Biomarker research with prospective study designs for the early detection of cancer

Biochimica et Biophysica Acta - Proteins and Proteomics

Volumn 1844, Issue 5, 2014, Pages 874-883

  Pesch, B ^a   Bruning T ^a   Johnen, G ^a   Casjens, S ^a   Bonberg, N ^a   Taeger, D ^a   Muller A ^a   Weber, D G ^a   Behrens, T ^a  

^a RUHR UNIVERSITY BOCHUM   (Germany)

Author keywords

Bias; Diagnostic marker; Prospective study; Screening; Study design; Validation

Indexed keywords

BIAS; DIAGNOSTIC MARKER; PROSPECTIVE STUDY; SCREENING; STUDY DESIGN; VALIDATION;

BIOMEDICAL RESEARCH; EARLY DETECTION OF CANCER; HUMANS; NEOPLASM PROTEINS; NEOPLASMS; PROSPECTIVE STUDIES; PROTEOMICS; RESEARCH DESIGN; TUMOR MARKERS, BIOLOGICAL;

EID: 84898883644     PISSN: 15709639     EISSN: 18781454     Source Type: Journal    
DOI: 10.1016/j.bbapap.2013.12.007     Document Type: Review

References (80)

1. O. Akin, S.B. Brennan, and D.D. Dershaw et al. Advances in oncologic imaging: update on 5 common cancers CA Cancer J. Clin. 62 2012 364 393
2. M.R. Alison, W.R. Lin, and S.M. Lim et al. Cancer stem cells: in the line of fire Cancer Treat. Rev. 38 2012 589 598
3. M. Babjuk, W. Oosterlinck, and R. Sylvester et al. EAU guidelines on non-muscle-invasive urothelial carcinoma of the bladder, the 2011 update Eur. Urol. 59 2011 997 1008
4. S.G. Baker, B.S. Kramer, and S. Srivastava Markers for early detection of cancer: statistical guidelines for nested case-control studies BMC Med. Res. Methodol. 2 2002 4
5. S. Banek, C. Schwentner, and D. Taeger et al. Prospective evaluation of fluorescence-in-situ-hybridization to detect bladder cancer: results from the UroScreen-study Urol. Oncol. 2012 10.1016/j.Urolonc.2012.04.015
6. A. Barla, G. Jurman, and S. Riccadonna et al. Machine learning methods for predictive proteomics Brief. Bioinform. 9 2008 119 128 (Pubitemid 351516998)
7. N. Becker, E. Motsch, and M.L. Gross et al. Randomized study on early detection of lung cancer with MSCT in Germany: study design and results of the first screening round J. Cancer Res. Clin. Oncol. 138 2012 1475 1486
8. T. Behrens, N. Bonberg, and S. Casjens et al. A practical guide to epidemiological practice and standards in the identification and validation of diagnostic markers using a bladder cancer example BBA Proteins Proteomics 2013 10.1016/j.bbpap.2013 (Article first published online:18 July 2013)
9. J. Beitz, C. Gnecco, and R. Justice Quality-of-life end points in cancer clinical trials: the U.S. Food and Drug Administration perspective J. Natl. Cancer Inst. Monogr. 1996 7 9
10. F. Betsou, E. Gunter, and J. Clements et al. Identification of evidence-based biospecimen quality-control tools: a report of the International Society for Biological and Environmental Repositories (ISBER) Biospecimen Science Working Group J. Mol. Diagn. 15 2013 3 16
11. D. Bolignano, F. Mattace-Raso, and C. Torino et al. The quality of reporting in clinical research: the CONSORT and STROBE initiatives Aging Clin. Exp. Res. 25 2013 9 15
12. TM test in the UroScreen study BJU Int. 2013 10.1111/j.1464-410X.2012.11666.x
13. D.E. Brenner, and D.P. Normolle Biomarkers for cancer risk, early detection, and prognosis: the validation conundrum Cancer Epidemiol. Biomarkers Prev. 16 2007 1918 1920 (Pubitemid 47621163)
14. W.R. Carpenter, A.M. Meyer, and A.P. Abernethy et al. A framework for understanding cancer comparative effectiveness research data needs J. Clin. Epidemiol. 65 2012 1150 1158
15. K. Chamie, C.S. Saigal, and J. Lai et al. Compliance with guidelines for patients with bladder cancer: variation in the delivery of care Cancer 117 2011 5392 5401
16. K. Chang, C.J. Creighton, and C. Davis et al. The Cancer Genome Atlas Pan-Cancer analysis project Nat. Genet. 45 2013 1113 1120
17. T.R. Church, M. Wandell, and C. Lofton-Day et al. Prospective evaluation of methylated SEPT9 in plasma for detection of asymptomatic colorectal cancer Gut 2013 10.1136/gutjnl-2012-304149
18. V.E. Cokkinides, A.C. Geller, and A. Jemal Trends in melanoma mortality among non-Hispanic whites by educational attainment, 1993 - 2007 Arch. Dermatol. 148 2012 587 591
19. J. Condeelis, and R. Weissleder In vivo imaging in cancer Cold Spring Harb. Perspect. Biol. 2 2010 a003848
20. M.S. Coumar, F.Y. Tsai, and J.R. Kanwar et al. Treat cancers by targeting survivin: just a dream or future reality? Cancer Treat. Rev. 39 2013 802 811
21. T.J. Crayford, S. Campbell, and T.H. Bourne et al. Benign ovarian cysts and ovarian cancer: a cohort study with implications for screening Lancet 355 2000 1060 1063 (Pubitemid 30162809)
22. L. Esserman, and I. Thompson Solving the overdiagnosis dilemma J. Natl. Cancer Inst. 102 2010 582 583
23. L.J. Esserman, I.M. Thompson, and B. Reid Overdiagnosis and overtreatment in cancer: an opportunity for improvement JAMA 310 2013 797 798
24. Z. Feng, J. Kagan, and M. Pepe et al. The Early Detection Research Network's Specimen reference sets: paving the way for rapid evaluation of potential biomarkers Clin. Chem. 59 2013 68 74
25. Z. Feng, R. Prentice, and S. Srivastava Research issues and strategies for genomic and proteomic biomarker discovery and validation: a statistical perspective Pharmacogenomics 5 2004 709 719 (Pubitemid 39236584)
26. R.E. Glasgow, V.P. Doria-Rose, and M.J. Khoury et al. Comparative effectiveness research in cancer: what has been funded and what knowledge gaps remain? J. Natl. Cancer Inst. 105 2013 766 773
27. M. Gube, D. Taeger, and D.G. Weber et al. Performance of biomarkers SMRP, CA125, and CYFRA 21-1 as potential tumor markers for malignant mesothelioma and lung cancer in a cohort of workers formerly exposed to asbestos Arch. Toxicol. 85 2011 185 192
28. S. Huber, C. Schwentner, and D. Taeger et al. Nuclear matrix protein-22: a prospective evaluation in a population at risk for bladder cancer. Results from the UroScreen study BJU Int. 110 2012 699 708
29. J.P. Ioannidis Biomarker failures Clin. Chem. 59 2013 202 204
30. G. Johnen, K. Gawrych, and H. Bontrup et al. Performance of survivin mRNA as a biomarker for bladder cancer in the prospective study UroScreen PLoS One 7 2012 e35363
31. M. Kohl, D.A. Megger, and M. Trippler et al. A practical data processing workflow for multi-OMICS projects Biochim. Biophys. Acta 2013 10.1016/j.bbapap.2013.02.029
32. P. Kraft, S. Wacholder, and M.C. Cornelis et al. Beyond odds ratios - communicating disease risk based on genetic profiles Nat. Rev. Genet. 10 2009 264 269
33. B.S. Kramer, and J.M. Croswell Cancer screening: the clash of science and intuition Annu. Rev. Med. 60 2009 125 137
34. S. Larre, J.W. Catto, and M.S. Cookson et al. Screening for bladder cancer: rationale, limitations, whom to target, and perspectives Eur. Urol. 63 2013 1049 1058
35. R.S. Lin, and S.K. Plevritis Comparing the benefits of screening for breast cancer and lung cancer using a novel natural history model Cancer Causes Control 23 2012 175 185
36. J.A. Ludwig, and J.N. Weinstein Biomarkers in cancer staging, prognosis and treatment selection Nat. Rev. Cancer 5 2005 845 856 (Pubitemid 41746029)
37. G. Marko-Varga, A. Vegvari, and C. Welinder et al. Standardization and utilization of biobank resources in clinical protein science with examples of emerging applications J. Proteome Res. 11 2012 5124 5134
38. M. Asslaber, and K. Zatloukal Biobanks: translational, European and global networks Brief. Funct. Genomic. Proteomic. 6 2007 193 201 (Pubitemid 351863876)
39. D.K. McClish Analyzing a portion of the ROC curve Med. Decis. Making. 9 1989 190 195
