Table 2 Synthesis of study characteristics
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 |