Comparative Genomic and Genetic Analysis of Paired Primary Breast - Metastatic Tumor Specimens Using High-throughput Platforms
1 other identifier
observational
N/A
1 country
1
Brief Summary
Adequate quality and quantity of RNA may be extracted from paraffin-embedded tumor blocks for gene expression analysis. This has clinical relevance as gene expression signatures may then be profiled using archival tumor blocks, which are more readily available than frozen tissues.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Aug 2010
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 21, 2010
CompletedFirst Posted
Study publicly available on registry
October 25, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedJanuary 22, 2014
January 1, 2014
4.3 years
October 21, 2010
January 21, 2014
Conditions
Study Arms (1)
Breast Tumor
Breast Tumor Blocks
Interventions
Eligibility Criteria
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.
You may qualify if:
- No participants are involved.
You may not qualify if:
- No participants are involved.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National University Hospital
Singapore, Singapore, Singapore
Related 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.
PMID: 20339913BACKGROUNDLim YW, Goh BC, Wang LZ, Tan SH, Chuah BYS, 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):2175-2182. doi: 10.1093/annonc/mdq230. Epub 2010 Apr 29.
PMID: 20430905BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 21, 2010
First Posted
October 25, 2010
Study Start
August 1, 2010
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
January 22, 2014
Record last verified: 2014-01