Research Article
Kahramanmaraş Bölgesine Ait Serum Örneklerinde Ölçülen Tümör Belirteçlerinin Referans Değerlerinin Belirlenmesi
Abstract
Amaç: Referans aralıkları hastalığın teşhisi, izlenmesi ve tedavisi için oldukça önemlidir. Bununla birlikte, referans aralıkları yaşa, cinsiyete, coğrafi bölgeye, diyet durumuna ve diğer faktörlere göre değişebilir. Bu çalışmanın amacı, Kahramanmaraş Bölgesine ait Alfa-fetoprotein (AFP), Karbonhidrat Antijen 15-3 (CA 15.3), Karbonhidrat Antijen 19.9 (CA 19.9), Karbonhidrat Antijen 125 (CA 125), Karsinoembriyonik Antijen (CEA), Prostat Spesifik Antijen (PSA), serbest PSA (fPSA) ve tiroglobulin (TG) için referans aralıklarını belirlemektir. Gereç ve Yöntem: Toplamda 64,687 kişilik veriden 21,190 kişinin seçilmesiyle Klinik Biyokimya Laboratuvarından türetilen veriler kullanılmıştır. Tüm parametreler için referans aralıkları hesaplanırken indirect ve parametrik olmayan yüzde tahmin yöntemi kullanılmıştır. Bulgular: Çalışılan parametreler için aşağıdaki gibi alt ve üst sınırlar belirlenmiştir - AFP: 0.52, 3.76 IU/ml; CA 15.3: 5.0, 37.60 IU/ml; CA 19.9: 2.46, 29.5 IU/ml; CA 125: 2.89, 22.7 IU/ml; CEA: 0.11, 3.67 ng/ml; fPSA: 0.02, 0.75 ng/ml; PSA: 0.14, 2.31 ng/ml; and TG: 0.34, 30.13 ng/ml.Sonuç: Bu çalışma, üretici firmalar tarafından incelenen parametreler için alıntı yapılan referans aralıklarının, popülasyonumuza özgü referans aralıklarıyla tam olarak örtüşmediğini göstermektedir. Bölgesel referans aralıkları belirlenerek tarama testlerinin verimliliğini artırabilir.
References
- [1] Diamandis E, Fritche H, Lilja H, Chan D, Schwartz M. Tumor Markers: Physiology, Pathobiology, Technology and Clinical Applications. Washington, DC, USA: AACC Press; 2002. [2] Sturgeon CM, Lai LC, Duffy MJ. Serum tumour markers: how to order and interpret them. Brit Med J. 2009;339. [3] Schilsky RL. Personalizing cancer care: American Society of Clinical Oncology presidential address 2009. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2009;27(23):3725-30. [4] Virji MA, Mercer DW, Herberman RB. Tumor markers in cancer diagnosis and prognosis. CA: a cancer journal for clinicians. 1988;38(2):104-26. [5] Perkins GL, Slater ED, Sanders GK, Prichard JG. Serum tumor markers. American family physician. 2003;68(6):1075-82. [6] Cheung KL, Graves CR, Robertson JF. Tumour marker measurements in the diagnosis and monitoring of breast cancer. Cancer treatment reviews. 2000;26(2):91-102. [7] Farinati F, Marino D, De Giorgio M, Baldan A, Cantarini M, Cursaro C, et al. Diagnostic and prognostic role of alpha-fetoprotein in hepatocellular carcinoma: both or neither? The American journal of gastroenterology. 2006;101(3):524-32. [8] Strom BL, Maislin G, West SL, Atkinson B, Herlyn M, Saul S, et al. Serum CEA and CA 19-9: potential future diagnostic or screening tests for gallbladder cancer? International journal of cancer. 1990;45(5):821-4. [9] Harris L, Fritsche H, Mennel R, Norton L, Ravdin P, Taube S, et al. American society of clinical oncology 2007 update of recommendations for the use of tumor markers in breast cancer. Journal of Clinical Oncology. 2007;25(33):5287-312. [10] Rustin GJ, van der Burg ME, Griffin CL, Guthrie D, Lamont A, Jayson GC, et al. Early versus delayed treatment of relapsed ovarian cancer (MRC OV05/EORTC 55955): a randomised trial. Lancet. 2010;376(9747):1155-63. [11] Smerage JB, Barlow WE, Hortobagyi GN, Winer EP, Leyland-Jones B, Srkalovic G, et al. Circulating tumor cells and response to chemotherapy in metastatic breast cancer: SWOG S0500. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2014;32(31):3483-9. [12] Solberg HE. International Federation of Clinical Chemistry (IFCC), Scientific Committee, Clinical Section, Expert Panel on Theory of Reference Values, and International Committee for Standardization in Haematology (ICSH), Standing Committee on Reference Values. Approved Recommendation (1986) on the theory of reference values. Part 1. The concept of reference values. Journal of clinical chemistry and clinical biochemistry Zeitschrift fur klinische Chemie und klinische Biochemie. 