The Development of Diagnostic Biomarker Panels for Hepatitis and Liver Cancer

Sponsor

Ministry of Health, Malaysia (Other)

Overall Status

Unknown status

CT.gov ID

NCT01310062

Collaborator

GeneNews Sdn Bhd (Other)

1,600

Enrollment

Locations

Duration (Months)

200

Patients Per Site

8.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis B,Chronic Carcinoma,Hepatocellular

Study Design

Study Type:

Observational

Anticipated Enrollment :

1600 participants

Time Perspective:

Cross-Sectional

Official Title:

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

Study Start Date :

Aug 1, 2010

Anticipated Study Completion Date :

Aug 1, 2012

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country
1	Sultanah Bahiyah Hospital	Alor Star	Kedah	Malaysia
2	Queen Elizabeth Hospital	Kota Kinabalu	Sabah	Malaysia
3	Hospital Umum Kuching Sarawak	Kuching	Sarawak	Malaysia
4	Selayang Hospital	Selayang	Selangor	Malaysia
5	Kuala Lumpur Hospital	Kuala Lumpur	Wilayah Persekutuan	Malaysia
6	Island Hospital	Pulau Pinang		Malaysia
7	Lam Wah Ee Hospital	Pulau Pinang		Malaysia
8	Penang Hospital	Pulau Pinang		Malaysia