Grant Details
Grant Number: |
7R01CA149051-04 Interpret this number |
Primary Investigator: |
Edwards, Karen |
Organization: |
University Of California-Irvine |
Project Title: |
Identification of Issues and Expectations of Subjects Participating in Genetic St |
Fiscal Year: |
2013 |
Abstract
DESCRIPTION (provided by applicant): Protocols submitted to Institutional Review Boards (IRB) for genetic research are increasing in number and complexity. Further, it is now recognized that to understand genetic susceptibility, including interactions with environmental factors, research studies will require large sample sizes. The need for large studies will result in increased use of existing data from repositories and large disease registries and will present new issues with regard to IRB approval of human genetic studies. While efforts to understand public views of genetic research are underway, there is less known about the views of participants already enrolled in established registries, and whose samples will be increasingly valuable to these efforts. Data was collected through the NIH/NHGRI funded Centers of Excellence for ethical genomic research at the University of Washington in Seattle and Case Western Reserve University in Cleveland to identify issues that IRB members and genetic scientists confront in this new era of genomic research, with an emphasis on identifying areas of tension and common concern. However, a third and important component, the views of those participating in human genetic studies, were not evaluated. We hypothesize that the views and concerns of research participants, particularly those individuals with a condition or disease with a genetic component that runs in families, will differ from those of the IRB and researchers. Further, individuals with diseases with a genetic component may have different motivations for and concerns about participating in genetic research than the general population. It is important that these stakeholder views be included in discussions of protections in human genetic research studies. Thus, the primary purpose of this study is to identify the specific concerns and expectations of cancer registry participants regarding participation in genetic research. The results from the proposed project will provide critical insight into the views and concerns of individuals participating in an ongoing cancer registry whose biological samples and personal and medical history information will be increasingly valuable and sought after for genetic studies. By adding data on this important stakeholder group to data already obtained on IRB professionals and genetic researchers from a recently completed UW CEER project, the results may ultimately affect how genetic research studies are reviewed and conducted.
Publications
A comparison of views regarding the use of de-identified data.
Authors: Goodman D.
, Johnson C.O.
, Bowen D.
, Smith M.
, Wenzel L.
, Edwards K.L.
.
Source: Translational Behavioral Medicine, 2018-01-29 00:00:00.0; 8(1), p. 113-118.
PMID: 29385588
Related Citations
The research participant perspective related to the conduct of genomic cohort studies: A systematic review of the quantitative literature.
Authors: Goodman D.
, Bowen D.
, Wenzel L.
, Tehrani P.
, Fernando F.
, Khacheryan A.
, Chowdhury F.
, Johnson C.O.
, Edwards K.
.
Source: Translational Behavioral Medicine, 2018-01-29 00:00:00.0; 8(1), p. 119-129.
PMID: 29385589
Related Citations
Controversies among Cancer Registry Participants, Genomic Researchers, and Institutional Review Boards about Returning Participants' Genomic Results.
Authors: Edwards K.L.
, Goodman D.
, Johnson C.O.
, Wenzel L.
, Condit C.
, Bowen D.
.
Source: Public Health Genomics, 2018; 21(1-2), p. 18-26.
EPub date: 2018-09-18 00:00:00.0.
PMID: 30227419
Related Citations
Consent Issues in Genetic Research: Views of Research Participants.
Authors: Goodman D.
, Johnson C.O.
, Wenzel L.
, Bowen D.
, Condit C.
, Edwards K.L.
.
Source: Public Health Genomics, 2016; 19(4), p. 220-8.
PMID: 27376949
Related Citations
Views of Cohort Study Participants about Returning Research Results in the Context of Precision Medicine.
Authors: Hyams T.
, Bowen D.J.
, Condit C.
, Grossman J.
, Fitzmaurice M.
, Goodman D.
, Wenzel L.
, Edwards K.L.
.
Source: Public Health Genomics, 2016; 19(5), p. 269-75.
PMID: 27553645
Related Citations
Participants' Role Expectations in Genetics Research and Re-consent: Revising the Theory and Methods of Mental Models Research Relating to Roles.
Authors: Condit C.M.
, Shen L.
, Edwards K.L.
, Bowen D.J.
, Korngiebel D.M.
, Johnson C.O.
.
Source: Journal Of Health Communication, 2016; 21(sup2), p. 16-24.
