Is serum human epididymis protein 4 ready for prime time?

Annals of Clinical Biochemistry

Volumn 51, Issue 2, 2014, Pages 128-136

  Ferraro, Simona ^a   Panteghini, Mauro ^a  

^a UNIVERSITY OF MILAN   (Italy)

Author keywords

biological variability; biomarker; Commutability; ovarian cancer; reference change value

Indexed keywords

BIOLOGICAL VARIABILITY; BIOMARKER; COMMUTABILITY; OVARIAN CANCER; REFERENCE CHANGE VALUE;

BIAS (EPIDEMIOLOGY); BLOOD CHEMICAL ANALYSIS; DATA INTERPRETATION, STATISTICAL; FEMALE; HUMANS; OVARIAN NEOPLASMS; PROTEINS; QUALITY CONTROL; TUMOR MARKERS, BIOLOGICAL;

EID: 84898686445     PISSN: 00045632     EISSN: 17581001     Source Type: Journal    
DOI: 10.1177/0004563213500657     Document Type: Article

References (72)

1. National Institute for Health and Clinical Excellence (NICE): Guidance. Ovarian cancer: the recognition and initial management of ovarian cancer. Cardiff, UK: National Collaborating Centre for Cancer; 2011:.
2. Grann AF,Nørgaard M,Blaakær J, et al.Survival of patients with ovarian cancer in central and northern Denmark, 1998-2009.Clin Epidemiol. 2011;3:59-64.
3. Autier P,Boniol M.Caution needed for country-specific cancer survival.Lancet. 2011;377:99-101.
4. Maringe C,Walters S,Butler J, et al.ICBP module 1 working group. Stage at diagnosis and ovarian cancer survival: evidence from the international cancer benchmarking partnership.Gynecol Oncol. 2012;127:75-82.
5. Gulland A.Women with symptoms of ovarian cancer should have a CA125 test, says NICE.BMJ. 2011;342:d2695-d2695.
6. Sturgeon CM,Duffy MJ,Walker G.The national institute for health and clinical excellence (NICE) guidelines for early detection of ovarian cancer: the pivotal role of the clinical laboratory.Ann Clin Biochem. 2011;48:295-299.
7. Cave JA.NICE on ovarian cancer. Please include GPs in developing guidelines.BMJ. 2011;342:d3023-d3023.
8. Olaitan A.NICE on ovarian cancer. Recommendations for detection in primary care are flawed.BMJ. 2011;342:d3022-d3022.
9. Woolas RP,Xu FJ,Jacobs IJ, et al.Elevation of multiple serum markers in patients with stage I ovarian cancer.J Natl Cancer Inst. 1993;85:1748-1751.
10. Markowska J,Manys G,Kubaszewska M.Value of CA 125 as a marker of ovarian cancer.Eur J Gynaecol Oncol. 1992;13:360-365.
11. Ferraro S, Braga F, Lanzoni M,et al.Serum human epididymis protein 4 vs carbohydrate antigen 125 for ovarian cancer diagnosis: a systematic review. J Clin Pathol 2013; 6: 273-281.
12. Buys SS,Partridge E,Black A, et al.PLCO project team. Effect of screening on ovarian cancer mortality: the prostate, lung, colorectal and ovarian (PLCO) cancer screening randomized controlled trial.JAMA. 2011;305:2295-2303.
13. Menon U,Kalsi J,Jacobs I.The UKCTOCS experience - reasons for hope?.Int J Gynecol Cancer. 2012;22:S18-20.
14. Rosenthal AN.Ovarian cancer screening in the high-risk population - the UK familial ovarian cancer screening study (UKFOCSS).Int J Gynecol Cancer. 2012;22:S27-S28.
15. Menon U,Jacobs IJ.Ovarian cancer screening in the general population: current status.Int J Gynecol Cancer. 2001;11:3-6.
16. Hogg R,Friedlander M.Biology of epithelial ovarian cancer: implications for screening women at high genetic risk.J Clin Oncol. 2004;22:1315-1327.
17. Crump C,McIntosh MW,Urban N, et al.Ovarian cancer tumor marker behavior in asymptomatic healthy women: implications for screening detection of asymptomatic ovarian cancer implications for screening.Cancer Epidemiol Biomarkers Prev. 2000;9:1107-1111.
18. Evans J,Ziebland S,McPherson A.Minimizing delays in ovarian cancer diagnosis: an expansion of Andersen's model of "total patient delay".Fam Pract. 2007;24:48-55.
19. Nagle CM,Francis JE,Nelson AE, et al.Reducing time to diagnosis does not improve outcomes for women with symptomatic ovarian cancer: a report from the Australian ovarian cancer study group.J Clin Oncol. 2011;29:2253-2258.
20. Holschneider CH,Berek JS.Ovarian cancer: epidemiology, biology, and prognostic factors.Semin Surg Oncol. 2000;19:3-10.
21. Clarke-Pearson DL.Clinical practice. Screening for ovarian cancer.N Engl J Med. 2009;361:170-177.
22. Crawford MProceedings of UK NEQAS participants' meeting, Edinburgh, UK, 24-26 September. NEQAS,. 2012:15-15.
