Breast CancerNCT01619514
Uncovering Potential Breast Cancer Biomarkers Amp; Possible Drug Targets Using Advanced Quantitative Mass Spectrometry
An observational study of Breast Cancer, run by National University Hospital, Singapore at 1 site in Singapore.
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). Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- How many people
- Not given
- Where
- 1 siteSingapore
- Study dates
- Mar 2012to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Tumor specimens that have been stored in the NUHS tissue repository will be retrieved
Who may be able to join
- Patients with breast cancer
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Nationa University Hospital
Singapore
Soo Chin Lee, MBBS, MRCP, +65 6779 5555, Soo_Chin_Lee@nuhs.edu.sg
Soo Chin Lee, MBBS, MRCP
About this study
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.
- Conditions
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2012 (estimated)
- Study startMar 2012
- Primary completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01619514
- Sponsor's protocol ID
- 2012/00106
- Status last verified
- Dec 2013
- First submitted
- 2 Apr 2012
- Last updated
- 11 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20364148Neubert TA, Tempst P. Super-SILAC for tumors and tissues. Nat Methods. 2010 May;7(5):361-2. doi: 10.1038/nmeth0510-361. No abstract available.
PubMed 20431548
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uncovering Potential Breast Cancer Biomarkers Amp; Possible Drug Targets Using Advanced Quantitative Mass Spectrometry
- ClinicalTrials.gov ID
- NCT01619514
- Acronym / sponsor ID
- 2012/00106
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Mar 2014 (estimated)
- First posted
- 14 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Tumor specimens that have been stored in the NUHS tissue repository will be retrieved
Key inclusion criteria (1 listed)
- Patients with breast cancer
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2013.
- Background: PubMed 20364148Geiger 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.
- Background: PubMed 20431548Neubert TA, Tempst P. Super-SILAC for tumors and tissues. Nat Methods. 2010 May;7(5):361-2. doi: 10.1038/nmeth0510-361. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Soo Chin Lee, MBBS, MRCP (+65 6779 5555, Soo_Chin_Lee@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the use of advanced quantitative mass spectometry (Super SILAC) as a discovery platform to uncover novel protein biomarkers in tumor. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01619514, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2013.