40. J.E. McDermott, J. Wang, and H. Mitchell et al. Challenges in biomarker discovery: combining expert insights with statistical analysis of complex omics data Expert Opin. Med. Diagn. 7 2013 37 51
41. D. McLerran, W.E. Grizzle, and Z. Feng et al. Analytical validation of serum proteomic profiling for diagnosis of prostate cancer: sources of sample bias Clin. Chem. 54 2008 44 52 (Pubitemid 351182595)
42. O. Miettinen Design options in epidemiologic research. an update Scand. J. Work Environ. Health 8 Suppl. 1 1982 7 14 (Pubitemid 12083633)
43. R. Montironi, and A. Lopez-Beltran The 2004 WHO classification of bladder tumors: a summary and commentary Int. J. Surg. Pathol. 13 2005 143 153 (Pubitemid 40617541)
44. G. Mowatt, S. Zhu, and M. Kilonzo et al. Systematic review of the clinical effectiveness and cost-effectiveness of photodynamic diagnosis and urine biomarkers (FISH, ImmunoCyt, NMP22) and cytology for the detection and follow-up of bladder cancer Health Technol. Assess. 14 2010 (1-iv)
45. M. Nasterlack, G. Feil, and G. Leng et al. Bladder cancer screening with urine-based tumour markers - occupational medical experience Aktuelle Urol. 42 2011 128 134
46. N. Pearce Classification of epidemiological study designs Int. J. Epidemiol. 41 2012 393 397
47. M.S. Pepe, R. Etzioni, and Z. Feng et al. Phases of biomarker development for early detection of cancer J. Natl. Cancer Inst. 93 2001 1054 1061 (Pubitemid 32717537)
48. M.S. Pepe, and Z. Feng Improving biomarker identification with better designs and reporting Clin. Chem. 57 2011 1093 1095
49. M.S. Pepe, Z. Feng, and H. Janes et al. Pivotal evaluation of the accuracy of a biomarker used for classification or prediction: standards for study design J. Natl. Cancer Inst. 100 2008 1432 1438
50. M.S. Pepe, and H.E. Janes Gauging the performance of SNPs, biomarkers, and clinical factors for predicting risk of breast cancer J. Natl. Cancer Inst. 100 2008 978 979 (Pubitemid 352019802)
51. B. Pesch, S. Casjens, and I. Stricker et al. NOTCH1, HIF1A and other cancer-related proteins in lung tissue from uranium miners - variation by occupational exposure and subtype of lung cancer PLoS One 7 2012 e45305
52. B. Pesch, B. Kendzia, and P. Gustavsson et al. Cigarette smoking and lung cancer-relative risk estimates for the major histological types from a pooled analysis of case-control studies Int. J. Cancer 131 2012 1210 1219
53. B. Pesch, M. Nasterlack, and F. Eberle et al. The role of haematuria in bladder cancer screening among men with former occupational exposure to aromatic amines BJU Int. 108 2011 546 552
54. B. Pesch, C.B. Pierl, and M. Gebel et al. Occupational risks for adenocarcinoma of the nasal cavity and paranasal sinuses in the German wood industry Occup. Environ. Med. 65 2008 191 196 (Pubitemid 351327457)
55. B. Pesch, D. Taeger, and G. Johnen et al. Screening for bladder cancer with urinary tumor markers in chemical workers with exposure to aromatic amines Int. Arch. Occup. Environ. Health 2013 10.1007/s00420-013-0916-3
56. B. Pesch, D. Taeger, and G. Johnen et al. Cancer mortality in a surveillance cohort of German males formerly exposed to asbestos Int. J. Hyg. Environ. Health 213 2010 44 51
57. P.F. Pinsky, A. Miller, and B.S. Kramer et al. Evidence of a healthy volunteer effect in the prostate, lung, colorectal, and ovarian cancer screening trial Am. J. Epidemiol. 165 2007 874 881 (Pubitemid 46536660)
58. P.C. Prorok, G.L. Andriole, and R.S. Bresalier et al. Design of the Prostate, Lung, Colorectal and Ovarian (PLCO) cancer screening trial Control. Clin. Trials 21 2000 273S 309S
59. D.F. Ransohoff Discovery-based research and fishing Gastroenterology 125 2003 290 (Pubitemid 36929405)
