The Development of Diagnostic Biomarker Panels for Hepati... | NCT01310062

Studies
The Development of Diagnostic Biomarker Panels for Hepatitis and Liver Cancer

NCT01310062

Sponsor

Ministry of Health, Malaysia

Status

Unknown status

Last Update Posted

Mar 7, 2011Estimated

Enrollment

1,600Estimated

Phase

Not provided

Conditions

Hepatitis B,Chronic
Carcinoma,Hepatocellular

Interventions

Not provided

Countries

Malaysia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2010

Primary Completion Date

Not provided

Completion Date

Aug 2012Estimated

First Submitted Date

Mar 4, 2011

First Submission Date that Met QC Criteria

Mar 4, 2011

First Posted Date

Mar 7, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 4, 2011

Last Update Posted Date

Mar 7, 2011Estimated

Name	Class
GeneNews Sdn Bhd	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,600Estimated

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Selected hospitals for study

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Clinical Research Centre	Contact	+603-40439300	113	shanthini@crc.gov.my

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sultanah Bahiyah Hospital	Recruiting	Alor Star	Kedah		Malaysia

Condition Browse Module

MeSH Terms

ID	Term
D019694	Hepatitis B, Chronic
D006528	Carcinoma, Hepatocellular

Ancestor Terms

ID	Term
D006509	Hepatitis B
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided