Breast TumorNCT01247467
Analysis of Prognostic and Predictive Genomic Signatures Using Archival Paraffin-embedded Breast Tumor - a Pilot Study
An observational study of Breast Tumor, run by National University Hospital, Singapore at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Tumor
- What is being tested?
- Breast Tumor Blocks
- How many people
- 10 participants
- Where
- 1 siteSingapore
- Study dates
- Aug 2010to Dec 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: Archival tumor samples that dates back to the 1990s
Who may be able to join
- 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).
Who cannot join
- Breast cancer patients diagnosed after year 2005.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Breast Tumor
- Being tested
- Breast Tumor Blocks
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast Tumor BlocksOther
| Study group | Role | What they receive |
|---|---|---|
| Breast Tumor | Breast Tumor Blocks Receives: Other: Breast Tumor Blocks |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2010 (estimated)
- Study startAug 2010
- Primary completionDec 2014 (estimated)
- Study completionDec 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 TumorStudies 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
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Investigators
- Soo Chin Lee, MBBS, MRCP, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01247467
- Sponsor's protocol ID
- BR04/21/10
- Status last verified
- Jan 2014
- First submitted
- 26 Aug 2010
- Last updated
- 22 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20339913Lim 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.
PubMed 20430905
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Prognostic and Predictive Genomic Signatures Using Archival Paraffin-embedded Breast Tumor - a Pilot Study
- ClinicalTrials.gov ID
- NCT01247467
- Acronym / sponsor ID
- BR04/21/10
- Conditions
- Breast Tumor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 24 Nov 2010 (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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast Tumor | – | Other: Breast Tumor BlocksBreast Tumor Blocks |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Archival tumor samples that dates back to the 1990s
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (1 listed)
- Breast cancer patients diagnosed after year 2005.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breast Tumor Blocks | Other | Breast Tumor |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2014.
- Background: PubMed 20339913Barrios 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.
- Background: PubMed 20430905Lim 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.
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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.
Soo Chin Lee, MBBS, MRCP principal investigator
National University Hospital, Singapore
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 Tumor, 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 2 inclusion and 1 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 22 Jan 2014. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01247467, 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 22 Jan 2014.