60. D.F. Ransohoff Rules of evidence for cancer molecular-marker discovery and validation Nat. Rev. Cancer 4 2004 309 314 (Pubitemid 38525286)
61. D.F. Ransohoff How to improve reliability and efficiency of research about molecular markers: roles of phases, guidelines, and study design J. Clin. Epidemiol. 60 2007 1205 1219 (Pubitemid 350061148)
62. D.F. Ransohoff Cultivating cohort studies for observational translational research Cancer Epidemiol. Biomarkers Prev. 22 2013 481 484
63. D.F. Ransohoff, and M.L. Gourlay Sources of bias in specimens for research about molecular markers for cancer J. Clin. Oncol. 28 2010 698 704
64. E. Riboli, K.J. Hunt, and N. Slimani et al. European Prospective Investigation into Cancer and Nutrition (EPIC): study populations and data collection Public Health Nutr. 5 2002 1113 1124 (Pubitemid 36313608)
65. A. Rundle, H. Ahsan, and P. Vineis Better cancer biomarker discovery through better study design Eur. J. Clin. Invest. 42 2012 1350 1359
66. A.G. Rundle, P. Vineis, and H. Ahsan Design options for molecular epidemiology research within cohort studies Cancer Epidemiol. Biomarkers Prev. 14 2005 1899 1907 (Pubitemid 41161198)
67. M. Sechler, A.D. Cizmic, and S. Avasarala et al. Non-small-cell lung cancer: molecular targeted therapy and personalized medicine - drug resistance, mechanisms, and strategies Pharmacogenomics Pers. Med. 6 2013 25 36
68. R.A. Smith, V. Cokkinides, and O.W. Brawley Cancer screening in the United States, 2012: A review of current American Cancer Society guidelines and current issues in cancer screening CA Cancer J. Clin. 2012 10.3322/caac.20143 (Article first published online 19 Jan 2012)
69. P.R. Srinivas, B.S. Kramer, and S. Srivastava Trends in biomarker research for cancer detection Lancet Oncol. 2 2001 698 704 (Pubitemid 33085816)
70. M. Turewicz, C. May, and M. Ahrens et al. Improving the default data analysis workflow for large autoimmune biomarker discovery studies with ProtoArrays Proteomics 13 2013 2083 2087
71. J. Vaught, and N.C. Lockhart The evolution of biobanking best practices Clin. Chim. Acta 413 2012 1569 1575
72. P. Vineis, A.E. Khan, and J. Vlaanderen et al. The impact of new research technologies on our understanding of environmental causes of disease: the concept of clinical vulnerability Environ. Health 8 2009 54
73. S. Wacholder Practical considerations in choosing between the case-cohort and nested case-control designs Epidemiology 2 1991 155 158
74. J.D. Warren, W. Xiong, and A.M. Bunker et al. Septin 9 methylated DNA is a sensitive and specific blood test for colorectal cancer BMC Med. 9 2011 133
75. H.G. Welch, and W.C. Black Using autopsy series to estimate the disease "reservoir" for ductal carcinoma in situ of the breast: how much more breast cancer can we find? Ann. Intern. Med. 127 1997 1023 1028 (Pubitemid 27516615)
76. E.P. Whitlock, J.S. Lin, and E. Liles et al. Screening for colorectal cancer: a targeted, updated systematic review for the U.S. Preventive Services Task Force Ann. Intern. Med. 149 2008 638 658
77. J.M.G. Wilson, and G. Jungner Principles and practice of screening for disease Bol. Oficina Sanit. Panam. 65 1968 281 393
78. M. Xing, B.R. Haugen, and M. Schlumberger Progress in molecular-based management of differentiated thyroid cancer Lancet 381 2013 1058 1069
79. C.S. Zhu, P.F. Pinsky, and D.W. Cramer et al. A framework for evaluating biomarkers for early detection: validation of biomarker panels for ovarian cancer Cancer Prev. Res. (Phila.) 4 2011 375 383
80. X. Zhu, P.J. van Leeuwen, and E. Holmberg et al. Efficacy versus effectiveness study design within the European screening trial for prostate cancer: consequences for cancer incidence, overall mortality and cancer-specific mortality J. Med. Screen. 19 2012 133 140