Ssedyabane Frank, Niyonzima Nixon, Ngonzi Joseph, Najjuma Josephine Nambi, Namuli Alexcer, Okeny Christopher, Nuwashaba Doreen, Birungi Abraham, Kajabwangu Rogers, Randall Thomas C, Castro Cesar M, Lee Hakho, Tusubira Deusdedit
Department of Medical Laboratory Science, Faculty of Medicine, Mbarara University of Science of Science and Technology, Mbarara, Uganda.
Research and Training Directorate, Uganda Cancer Institute, Kampala, Uganda.
Anal Cell Pathol (Amst). 2025 May 6;2025:1931921. doi: 10.1155/ancp/1931921. eCollection 2025.
Expression of P16ink4A and FOXP3 is correlated with the grades of cervical lesions. In this study, we determined the diagnostic accuracy of serum P16ink4A and FOXP3 concentrations for detection of cervical intraepithelial neoplasia (CIN) and cervical cancer (CC) in a rural setting in Southwestern Uganda. CIN and CC cases (93 each before treatment), and 93 controls were identified. Clinical and demographic data were documented before quantifying serum P16ink4A and FOXP3 concentrations using quantitative ELISA kits. Cases were confirmed by cytology and/or histology. We employed descriptive statistics, cross-tabulation, and receiver operating curves (ROC) using statistical software for data science (STATA) 17. -values <0.05 were considered statistically significant. Serum FOXP3 concentration of 0.0545 ng/mL < showed moderate sensitivity (32.22% and 57.78%) for detection of CIN and CC from healthy controls, respectively. It also showed a moderately high specificity of 68.89% for detection of both CIN and CC from healthy controls (AUC-0.6014 and 0.7679, respectively). Serum P16ink4A concentration of 0.946 ng/mL < showed moderate sensitivities (50.00% and 60.00%) and specificities (56.67% and 55.56%) for the detection of CIN and CC from healthy controls, respectively (AUC-0.6085 and 0.7592, respectively). A combination of elevated serum FOXP3 and P16ink4A showed very low sensitivities of 18.89% in detecting CIN from healthy controls and 33.33% for detecting CC from healthy controls. This combination showed high specificity of 83.33% in detecting both CIN and CC from healthy controls (AUC-0.5992 and 0.7642, respectively). Although serum P16ink4A and FOXP3 concentrations showed moderate accuracy, their combination was more specific than sensitive. This combination has a high potential to be applied for diagnosis rather than screening for cervical lesions, at least in the Ugandan population. Combinations of P16ink4A and FOXP3 with other biomarkers could improve diagnostic accuracies. Additionally, studies could be conducted to assess the performance of these biomarkers in the detection of cervical lesions in specific populations, say Human Immunodeficiency Virus (HIV)-positive and HIV-negative populations.
P16ink4A和FOXP3的表达与宫颈病变的分级相关。在本研究中，我们确定了血清P16ink4A和FOXP3浓度在乌干达西南部农村地区检测宫颈上皮内瘤变（CIN）和宫颈癌（CC）的诊断准确性。确定了CIN和CC病例（各93例，均为治疗前）以及93名对照。在使用定量ELISA试剂盒定量血清P16ink4A和FOXP3浓度之前，记录临床和人口统计学数据。病例通过细胞学和/或组织学确诊。我们使用数据科学统计软件（STATA）17进行描述性统计、交叉制表和受试者工作特征曲线（ROC）分析。P值<0.05被认为具有统计学意义。血清FOXP3浓度<0.0545 ng/mL时，分别显示出从健康对照中检测CIN和CC的中度敏感性（分别为32.22%和57.78%）。它还显示出从健康对照中检测CIN和CC的中度高特异性，为68.89%（AUC分别为0.6014和0.7679）。血清P16ink4A浓度<0.946 ng/mL时，分别显示出从健康对照中检测CIN和CC的中度敏感性（分别为50.00%和60.00%）和特异性（分别为56.67%和55.56%）（AUC分别为0.6085和0.7592）。血清FOXP3和P16ink4A升高的组合在从健康对照中检测CIN时敏感性极低，为18.89%，在从健康对照中检测CC时为33.33%。该组合在从健康对照中检测CIN和CC时显示出83.33%的高特异性（AUC分别为0.5992和0.7642）。尽管血清P16ink4A和FOXP3浓度显示出中等准确性，但其组合的特异性高于敏感性。至少在乌干达人群中，这种组合在诊断宫颈病变方面具有很高的应用潜力，而不是用于筛查。P16ink4A和FOXP3与其他生物标志物的组合可能会提高诊断准确性。此外，可以开展研究以评估这些生物标志物在特定人群（如人类免疫缺陷病毒（HIV）阳性和HIV阴性人群）中检测宫颈病变的性能。
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