NCT00767936

Brief Summary

Adult liver cancer is the third leading cause of cancer deaths worldwide. The major risk factor for liver cancer is hepatitis B virus (HBV) infection. The purpose of the study is to sequence the HBV genome in patients with chronic HBV infection, and in patients with liver cancer resulting from chronic HBV infection. The goal is to identify mutations in the HBV genome that predisposes these high risk individuals to the development of liver cancer.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
135

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 7, 2008

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

June 29, 2016

Status Verified

June 1, 2016

Enrollment Period

5 years

First QC Date

October 3, 2008

Last Update Submit

June 28, 2016

Conditions

Liver CancerHepatitis BHepatitis CHepatobiliary Cancers LiverHepatobiliary Cancers

Outcome Measures

Primary Outcomes (1)

  • identify mutations in the hepatitis B virus genome that predisposes these high risk individuals to the development of liver cancer

    We will be using blood specimens collected through another protocol

    one time

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

liver cancer and non-cancer liver conditions

You may qualify if:

  • \. Patients with non-cancer liver conditions such as cirrhosis, adenoma, cholangioma, or nodular hyperplasia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood

MeSH Terms

Conditions

Liver NeoplasmsHepatitis BHepatitis C

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver DiseasesBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisFlaviviridae InfectionsRNA Virus Infections

Study Officials

  • Samuel So

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2008

First Posted

October 7, 2008

Study Start

March 1, 2008

Primary Completion

March 1, 2013

Study Completion

September 1, 2013

Last Updated

June 29, 2016

Record last verified: 2016-06

Locations

US(1)