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The Development of Diagnostic Biomarker Panels for Hepatitis and Liver Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Ministry of Health, Malaysia.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
GeneNews Sdn Bhd
Information provided by:
Ministry of Health, Malaysia
ClinicalTrials.gov Identifier:
NCT01310062
First received: March 4, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted
  Purpose

More recent studies have shown that the HBV-infected population has a greater risk of development of hepatocellular carcinoma. Nevertheless, there are still a significant number of people chronically infected by HBV who do not develop the complication. Hence, there exist biological markers that could be indicator for the disease-inducing and carcinogenic potential of the virus.


Condition
Hepatitis B,Chronic
Carcinoma,Hepatocellular

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Strategic Alliance for The Development of Diagnostic Biomarker Panels for Hepatitis and Liver Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ministry of Health, Malaysia:

Biospecimen Retention:   Samples With DNA

Red blood cell and white blood cell


Estimated Enrollment: 1600
Study Start Date: August 2010
Estimated Study Completion Date: August 2012
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Selected hospitals for study

Criteria

Inclusion Criteria:

  • Patients of at least 21 years old on day of giving consent for study
  • Patients must be able and wiling to give an informed consent
  • Patient with chronic HBV infection
  • Patient with active hepatocellular carcinoma and chronic hepatitis B
  • Healthy subjects

Exclusion Criteria:

  • Patients who have co-infection with HIV or chronic hepatitis C
  • Subjects with other types of cancer
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01310062

Contacts
Contact: Clinical Research Centre +603-40439300 ext 113 shanthini@crc.gov.my

Locations
Malaysia
Sultanah Bahiyah Hospital Recruiting
Alor Star, Kedah, Malaysia
Principal Investigator: Dato' Dr. Muhammad Radzi Abu Hassan            
Queen Elizabeth Hospital Recruiting
Kota Kinabalu, Sabah, Malaysia
Principal Investigator: Dato' Dr. Jayaram Menon            
Sub-Investigator: Dr. Raman Muthukaruppan            
Hospital Umum Kuching Sarawak Not yet recruiting
Kuching, Sarawak, Malaysia
Principal Investigator: Mr. Nik Azim Nik Abdullah            
Selayang Hospital Recruiting
Selayang, Selangor, Malaysia
Principal Investigator: Dr. Haniza Omar            
Sub-Investigator: Dr. Soek Siam Tan            
Kuala Lumpur Hospital Not yet recruiting
Kuala Lumpur, Wilayah Persekutuan, Malaysia
Lam Wah Ee Hospital Recruiting
Pulau Pinang, Malaysia
Principal Investigator: Mr. Kok Thye Yip            
Island Hospital Not yet recruiting
Pulau Pinang, Malaysia
Principal Investigator: Dato' Dr. Robert Ding Phooi Huat            
Penang Hospital Recruiting
Pulau Pinang, Malaysia
Principal Investigator: Dr. Boon Phoe Ooi            
Sponsors and Collaborators
Ministry of Health, Malaysia
GeneNews Sdn Bhd
  More Information

No publications provided

Responsible Party: Professor Dato' Dr. Liew Choong Chin, GeneNews Sdn Bhd
ClinicalTrials.gov Identifier: NCT01310062     History of Changes
Other Study ID Numbers: 09-317-3991
Study First Received: March 4, 2011
Last Updated: March 4, 2011
Health Authority: Malaysia: Ministry of Health

Keywords provided by Ministry of Health, Malaysia:
hepatocellular carcinoma
microarray
gene expression profiling
biomarkers

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

ClinicalTrials.gov processed this record on May 23, 2013