The Development of Diagnostic Biomarker Panels for Hepatitis and Liver Cancer

Hepatitis B,Chronic Clinical Trial

Official title:

Strategic Alliance for The Development of Diagnostic Biomarker Panels for Hepatitis and Liver Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01310062
• Other study ID #: 09-317-3991
• Status: Recruiting
• Phase: N/A
• First received: March 4, 2011
• Last updated: March 4, 2011
• Start date: August 2010
• Est. completion date: August 2012

Study information

• Verified date: March 2011
• Source: Ministry of Health, Malaysia
• Contact: Clinical Research Centre
• Phone: +603-40439300
• Email: shanthini[@]crc.gov.my
• Is FDA regulated: No
• Health authority: Malaysia: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1600
• Est. completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Carcinoma,Hepatocellular
• Hepatitis
• Hepatitis A
• Hepatitis B, Chronic
• Hepatitis B,Chronic

Locations

Country	Name	City	State
Malaysia	Sultanah Bahiyah Hospital	Alor Star	Kedah
Malaysia	Queen Elizabeth Hospital	Kota Kinabalu	Sabah
Malaysia	Kuala Lumpur Hospital	Kuala Lumpur	Wilayah Persekutuan
Malaysia	Hospital Umum Kuching Sarawak	Kuching	Sarawak
Malaysia	Island Hospital	Pulau Pinang
Malaysia	Lam Wah Ee Hospital	Pulau Pinang
Malaysia	Penang Hospital	Pulau Pinang
Malaysia	Selayang Hospital	Selayang	Selangor

Sponsors (2)

Lead Sponsor	Collaborator
Ministry of Health, Malaysia	GeneNews Sdn Bhd

Country where clinical trial is conducted

Malaysia,