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Analysis of Prognostic and Predictive Genomic Signatures Using Archival Paraffin-embedded Breast Tumor - a Pilot Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by National University Hospital, Singapore.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT01247467
First received: August 26, 2010
Last updated: November 23, 2010
Last verified: November 2010
History of Changes
  Purpose

A number of prognostic and/or predictive genomic signatures for breast cancer have been developed by Genome Institute of Singapore (GIS). In the past 1 year, GIS has developed protocols and methods to conduct expression assays from formalin-fixed, paraffin-embedded (FFPE) tumor specimens. A study on 800 tumor samples is planned to analyze these gene signatures and compare them with conventional clinical prognosticators and predictors. As the investigators plan to use archival tumor samples that dates back to the 1990s, the aim of this pilot study is to first analyze 10 anonymized samples to determine the feasibility of running these assays on old archival blocks. The information generated will help us determine whether very old samples (diagnosed before 2000) may be selected for the actual study.


Condition Intervention
Breast Tumor
 Other: Breast Tumor Blocks

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National University Hospital, Singapore:

Estimated Enrollment: 10
Study Start Date: August 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Breast Tumor
Breast Tumor Blocks
 Other: Breast Tumor Blocks

Detailed Description:

Up to 10 archival breast tumor blocks will be obtained from the Department of Pathology, NUH - half of these blocks will be from patients who were diagnosed before year 2000, and the other half of the blocks will be from patients diagnosed between year 2000-2005 (control specimens). Basic tumor and patient information will be collected without patient identifiers - grade, stage, ER/PR/HER2 status, treatment received, outcome data. 8-10 ten-micron sections will be cut from each tumor block. RNA will be extracted from the tumor sections using the Roche High Pure FFPE RNA Micro Kit. RNA will be profiled using the Illumina Veracode assay and the Affymetrix Quantigene assay. RNA extraction and gene expression profiling will be performed by collabroators at the Genome Institute of Singapore.

  Eligibility

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

Archival tumor samples that dates back to the 1990s

Criteria

Inclusion Criteria:

  • Half of these blocks will be from breast cancer patients who were diagnosed before year 2000.
  • Half of the blocks will be from breast cancer patients diagnosed between year 2000-2005 (control specimens).

Exclusion Criteria:

  • Breast cancer patients diagnosed after year 2005.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01247467

Locations
Singapore
National University Hospital
Singapore, Singapore
Sponsors and Collaborators
National University Hospital, Singapore
Investigators
Principal Investigator: Soo Chin Lee, MBBS, MRCP National University Hospital, Singapore
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT01247467     History of Changes
Other Study ID Numbers: BR04/21/10
Study First Received: August 26, 2010
Last Updated: November 23, 2010
Health Authority: Singapore: Domain Specific Review Boards

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 16, 2013