early diagnostic markers are still needed.

The global analysis of cellular proteins has recently been termed proteomics and is a key area if research that is developing in the postgenomic ear. With respect to cancer, proteomics has the potential to identify novel targets for therapy or markers for diagnosis. The proteomic profiling techniques in biomarker discovery include (1) 2-D PAGE / MALDI-MS (two-dimensional gel electrophoresis, polyacrylamide gel electrophoresis) / matrix assisted laser desorption / ionization-mass spectrometry), (2) LC/MS/MS (liquid chromatography/MS/MS), (3) SELDI-TOF (surface-enhanced laser desorption ionization time-of-flight). These techniques have their own advantages and shortcomings.

SELDI is a recently descried modification of MALDI-TOP in which small amounts of protein are directly applied to a biochip coated with specific chemical matrices (hydrophobic, cationic, anionic, normal phase, and so forth) or biochemical molecules such as DNA oligonucleotides or purified proteins. The bound proteins retained after washing are analyzed by mass spectrometry to obtain the protein fingerprint of the sample. The detected proteins are displayed as a series of peaks.

SELDI-TOF MS can offer high-throughput protein profiles. Blood, urine, body fluid, or tissue specimen are taken from the patients and then are applied onto different ProteinChip Arrays. The differences in the protein expression profiles of two or more distinct samples are thus obtained. SELDI approach has been successfully used to identify biomarkers of various cancers, such as prostate cancer, bladder cancer, ovarian cancer, lung cancer, colon cancer, breast cancer and pancreatic cancer.

In this current project we will apply the SELDI technique to identify the HCC biomarkers. Sera samples from the HCC patients and relevant controls will be collected. The samples will then be applied to SELDI analysis. We hope that we can find the new HCC biomarkers. If biomarkers of HCC are identified, this can be used to clinical application for the possible early detection of HCCs.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Clinical diagnosis of hepatocellular carcinoma
  • Clinical diagnosis of hepatitis B
  • Clinical diagnosis of hepatitis C

Exclusion Criteria:

  • N/A
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00154531

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Jin-Chuan Sheu, M.D. Ph.D.    886-2-23123456 ext 6579    sheuhcc@ha.mc.ntu.edu.tw   
Principal Investigator: Chien-Hung Chen, M.D. PhD         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Jin-Chuan Sheu National Taiwan University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00154531     History of Changes
Other Study ID Numbers: 9261701418
Study First Received: September 9, 2005
Last Updated: December 19, 2005
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Carcinoma
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis C
Carcinoma, Hepatocellular
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Flaviviridae Infections
Adenocarcinoma

ClinicalTrials.gov processed this record on July 24, 2014