Abstract
Biospecimens are the essential substrates for human biomarker research. Across the globe, biobanks have developed the facilities and mechanisms to collect, process, store and distribute those substrates to researchers. However, despite some notable successes, less than one hundred of the tens of thousands of purported biomarkers have been independently validated. We propose the need for a new paradigm in biobanking; simply pursuing larger numbers of participants, larger networks of biobanks and higher sample integrity will not, in itself, transform the success rate or efficiency of biomarker research. We propose that biobanks must embrace the intrinsic observational nature of biospecimens and furnish the recipients of biospecimens with the population metrics (descriptive statistics) that can facilitate the scientific rigor that is mandated in other areas of observational research. In addition, we discuss the value of population-based ascertainment and recruitment and the importance of the timing of biospecimen collections. Any assessment of biospecimen quality must go beyond the sample itself and consider both the patient/participant selection and the most appropriate and informative timing for specimen collection, particularly prior to any treatment intervention in diseased populations. The examples and rationales that we present are based largely on cancer-related collections because the feasibility of population metrics is greatly assisted by the comprehensive registries that are more common for cancer than other chronic diseases. Changing the biobanking paradigm from tacitly ‘experimental’ to explicitly ‘observational’ represents a profound but urgent methodological shift that will influence the establishment, management, reporting and impact of biobanks in the twenty-first century.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
Henderson GE, Cadigan RJ, Edwards TP, Conlon I, Nelson AG, Evans JP et al (2013) Characterizing biobank organizations in the U.S.: results from a national survey. Genome Med 5(1):3
Compton C (2007) Getting to personalized cancer medicine: taking out the garbage. Cancer 110(8):1641–1643
Hewitt RE (2011) Biobanking: the foundation of personalized medicine. Curr Opin Oncol 23(1):112–119
Olson JE, Ryu E, Johnson KJ, Koenig BA, Maschke KJ, Morrisette JA et al (2013) The Mayo Clinic Biobank: a building block for individualized medicine. Mayo Clin Proc 88(9):952–962
Vaught J, Rogers J, Myers K, Lim MD, Lockhart N, Moore H et al (2011) An NCI perspective on creating sustainable biospecimen resources. J Natl Cancer Inst Monogr 2011(42):1–7
de Castro DG, Clarke PA, Al-Lazikani B, Workman P (2013) Personalized cancer medicine: molecular diagnostics, predictive biomarkers, and drug resistance. Clin Pharmacol Ther 93(3):252–259
Khleif SN, Doroshow JH, Hait WN, Collaborative A-F-NCB (2010) AACR-FDA-NCI Cancer Biomarkers Collaborative consensus report: advancing the use of biomarkers in cancer drug development. Clin Cancer Res 16(13):3299–3318
Vineis P, Perera F (2007) Molecular epidemiology and biomarkers in etiologic cancer research: the new in light of the old. Cancer Epidemiol Biomarkers Prev 16(10):1954–1965
Wagner PD, Verma M, Srivastava S (2004) Challenges for biomarkers in cancer detection. In: Hoon DSB, Taback B (eds) Circulating nucleic acids in plasma/serum III and serum proteomics, vol 1022, Annals of the New York academy of sciences. New York Academy of Sciences, New York, pp 9–16
Hu SX, Aitken ML, Epstein AM, Trusheim MR, Berndt ER (2013) MARKET WATCH defining and quantifying the use of personalized medicines. Nat Rev Drug Discov 12(12):896–897
Ludwig JA, Weinstein JN (2005) Biomarkers in cancer staging, prognosis and treatment selection. Nat Rev Cancer 5(11):845–856
Ransohoff DF (2005) Bias as a threat to the validity of cancer molecular-marker research. Nat Rev Cancer 5(2):142–149
