Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Analysis of Expression of Specific Markers in Hepatocellular Carcinoma

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00858000
First received: March 5, 2009
Last updated: December 23, 2009
Last verified: December 2009
  Purpose

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.


Condition Intervention
Hepatocellular Carcinoma
Other: Retrospective analysis of already archived samples

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Analysis of the Incidence of Expression of a Specific Set of Genes and of Tumor Antigens in Cancer Tissue From Patients With Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • This study will also analyze whether this gene-expression signature is present in matched cirrhotic tissue and the interface tissue with the tumor. [ Time Frame: At the time of analysis. ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: At the time of analysis. ] [ Designated as safety issue: No ]

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


Enrollment: 30
Study Start Date: July 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group A
No intervention
Other: Retrospective analysis of already archived samples
RNA extracted from tissue samples already archived

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

N/A

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00858000

Locations
Italy
GSK Investigational Site
Firenze, Toscana, Italy, 50134
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00858000     History of Changes
Other Study ID Numbers: 111722
Study First Received: March 5, 2009
Last Updated: December 23, 2009
Health Authority: Italy: Agenzia Italiana del Farmaco

Keywords provided by GlaxoSmithKline:
markers
expression analysis

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Adenocarcinoma
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 25, 2014