Hepatitis B,ChronicNCT01310062
The Development of Diagnostic Biomarker Panels for Hepatitis and Liver Cancer
An observational study of Hepatitis B,Chronic and Carcinoma,Hepatocellular, run by Ministry of Health, Malaysia at 8 sites in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B,Chronic, Carcinoma,Hepatocellular
- How many people
- 1,600 participants
- Where
- 8 sitesMalaysia
- Study dates
- Aug 2010to Aug 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Selected hospitals for study
Who may be able to join
- 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
Who cannot join
- Patients who have co-infection with HIV or chronic hepatitis C
- Subjects with other types of cancer
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Malaysia8 sites, 8 recruiting
- Recruiting
Sultanah Bahiyah Hospital
Alor Star, Kedah
Dato' Dr. Muhammad Radzi Abu Hassan
- Recruiting
Queen Elizabeth Hospital
Kota Kinabalu, Sabah
Dato' Dr. Jayaram Menon
Dr. Raman Muthukaruppan
- Not yet recruiting
Kuala Lumpur Hospital
Kuala Lumpur, Kuala Lumpur
- Not yet recruiting
Hospital Umum Kuching Sarawak
Kuching, Sarawak
Mr. Nik Azim Nik Abdullah
- Not yet recruiting
Island Hospital
Pulau Pinang, Pulau Pinang
Dato' Dr. Robert Ding Phooi Huat
- Recruiting
Lam Wah Ee Hospital
Pulau Pinang, Pulau Pinang
Mr. Kok Thye Yip
- Recruiting
Penang Hospital
Pulau Pinang, Pulau Pinang
Dr. Boon Phoe Ooi
- Recruiting
Selayang Hospital
Selayang Baru Utara, Selangor
Dr. Haniza Omar
Dr. Soek Siam Tan
About this study
Official title: 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.
- Conditions
- Hepatitis B,Chronic, Carcinoma,Hepatocellular
- Keywords
- hepatocellular carcinoma, microarray, gene expression profiling, biomarkers
- Medical subject headings
- Hepatitis B, Chronic, Carcinoma, Hepatocellular
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2011 (estimated)
- Study startAug 2010
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B,ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Malaysia
- Sponsor type
- Other government
- Collaborators
- GeneNews Sdn Bhd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01310062
- Sponsor's protocol ID
- 09-317-3991
- Status last verified
- Mar 2011
- First submitted
- 4 Mar 2011
- Last updated
- 7 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategic Alliance for The Development of Diagnostic Biomarker Panels for Hepatitis and Liver Cancer
- ClinicalTrials.gov ID
- NCT01310062
- Acronym / sponsor ID
- 09-317-3991
- Conditions
- Hepatitis B,Chronic, Carcinoma,Hepatocellular
- Keywords
- hepatocellular carcinoma, microarray, gene expression profiling, biomarkers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Ministry of Health, MalaysiaOther government
- Collaborators
- GeneNews Sdn Bhd
- Study start
- Aug 2010
- Study completion
- Aug 2012 (estimated)
- First posted
- 7 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Selected hospitals for study
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Patients who have co-infection with HIV or chronic hepatitis C
- Subjects with other types of cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B,Chronic and Carcinoma,Hepatocellular, run by Ministry of Health, Malaysia at 8 sites in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clinical Research Centre (+603-40439300 ext. 113, shanthini@crc.gov.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2011.