EPub date: 2016-09-21 00:00:00.0.
PMID: 27653592
Related Citations
Association of cognitive domains with postural instability/gait disturbance in Parkinson's disease.
Authors: Kelly V.E.
, Johnson C.O.
, McGough E.L.
, Shumway-Cook A.
, Horak F.B.
, Chung K.A.
, Espay A.J.
, Revilla F.J.
, Devoto J.
, Wood-Siverio C.
, et al.
.
Source: Parkinsonism & Related Disorders, 2015 Jul; 21(7), p. 692-7.
EPub date: 2015-04-14 00:00:00.0.
PMID: 25943529
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What Should Be the Character of the Researcher- Participant Relationship? Views of Participants in a Long-standing Cancer Genetic Registry.
Authors: Condit C.M.
, Korngiebel D.M.
, Pfeifer L.
, Renz A.D.
, Bowen D.J.
, Kaufman D.
, Kollar L.M.
, Edwards K.L.
.
Source: Irb, 2015 Jul-Aug; 37(4), p. 1-10.
PMID: 26331187
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Cognitive profile of LRRK2-related Parkinson's disease.
Authors: Srivatsal S.
, Cholerton B.
, Leverenz J.B.
, Wszolek Z.K.
, Uitti R.J.
, Dickson D.W.
, Weintraub D.
, Trojanowski J.Q.
, Van Deerlin V.M.
, Quinn J.F.
, et al.
.
Source: Movement Disorders : Official Journal Of The Movement Disorder Society, 2015-04-15 00:00:00.0; 30(5), p. 728-33.
EPub date: 2015-02-04 00:00:00.0.
PMID: 25650144
Related Citations
APOE, MAPT, and SNCA genes and cognitive performance in Parkinson disease.
Authors: Mata I.F.
, Leverenz J.B.
, Weintraub D.
, Trojanowski J.Q.
, Hurtig H.I.
, Van Deerlin V.M.
, Ritz B.
, Rausch R.
, Rhodes S.L.
, Factor S.A.
, et al.
.
Source: Jama Neurology, 2014 Nov; 71(11), p. 1405-12.
PMID: 25178429
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People with Parkinson's disease and normal MMSE score have a broad range of cognitive performance.
Authors: Burdick D.J.
, Cholerton B.
, Watson G.S.
, Siderowf A.
, Trojanowski J.Q.
, Weintraub D.
, Ritz B.
, Rhodes S.L.
, Rausch R.
, Factor S.A.
, et al.
.
Source: Movement Disorders : Official Journal Of The Movement Disorder Society, 2014 Sep; 29(10), p. 1258-64.
EPub date: 2014-07-29 00:00:00.0.
PMID: 25073717
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Challenges of linkage analysis in the era of whole-genome sequencing.
Authors: Santorico S.A.
, Edwards K.L.
.
Source: Genetic Epidemiology, 2014 Sep; 38 Suppl 1, p. S92-6.
PMID: 25112196
Related Citations
Evaluation of mild cognitive impairment subtypes in Parkinson's disease.
Authors: Cholerton B.A.
, Zabetian C.P.
, Wan J.Y.
, Montine T.J.
, Quinn J.F.
, Mata I.F.
, Chung K.A.
, Peterson A.
, Espay A.J.
, Revilla F.J.
, et al.
.
Source: Movement Disorders : Official Journal Of The Movement Disorder Society, 2014 May; 29(6), p. 756-64.
EPub date: 2014-04-07 00:00:00.0.
PMID: 24710804
Related Citations
Association mapping of the PARK10 region for Parkinson's disease susceptibility genes.
Authors: Wan J.Y.
, Edwards K.L.
, Hutter C.M.
, Mata I.F.
, Samii A.
, Roberts J.W.
, Agarwal P.
, Checkoway H.
, Farin F.M.
, Yearout D.
, et al.
.
Source: Parkinsonism & Related Disorders, 2014 Jan; 20(1), p. 93-8.
EPub date: 2013-10-11 00:00:00.0.
PMID: 24156912
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Use of admixture and association for detection of quantitative trait loci in the Type 2 Diabetes Genetic Exploration by Next-Generation Sequencing in Ethnic Samples (T2D-GENES) study.
Authors: Yorgov D.
, Edwards K.L.
, Santorico S.A.
