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The Development of Diagnostic Biomarker Panels for Hepatitis and Liver Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2011 by Ministry of Health, Malaysia.
Recruitment status was:  Recruiting
GeneNews Sdn Bhd
Information provided by:
Ministry of Health, Malaysia Identifier:
First received: March 4, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted
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.

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:

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

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Selected hospitals for study

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01310062

Contact: Clinical Research Centre +603-40439300 ext 113

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
Island Hospital Not yet recruiting
Pulau Pinang, Malaysia
Principal Investigator: Dato' Dr. Robert Ding Phooi Huat         
Lam Wah Ee Hospital Recruiting
Pulau Pinang, Malaysia
Principal Investigator: Mr. Kok Thye Yip         
Penang Hospital Recruiting
Pulau Pinang, Malaysia
Principal Investigator: Dr. Boon Phoe Ooi         
Sponsors and Collaborators
Ministry of Health, Malaysia
GeneNews Sdn Bhd
  More Information

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

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

Additional relevant MeSH terms:
Hepatitis A
Hepatitis B
Liver Neoplasms
Carcinoma, Hepatocellular
Hepatitis B, Chronic
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
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Hepatitis, Chronic processed this record on August 18, 2017