NCT00629421

Brief Summary

Although serum alpha-fetoprotein level and abdominal sonography are the main methods to screening hepatocellular carcinoma (HCC) in cirrhotic patients, the adequate time and methods used are not completely well-defined. This study aims to assess the better timing and methods for prospectively screening HCC in patients with cirrhosis

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2001

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2001

Completed
7.2 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 6, 2008

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
Last Updated

August 22, 2017

Status Verified

August 1, 2017

Enrollment Period

16 years

First QC Date

February 26, 2008

Last Update Submit

August 20, 2017

Conditions

CirrhosisHepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

  • development of hepatocellular carcinoma

    nodule (with or without seum AFP greater than 400 ng/ml) confirmed by biopsy

    during observation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Well-dignosed patients with cirrhosis

You may qualify if:

  • Image diagnosis or biochemical diagnosis or presence of portal hypertension

You may not qualify if:

  • Presence of hepatocellular carcinoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

Location

MeSH Terms

Conditions

FibrosisCarcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Jung-Fa Tsai, M.D., Ph.D.

    Kaohsiung Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

February 26, 2008

First Posted

March 6, 2008

Study Start

January 1, 2001

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

August 22, 2017

Record last verified: 2017-08

Locations

TW(1)