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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01619514
Other study ID # 2012/00106
Secondary ID
Status Recruiting
Phase N/A
First received April 2, 2012
Last updated December 10, 2013
Start date March 2012

Study information

Verified date December 2013
Source National University Hospital, Singapore
Contact Soo Chin Lee, MBBS, MRCP
Phone +65 6779 5555
Email Soo_Chin_Lee@nuhs.edu.sg
Is FDA regulated No
Health authority Singapore: Domain Specific Review Boards
Study type Observational

Clinical Trial Summary

The purpose of this study is to evaluate the use of advanced quantitative mass spectometry (Super SILAC) as a discovery platform to uncover novel protein biomarkers in tumor and to compare the protein profile between different subtypes of breast cancer (ER positive, HER2 positive, triple negative). A maximum of 100 breast tumor specimens will be obtained from the NUHS Tissue repository, comprising approximately equal proportion of ER positive, HER2 positive, and triple negative tumors. Samples will be analyzed using advanced Mass Spectrometry (Super SILAC) as a discovery platform to identify novel protein biomarkers that may be important in cancer. DNA and RNA will also be extracted from tumor samples for correlative analysis with the proteomics data. Genomics and proteomics data will be correlated with clinical data including treatment response and survival data. Importance of proposed research to science or medicine:Identification of tumor biomarkers may allow better prognostication, follow-up, and selection of treatment for cancer patients in the future. Potential benefits and risks: No direct benefit to the patient. Risk to the subjects is minimal as there is no direct patient contact, and analysis is done on previously donated tumor samples. Patients have previously provided consent to donate their samples for research into the NUHS Tissue Repository.

Novel tumor biomarkers that determine tumor biology, including prognosis and treatment sensitivity, may be detectable using the novel advanced quantitative mass spectromy method (Super SILAC). Different subtypes of breast cancers will have different proteomic profiles analyzed using super SILAC.


Recruitment information / eligibility

Status Recruiting
Enrollment 0
Est. completion date
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients with breast cancer

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
Singapore Nationa University Hospital Singapore

Sponsors (1)

Lead Sponsor Collaborator
National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

References & Publications (2)

Geiger T, Cox J, Ostasiewicz P, Wisniewski JR, Mann M. Super-SILAC mix for quantitative proteomics of human tumor tissue. Nat Methods. 2010 May;7(5):383-5. doi: 10.1038/nmeth.1446. Epub 2010 Apr 4. — View Citation

Neubert TA, Tempst P. Super-SILAC for tumors and tissues. Nat Methods. 2010 May;7(5):361-2. doi: 10.1038/nmeth0510-361. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluate the use of advanced quantitative mass spectometry (Super SILAC) as a discovery platform to uncover novel protein biomarkers in tumor SILAC is a method of advanced quantitative mass spectometry that allows whole proteome analysis as comprehensively as transcriptome analysis. It allows quantification of whole-proteome, measure post-translational modifications and map complete interactome of a protein. Super-SILAC, an improvement of the SILAC method, enables the comparison of the amounts of hundreds or thousands of proteins from a particular tissue between different patients. This technology may enable the discovery of novel tumor protein markers that may be important in tumor progression and treatment response.
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