.
Source: Bmc Proceedings, 2014; 8(Suppl 1), p. S6.
EPub date: 2014-06-17 00:00:00.0.
PMID: 25519335
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Risk prediction for complex diseases: application to Parkinson disease.
Authors: Hall T.O.
, Wan J.Y.
, Mata I.F.
, Kerr K.F.
, Snapinn K.W.
, Samii A.
, Roberts J.W.
, Agarwal P.
, Zabetian C.P.
, Edwards K.L.
.
Source: Genetics In Medicine : Official Journal Of The American College Of Medical Genetics, 2013 May; 15(5), p. 361-7.
EPub date: 2012-12-06 00:00:00.0.
PMID: 23222663
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A single nucleotide polymorphism in the p27(Kip1) gene is associated with primary patency of lower extremity vein bypass grafts.
Authors: Conte M.S.
, Owens C.D.
, Belkin M.
, Creager M.A.
, Edwards K.L.
, Gasper W.J.
, Kenagy R.D.
, LeBoeuf R.C.
, Sobel M.
, Clowes A.
.
Source: Journal Of Vascular Surgery, 2013 May; 57(5), p. 1179-85.e1-2.
EPub date: 2013-01-09 00:00:00.0.
PMID: 23312942
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APOE ε4 increases risk for dementia in pure synucleinopathies.
Authors: Tsuang D.
, Leverenz J.B.
, Lopez O.L.
, Hamilton R.L.
, Bennett D.A.
, Schneider J.A.
, Buchman A.S.
, Larson E.B.
, Crane P.K.
, Kaye J.A.
, et al.
.
Source: Jama Neurology, 2013 Feb; 70(2), p. 223-8.
PMID: 23407718
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Pacific Northwest Udall Center of excellence clinical consortium: study design and baseline cohort characteristics.
Authors: Cholerton B.A.
, Zabetian C.P.
, Quinn J.F.
, Chung K.A.
, Peterson A.
, Espay A.J.
, Revilla F.J.
, Devoto J.
, Watson G.S.
, Hu S.C.
, et al.
.
Source: Journal Of Parkinson's Disease, 2013; 3(2), p. 205-14.
PMID: 23938350
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Common variation in the LRRK2 gene is a risk factor for Parkinson's disease.
Authors: Mata I.F.
, Checkoway H.
, Hutter C.M.
, Samii A.
, Roberts J.W.
, Kim H.M.
, Agarwal P.
, Alvarez V.
, Ribacoba R.
, Pastor P.
, et al.
.
Source: Movement Disorders : Official Journal Of The Movement Disorder Society, 2012 Dec; 27(14), p. 1822-5.
EPub date: 2012-10-31 00:00:00.0.
PMID: 23115130
Related Citations
GBA mutations increase risk for Lewy body disease with and without Alzheimer disease pathology.
Authors: Tsuang D.
, Leverenz J.B.
, Lopez O.L.
, Hamilton R.L.
, Bennett D.A.
, Schneider J.A.
, Buchman A.S.
, Larson E.B.
, Crane P.K.
, Kaye J.A.
, et al.
.
Source: Neurology, 2012-11-06 00:00:00.0; 79(19), p. 1944-50.
EPub date: 2012-10-03 00:00:00.0.
PMID: 23035075
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Awareness and uptake of direct-to-consumer genetic testing among cancer cases, their relatives, and controls: the Northwest Cancer Genetics Network.
Authors: Hall T.O.
, Renz A.D.
, Snapinn K.W.
, Bowen D.J.
, Edwards K.L.
.
Source: Genetic Testing And Molecular Biomarkers, 2012 Jul; 16(7), p. 744-8.
PMID: 22731649
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Aristolochic Acid-associated Urothelial Cancer In Taiwan
Authors: Chen,C.H.
, Dickman,K.G.
, Moriya,M.
, Zavadil,J.
, Sidorenko,V.S.
, Edwards,K.L.
, Gnatenko,D.V.
, Wu,L.
, Turesky,R.J.
, Wu,X.R.
, et al.
.
Source: Proceedings Of The National Academy Of Sciences Of The United States Of America, 2012-05-22 00:00:00.0; 109(21), p. 8241-6.
PMID: 22493262
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Aristolactam-dna Adducts Are A Biomarker Of Environmental Exposure To Aristolochic Acid
Authors: Jelakovi¿,B.