23. Tuxen MK,Sölétormos G,Petersen PH, et al.Assessment of biological variation and analytical imprecision of CA 125, CEA, and TPA in relation to monitoring of ovarian cancer.Gynecol Oncol. 1999;74:12-22.
24. Su Z,Graybill WS,Zhu Y.Detection and monitoring of ovarian cancer.Clin Chim Acta. 2013;415:341-345.
25. Anderson GL,McIntosh M,Wu L, et al.Assessing lead time of selected ovarian cancer biomarkers: a nested case-control study.J Natl Cancer Inst. 2010;102:26-38.
26. Tseng PC,Sprance HE,Carcangiu ML, et al.CA 125, NB/70K, and lipid-associated sialic acid in monitoring uterine papillary serous carcinoma.Obstet Gynecol. 1989;74:384-387.
27. Hori SS,Gambhir SS.Mathematical model identifies blood biomarker-based early cancer detection strategies and limitations.Sci Transl Med. 2011;3:109-116.
28. Sturgeon CM,Hoffman BR,Chan DW, et al.National academy of clinical biochemistry laboratory medicine practice guidelines for use of tumor markers in clinical practice: quality requirements.Clin Chem. 2008;54:e1-e10.
29. Duffy MJ,Bonfrer JM,Kulpa J, et al.CA125 in ovarian cancer: European group on tumor markers guidelines for clinical use.Int J Gynecol Cancer. 2005;15:679-691.
30. Konforte D,Diamandis EP.Is early detection of cancer with circulating biomarkers feasible?.Clin Chem. 2013;59:35-37.
31. Carlson KJ,Skates SJ,Singer DE.Screening for ovarian cancer.Ann Intern Med. 1994;121:124-132.
32. Escudero JM,Auge JM,Filella X, et al.Comparison of serum human epididymis protein 4 with cancer antigen 125 as a tumor marker in patients with malignant and nonmalignant diseases.Clin Chem. 2011;57:1534-1544.
33. Abdel-Azeez HA,Labib HA,Sharaf SM, et al.HE4 and mesothelin: novel biomarkers of ovarian carcinoma in patients with pelvic masses.Asian Pac J Cancer Prev. 2010;11:111-116.
34. Nolen B,Velikokhatnaya L,Marrangoni A, et al.Serum biomarker panels for the discrimination of benign from malignant cases inpatients with an adnexal mass.Gynecol Oncol. 2010;117:440-445.
35. Bolstad N,Oijordsbakken M,Nustad K, et al.Human epididymis protein 4 reference limits and natural variation in a Nordic reference population.Tumour Biol. 2012;33:141-148.
36. Karlsen MA,Sandhu N,Høgdall C, et al.Evaluation of HE4, CA125, risk of ovarian malignancy algorithm (ROMA) and risk of malignancy index (RMI) as diagnostic tools of epithelial ovarian cancer in patients with a pelvic mass.Gynecol Oncol. 2012;127:379-383.
37. Novotny Z,Presl J,Kucera R, et al.HE4 and ROMA index in Czech postmenopausal women.Anticancer Res. 2012;32:4137-4140.
38. Chan KK,Chen CA,Nam JH, et al.The use of HE4 in the prediction of ovarian cancer in Asian women with a pelvic mass.Gynecol Oncol. 2013;128:239-244.
39. Bandiera E,Romani C,Specchia C, et al.Serum human epididymis protein 4 and risk for ovarian malignancy algorithm as new diagnostic and prognostic tools for epithelial ovarian cancer management.Cancer Epidemiol Biomarkers Prev. 2011;20:2496-2506.
40. Molina R,Escudero JM,Augé JM, et al.HE4 a novel tumour marker for ovarian cancer: comparison with CA 125 and ROMA algorithm in patients with gynaecological diseases.Tumour Biol. 2011;32:1087-1095.
41. Van Gorp T,Cadron I,Despierre E, et al.HE4 and CA-125 as a diagnostic test in ovarian cancer: prospective validation of the risk of ovarian malignancy algorithm.Br J Cancer. 2011;104:863-870.
42. Schimmel H,Zegers I,Emons H.Standardization of protein biomarker measurements: is it feasible?.Scand J Clin Lab Investig. 2010;70:27-33.
43. Ferraro S,Mozzi R,Panteghini M.Revaluating serum ferritin as a marker of body iron stores in the traceability era.Clin Chem Lab Med. 2012;50:1911-1916.
44. Klee GG.Clinical interpretation of reference intervals and reference limits. A plea for assay harmonization.Clin Chem Lab Med. 2004;42:752-757.
45. Sturgeon CM.Tumor markers in the laboratory: closing the guideline-practice gap.Clin Biochem. 2001;34:353-359.
46. Mongia SK,Rawlins ML,Owen WE, et al.Performance characteristics of seven automated CA 125 assays.Am J Clin Pathol. 2006;125:921-927.
47. Gallagher MP, Mobley LR, Klee GG,et al.The impact of calibration error in medical decision making. NIST Planning Report 04-1. 2004. http://www.rti.org/pubs/Calibration_Error.pdf (accessed 15 March 2013).