1987;25(5):337-42. [13] Wayne PA. Defining, establishing, and verifying reference intervals in the clinical laboratory; approved guideline. Clinical and Laboratory Standards Institute. 2010. [14] Qin X, Lin L, Mo Z, Lv H, Gao Y, Tan A, et al. Reference intervals for serum alpha-fetoprotein and carcinoembryonic antigen in Chinese Han ethnic males from the Fangchenggang Area Male Health and Examination Survey. The International journal of biological markers. 2011;26(1):65-71. [15] Zhang GM, Guo XX, Ma XB, Zhang GM. Reference Intervals of Alpha-Fetoprotein and Carcinoembryonic Antigen in the Apparently Healthy Population. Medical science monitor : international medical journal of experimental and clinical research. 2016;22:4875-80. [16] Bjerner J, Hogetveit A, Wold Akselberg K, Vangsnes K, Paus E, Bjoro T, et al. Reference intervals for carcinoembryonic antigen (CEA), CA125, MUC1, Alfa-foeto-protein (AFP), neuron-specific enolase (NSE) and CA19.9 from the NORIP study. Scandinavian journal of clinical and laboratory investigation. 2008;68(8):703-13. [17] Ri G, Ohno S, Yamamoto T, Ito E, Furutani M, Furutani Y, et al. Serum Levels of CA15-3, KL-6 and BCA225 Are Positively Correlated with Each Other in the General Population. Anticancer Res. 2009;29(10):4239-42. [18] Sagi-Dain L, Lavie O, Auslander R, Sagi S. Clinical Use and Optimal Cutoff Value of Ca15-3 in Evaluation of Adnexal Mass: Retrospective Cohort Study and Review of the Literature. Am J Clin Oncol. 2018;41(9):838-44. [19] Woo HY, Kim YJ, Park H. Establishment of reference intervals of tumor markers in Korean adults. The Korean journal of laboratory medicine. 2008;28(3):179-84. [20] Behbehani AI, Mathew A, Farghaly M, van Dalen A. Reference levels of the tumor markers carcinoembryonic antigen, the carbohydrate antigens 19-9 and 72-4, and cytokeratin fragment 19 using the Elecsys Relecsys 1010 analyzer in a normal population in Kuwait. The importance of the determination of local reference levels. The International journal of biological markers. 2002;17(1):67-70. [21] Lao X, Yang D, Mo Z, Gao Y, Deng Y, Qin X, et al. Reference Intervals for Alpha-Fetoprotein (AFP) and Carcinoembryonic Antigen (CEA) in Guangxi Zhuang Ethnic Males from the FAMHES Project. Clinical laboratory. 2016;62(5):955-61. [22] Barcelo B, Ayllon O, Belmonte M, Barcelo A, Vidal R, Forteza-Rey J, et al. Proposed reference value of the CA 125 tumour marker in men. Potential applications in clinical practice. Clinical biochemistry. 2008;41(9):717-22. [23] Bonfrer JM, Korse CM, Verstraeten RA, van Kamp GJ, Hart GA, Kenemans P. Clinical evaluation of the Byk LIA-mat CA125 II assay: discussion of a reference value. Clinical chemistry. 1997;43(3):491-7. [24] Liu ZY, Sun YH, Xu CL, Gao X, Zhang LM, Ren SC. Age-specific PSA reference ranges in Chinese men without prostate cancer. Asian J Androl. 2009;11(1):100-3. [25] Lee SE, Kwak C, Park MS, Lee CH, Kang W, Oh SJ. Ethnic differences in the age-related distribution of serum prostate-specific antigen values: a study in a healthy Korean male population. Urology. 2000;56(6):1007-10. [26] Yang J, Tang A, Zhang S, Sun X, Ming L. The age-specific reference intervals for tPSA, fPSA, and %fPSA in healthy Han ethnic male. Journal of clinical laboratory analysis. 2016. [27] Nakamura S, Sakata S, Minamori Y, Komaki T, Kojima N, Kamikubo K, et al. Serum thyroglobulin (Tg) concentration in healthy subjects: absence of age- and sex-related differences. Endocrinologia japonica. 1984;31(1):93-8. [28] Giovanella L, Imperiali M, Ferrari A, Palumbo A, Furlani L, Graziani MS, et al. Serum thyroglobulin reference values according to NACB criteria in healthy subjects with normal thyroid ultrasound. Clinical chemistry and laboratory medicine. 2012;50(5):891-3.
Year 2019,
Volume: 14 Issue: 3, 124 - 134, 15.11.2019
Abstract
Objectives: Reference intervals are important for disease diagnosis, monitoring and treatment. However, reference intervals may vary by age, gender, geographical location, dietary status and other factors.The aim of this study is to determine the reference intervals for alpha-fetoprotein
(AFP), CarbohydrateAntigen 15-3 (CA 15.3), Carbohydrate Antigen 19.9 (CA 19.9),
Carbohydrate Antigen 125 (CA 125), Carcinoembryonic
Antigen (CEA), Prostate Specific Antigen (PSA), free PSA (fPSA), and
thyroglobulin (TG) in Kahramanmaraş Region, Turkey.
Material and Methods: Data derived from 21,190 individuals in 64,687 were
obtained from the Clinical Biochemistry Laboratory. The reference intervals for
the parameters were determined using indirect and non-parametric percentile
estimation method.
Results: In
the study, the following respective lower and upper limits for the studied
parameters were determined- AFP: 0.52, 3.76 IU/ml; CA 15.3: 5.0, 37.60 IU/ml;
CA 19.9: 2.46, 29.5 IU/ml; CA 125: 2.89, 22.7 IU/ml; CEA: 0.11, 3.67 ng/ml;
fPSA: 0.02, 0.75 ng/ml; PSA: 0.14, 2.31 ng/ml; and TG: 0.34, 30.13 ng/ml.
Conclusion: This study
demonstrates that the reference intervals quoted by the manufacturers for the
parameters examined do not perfectly coincide with the reference intervals that
are specific to our population. Establishing local reference intervals
increases the utility of screening tests.
References
- [1] Diamandis E, Fritche H, Lilja H, Chan D, Schwartz M. Tumor Markers: Physiology, Pathobiology, Technology and Clinical Applications. Washington, DC, USA: AACC Press; 2002. [2] Sturgeon CM, Lai LC, Duffy MJ. Serum tumour markers: how to order and interpret them. Brit Med J. 2009;339. [3] Schilsky RL. Personalizing cancer care: American Society of Clinical Oncology presidential address 2009. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2009;27(23):3725-30. [4] Virji MA, Mercer DW, Herberman RB. Tumor markers in cancer diagnosis and prognosis. CA: a cancer journal for clinicians. 1988;38(2):104-26. [5] Perkins GL, Slater ED, Sanders GK, Prichard JG. Serum tumor markers. American family physician. 2003;68(6):1075-82. [6] Cheung KL, Graves CR, Robertson JF. Tumour marker measurements in the diagnosis and monitoring of breast cancer. Cancer treatment reviews. 2000;26(2):91-102. [7] Farinati F, Marino D, De Giorgio M, Baldan A, Cantarini M, Cursaro C, et al. Diagnostic and prognostic role of alpha-fetoprotein in hepatocellular carcinoma: both or neither? The American journal of gastroenterology. 2006;101(3):524-32. [8] Strom BL, Maislin G, West SL, Atkinson B, Herlyn M, Saul S, et al. Serum CEA and CA 19-9: potential future diagnostic or screening tests for gallbladder cancer? International journal of cancer. 1990;45(5):821-4. [9] Harris L, Fritsche H, Mennel R, Norton L, Ravdin P, Taube S, et al. American society of clinical oncology 2007 update of recommendations for the use of tumor markers in breast cancer. Journal of Clinical Oncology. 2007;25(33):5287-312. [10] Rustin GJ, van der Burg ME, Griffin CL, Guthrie D, Lamont A, Jayson GC, et al. Early versus delayed treatment of relapsed ovarian cancer (MRC OV05/EORTC 55955): a randomised trial. Lancet. 2010;376(9747):1155-63. [11] Smerage JB, Barlow WE, Hortobagyi GN, Winer EP, Leyland-Jones B, Srkalovic G, et al. Circulating tumor cells and response to chemotherapy in metastatic breast cancer: SWOG S0500. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2014;32(31):3483-9. [12] Solberg HE. International Federation of Clinical Chemistry (IFCC), Scientific Committee, Clinical Section, Expert Panel on Theory of Reference Values, and International Committee for Standardization in Haematology (ICSH), Standing Committee on Reference Values. Approved Recommendation (1986) on the theory of reference values. Part 1. The concept of reference values. Journal of clinical chemistry and clinical biochemistry Zeitschrift fur klinische Chemie und klinische Biochemie. 1987;25(5):337-42. [13] Wayne PA. Defining, establishing, and verifying reference intervals in the clinical laboratory; approved guideline. Clinical and Laboratory Standards Institute. 2010. [14] Qin X, Lin L, Mo Z, Lv H, Gao Y, Tan A, et al. Reference intervals for serum alpha-fetoprotein and carcinoembryonic antigen in Chinese Han ethnic males from the Fangchenggang Area Male Health and Examination Survey. The International journal of biological markers. 2011;26(1):65-71. [15] Zhang GM, Guo XX, Ma XB, Zhang GM. Reference Intervals of Alpha-Fetoprotein and Carcinoembryonic Antigen in the Apparently Healthy Population. Medical science monitor : international medical journal of experimental and clinical research. 2016;22:4875-80. [16] Bjerner J, Hogetveit A, Wold Akselberg K, Vangsnes K, Paus E, Bjoro T, et al. Reference intervals for carcinoembryonic antigen (CEA), CA125, MUC1, Alfa-foeto-protein (AFP), neuron-specific enolase (NSE) and CA19.9 from the NORIP study. Scandinavian journal of clinical and laboratory investigation. 2008;68(8):703-13. [17] Ri G, Ohno S, Yamamoto T, Ito E, Furutani M, Furutani Y, et al. Serum Levels of CA15-3, KL-6 and BCA225 Are Positively Correlated with Each Other in the General Population. Anticancer Res. 2009;29(10):4239-42. [18] Sagi-Dain L, Lavie O, Auslander R, Sagi S. Clinical Use and Optimal Cutoff Value of Ca15-3 in Evaluation of Adnexal Mass: Retrospective Cohort Study and Review of the Literature. Am J Clin Oncol. 2018;41(9):838-44. [19] Woo HY, Kim YJ, Park H. Establishment of reference intervals of tumor markers in Korean adults. The Korean journal of laboratory medicine. 2008;28(3):179-84. [20] Behbehani AI, Mathew A, Farghaly M, van Dalen A. Reference levels of the tumor markers carcinoembryonic antigen, the carbohydrate antigens 19-9 and 72-4, and cytokeratin fragment 19 using the Elecsys Relecsys 1010 analyzer in a normal population in Kuwait. The importance of the determination of local reference levels. The International journal of biological markers. 2002;17(1):67-70. [21] Lao X, Yang D, Mo Z, Gao Y, Deng Y, Qin X, et al. Reference Intervals for Alpha-Fetoprotein (AFP) and Carcinoembryonic Antigen (CEA) in Guangxi Zhuang Ethnic Males from the FAMHES Project. Clinical laboratory. 2016;62(5):955-61. [22] Barcelo B, Ayllon O, Belmonte M, Barcelo A, Vidal R, Forteza-Rey J, et al. Proposed reference value of the CA 125 tumour marker in men. Potential applications in clinical practice. Clinical biochemistry. 2008;41(9):717-22. [23] Bonfrer JM, Korse CM, Verstraeten RA, van Kamp GJ, Hart GA, Kenemans P. Clinical evaluation of the Byk LIA-mat CA125 II assay: discussion of a reference value. Clinical chemistry. 1997;43(3):491-7. [24] Liu ZY, Sun YH, Xu CL, Gao X, Zhang LM, Ren SC. Age-specific PSA reference ranges in Chinese men without prostate cancer. Asian J Androl. 2009;11(1):100-3. [25] Lee SE, Kwak C, Park MS, Lee CH, Kang W, Oh SJ. Ethnic differences in the age-related distribution of serum prostate-specific antigen values: a study in a healthy Korean male population. Urology. 2000;56(6):1007-10. [26] Yang J, Tang A, Zhang S, Sun X, Ming L. The age-specific reference intervals for tPSA, fPSA, and %fPSA in healthy Han ethnic male. Journal of clinical laboratory analysis. 2016. [27] Nakamura S, Sakata S, Minamori Y, Komaki T, Kojima N, Kamikubo K, et al. Serum thyroglobulin (Tg) concentration in healthy subjects: absence of age- and sex-related differences. Endocrinologia japonica. 1984;31(1):93-8. [28] Giovanella L, Imperiali M, Ferrari A, Palumbo A, Furlani L, Graziani MS, et al. Serum thyroglobulin reference values according to NACB criteria in healthy subjects with normal thyroid ultrasound. Clinical chemistry and laboratory medicine. 2012;50(5):891-3.
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Details
| Primary Language | English |
|---|---|
| Subjects | Health Care Administration |
| Journal Section | Araştırma Makaleleri |
| Authors | |
| Publication Date | November 15, 2019 |
| Submission Date | May 8, 2019 |
| Acceptance Date | September 18, 2019 |
| Published in Issue | Year 2019 Volume: 14 Issue: 3 |