Ransohoff DF (2007) How to improve reliability and efficiency of research about molecular markers: roles of phases, guidelines, and study design. J Clin Epidemiol 60(12):1205–1219
McShane LM, Cavenagh MM, Lively TG, Eberhard DA, Bigbee WL, Williams PM et al (2013) Criteria for the use of omics-based predictors in clinical trials: explanation and elaboration. BMC Med 11:220
Ransohoff DF, Gourlay ML (2010) Sources of bias in specimens for research about molecular markers for cancer. J Clin Oncol 28(4):698–704
Rothman KJEPIDEMIOLOGICMETHODSIN (1977) Epidemiologic methods in clinical-trials. Cancer 39(4):1771–1775
Vandenbroucke JP, von Elm E, Altman DG, Gotzsche PC, Mulrow CD, Pocock SJ et al (2007) Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): explanation and elaboration. PLoS Med 4(10):e297
McShane LM, Altman DG, Sauerbrei W, Taube SE, Gion M, Clark GM (2005) Reporting recommendations for tumor marker prognostic studies. J Clin Oncol 23(36):9067–9072
Gallo V, Egger M, McCormack V, Farmer PB, Ioannidis JP, Kirsch-Volders M, Matullo G, Phillips DH, Schoket B, Stromberg U, Vermeulen R, Wild C, Porta M, Vineis P; STROBE Statement (2011) STrengthening the Reporting of OBservational studies in Epidemiology–Molecular Epidemiology (STROBEME): an extension of the STROBE statement. PLoS Med 8(10):e1001117. doi:10.1371/journal.pmed.1001117. Epub 2011 Oct 25. PMID: 22039356
Pesch B, Bruning T, Johnen G, Casjens S, Bonberg N, Taeger D et al (2014) Biomarker research with prospective study designs for the early detection of cancer. Biochim Et Biophys Acta Proteins Proteomic 1844(5):874–883
Pepe MS, Etzioni R, Feng Z, Potter JD, Thompson ML, Thornquist M et al (2001) Phases of biomarker development for early detection of cancer. J Natl Cancer Inst 93(14):1054–1061
Srivastava S (2013) The early detection research network: 10-year outlook. Clin Chem 59(1):60–67
Ransohoff DF (2004) Opinion – rules of evidence for cancer molecular-marker discovery and validation. Nat Rev Cancer 4(4):309–314
Pepe MS, Feng Z, Janes H, Bossuyt PM, Potter JD (2008) Pivotal evaluation of the accuracy of a biomarker used for classification or prediction: standards for study design. J Natl Cancer Inst 100(20):1432–1438
Rothwell PM (2005) External validity of randomised controlled trials: “to whom do the results of this trial apply?”. Lancet 365(9453):82–93
Mitry E, Rollot F, Jooste V, Guiu B, Lepage C, Ghiringhelli F et al (2013) Improvement in survival of metastatic colorectal cancer: are the benefits of clinical trials reproduced in population-based studies? Eur J Cancer 49(13):2919–2925
Elting LS, Cooksley C, Bekele BN, Frumovitz M, Avritscher EB, Sun C et al (2006) Generalizability of cancer clinical trial results: prognostic differences between participants and nonparticipants. Cancer 106(11):2452–2458
Pollock AM, Benster R, Vickers N (1995) Why did treatment rates for colorectal cancer in south east England fall between 1982 and 1988? The effect of case ascertainment and registration bias. J Public Health Med 17(4):419–428
Ellenberg JH (1994) Selection bias in observational and experimental studies. Stat Med 13(5–7):557–567
Berger VW (2005) Quantifying the magnitude of baseline covariate imbalances resulting from selection bias in randomized clinical trials. Biom J Biom Z 47(2):119–127; discussion 28–39
Hewitt R, Watson P (2013) Defining biobank. Biopreserv Biobank 11(5):309–315
Gunn PP, Fremont AM, Bottrell M, Shugarman LR, Galegher J, Bikson T (2004) The health insurance portability and accountability act privacy rule – a practical guide for researchers. Med Care 42(4):321–327
Kulynych J, Korn D (2003) The new HIPAA (Health Insurance Portability and Accountability Act of 1996) medical privacy rule – help or hindrance for clinical research? Circulation 108(8):912–914
