Methodological requirements for valid tissue-based biomarker studies that can be used in clinical practice

Virchows Archiv

Volumn 464, Issue 3, 2014, Pages 257-263

  True, Lawrence D ^a  

^a UNIVERSITY OF WASHINGTON MEDICAL CENTER   (United States)

Author keywords

Immunohistochemistry; Preanalytical; Predictive; Prognostic; Tissue; Variables

Indexed keywords

ANTIBODY; BIOLOGICAL MARKER; DNA; ESTROGEN RECEPTOR; LONG UNTRANSLATED RNA; MESSENGER RNA; MICRORNA; PEROXIDASE; PROGESTERONE RECEPTOR;

ACCURACY; ASSAY; CATALYSIS; CLINICAL PRACTICE; COLD ISCHEMIA; DNA SEQUENCE; ENVIRONMENTAL TEMPERATURE; HUMAN; IMMUNOREACTIVITY; ISCHEMIA; KIDNEY CARCINOMA; MACROMOLECULE; MASS SPECTROMETRY; PH; PRACTICE GUIDELINE; PRIORITY JOURNAL; PROSTATE CARCINOMA; PROSTATIC INTRAEPITHELIAL NEOPLASIA; PROTEIN CONTENT; PROTEIN EXPRESSION; REVIEW; SENSITIVITY AND SPECIFICITY; STORAGE; STORAGE TEMPERATURE; TIME; TISSUE PRESERVATION; TISSUES;

BIOLOGICAL MARKERS; GUIDELINES AS TOPIC; HUMANS; IMMUNOHISTOCHEMISTRY; NEOPLASMS; TISSUE AND ORGAN PROCUREMENT;

EID: 84897055842     PISSN: 09456317     EISSN: 14322307     Source Type: Journal    
DOI: 10.1007/s00428-013-1531-0     Document Type: Review

References (23)

