Arquer Diagnostics Ltd, North East Business and Innovation Centre, Wearfield, Sunderland, SR5 2TA, UK.
Department of Obstetrics and Gynaecology, Manchester Academic Health Science Centre, Saint Mary's Hospital, Central Manchester NHS Foundation Trust, Manchester Academic Health Science Centre, Level 5, Research Floor, Oxford Road, Manchester, M13 9WL, UK.
BMC Cancer. 2020 Oct 15;20(1):1000. doi: 10.1186/s12885-020-07468-y.
MCM5 is a protein involved in DNA replication, facilitating cell proliferation. In normal epithelium MCM5 expression is restricted to the cells in the basal proliferative compartments, however in the presence of a tumour MCM5 positive cells are present at the surface epithelium and are shed into bodily fluids. The aim of this study was to determine the sensitivity of MCM5 as a biomarker for the detection of endometrial and ovarian cancer.
Patients with known ovarian or endometrial cancers, or known benign gynaecological conditions, were enrolled. Informed consent was obtained prior to the collection of full void urine, and either a vaginal tampon (worn for 6-8 h), or a vaginal swab. Vaginal secretions were extracted from the tampon or swab, centrifuged and lysed. Urine samples were centrifuged and lysed. MCM5 levels were determined by MCM5-ELISA (Arquer Diagnostics Ltd).
125 patients completed the study protocol, 41 patients had endometrial cancer, 26 ovarian cancer, and 58 benign controls. All patients provided a urine sample and either a tampon or vaginal swab sample. Urine MCM5 levels were higher in cancer patients than controls (p < 0.0001), there was no significant difference in levels between tampon samples or vaginal swab samples in cancer patients when compared to controls. Performance of MCM5 to discriminate cancer from benign disease was high with an area under the ROC curve of 0.83 for endometrial cancer and 0.68 for ovarian cancer. Using a cut off of 12 pg/mL, overall sensitivity for endometrial cancer was 87.8, and 61.5% for ovarian cancer with a specificity of 75.9%.
MCM5 is a novel sensitive and specific biomarker for the detection of ovarian and endometrial tumours in urine samples, which is likely to have clinical utility as a diagnostic aid.
MCM5 是一种参与 DNA 复制的蛋白质，促进细胞增殖。在正常上皮中，MCM5 表达仅限于基底增殖区的细胞，但在存在肿瘤的情况下，MCM5 阳性细胞存在于表面上皮，并脱落到体液中。本研究旨在确定 MCM5 作为检测子宫内膜癌和卵巢癌的生物标志物的敏感性。
招募了已知患有卵巢癌或子宫内膜癌或已知良性妇科疾病的患者。在收集完整的尿液之前，获得了患者的知情同意，并采集了阴道棉塞（佩戴 6-8 小时）或阴道拭子。从棉塞或拭子中提取阴道分泌物，离心并裂解。通过 MCM5-ELISA（Arquer Diagnostics Ltd）测定 MCM5 水平。
125 名患者完成了研究方案，41 名患者患有子宫内膜癌，26 名患者患有卵巢癌，58 名患者为良性对照。所有患者均提供了尿液样本和阴道棉塞或阴道拭子样本。癌症患者的尿液 MCM5 水平高于对照组（p<0.0001），与对照组相比，癌症患者的棉塞样本或阴道拭子样本之间的水平没有显著差异。MCM5 区分癌症与良性疾病的性能很高，子宫内膜癌的ROC 曲线下面积为 0.83，卵巢癌为 0.68。使用 12pg/mL 的截断值，子宫内膜癌的总体敏感性为 87.8%，卵巢癌的敏感性为 61.5%，特异性为 75.9%。
MCM5 是一种新型的敏感和特异性生物标志物，可用于检测尿液样本中的卵巢和子宫内膜肿瘤，有望作为诊断辅助工具具有临床应用价值。
