An observational study in Ovarian Cancer, sponsored by Azienda USL Reggio Emilia - IRCCS. Recruiting at 1 site in Italy. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-24.
Sponsored by Azienda USL Reggio Emilia - IRCCS · Observational
This observational study aims to identfy genetic targets involved in the pathogenesis of gynecological tumors, with a focus on high-grade serous ovarian carcinoma. Using a triple approach - in silico, ex vivo and in vitro - the study will investigate the role of gonadotropins and their related signaling pathways in the epithelial ovarian cancers. Gene and protein expression levels will be evaluated through transcriptomic analysis, immunohistochemistry and functional assays on tumor cell lines. The goal is to uncover potential diagnostic or therapeutic targets in gynecological malignancies.
Ovarian cancer is the leading cause of death among gynecological malignanciens. High-grade serous ovarian carcinoma (HGSOC) represents the most common and aggressive subtype. Growing evidence suggests that gonadotropins and their receptors (FSHR and LHCGR), as well as membrane estrogen receptors (GPER), may play a significant role in ovarian carcinogenesis by modulating proliferative and anti-apoptotic signals. The GEN EX CO 2021 study is a monocentric, observational project conducted at AUSL-IRCCS Reggio Emilia. It is both prospective and retrospective, and it aims to identify gene expression patterns that differentiate ovarian tumor tissues from normal ovarian epithelium. The study uses a triple experimental approach:
Participants include both prospective cases and retrospective samples, as well as control tissues from patients undergoing surgery for benign conditions. Gene expressions will be assessed through digital PCR, while protein levels will be analyzed via immunohistochemistry. Functional studies will explore the biological impact of selected genes on tumor cell behavior. Data will be collected using a secure, coded e-CRF in compliance with ethical and privacy regulations. The ultimate goal is to identify novel molecular targets that could inform future diagnostic or therapeutic approaches in ovarian cancer.
3,381 studies on the registry are indexed under Ovarian Neoplasms; 790 are open to participants now.
This study's planned enrollment of 180 is close to the median of 200 across 616 observational studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →Azienda USL Reggio Emilia - IRCCS is the lead sponsor of 93 studies on the registry; 26 are open to participants now.
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Adult female patients diagnosed with epithelial ovarian cancer - including high-grade serous, endometrioid, mucinous, clear cell and mesonephric-like tumors - treated at AUSL-IRCCS Reggio Emilia, as well as women undergoing surgery for benign gynecological conditions (controls).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with high-grade serous ovarian carcinoma (HGSOC) or other rare epithelial ovarian tumor subtypes (e.g., mucinous, endometrioid, clear cell, mesonephric-like). Includes both prospectively enrolled patients and retrospectively collected samples. Purpose: to analyze gene and protein expression profiles in tumor tissues and compare them with normal ovarian epithelium.
Other: RNA extraction and gene expression
Patients undergoing surgery for benign gynecological conditions, from whom non-tumoral ovarian epithelial tissue is obtained. Purpose: to provide baseline biological controls for comparison with ovarian cancer samples.
Other: RNA extraction and gene expression
RNA extraction and gene expression
Gene expression profiling of selected target genes
Quantification of gene expression levels (e.g., PRKAR1A, GNAS, GNAQ, ERBB2, GPM6B, etc.) in ovarian tumor tissue vs normal ovarian epithelium using digital PCR.
Time frame: 18 months
Protein expression analysis by immunohistochemistry
evaluation of protein levels of selected genes in ovarian tumor and control tissues.
Time frame: 24 months
Functional in vitro validation
assessment of cellular response to gene modulation (overexpression / silencing) in ovarian tumor cell lines.
Time frame: 30 months
Transcriptome-wide analysis in recurrent cases
extended differential gene expression and pathway analysis in samples from patients with tumor recurrence.
Time frame: 30 months
Plan to share: No
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Azienda USL Reggio Emilia - IRCCS