Tu JV, Willison DJ, Silver FL, Fang J, Richards JA, Laupacis A et al (2004) Impracticability of informed consent in the Registry of the Canadian Stroke Network. N Engl J Med 350(14):1414–1421
Armstrong D, Kline-Rogers E, Jani SM, Goldman EB, Fang J, Mukherjee D et al (2005) Potential impact of the HIPAA privacy rule on data collection in a registry of patients with acute coronary syndrome. Arch Intern Med 165(10):1125–1129
Seiffert JE (1997) Development and use of the North American Association of Central Cancer Registries standards for cancer registries. Top Health Inf Manage 17(3):35–44
McMullen L (2013) Oncology nurse navigators and the continuum of cancer care. Semin Oncol Nurs 29(2):105–117
Borugian MJ, Robson P, Fortier I, Parker L, McLaughlin J, Knoppers BM et al (2010) The Canadian partnership for tomorrow project: building a pan-Canadian research platform for disease prevention. CMAJ 182(11):1197–1201
Bryant H, Robson PJ, Ullman R, Friedenreich C, Dawe U (2006) Population-based cohort development in Alberta, Canada: a feasibility study. Chronic Dis Can 27(2):51–59
Riegman PH, Morente MM, Betsou F, de Blasio P, Geary P, Marble Arch International Working Group on Biobanking for Biomedical Research (2008) Biobanking for better healthcare. Mol Oncol 2(3):213–222
Boffetta P, Colditz GA, Potter JD, Kolonel L, Robson PJ, Malekzadeh R et al (2011) Cohorts and consortia conference: a summary report (Banff, Canada, June 17–19, 2009). Cancer Causes Control 22(3):463–468
Hanash SM, Baik CS, Kallioniemi O (2011) Emerging molecular biomarkers–blood-based strategies to detect and monitor cancer. Nat Rev Clin Oncol 8(3):142–150
Hundt S, Haug U, Brenner H (2007) Blood markers for early detection of colorectal cancer: a systematic review. Cancer Epidemiol Biomarkers Prev 16(10):1935–1953
Courneya KS, Vallance JK, Culos-Reed SN, McNeely ML, Bell GJ, Mackey JR et al (2012) The Alberta moving beyond breast cancer (AMBER) cohort study: a prospective study of physical activity and health-related fitness in breast cancer survivors. BMC Cancer 12:525
Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I et al (1996) Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA 276(8):637–639
Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ et al (2010) CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ Br Med J 340:c869
Hughes SE, Barnes RO, Watson PH (2010) Biospecimen use in cancer research over two decades. Biopreserv Biobank 8(2):89–97
Moore HM, Kelly AB, Jewell SD, McShane LM, Clark DP, Greenspan R et al (2011) Biospecimen reporting for improved study quality (BRISQ). J Proteome Res 10(8):3429–3438
Barnes R, Albert M, Damaraju S, de Sousa-Hitzler J, Kodeeswaran S, Mes-Masson AM et al (2013) Generating a comprehensive set of standard operating procedures for a biorepository network-The CTRNet experience. Biopreserv Biobank 11(6):387–396
Matzke EAM, O’Donoghue S, Barnes RO, Daudt H, Cheah S, Suggitt A et al (2012) Certification for biobanks: the program developed by the Canadian tumour repository network (CTRNet). Biopreserv Biobank 10(5):426–432
Gail MH (2005) Frequency matching. Encyclopedia of biostatistics. John Wiley & Sons, Ltd, Chichester
Samy N, Abd El-Maksoud MD, Mousa TE, El-Mezayen HA, Shaalan M (2011) Potential role of serum level of soluble CD44 and IFN-gamma in B-cell chronic lymphocytic leukemia. Med Oncol 28(Suppl 1):S471–S475
Kong FM, Anscher MS, Murase T, Abbott BD, Iglehart JD, Jirtle RL (1995) Elevated plasma transforming growth factor-beta 1 levels in breast cancer patients decrease after surgical removal of the tumor. Ann Surg 222(2):155–162
Rocca A, Cancello G, Bagnardi V, Sandri MT, Torrisi R, Zorzino L et al (2009) Perioperative serum VEGF and extracellular domains of EGFR and HER2 in early breast cancer. Anticancer Res 29(12):5111–5119