, Karanovi¿,S.
, Vukovi¿-Lela,I.
, Miller,F.
, Edwards,K.L.
, Nikoli¿,J.
, Tomi¿,K.
, Slade,N.
, Brdar,B.
, Turesky,R.J.
, et al.
.
Source: Kidney International, 2012 Mar; 81(6), p. 559-67.
PMID: 22071594
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Genetics researchers' and IRB professionals' attitudes toward genetic research review: a comparative analysis.
Authors: Edwards K.L.
, Lemke A.A.
, Trinidad S.B.
, Lewis S.M.
, Starks H.
, Snapinn K.W.
, Griffin M.Q.
, Wiesner G.L.
, Burke W.
, GRRIP Consortium
.
Source: Genetics In Medicine : Official Journal Of The American College Of Medical Genetics, 2012 Feb; 14(2), p. 236-42.
PMID: 22241102
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Cerebrospinal Fluid Amyloid ¿ And Tau In Lrrk2 Mutation Carriers
Authors: Aasly,J.O.
, Shi,M.
, Sossi,V.
, Stewart,T.
, Johansen,K.K.
, Wszolek,Z.K.
, Uitti,R.J.
, Hasegawa,K.
, Yokoyama,T.
, Zabetian,C.P.
, et al.
.
Source: Neurology, 2012-01-03 00:00:00.0; 78(1), p. 55-61.
PMID: 22170881
Related Citations
Could disappearance of endemic (Balkan) nephropathy be expected in forthcoming decades?
Authors: Cvitković A.
, Vuković-Lela I.
, Edwards K.L.
, Karanović S.
, Jurić D.
, Cvorišćec D.
, Fuček M.
, Jelaković B.
.
Source: Kidney & Blood Pressure Research, 2012; 35(3), p. 147-52.
EPub date: 2011-11-23 00:00:00.0.
PMID: 22116163
Related Citations
What are our AIMs? Interdisciplinary Perspectives on the Use of Ancestry Estimation in Disease Research.
Authors: Yu J.H.
, Taylor J.S.
, Edwards K.L.
, Fullerton S.M.
.
Source: Ajob Primary Research, 2012; 3(4), p. 87-97.
PMID: 25419472
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Clinically relevant changes in family history of cancer over time.
Authors: Ziogas A.
, Horick N.K.
, Kinney A.Y.
, Lowery J.T.
, Domchek S.M.
, Isaacs C.
, Griffin C.A.
, Moorman P.G.
, Edwards K.L.
, Hill D.A.
, et al.
.
Source: Jama, 2011-07-13 00:00:00.0; 306(2), p. 172-8.
PMID: 21750294
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The Uchl1 S18y Polymorphism And Parkinson's Disease In A Japanese Population
Authors: Snapinn,K.W.
, Larson,E.B.
, Kawakami,H.
, Ujike,H.
, Borenstein,A.R.
, Izumi,Y.
, Kaji,R.
, Maruyama,H.
, Mata,I.F.
, Morino,H.
, et al.
.
Source: Parkinsonism & Related Disorders, 2011 Jul; 17(6), p. 473-5.
PMID: 21345711
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Multivariate Linkage Scan For Metabolic Syndrome Traits In Families With Type 2 Diabetes
Authors: Edwards,K.L.
, Wan,J.Y.
, Hutter,C.M.
, Fong,P.Y.
, Santorico,S.A.
.
Source: Obesity (silver Spring, Md.), 2011 Jun; 19(6), p. 1235-43.
PMID: 21183932
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Replication Of Mapt And Snca, But Not Park16-18, As Susceptibility Genes For Parkinson's Disease
Authors: Mata,I.F.
, Yearout,D.
, Alvarez,V.
, Coto,E.
, de Mena,L.
, Ribacoba,R.
, Lorenzo-Betancor,O.
, Samaranch,L.
, Pastor,P.
, Cervantes,S.
, et al.
.
Source: Movement Disorders : Official Journal Of The Movement Disorder Society, 2011 Apr; 26(5), p. 819-23.
PMID: 21425343
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Complement 3 And Factor H In Human Cerebrospinal Fluid In Parkinson's Disease, Alzheimer's Disease, And Multiple-system Atrophy
Authors: Wang,Y.
