Background
Materials and methods
Search strategy and eligibility criteria
Data extraction and collection
Study selection
Data items
Summary measures
Risk of bias
Quality assessment of selected studies
Results
Study characteristics
No. of studies [reference] | |
---|---|
Study type | |
Retrospective study | |
Prospective study | 1 [39] |
Biospecimen type | |
Serum | |
Plasma | 1 [33] |
Serum and plasma | 1 [36] |
Serum and pleural effusion | 1[37] |
Serum and saliva | 1 [38] |
Storage temperature (°C) | |
− 80 | |
− 20 | |
− 70 | 1 [31] |
− 85 | 1 [33] |
− 20; − 70 | 1 [36] |
Patient status/disease | |
Breast cancer | |
Pleural effusion | 1 [37] |
Adnexal masses and ovarian cancer | 1 [30] |
Pregnancy | 1 [39] |
Multiple disease | 1 [36] |
Measurement unit | |
U/mL | |
ng/mL | |
U/L | 1 [31] |
Kit or instrument | |
CLEIA | |
EIA | |
ELISA | |
HumaReader Plus made by HUMAN GmbH | |
MEIA | |
RIA | |
CMIA | 1 [33]) |
Vista vs Advia Centaur | 1 [36] |
Synthesis of results
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 |