NCT01310062

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2010

Geographic Reach
1 country

8 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 7, 2011

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

March 7, 2011

Status Verified

March 1, 2011

First QC Date

March 4, 2011

Last Update Submit

March 4, 2011

Conditions

Keywords

hepatocellular carcinomamicroarraygene expression profilingbiomarkers

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Selected hospitals for study

You may qualify if:

  • 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

You may not qualify if:

  • Patients who have co-infection with HIV or chronic hepatitis C
  • Subjects with other types of cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Sultanah Bahiyah Hospital

Alor Star, Kedah, Malaysia

RECRUITING

Kuala Lumpur Hospital

Kuala Lumpur, Kuala Lumpur, Malaysia

NOT YET RECRUITING

Island Hospital

Pulau Pinang, Pulau Pinang, Malaysia

NOT YET RECRUITING

Lam Wah Ee Hospital

Pulau Pinang, Pulau Pinang, Malaysia

RECRUITING

Penang Hospital

Pulau Pinang, Pulau Pinang, Malaysia

RECRUITING

Queen Elizabeth Hospital

Kota Kinabalu, Sabah, Malaysia

RECRUITING

Hospital Umum Kuching Sarawak

Kuching, Sarawak, Malaysia

NOT YET RECRUITING

Selayang Hospital

Selayang Baru Utara, Selangor, Malaysia

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Red blood cell and white blood cell

MeSH Terms

Conditions

Hepatitis B, ChronicCarcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by Site

Central Study Contacts

Clinical Research Centre

CONTACT

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

March 4, 2011

First Posted

March 7, 2011

Study Start

August 1, 2010

Study Completion

August 1, 2012

Last Updated

March 7, 2011

Record last verified: 2011-03

Locations