Skip Navigation Links

Project Information

NATIONAL UTILIZATION PATTERNS OF ONCOTYPE DX IN EARLY STAGE BREAST CANCER

Agency:
AHRQ

HHS/Agency for Healthcare Research and Quality

Project Number:
5K99HS022189-02
Contact PI / Project Leader:
DINAN, MICHAELA ANN
Awardee Organization:
DUKE UNIVERSITY

Description

Abstract Text:
DESCRIPTION (provided by applicant): The OncotypeDX 21-gene recurrence score assay (ODX) is the most widely used gene signature for guiding the management of patients with early stage, estrogen receptor positive (ER+), lymph node negative breast cancers. The use of ODX within the context of clinical trials and small patient populations indicates that in controlled settings, ODX likely changes management decisions in roughly 25-33% of patients and may reduce the use of chemotherapy and associated costs,toxicities, and impediments to quality of life, with one private insurer estimating savings of $1,200 per patient. Updated 2007 ASCO guidelines recommend that ODX testing may be used in patients to determine both patient prognosis and the relative benefit of chemotherapy. There is a critical need to understand which patients in the general U.S. cancer population actually receive ODX testing and how it affects their treatment, outcomes, and costs, as no epidemiologic studies of its use have been conducted outside of controlled clinical trial or modeling settings. In this proposal, we investigate the use of OncotypeDX (ODX) genomic testing in a nationally representative elderly breast cancer patient population. Aim 1: Characterize Nationwide Utilization of ODX in early stage breast cancer Aim 2: Investigate differential chemotherapy utilization associated with ODX utilization Aim 3: Investigate differential health care costs associated with ODX utilization The adoption of molecular medicine into general practice relies on many factors that are not addressed within the setting of clinical trials that include access to emerging technologies, variation in guideline adherence and quality of care, costs, patient demographics, regional variation, and other unobserved patient and physician factors that may significantly impact care. The proposed research addresses the significant need to understand how molecular technologies such as the Oncotype DX genomic test are being used in actual practice and details an innovative conceptual approach using novel claims methods and physician-patient sharing network modeling in combination with conventional rigorous methodologies to examine clinically important questions on a national scale in order to optimize current clinical practice fr breast cancer patients.
Project Terms:
Address; Adoption; Affect; American Society of Clinical Oncology; Biological Assay; Cancer Patient; Caring; chemotherapy; clinical practice; Clinical Trials; Controlled Clinical Trials; cost; demographics; Elderly; Emerging Technologies; Epidemiologic Studies; epidemiology study; Estrogen receptor positive; General Practices; Genes; Genomics; Guideline Adherence; Guidelines; Health Care Costs; innovation; Insurance Carriers; lymph nodes; malignant breast neoplasm; Malignant Neoplasms; Methodology; Methods; Modeling; Molecular; Molecular Medicine; network models; novel; outcome forecast; patient population; Patients; Pattern; Physicians; Population; Quality of Care; Quality of life; Recurrence; Relative (related person); Research; Savings; Staging; Technology; Testing; Toxic effect; Treatment outcome; Update; Variant

Details

Contact PI / Project Leader Information:
Name:  DINAN, MICHAELA ANN
Other PI Information:
Not Applicable
Awardee Organization:
Name:  DUKE UNIVERSITY
City:  DURHAM    
Country:  UNITED STATES
Congressional District:
State Code:  NC
District:  01
Other Information:
Fiscal Year: 2014
Award Notice Date: 11-Jul-2014
DUNS Number: 044387793
Project Start Date: 01-Aug-2013
Budget Start Date: 01-Aug-2014
CFDA Code: 226
Project End Date: 31-Jul-2015
Budget End Date: 31-Jul-2015
Agency: ?

Agency: The entity responsible for the administering of a research grant, project, or contract. This may represent a federal department, agency, or sub-agency (institute or center). Details on agencies in Federal RePORTER can be found in the FAQ page.

HHS/Agency for Healthcare Research and Quality
Project Funding Information for 2014:
Year Agency

Agency: The entity responsible for the administering of a research grant, project, or contract. This may represent a federal department, agency, or sub-agency (institute or center). Details on agencies in Federal RePORTER can be found in the FAQ page.

FY Total Cost
2014 AHRQ

HHS/Agency for Healthcare Research and Quality

$135,827

Results

i

It is important to recognize, and consider in any interpretation of Federal RePORTER data, that the publication and patent information cannot be associated with any particular year of a research project. The lag between research being conducted and the availability of its results in a publication or patent award varies substantially. For that reason, it's difficult, if not impossible, to associate a publication or patent with any specific year of the project. Likewise, it is not possible to associate a publication or patent with any particular supplement to a research project or a particular subproject of a multi-project grant.

ABOUT FEDERAL REPORTER RESULTS

Publications: i

Click on the column header to sort the results

PubMed = PubMed PubMed Central = PubMed Central Google Scholar = Google Scholar

Patents: i

Click on the column header to sort the results

Similar Projects

Download Adobe Acrobat Reader:Adobe Acrobat VERSION: 3.41.0 Release Notes
Back to Top