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Grant Details

Grant Number: 5UC2CA148310-02 Interpret this number
Primary Investigator: Armstrong, Katrina
Organization: University Of Pennsylvania
Project Title: Comparative Effectiveness in Genomic Medicine
Fiscal Year: 2010
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Abstract

DESCRIPTION (Provided by the applicant): Advances in genomics have the potential to improve the delivery of health care by targeting interventions to individuals who will receive the greatest benefit and experience the lowest risk of adverse events. More effective targeting of interventions is particularly appealing because it is one of the few approaches that can both improve outcomes and reduce costs- the unquestioned sweet spot of health care reform. However, genomic medicine has a long way to go before it gets to that sweet spot. Some of what is needed is discovery of gene-disease associations that lead to the development of a clinical genetic test. But increasingly, the needs lie not in developing the test but in deciding whether using the test is better than doing what we are currently doing - i.e. comparative effectiveness. The overarching goal of this project is to develop a coordinated, multidisciplinary center for the generation and synthesis of evidence to support the translation of genomic tests into improvements in cancer prevention, screening, diagnosis, treatment and survivorship. The center (entitled the Center for Comparative Effectiveness in Genomic Medicine or CCEGM) will involve two primary scientific components: (1) evidence generation; and (2) evidence synthesis and modeling. The goal of the evidence generation component is to conduct observational and experimental studies of the comparative effectiveness of genomic test that are clinically available or nearly clinically available. Four proof of principle, pilot studies are included in this proposal: (1) pharmacogenomics of nicotine addiction treatment; (2) incremental information from breast cancer SNP panels in breast cancer risk screening and prevention; (3) personalized treatment for non small cell lung cancer; and (4) CDKN2A/p16 testing and adherence to melanoma prevention behaviors. The goal of the evidence synthesis component is to use statistical and modeling methods to bring together existing evidence to inform recommendations about clinical practice. Three corresponding evidence synthesis pilot projects are included: a systematic review of the clinical validity of EGFr and K-ras mutations in predicting response to treatment, a decision model of the use of SNP panels in breast cancer screening, a cost- effectiveness model of nicotine metabolism markers in treatment of nicotine addiction. PUBLIC HEALTH RELEVANCE: Advances in genomics have the potential to improve the delivery of health care. Increasingly, there is a need to decide whether the use of genomic tests is better than doing what we are currently doing - i.e. comparative effectiveness. The overarching goal of this project is to develop a coordinated, multidisciplinary center for the generation and synthesis of evidence to support the translation of genomic tests into improvements in cancer prevention, screening, diagnosis, treatment and survivorship.

