NCT00709085

Brief Summary

The purpose of this study is to identify genetic determinants of susceptibility to liver cirrhosis and hepatocellular carcinoma. It will assist in predicting individual risks of disease progression and would help to clarify pathophysiologic mechanisms of liver cirrhosis and hepatocellular carcinoma.

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
320

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2008

Geographic Reach
1 country

1 active site

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

April 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 3, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

November 25, 2009

Status Verified

November 1, 2009

Enrollment Period

1.7 years

First QC Date

June 30, 2008

Last Update Submit

November 23, 2009

Conditions

Liver Cirrhosis

Keywords

single nucleotide polymorphism

Study Arms (2)

1

HCC patients without liver cirrhosis

2

HCC patients with liver cirrhosis

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

A total of 596 patients with histologically proven HCC were collected by Dr. Po-Huang Lee's Lab. (The Department of Surgery, National Taiwan University Hospital, Taipei, Taiwan)

You may qualify if:

  • Clinical diagnosis of hepatocellular carcinoma
  • restrict the casual agent of liver disease to viral infection

You may not qualify if:

  • the casual aget of liver disease is not viral infection, such as alcohol abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

liver tissue (non-tumor part)

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ming-Fu Chang, Ph.D.

    National Taiwan University College of Medicine

    STUDY CHAIR

Central Study Contacts

Tzu-Min Hung, M.S.

CONTACT

886-2-2312-3456mean6722@ms65.hinet.net

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 30, 2008

First Posted

July 3, 2008

Study Start

April 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

November 25, 2009

Record last verified: 2009-11

Locations

TW(1)