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

Breast Tumor Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01247467
• Other study ID #: BR04/21/10
• Status: Active, not recruiting
• Phase: N/A
• First received: August 26, 2010
• Last updated: January 21, 2014
• Start date: August 2010
• Est. completion date: December 2014

Study information

• Verified date: January 2014
• Source: National University Hospital, Singapore
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Domain Specific Review Boards
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Breast Neoplasms
• Breast Tumor

Intervention

Other:
• Breast Tumor Blocks

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

References & Publications (2)

Barrios CH, Liu MC, Lee SC, Vanlemmens L, Ferrero JM, Tabei T, Pivot X, Iwata H, Aogi K, Lugo-Quintana R, Harbeck N, Brickman MJ, Zhang K, Kern KA, Martin M. Phase III randomized trial of sunitinib versus capecitabine in patients with previously treated HER2-negative advanced breast cancer. Breast Cancer Res Treat. 2010 May;121(1):121-31. doi: 10.1007/s10549-010-0788-0. Epub 2010 Mar 26. — View Citation

Lim YW, Goh BC, Wang LZ, Tan SH, Chuah BY, Lim SE, Iau P, Buhari SA, Chan CW, Sukri NB, Cordero MT, Soo R, Lee SC. Pharmacokinetics and pharmacodynamics of docetaxel with or without ketoconazole modulation in chemonaive breast cancer patients. Ann Oncol. 2010 Nov;21(11):2175-82. doi: 10.1093/annonc/mdq230. Epub 2010 Apr 29. — View Citation