, Hancock,A.M.
, Bradner,J.
, Chung,K.A.
, Quinn,J.F.
, Peskind,E.R.
, Galasko,D.
, Jankovic,J.
, Zabetian,C.P.
, Kim,H.M.
, et al.
.
Source: The American Journal Of Pathology, 2011 Apr; 178(4), p. 1509-16.
PMID: 21435440
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Attitudes Toward Genetic Research Review: Results From A Survey Of Human Genetics Researchers
Authors: Edwards,K.L.
, Lemke,A.A.
, Trinidad,S.B.
, Lewis,S.M.
, Starks,H.
, Quinn Griffin,M.T.
, Wiesner,G.L.
.
Source: Public Health Genomics, 2011; 14(6), p. 337-45.
PMID: 21487211
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Snca Variant Associated With Parkinson Disease And Plasma Alpha-synuclein Level
Authors: Mata,I.F.
, Shi,M.
, Agarwal,P.
, Chung,K.A.
, Edwards,K.L.
, Factor,S.A.
, Galasko,D.R.
, Ginghina,C.
, Griffith,A.
, Higgins,D.S.
, et al.
.
Source: Archives Of Neurology, 2010 Nov; 67(11), p. 1350-6.
PMID: 21060011
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Attitudes Toward Genetic Research Review: Results From A National Survey Of Professionals Involved In Human Subjects Protection
Authors: Lemke,A.A.
, Trinidad,S.B.
, Edwards,K.L.
, Starks,H.
, Wiesner,G.L.
, GRRIP Consortium
.
Source: Journal Of Empirical Research On Human Research Ethics : Jerhre, 2010 Mar; 5(1), p. 83-91.
PMID: 20235866
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Single Nucleotide Polymorphism Discovery In Tbx1 In Individuals With And Without 22q11.2 Deletion Syndrome
Authors: Heike,C.L.
, Starr,J.R.
, Rieder,M.J.
, Cunningham,M.L.
, Edwards,K.L.
, Stanaway,I.B.
, Crawford,D.C.
.
Source: Birth Defects Research. Part A, Clinical And Molecular Teratology, 2010 Jan; 88(1), p. 54-63.
PMID: 19645056
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Lrrk2 R1441g-related Parkinson's Disease: Evidence Of A Common Founding Event In The Seventh Century In Northern Spain
Authors: Mata,I.F.
, Hutter,C.M.
, González-Fernández,M.C.
, de Pancorbo,M.M.
, Lezcano,E.
, Huerta,C.
, Blazquez,M.
, Ribacoba,R.
, Guisasola,L.M.
, Salvador,C.
, et al.
.
Source: Neurogenetics, 2009 Oct; 10(4), p. 347-53.
PMID: 19308469
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When Family Means More (or Less) Than Genetics: The Intersection Of Culture, Family And Genomics
Authors: McGrath,B.B.
, Edwards,K.L.
.
Source: Journal Of Transcultural Nursing : Official Journal Of The Transcultural Nursing Society / Transcultural Nursing Society, 2009 Jul; 20(3), p. 270-7.
PMID: 19398610
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Lrrk2 Mutations And Risk Variants In Japanese Patients With Parkinson's Disease
Authors: Zabetian,C.P.
, Yamamoto,M.
, Lopez,A.N.
, Ujike,H.
, Mata,I.F.
, Izumi,Y.
, Kaji,R.
, Maruyama,H.
, Morino,H.
, Oda,M.
, et al.
.
Source: Movement Disorders : Official Journal Of The Movement Disorder Society, 2009-05-15 00:00:00.0; 24(7), p. 1034-41.
PMID: 19343804
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Public Awareness And Use Of Direct-to-consumer Genetic Tests: Results From 3 State Population-based Surveys, 2006
Authors: Goddard,K.A.
, Duquette,D.
, Zlot,A.
, Johnson,J.
, Annis-Emeott,A.
, Lee,P.W.
, Bland,M.P.
, Edwards,K.L.
, Oehlke,K.
, Giles,R.T.
, et al.
.
Source: American Journal Of Public Health, 2009 Mar; 99(3), p. 442-5.
PMID: 19106425
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Visual Assessment Of Endemic Nephropathy Markers Relationship
Authors: Sonicki,Z.
, Cvitkovi¿,A.
, Edwards,K.L.