48. Galgano MT,Hampton GM,Frierson HF.Comprehensive analysis of HE4 expression in normal and malignant human tissues.Mod Pathol. 2006;19:847-853.
49. Jacobs IJ,Skates S,Davies AP, et al.Risk of diagnosis of ovarian cancer after raised serum CA 125 concentration: a prospective cohort study.Br Med J. 1996;313:1355-1358.
50. Rustin GJ.Follow-up with CA125 after primary therapy of advanced ovarian cancer has major implications for treatment outcome and trial performances and should not be routinely performed.Ann Oncol. 2011;22:viii45-viii48.
51. Drescher CW,Shah C,Thorpe J, et al.Longitudinal screening algorithm that incorporates change over time in CA125 levels identifies ovarian cancer earlier than a single-threshold rule.J Clin Oncol. 2013;31:387-392.
52. Moore RG,Brown AK,Miller MC, et al.The use of multiple novel tumor biomarkers for the detection of ovarian carcinoma in patients with a pelvic mass.Gynecol Oncol. 2008;108:402-408.
53. Jacob F,Meier M,Caduff R, et al.No benefit from combining HE4 and CA125 as ovarian tumor markers in a clinical setting.Gynecol Oncol. 2011;121:487-491.
54. Moore RG,Miller MC,Disilvestro P, et al.Evaluation of the diagnostic accuracy of the risk of ovarian malignancy algorithm in women with a pelvic mass.Obstet Gynecol. 2011;118:280-288.
55. Li F,Tie R,Chang K, et al.Does risk for ovarian malignancy algorithm excel human epididymis protein 4 and CA125 in predicting epithelial ovarian cancer: a meta-analysis.BMC Cancer. 2012;12:258-258.
56. Fraser CG,Harris EK.Generation and application of data on biological variation in clinical chemistry.Crit Rev Clin Lab Sci. 1989;27:409-437.
57. Fraser CG.Reference change values.Clin Chem Lab Med. 2012;50:807-812.
58. Desirable Specifications for Total Error, Imprecision, and Bias, Derived from Intra- and Inter-IndividualBiologic Variation. Updated in 2010. http://www.westgard.com/biodatabase1.htm?format=phocapdf (accessed 15 March 2013).
59. Harris EK.Effects of intra- and inter-individual variation on the appropriate use of normal range.Clin Chem. 1974;20:1535-1542.
60. Fraser CG,Petersen PH.The importance of imprecision.Ann Clin Biochem. 1991;28:207-211.
61. Dolci A,Scapellato L,Mozzi R, et al.Imprecision of tumour biomarker measurements on Roche modular E170 platform fulfills desirable goals derived from biological variation.Ann Clin Biochem. 2010;47:171-173.
62. Trapé J,Perez de Olaguer J,Buxó J, et al.Biological variation of tumor markers and its application in the detection of disease progression in patients with non-small cell lung cancer.Clin Chem. 2005;51:219-222.
63. Browning MCK,McFarlane NP,Horobin JM, et al.Objective interpretation of results for tumour marker.J Nucl Med Allied Sci. 1990;34:89s-91s.
64. Braga F,Dolci A,Mosca A, et al.Biological variability of glycated hemoglobin.Clin Chim Acta. 2010;411:1606-1610.
65. Braga F,Panteghini M.Biologic variability of C-reactive protein: is the available information reliable?.Clin Chim Acta. 2012;413:1179-1183.
66. Dehaghani AS,Ghiam AF,Hosseini M, et al.Factors influencing serum concentration of CA125 and CA15-3 in Iranian healthy postmenopausal women.Pathol Oncol Res. 2007;13:360-364.
67. Hallamaa M,Suvitie P,Huhtinen K, et al.Serum HE4 concentration is not dependent on menstrual cycle or hormonal treatment among endometriosis patients and healthy premenopausal women.Gynecol Oncol. 2012;125:667-672.
68. Anastasi E,Granato T,Marchei GG, et al.Ovarian tumor marker HE4 is differently expressed during the phases of the menstrual cycle in healthy young women.Tumour Biol. 2010;31:411-415.
69. Erbaǧci AB,Yilmaz N,Kutlar I.Menstrual cycle dependent variability for serum tumor markers CEA, AFP, CA 19-9, CA 125 and CA 15-3 in healthy women.Dis Markers. 1999;15:259-267.
70. Dolci A,Scapellato L,Panteghini M.One-year audit of the implementation of recommendations for optimal use of tumor biomarkers in a university hospital.Biochim Clin. 2008;32:181-185.
71. Cohen DJ,Reynolds MR.Interpreting the results of cost-effectiveness studies.J Am Coll Cardiol. 2008;52:2119-2126.
72. Horvath AR,Kis E,Dobos E.Guidelines for the use of biomarkers: principles, processes and practical considerations.Scand J Clin Lab Invest. 2010;242:109-116.