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I-SPY
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Overview
The I-SPY trial is a national study to identify biomarkers predictive of response to
therapy throughout the treatment cycle for women with Stage 3 breast cancer.
The I-SPY study is sponsored by the Specialized Programs of Research Excellence
(SPORES) and includes participation from the Cancer and Leukemia Group B (CALGB)
and American College of Radiology Imaging Network (ACRIN). The study involves
the use of a contrast-enhanced breast MRI for the evaluation of locally-advanced
breast cancer patients undergoing neoadjuvant treatment. The I-SPY study aims
to correlate MRI results with molecular markers to identify the right surrogate
marker for early response.
The I-SPY informatics effort involves providing informatics support for the I-SPY trial.
This involves the integration, and analysis of diverse data types including clinical,
MRI imaging, gene expression, Comparative Genome Hybridization (CGH), immunohistochemistry
(IHC), Fluorescent In Situ Hybridization (FISH), and cell lysates throughout the breast
cancer treatment cycle. By providing an integrative platform designed to correlate
molecular data with MRI patterns, study researchers will be able to more effectively
identify surrogate markers for early response which will ultimately result in more
effective therapies for breast cancer patients.
To facilitate the integration and analysis of diverse data types, the NCICB
caIntegrator data warehousing solution in conjunction with existing NCICB datamarts
will be leveraged. caIntegrator data mining query and reporting tools will be
accessible via a customized I-SPY application portal. The application portal
will illustrate how research data is shared across study organizations and
integrated in support of translational research.
Due to data access restrictions, the I-SPY data portal and the quality indicator portal are currently available only to I-SPY investigators.
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Objectives
The main research objectives of the I-SPY trial are to:
- Identify biomarkers that predict response to therapy throughout the course of the
cancer treatment cycle.
- Identify surrogate markers of response to preoperative chemotherapy that are
predictive of survival and pathologic remission in Stage 3 breast cancer.
- Determine whether molecular markers alone or in conjunction with MRI will
predict 3 year disease free survival and whether these markers are good predictors of
residual disease at the time of surgery.
- Classify groups of participants with statistically different disease free survival.
- Determine the correlation between molecular markers and MRI imaging patterns.
The informatics objectives supporting the I-SPY trial are to:
- Collect and share biomedical research study results with study members,
the SPORES community, and the NCI intramural/extramural community.
- Integrate biomedical research study results and analyze in support of translational research.
- Provide technologies supporting the capture and identification of biomarkers and surrogate
markers that predict clinical outcome.
- Design technologies that can be re-used and customized to support a variety of
cancer studies.
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Potential Benefits
The information learned in the I-SPY effort will assist physicians in providing a
better prognosis for breast cancer patients and selecting more effective treatments
based on a patient’s clinical and genomic signature. The I-SPY effort will also result
in better integration of diverse data types across the research spectrum, directly
supporting translational research. Additionally, the informatics platform will
facilitate data sharing and scientific collaboration amongst research shareholders
including cancer centers, cooperative groups, SPORES, and the NCI community.
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Detailed Scope
The scope of the I-SPY Informatics effort involves the capture and integration of I-SPY
study data from Stage 3 breast cancer patients treated with neo-adjuvant chemotherapy in
a phased implementation approach. Below are details of each Phase:
Phase 1: Requirements Analysis and Proof-of-Concept
The Phase 1 requirements analysis will include the development of use cases, wire frames,
and workflow documentation supporting the capture and integration of select I-SPY data components.
The I-SPY proof-of-concept will demonstrate the capture of pre-analysis data (quality indicators)
as well as the integration of clinical, gene expression, and CGH data via the caIntegrator
data warehouse framework. This includes the development of an I-SPY data warehouse and
customized caIntegrator query and reporting tools that will be shared among several
participating organizations via the I-SPY data portal. Query and reporting tools will
facilitate the analysis of proliferation markers, angiogenesis, apoptosis, hormone
receptors, gene expression arrays, and MRI measurements.
The I-SPY requirements analysis effort for the prototype was completed in Q4 2004 and
the proof-of-concept with support for gene expression, IHC, FISH and clinical outcomes was delivered to the ISPY investigator community in Q2 2005
Phase 2: Support for Additional Data types
The Phase 2 effort will involve support for additional data types MRI images, and cell lysates. This will involve extensions to the I-SPY
data warehouse and ad hoc query and reporting tools.
Support for additional data types is scheduled for a Q2 2006 completion.
In addition to the data portal, a quality indicator portal was created to capture quality data for the frozen adn paraffin sections collected on this trial.
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Integration
The I-SPY effort involves leveraging and extending existing NCICB infrastructure
components and software applications. These components and applications will become
part of the Cancer Bioinformatics Grid (caBIG) architecture as caBIG is developed
and fully realized. The practical experience gained in supporting I-SPY will ensure
that these components and applications are robust parts of caBIG as it is developed.
Additionally, this experience can be leveraged in other studies throughout the NCI
intramural and extramural community.
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