, Mileti¿-Medved,M.
, Cvoris¿ec,D.
, Babus,V.
, Jelakovi¿,B.
.
Source: Studies In Health Technology And Informatics, 2009; 150, p. 836-40.
PMID: 19745430
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Genome-wide Linkage Scan For The Metabolic Syndrome: The Gennid Study
Authors: Edwards,K.L.
, Hutter,C.M.
, Wan,J.Y.
, Kim,H.
, Monks,S.A.
.
Source: Obesity (silver Spring, Md.), 2008 Jul; 16(7), p. 1596-601.
PMID: 18421265
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Lack Of Evidence For An Association Between Uchl1 S18y And Parkinson's Disease
Authors: Hutter,C.M.
, Samii,A.
, Factor,S.A.
, Nutt,J.G.
, Higgins,D.S.
, Bird,T.D.
, Griffith,A.
, Roberts,J.W.
, Leis,B.C.
, Montimurro,J.S.
, et al.
.
Source: European Journal Of Neurology : The Official Journal Of The European Federation Of Neurological Societies, 2008 Feb; 15(2), p. 134-9.
PMID: 18093156
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Association Analysis Of Mapt H1 Haplotype And Subhaplotypes In Parkinson's Disease
Authors: Zabetian,C.P.
, Hutter,C.M.
, Factor,S.A.
, Nutt,J.G.
, Higgins,D.S.
, Griffith,A.
, Roberts,J.W.
, Leis,B.C.
, Kay,D.M.
, Yearout,D.
, et al.
.
Source: Annals Of Neurology, 2007 Aug; 62(2), p. 137-44.
PMID: 17514749
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Dbh -1021c-->t Does Not Modify Risk Or Age At Onset In Parkinson's Disease
Authors: Chun,L.S.
, Samii,A.
, Hutter,C.M.
, Griffith,A.
, Roberts,J.W.
, Leis,B.C.
, Mosley,A.D.
, Wander,P.L.
, Edwards,K.L.
, Payami,H.
, et al.
.
Source: Annals Of Neurology, 2007 Jul; 62(1), p. 99-101.
PMID: 17503507
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Lrrk2 G2019s In Families With Parkinson Disease Who Originated From Europe And The Middle East: Evidence Of Two Distinct Founding Events Beginning Two Millennia Ago
Authors: Zabetian,C.P.
, Hutter,C.M.
, Yearout,D.
, Lopez,A.N.
, Factor,S.A.
, Griffith,A.
, Leis,B.C.
, Bird,T.D.
, Nutt,J.G.
, Higgins,D.S.
, et al.
.
Source: American Journal Of Human Genetics, 2006 Oct; 79(4), p. 752-8.
PMID: 16960813
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Tumor Necrosis Factor Alpha And Interleukin 10 Promoter Region Polymorphisms And Risk Of Late-onset Alzheimer Disease
Authors: Ramos,E.M.
, Lin,M.T.
, Larson,E.B.
, Maezawa,I.
, Tseng,L.H.
, Edwards,K.L.
, Schellenberg,G.D.
, Hansen,J.A.
, Kukull,W.A.
, Jin,L.W.
.
Source: Archives Of Neurology, 2006 Aug; 63(8), p. 1165-9.
PMID: 16908746
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Association Of Endothelial Lipase Gene (lipg) Haplotypes With High-density Lipoprotein Cholesterol Subfractions And Apolipoprotein Ai Plasma Levels In Japanese Americans
Authors: Hutter,C.M.
, Austin,M.A.
, Farin,F.M.
, Viernes,H.M.
, Edwards,K.L.
, Leonetti,D.L.
, McNeely,M.J.
, Fujimoto,W.Y.
.
Source: Atherosclerosis, 2006 Mar; 185(1), p. 78-86.
PMID: 16023652
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Genetic Susceptibility To Prostate Cancer: Prostate-specific Antigen And Its Interaction With The Androgen Receptor (united States)
Authors: Sieh,W.
, Edwards,K.L.
, Fitzpatrick,A.L.
, Srinouanprachanh,S.L.
, Farin,F.M.
, Monks,S.A.
, Kronmal,R.A.
, Eaton,D.L.
.
Source: Cancer Causes & Control : Ccc, 2006 Mar; 17(2), p. 187-97.
PMID: 16425097
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