Abstract
BackgroundMCM5 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.MethodsPatients 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).Results125 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%.ConclusionsMCM5 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.
Highlights
Mini chromosome maintenance 5 (MCM5) is a protein involved in Deoxyribonucleic acid (DNA) replication, facilitating cell proliferation
Ovarian and endometrial cancers, the cancers of the upper female genital tract, share many similarities [1, 2]. They represent a major disease burden with over 16,000 cases diagnosed each year in the United Kingdom (UK). Both represent a collection of different histological subtypes, some of these subtypes being common to both ovarian and endometrial cancer, and both organs are in direct continuity, via the fallopian tubes and the cervix, with the lower genital tract
Many patients with endometrial cancer present with post menopausal bleeding this is by no means universal whilst ovarian cancer is notorious for late presentation, in part because of a lack of red flag symptoms
Summary
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, in the presence of a tumour MCM5 positive cells are present at the surface epithelium and are shed into bodily fluids. The cancers of the upper female genital tract, share many similarities [1, 2]. Combined, they represent a major disease burden with over 16,000 cases diagnosed each year in the UK. They represent a major disease burden with over 16,000 cases diagnosed each year in the UK Both represent a collection of different histological subtypes, some of these subtypes being common to both ovarian and endometrial cancer, and both organs are in direct continuity, via the fallopian tubes and the cervix, with the lower genital tract. Diagnostic tests for patients suspected of having endometrial and ovarian disease lack specificity, leading to unnecessary surgery, and are invasive which patients find unacceptable
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