De Angelis, Maria Chiara (2023) Validation of a panel of circulating micro-RNAs as potential biomarkers in the diagnosis and follow-up of women with atypical endometrial hyperplasia and endometrial cancer. [Tesi di dottorato]

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Abstract

Objective The aim of this study was to determine the accuracy of the predictive value of a selected panel of microRNA (microRNA-504, microRNA-429) obtained on endometrial tissue samples, in detecting endometrial cancer (EC) and its precursor, atypical endometrial hyperplasia (AEH). Materials and Methods A prospective observational single center study was conducted at the Hysteroscopy Unit, Department of Gynecology and Obstetrics of Tertiary Care University Hospital, University of Naples “Federico II”. Patients over the age of 18, with diagnosis of EC or AEH, not receiving any previous treatment were included. Women with other kind of malignancy were excluded. Patients were divided into three groups: women with EC (group 1), women with AEH (Group 2), women with normal proliferative endometrium (Group 3). All patients underwent office hysteroscopic biopsy using a standardized “grasp biopsy” technique. For each sample, after RNA extraction, subsequent reverse transcription in cDNA, the PCR Real Time analysis was performed by using Taqman Advanced microRNA Assay (Thermo Fisher Scientific, MA, USA) to evaluate microRNA expression (microRNA 504-5p, microRNA 429) in order to compare the different level of expression between endometrial cancer tissue, atypical hyperplasia tissue and healthy endometrial tissue. Patient’s data and biologic materials were managed according to Helsinki declaration. RESULTS A total of 33 women were enrolled. Specifically, 15/33 (45.5%) women were diagnosed with endometrial cancer, 15/33 (45.5%) patients with hyperplasia and 3/33 (9%) with normal proliferative endometrium. In Group 1, a valid amplification plot for the microRNA-504-5p was expressed in 14/15 (93.3%) women, and in 15/15 (100%) of women for miroRNA-429 with a median Ct value of 32.3 and 29.7 for microRNA-504-5p and miroRNA-429 analysis respectively. In Group 2, a valid amplification plot was found in 14/15 (93.3%) patients for microRNA-504-5p and in 13/15 (86.7%) patients for microRNA-429. In Group 3, microRNA-504-5p was detected in 3/3 patients (100%) while mi-croRNA-429 in 2/3 (66.7%) women with a median Ct value of 25.0 and 24.0 respectively. CONCLUSIONS This preliminary data demonstrated that this panel of two microRNA could be proposed as a potential biomarker for diagnosis of EC and/or AEH; microRNA-504-5p and microRNA-429 may act as a non-invasive biomarker for early-stage EC. In particular, miroRNA-429 expression could be more related to EC compared to AEH. Further studies are needed in order to validate the role of microRNAs for an earlier and re-liable diagnosis.

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