Hormbrey E, Han C, Roberts A, McGrouther DA, Harris AL (2003) The relationship of human wound vascular endothelial growth factor (VEGF) after breast cancer surgery to circulating VEGF and angiogenesis. Clin Cancer Res 9(12):4332–4339
Perez-Rivas LG, Jerez JM, Fernandez-De Sousa CE, de Luque V, Quero C, Pajares B et al (2012) Serum protein levels following surgery in breast cancer patients: a protein microarray approach. Int J Oncol 41(6):2200–2206
Xue G, Wang X, Yang Y, Liu D, Cheng Y, Zhou J et al (2014) Colon cancer-specific antigen-2 may be used as a detecting and prognostic marker in colorectal cancer: a preliminary observation. PLoS One 9(4):e94252
Shim KS, Kim KH, Han WS, Park EB (1999) Elevated serum levels of transforming growth factor-beta1 in patients with colorectal carcinoma: its association with tumor progression and its significant decrease after curative surgical resection. Cancer 85(3):554–561
Belizon A, Balik E, Feingold DL, Bessler M, Arnell TD, Forde KA et al (2006) Major abdominal surgery increases plasma levels of vascular endothelial growth factor: open more so than minimally invasive methods. Ann Surg 244(5):792–798
De Vita F, Orditura M, Lieto E, Infusino S, Morgillo F, Martinelli E et al (2004) Elevated perioperative serum vascular endothelial growth factor levels in patients with colon carcinoma. Cancer 100(2):270–278
Curigliano G, Petit JY, Bertolini F, Colleoni M, Peruzzotti G, de Braud F et al (2005) Systemic effects of surgery: quantitative analysis of circulating basic fibroblast growth factor (bFGF), vascular endothelial growth factor (VEGF) and transforming growth factor beta (TGF-beta) in patients with breast cancer who underwent limited or extended surgery. Breast Cancer Res Treat 93(1):35–40
Ordemann J, Jacobi CA, Schwenk W, Stosslein R, Muller JM (2001) Cellular and humoral inflammatory response after laparoscopic and conventional colorectal resections. Surg Endosc 15(6):600–608
Gabay C, Kushner I (1999) Acute-phase proteins and other systemic responses to inflammation. N Engl J Med 340(6):448–454
Perez RO, Sao Juliao GP, Habr-Gama A, Kiss D, Proscurshim I, Campos FG et al (2009) The role of carcinoembriogenic antigen in predicting response and survival to neoadjuvant chemoradiotherapy for distal rectal cancer. Dis Colon Rectum 52(6):1137–1143
Aldulaymi B, Christensen IJ, Soletormos G, Jess P, Nielsen SE, Laurberg S et al (2010) Chemoradiation-induced changes in serum CEA and plasma TIMP-1 in patients with locally advanced rectal cancer. Anticancer Res 30(11):4755–4759
Lee JS, Son BH, Ahn SH (2012) The predictive value of serum HER2/neu for response to anthracycline-based and trastuzumab-based neoadjuvant chemotherapy. J Breast Cancer 15(2):189–196
Gupta N, Goswami B, Mittal P (2012) Effect of standard anthracycline based neoadjuvant chemotherapy on circulating levels of serum IL-6 in patients of locally advanced carcinoma breast – a prospective study. Int J Surg 10(10):638–640
Banerjee S, Pancholi S, A’Hern R, Ghazoui Z, Smith IE, Dowsett M et al (2008) The effects of neoadjuvant anastrozole and tamoxifen on circulating vascular endothelial growth factor and soluble vascular endothelial growth factor receptor 1 in breast cancer. Clin Cancer Res 14(9):2656–2663
Winter MC, Wilson C, Syddall SP, Cross SS, Evans A, Ingram CE et al (2013) Neoadjuvant chemotherapy with or without zoledronic acid in early breast cancer–a randomized biomarker pilot study. Clin Cancer Res 19(10):2755–2765
Leon SA, Shapiro B, Sklaroff DM, Yaros MJ (1977) Free DNA in the serum of cancer patients and the effect of therapy. Cancer Res 37(3):646–650
Kodahl AR, Zeuthen P, Binder H, Knoop AS, Ditzel HJ (2014) Alterations in circulating miRNA levels following early-stage estrogen receptor-positive breast cancer resection in post-menopausal women. PLoS One 9(7):e101950
Jung EJ, Santarpia L, Kim J, Esteva FJ, Moretti E, Buzdar AU et al (2012) Plasma microRNA 210 levels correlate with sensitivity to trastuzumab and tumor presence in breast cancer patients. Cancer 118(10):2603–2614
