- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01310062
The Development of Diagnostic Biomarker Panels for Hepatitis and Liver Cancer
March 4, 2011 updated by: Ministry of Health, Malaysia
Strategic Alliance for The Development of Diagnostic Biomarker Panels for Hepatitis and Liver Cancer
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.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
1600
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pulau Pinang, Malaysia
- Not yet recruiting
- Island Hospital
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Principal Investigator:
- Dato' Dr. Robert Ding Phooi Huat
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Pulau Pinang, Malaysia
- Recruiting
- Lam Wah Ee Hospital
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Principal Investigator:
- Mr. Kok Thye Yip
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Pulau Pinang, Malaysia
- Recruiting
- Penang Hospital
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Principal Investigator:
- Dr. Boon Phoe Ooi
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Kedah
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Alor Star, Kedah, Malaysia
- Recruiting
- Sultanah Bahiyah Hospital
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Principal Investigator:
- Dato' Dr. Muhammad Radzi Abu Hassan
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Sabah
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Kota Kinabalu, Sabah, Malaysia
- Recruiting
- Queen Elizabeth Hospital
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Principal Investigator:
- Dato' Dr. Jayaram Menon
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Sub-Investigator:
- Dr. Raman Muthukaruppan
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Sarawak
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Kuching, Sarawak, Malaysia
- Not yet recruiting
- Hospital Umum Kuching Sarawak
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Principal Investigator:
- Mr. Nik Azim Nik Abdullah
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Selangor
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Selayang, Selangor, Malaysia
- Recruiting
- Selayang Hospital
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Principal Investigator:
- Dr. Haniza Omar
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Sub-Investigator:
- Dr. Soek Siam Tan
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Wilayah Persekutuan
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Kuala Lumpur, Wilayah Persekutuan, Malaysia
- Not yet recruiting
- Kuala Lumpur Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Selected hospitals for study
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2010
Study Completion (ANTICIPATED)
August 1, 2012
Study Registration Dates
First Submitted
March 4, 2011
First Submitted That Met QC Criteria
March 4, 2011
First Posted (ESTIMATE)
March 7, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
March 7, 2011
Last Update Submitted That Met QC Criteria
March 4, 2011
Last Verified
March 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Digestive System Neoplasms
- Liver Diseases
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis, Chronic
- Hepatitis B
- Hepatitis
- Carcinoma, Hepatocellular
- Hepatitis A
- Hepatitis B, Chronic
- Liver Neoplasms
Other Study ID Numbers
- 09-317-3991
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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