NCT00858000

Brief Summary

Hepatocellular carcinoma is an aggressive disease with limited therapeutic options. Therefore, new approaches to treat this type of cancer are needed with immunotherapy potentially being one of these. As a first step in the development of novel therapies, expression analysis of specific markers, including tumor antigens will be carried out. This will be done retrospectively using available hepatocellular carcinoma tissue samples.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2009

Shorter than P25 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

First Submitted

Initial submission to the registry

March 5, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 9, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
5 months 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

December 24, 2009

Status Verified

December 1, 2009

Enrollment Period

5 months

First QC Date

March 5, 2009

Last Update Submit

December 23, 2009

Conditions

Hepatocellular Carcinoma

Keywords

markersexpression analysis

Outcome Measures

Primary Outcomes (2)

  • This study will also analyze whether this gene-expression signature is present in matched cirrhotic tissue and the interface tissue with the tumor.

    At the time of analysis.

  • Proportion of hepatocellular carcinoma cancer patients whose tumor tissue -expresses any one or more of specific target antigens -overexpresses c-MET -expresses a pre-defied gene-expression signature

    At the time of analysis.

Study Arms (1)

Group A

No intervention

Other: Retrospective analysis of already archived samples

Interventions

Retrospective analysis of already archived samplesOTHER

RNA extracted from tissue samples already archived

Group A

Eligibility Criteria

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

Primary care clinic

You may qualify if:

  • The patient had pathologically proven hepatocellular carcinoma
  • All the data required are available from patient's records
  • A sufficient amount of RNA is available for all three tissue samples

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Florence, Tuscany, 50134, Italy

Location

Biospecimen

Retention: NONE RETAINED

This retrospective study is based upon the analysis of archived samples and patient-related data already available at the investigational site

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

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

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 5, 2009

First Posted

March 9, 2009

Study Start

July 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

December 24, 2009

Record last verified: 2009-12

Locations

IT(1)