Tenori L, Oakman C, Claudino WM, Bernini P, Cappadona S, Nepi S et al (2012) Exploration of serum metabolomic profiles and outcomes in women with metastatic breast cancer: A pilot study. Mol Oncol 6(4):437–444
Carlsson A, Wingren C, Kristensson M, Rose C, Ferno M, Olsson H et al (2011) Molecular serum portraits in patients with primary breast cancer predict the development of distant metastases. Proc Natl Acad Sci U S A 108(34):14252–14257
Neal RD (2009) Do diagnostic delays in cancer matter? Br J Cancer 101(Suppl 2):S9–S12
Wright GP, Wong JH, Morgan JW, Roy-Chowdhury S, Kazanjian K, Lum SS (2010) Time from diagnosis to surgical treatment of breast cancer: factors influencing delays in initiating treatment. Am Surg 76(10):1119–1122
Lund L, Svolgaard N, Poulsen MH (2014) Prostate cancer: a review of active surveillance. Res Rep Urol 6:107–112
Simunovic M, Rempel E, Theriault ME, Baxter NN, Virnig BA, Meropol NJ et al (2009) Influence of delays to nonemergent colon cancer surgery on operative mortality, disease-specific survival and overall survival. Can J Surg 52(4):E79–E86
Eiseman E, Bloom G, Brower J, Clancy N, Olmsted SS (2003) Case studies of existing human tissue repositories. National Cancer Institute (ed). RAND. Santa Monica
Campos PF, Gilbert TM (2012) DNA extraction from formalin-fixed material. Methods Mol Biol 840:81–85
Berg D, Malinowsky K, Reischauer B, Wolff C, Becker KF (2011) Use of formalin-fixed and paraffin-embedded tissues for diagnosis and therapy in routine clinical settings. Methods Mol Biol 785:109–122
Kokkat TJ, Patel MS, McGarvey D, LiVolsi VA, Baloch ZW (2013) Archived formalin-fixed paraffin-embedded (FFPE) blocks: a valuable underexploited resource for extraction of DNA, RNA, and protein. Biopreserv Biobank 11(2):101–106
Wolff C, Schott C, Porschewski P, Reischauer B, Becker KF (2011) Successful protein extraction from over-fixed and long-term stored formalin-fixed tissues. PLoS One 6(1):e16353
Mahoney DW, Therneau TM, Anderson SK, Jen J, Kocher JP, Reinholz MM et al (2013) Quality assessment metrics for whole genome gene expression profiling of paraffin embedded samples. BMC Res Notes 6:33
Giusti L, Lucacchini A (2013) Proteomic studies of formalin-fixed paraffin-embedded tissues. Expert Rev Proteomics 10(2):165–177
Camp RL, Neumeister V, Rimm DL (2008) A decade of tissue microarrays: progress in the discovery and validation of cancer biomarkers. J Clin Oncol 26(34):5630–5637
Ransohoff DF (2013) Cultivating cohort studies for observational translational research. Cancer Epidemiol Biomarkers Prev 22(4):481–484
Scudellari M (2013) Biobank managers bemoan underuse of collected samples. Nat Med 19(3):253
Eiseman E, Bloom G, Brower J, Clancy N, Olmsted SS (2003) Case studies of existing human tissue repositories. In: National Cancer Institute of Cancer, editor. RAND, Santa Monica
Acknowledgements
We would like to thank Dr. C. M. Friedenreich for her insightful review of this book chapter along with the Alberta Cancer Foundation and the Canadian Breast Cancer Foundation for their generous funding and support of the Alberta Cancer Research Biobank.
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2015 Springer International Publishing Switzerland
About this chapter
Cite this chapter
Roberts, J.N. et al. (2015). Biobanking in the Twenty-First Century: Driving Population Metrics into Biobanking Quality. In: Karimi-Busheri, F. (eds) Biobanking in the 21st Century. Advances in Experimental Medicine and Biology, vol 864. Springer, Cham. https://doi.org/10.1007/978-3-319-20579-3_8
Download citation
DOI: https://doi.org/10.1007/978-3-319-20579-3_8
Publisher Name: Springer, Cham
Print ISBN: 978-3-319-20578-6
Online ISBN: 978-3-319-20579-3
eBook Packages: Biomedical and Life SciencesBiomedical and Life Sciences (R0)