1. Meshinchi S, Hunger SP, Aplenc R, Adamson PC, Jessup JM (2012) Lessons learned from the investigational device exemption review of Children's Oncology Group trial AAML1031. Clin Cancer Res 18:1547-1554
2. Hewitt SM, Badve SS, True LD (2012) Impact of preanalytic factors on the design and application of integral biomarkers for directing patient therapy. Clin Cancer Res 18:1524-1530
3. O'Huallachain M, Karczewski KJ, Weissman SM, Urban AE, Snyder MP (2012) Extensive genetic variation in somatic human tissues. Proc Natl Acad Sci U S A 109:18018-18023
4. Engel KB, Moore HM (2011) Effects of preanalytical variables on the detection of proteins by immunohistochemistry in formalin-fixed, paraffin-embedded tissue. Arch Pathol Lab Med 135:537-543
5. Neumeister VM, Anagnostou V, Siddiqui S, England AM, Zarrella ER, Vassilakopoulou M, Parisi F, Kluger Y, Hicks DG, Rimm DL (2012) Uantitative assessment of effect of preanalytic cold ischemic time on protein expression in breast cancer tissues. J Natl Cancer Inst 104:1815-1824
6. Bordeaux J, Welsh A, Agarwal S, Killiam E, Baquero M, Hanna J, Anagnostou V, Rimm D (2010) Antibody validation. Biotechniques 48:197-209
7. Gross DS, Rothfeld JM (1985) Quantitative immunocytochemistry of hypothalamic and pituitary hormones: validation of an automated, computerized image analysis system. J Histochem Cytochem 33:11-20 (Pubitemid 15189487)
8. Zrazhevskiy P, Gao X (2009) Multifunctional quantum dots for personalized medicine. Nano Today 4:414-428
9. Fandel TM, Pfnür M, Schäfer SC, Bacchetti P, Mast FW, Corinth C, Ansorge M, Melchior SW, Thüroff JW, Kirkpatrick CJ, Lehr HA (2008) Do we truly see what we think we see? The role of cognitive bias in pathological interpretation. J Pathol 216:193-200
10. Wells WA, Rainer RO, Memoli VA (1993) Equipment, standardization, and applications of image processing. J Clin Pathol 99:48-56 (Pubitemid 23030671)
11. True LD (1988) Quantitative immunohistochemistry: a new tool for surgical pathology? Am J Clin Pathol 90:324-325
12. Rubin MA, Zerkowski MP, Camp RL, Kuefer R, Hofer MD, Chinnaiyan AM, Rimm DL (2004) Quantitative determination of expression of the prostate cancer protein alpha-methylacyl-CoA racemase using automated quantitative analysis (AQUA): a novel paradigm for automated and continuous biomarker measurements. Am J Pathol 164:831-840 (Pubitemid 38235465)
13. Etzioni R, Hawley S, Billheimer D, True LD, Knudsen B (2005) Analyzing patterns of staining in immunohistochemical studies: application to a study of prostate cancer recurrence. Cancer Epidemiol Biomarkers Prev 14:1040-1046 (Pubitemid 40656445)
14. Gerlinger M, Rowan AJ, Horswell S, Larkin J, Endesfelder D, Gronroos E, Martinez P, Matthews N, Stewart A, Tarpey P, Varela I, Phillimore B, Begum S, McDonald NQ, Butler A, Jones D, Raine K, Latimer C, Santos CR, Nohadani M, Eklund AC, Spencer-Dene B, Clark G, Pickering L, Stamp G, Gore M, Szallasi Z, Downward J, Futreal PA, Swanton C (2012) Intratumor heterogeneity and branched evolution revealed by multiregion sequencing. N Engl J Med 366:883-892
15. Deutsch EW, Ball CA, Berman JJ, Bova GS, Brazma A, Bumgarner RE, Campbell D, Causton HC, Christiansen JH, Daian F, Dauga D, Davidson DR, Gimenez G, Goo YA, Grimmond S, Henrich T, Herrmann BG, Johnson MH, Korb M, Mills JC, Oudes AJ, Parkinson HE, Pascal LE, Pollet N, Quackenbush J, Ramialison M, Ringwald M, Salgado D, Sansone SA, Sherlock G, Stoeckert CJ Jr, Swedlow J, Taylor RC, Walashek L, Warford A, Wilkinson DG, Zhou Y, Zon LI, Liu AY, True LD (2008) Minimum information specification for in situ hybridization and immunohistochemistry experiments (MISFISHIE). Nat Biotechnol 26:305-312 (Pubitemid 351355130)
16. McShane LM, Altman DG, Sauerbrei W, Taube SE, Gion M, Clark GM, Statistics Subcommittee of the NCI-EORTC Working Group on Cancer Diagnostics (2005) Reporting recommendations for tumor marker prognostic studies (REMARK). J Natl Cancer Inst 97:1180-1184 (Pubitemid 41258223)
17. McShane LM, Cavenagh MM, Lively TG, Eberhard DA, Bigbee WL, Williams PM, Mesirov JP, Polley MY, Kim KY, Tricoli JV, Taylor JM, Shuman DJ, Simon RM, Doroshow JH, Conley BA (2013) Criteria for the use of omics-based predictors in clinical trials. Nature 502:317-320
18. Poste G, Carbone DP, Parkinson DR, Verweij J, Hewitt SM, Jessup JM (1996) Eveling the playing field: bringing development of biomarkers and molecular diagnostics up to the standards for drug development. J Natl Cancer Inst 88:1456-1466
19. Hayes DF, Bast RC, Desch CE, Fritsche H Jr, Kemeny NE, Jessup JM, Locker GY, Macdonald JS, Mennel RG, Norton L, Ravdin P, Taube S, Winn RJ (2012) Tumor marker utility grading system: framework to evaluate clinical utility of tumormarkers. Clin Cancer Res 18:1515-1523
20. Febbo PG, Ladanyi M, Aldape KD, De Marzo AM, Hammond ME, Hayes DF, Iafrate AJ, Kelley RK, Marcucci G, Ogino S, Pao W, Sgroi DC, Birkeland ML (2011) NCCN Task Force report: evaluating the clinical utility of tumor markers in oncology. J Natl Compr Canc Netw 9(Suppl 5):S1-S32
21. Williams PM, Lively TG, Jessup JM, Conley BA (2012) Bridging the gap: moving predictive and prognostic assays from research to clinical use. Clin Cancer Res 18:1531-1539
22. Begley CG, Ellis LM (2012) Drug development: raise standards for preclinical cancer research. Nature 483:531-533
23. Leong AS, Leong TY (2011) Standardization in immunohistology. Methods Mol Biol 724:37-68