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Publications

Associations between breast density and a panel of single nucleotide polymorphisms linked to breast cancer risk: a cohort study with digital mammography.
Authors: Keller B.M. , McCarthy A.M. , Chen J. , Armstrong K. , Conant E.F. , Domchek S.M. , Kontos D. .
Source: BMC cancer, 2015-03-18; 15, p. 143.
EPub date: 2015-03-18.
PMID: 25881232
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Effectiveness of androgen-deprivation therapy and radiotherapy for older men with locally advanced prostate cancer.
Authors: Bekelman J.E. , Mitra N. , Handorf E.A. , Uzzo R.G. , Hahn S.A. , Polsky D. , Armstrong K. .
Source: Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2015-03-01; 33(7), p. 716-22.
EPub date: 2015-01-05.
PMID: 25559808
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Effects of tailored risk communications for skin cancer prevention and detection: the PennSCAPE randomized trial.
Authors: Glanz K. , Volpicelli K. , Jepson C. , Ming M.E. , Schuchter L.M. , Armstrong K. .
Source: Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology, 2015 Feb; 24(2), p. 415-21.
EPub date: 2014-11-28.
PMID: 25432953
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The use of the Gail model, body mass index and SNPs to predict breast cancer among women with abnormal (BI-RADS 4) mammograms.
Authors: McCarthy A.M. , Keller B. , Kontos D. , Boghossian L. , McGuire E. , Bristol M. , Chen J. , Domchek S. , Armstrong K. .
Source: Breast cancer research : BCR, 2015-01-08; 17, p. 1.
EPub date: 2015-01-08.
PMID: 25567532
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Determinants of survival in advanced non--small-cell lung cancer in the era of targeted therapies.
Authors: Bauml J. , Mick R. , Zhang Y. , Watt C.D. , Vachani A. , Aggarwal C. , Evans T. , Langer C. .
Source: Clinical lung cancer, 2013 Sep; 14(5), p. 581-91.
EPub date: 2013-07-01.
PMID: 23827517
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Frequency of EGFR and KRAS mutations in patients with non small cell lung cancer by racial background: do disparities exist?
Authors: Bauml J. , Mick R. , Zhang Y. , Watt C.D. , Vachani A. , Aggarwal C. , Evans T. , Langer C. .
Source: Lung cancer (Amsterdam, Netherlands), 2013 Sep; 81(3), p. 347-353.
EPub date: 2013-06-24.
PMID: 23806795
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Radical cystectomy versus bladder-preserving therapy for muscle-invasive urothelial carcinoma: examining confounding and misclassification biasin cancer observational comparative effectiveness research.
Authors: Bekelman J.E. , Handorf E.A. , Guzzo T. , Evan Pollack C. , Christodouleas J. , Resnick M.J. , Swisher-McClure S. , Vaughn D. , Ten Have T. , Polsky D. , et al. .
Source: Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research, 2013 Jun; 16(4), p. 610-8.
EPub date: 2013-04-24.
PMID: 23796296
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Incremental impact of breast cancer SNP panel on risk classification in a screening population of white and African American women.
Authors: McCarthy A.M. , Armstrong K. , Handorf E. , Boghossian L. , Jones M. , Chen J. , Demeter M.B. , McGuire E. , Conant E.F. , Domchek S.M. .
Source: Breast cancer research and treatment, 2013 Apr; 138(3), p. 889-98.
EPub date: 2013-03-10.
PMID: 23474973
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Melanoma genetic testing, counseling, and adherence to skin cancer prevention and detection behaviors.
Authors: Glanz K. , Volpicelli K. , Kanetsky P.A. , Ming M.E. , Schuchter L.M. , Jepson C. , Domchek S.M. , Armstrong K. .
Source: Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology, 2013 Apr; 22(4), p. 607-14.
EPub date: 2013-02-07.
PMID: 23392000
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EVALUATING COSTS WITH UNMEASURED CONFOUNDING: A SENSITIVITY ANALYSIS FOR THE TREATMENT EFFECT.
Authors: Handorf E.A. , Bekelman J.E. , Heitjan D.F. , Mitra N. .
Source: The annals of applied statistics, 2013; 7(4), p. 2062-2080.
PMID: 24587844
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Breast cancer risk prediction and mammography biopsy decisions: a model-based study.
Authors: Armstrong K. , Handorf E.A. , Chen J. , Bristol Demeter M.N. .
Source: American journal of preventive medicine, 2013 Jan; 44(1), p. 15-22.
PMID: 23253645
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Effect of HIV on survival in patients with non-small-cell lung cancer in the era of highly active antiretroviral therapy: a population-based study.
Authors: Rengan R. , Mitra N. , Liao K. , Armstrong K. , Vachani A. .
Source: The Lancet. Oncology, 2012 Dec; 13(12), p. 1203-9.
EPub date: 2012-11-16.
PMID: 23164952
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Methods in comparative effectiveness research.
Authors: Armstrong K. .
Source: Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2012-12-01; 30(34), p. 4208-14.
EPub date: 2012-10-15.
PMID: 23071240
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Genomics and health care disparities: the role of statistical discrimination.
Authors: Armstrong K. .
Source: JAMA, 2012-11-21; 308(19), p. 1979-80.
PMID: 23138130
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Cost effectiveness of personalized therapy for first-line treatment of stage IV and recurrent incurable adenocarcinoma of the lung.
Authors: Handorf E.A. , McElligott S. , Vachani A. , Langer C.J. , Bristol Demeter M. , Armstrong K. , Asch D.A. .
Source: Journal of oncology practice, 2012 Sep; 8(5), p. 267-74.
EPub date: 2012-06-19.
PMID: 23277762
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How genetic variant libraries effectively extend gene testing patents: implications for intellectual property and good clinical care.
Authors: McElligott S. , Field R.I. , Bristol-Demeter M. , Domchek S.M. , Asch D.A. .
Source: Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2012-08-20; 30(24), p. 2943-5.
EPub date: 2012-07-16.
PMID: 22802312
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Developing a Rational Approach to Tobacco Use Treatment in Pulmonary Practice: A Review of the Biological Basis of Nicotine Addiction.
Authors: Leone F.T. , Evers-Casey S. .
Source: Clinical pulmonary medicine, 2012-03-01; 19(2), p. 53-61.
PMID: 22707873
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