COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01247467
Recruitment Status : Unknown
Verified January 2014 by National University Hospital, Singapore.
Recruitment status was:  Active, not recruiting
First Posted : November 24, 2010
Last Update Posted : January 22, 2014
Information provided by:
National University Hospital, Singapore

Brief Summary:
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 or disease Intervention/treatment
Breast Tumor 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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Retrospective
Study Start Date : August 2010
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort Intervention/treatment
Breast Tumor
Breast Tumor Blocks
Other: Breast Tumor Blocks

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Archival tumor samples that dates back to the 1990s

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01247467

Layout table for location information
National University Hospital
Singapore, Singapore
Sponsors and Collaborators
National University Hospital, Singapore
Layout table for investigator information
Principal Investigator: Soo Chin Lee, MBBS, MRCP National University Hospital, Singapore
Layout table for additonal information Identifier: NCT01247467    
Other Study ID Numbers: BR04/21/10
First Posted: November 24, 2010    Key Record Dates
Last Update Posted: January 22, 2014
Last Verified: January 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases