NCT01177631

Brief Summary

This is a pilot study to evaluate the difference between the protein expression between hepatocellular carcinoma and tumor with vessel invasion in Asian patients with hepatocellular carcinoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2009

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

February 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
7 months until next milestone

First Posted

Study publicly available on registry

August 9, 2010

Completed
Last Updated

February 5, 2016

Status Verified

February 1, 2016

Enrollment Period

11 months

First QC Date

June 2, 2009

Last Update Submit

February 4, 2016

Conditions

Carcinoma, Hepatocellular

Keywords

Carcinoma, hepatocellularPortal veinProteomics

Outcome Measures

Primary Outcomes (1)

  • Recurrence

    Evidence of clinically definite vascular invasion of hepatocellular carcinoma. Confirmed by operation. Compare the proteomic expression of tumor, non-tumor ans tumor tissue in vascular part.

    one year

Interventions

OperationPROCEDURE

Operation for clinically evaluated resectable hepatocelluar carcinoma. Compare the different expression of protein between tumor, non-tumor and tumor with vascular invasion part.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Arm A: Hepatocellular carcinoma with vessel invasion:
  • hepatocellular carcionoma, pathologic diagnosed.
  • image documented vessel invasion, including portal vein thrombosis
  • eligible for surgical intervension.
  • Arm B: hepatocellular carcinoma without vessel invasion:
  • hepatocellular carcinoma, pathologic diagnosed or clinical diagnosed according to EASL criteria.
  • no vessel invasion on image.
  • Arm C: Healthy hepatitis carrier:
  • patients age \>18 years old with hepatitis B or C
  • normal liver function.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Far Eastern Memorial Hospital

Taipei, 220, Taiwan

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

June 2, 2009

First Posted

August 9, 2010

Study Start

February 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

February 5, 2016

Record last verified: 2016-02

Locations

TW(1)