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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT01247467
First received: August 26, 2010
Last updated: January 21, 2014
Last verified: January 2014

August 26, 2010
January 21, 2014
August 2010
December 2014   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01247467 on ClinicalTrials.gov Archive Site
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Analysis of Prognostic and Predictive Genomic Signatures Using Archival Paraffin-embedded Breast Tumor - a Pilot Study
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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.

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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Non-Probability Sample

Archival tumor samples that dates back to the 1990s

Breast Tumor
Other: Breast Tumor Blocks
Breast Tumor
Breast Tumor Blocks
Intervention: Other: Breast Tumor Blocks

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
10
December 2014
December 2014   (final data collection date for primary outcome measure)

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.
Female
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No
Contact information is only displayed when the study is recruiting subjects
Singapore
 
NCT01247467
BR04/21/10
No
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National University Hospital, Singapore
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Principal Investigator: Soo Chin Lee, MBBS, MRCP National University Hospital, Singapore
National University Hospital, Singapore
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP