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Table 2 Synthesis of study characteristics

From: The impact of different preanalytical methods related to CA 15-3 determination in frozen human blood samples: a systematic review

Study/year Case/control Study period Outcomes Methods Age (years) Subgroups Age-/sex-matched case-control Follow-up length Clinical-pathological association/correlation CA 15-3 cutoff (U/mL) Kit or instrument Sample type Store temperature (°C)
Chukwurah et al. 2018 [22] (89/21) naive BC vs healthy 2015–2017 CA 15-3 for BC surveillance Mean ± SD Age range (29–65) Yes Yes Up to 3 and 6 months Yes < 35 ELISA Serum − 20
Mahmood et al. 2016 [23] (70/20) premenopausal BC vs healthy Ferritin vs CA 15-3 in BC Mean ± SD; ANOVA Age range (20–50) Yes Yes Yes < 119.39 HumaReader Plus made by HUMAN GmbH Serum − 20
Said 2019 [24] (84/71) BC vs healthy 2016–2017 CBC with ALP and LDH for BC prognosis ROC analysis Mean age (32.7 ± 18.3) No Yes No < 15.3 HumaReader Plus made by HUMAN GmbH Serum − 20
Moazzezy et al. 2014 [25] (30/30) BC naive vs healthy 2012–2013 Preoperative and clinicopathological BC features Mean ± SEM unpaired Student’s t-test; regression analysis Mean age 48 (23–87) Yes Yes Yes < 30 EIA Serum − 20
El-Moneim Ebied et al. 2013 [26] (50/50) BC naive vs healthy 2010–2010 Diagnostic, prognostic, and follow-up value of CA 15-3 in BC Mean ± SE. ROC analysis; univariate survival analysis KM Mean age (41.73 ± 12.2) Yes No (comparable age (40.18 ± 11.05 years)) 2 years Yes < 25 RIA Serum − 80
Svobodova et al. 2018 [27] (412/60) BC-DR vs NDR TPS, CEA, and CA 15-3 (months 1–3–6 after surgery). DR was recorded between 7 and 12 months after surgery Mean ± SD and Wilcoxon test Median age 61 No Yes 1, 3, and 6 months (after surgery).
7 and 12 months for DR
No < 30 CLEIA Serum − 80
Pedersen et al. 2013 [28] (83/24) BC metastatic vs LR 2004– 2010 CA 15-3, CEA, and HER2 in the early diagnosis of metastatic HER2+ BC 95% confidence intervals Median age 59.1 (30–86) Yes Yes < 32.4 CLEIA Serum − 80
Di Gioia et al. 2015 [29] (241) BC patients 1998–2007 Prognostic value of HER2 and CA 15-3 and DFS and cancer-specific survival in preoperative BC Wilcoxon rank-sum test Median age 57 (range 29–89) Yes 7–91.4 months Yes < 24 EIA Serum − 80
Sen et al. 2011 [30] (13/12/25/19) OV stage I/II, OV stage III/IV; benign ovarian vs healthy 2009–2011 CA 15-3, IL-6, Leptin, VEGF, and CRP for ovarian cancer prediction Mean difference and Mann-Whitney U-test; Wilcoxon; Kruskal-Wallis test OV stage I/II (44.6±4.65), OV stage III/IV (49.6±6.4); benign ovarian (41.6±10.3); HC (40.1±8.9) No No Yes < 30 MEIA Serum − 80
Metwally et al. 2010 [31] (44/15) BC patients vs healthy 2009–2010 Diagnostic value of VEGF, IL-18, and NO levels in BC patients Mean and SEM difference; ROC curve Median age 36 (23–56) Yes Yes < 11.2 MEIA Serum − 70
Hewala et al. 2012 [32] (35/35) BC naive vs healthy 01/2010–08/2010 sFas and p53 protein vs CA 15-3 to monitor BC patients Mean ± SE; Kruskal-Wallis test; ROC analysis Case mean age (43.73 ± 12.2); HC mean age (42.18 ± 11.05) Yes Yes (comparable mean age) 1 year Yes < 23 RIA Serum − 80
Zajkowska et al. 2020 [33] (120/28/32) BC patients/benign tumors (adenoma 10), fibroadenoma (18) vs healthy VEGF plasma concentrations alone or combination with CA 15-3 in BC patients Median range; ROC curve BC cases median age 58 years, range (39–83); benign tumors 48, range (36–71) Yes Yes Yes < 18.45 CMIA Plasma − 85
Zaleski et al. 2018 [34] (55/20/28) BC patients/benign breast disease vs healthy 2010–2013 miRNAs compared with CA 15-3 in BC monitoring Mean; ROC curve BC cases, 44 median age (20.1–64.5); benign breast disease, 54 median age (24.2–81.8); HC, 59 median age (32.6–85.8) Yes Yes NA Yes < 27 CLEIA Serum − 80
Tang et al. 2018 [35] (40/40/40) BC patients/benign mammary hyperplasia vs healthy 2004–2005 ALU115, ALU247/115, CEA, and CA15 in BC Median and Mann-Whitney U-test Median age 48 years, range 28–64. BC cases median age 46, HC median age 45 Yes Yes NA Yes < 31.3 CLEIA Serum − 80
Christenson et al. 2011 [36] (66/77) CA 15-3 serum vs plasma Validation of CA 15-3, CA 19-9, CA 125 II, CEA, and AFP for instrument comparison Mean; ROC curve All patient samples > 18 No Day 0 and 1 year No < 42.1 Vista vs Advia Centaur Serum and plasma − 20; − 70
Saba et al. 2017 [37] (44/49) malignant pleural fluid vs benign pleural fluid 2013–2014 CA 15-3 and NSE solely or in pleural fluid ROC curve Malignant cases mean age 66.6 ± 16.6 years versus benign pleural effusion controls 73.4 ± 16.5 No No NA < 13.9 and < 6.68 L* ELISA Serum and pleural effusion − 20
Laidi et al. 2014 [38] (29/31) BC patients vs healthy Correlation of salivary and serum CA 15-3 in BC patients Median value; Mann-Whitney test Mean age cases 7.24 ± 9.52 and HCs 43.45 ± 14.72 No No NA Yes (lymph node status) < 16.7 ELISA Serum and saliva − 80
Ercan et al. 2012 [39] 30 healthy pregnant women Specificity of CA-125, CA 15-3, CA 19-9, and CEA during pregnancy ANOVAs Median age 29 years range 28–64 No No 10–36 weeks No <25 EIA Serum − 20
  1. BC breast cancer, DFS disease-free survival, DR disease recurrence, LR local recurrence, NA not accessible
  2. Note: *Different measurement unit for CA 15-3 cutoff value