Identifying Genetic Targets in Gynecological Tumors

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorAzienda USL Reggio Emilia - IRCCS

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult women ≥18 years old

Histologically confirmed diagnosis of epithelial ovarian cancer (including high- grade serous, endometrioid, mucinous, clear cell, or mesonephric-like histotypes)

Signed informed consent (for prospective cases) or ethically approved waiver (for retrospective samples)

Disqualifiers

Refusal to sign informed consent

Diagnosis of low-grade or non-epithelial ovarian tumors

Patients whose clinical or pathological data are unavailable or insufficient for study inclusion

Trial population

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).

Trial design

Design model

Case-control

Time perspective

Other

Treatments tested in this trial

  • RNA extraction and gene expression

    Other intervention

    RNA extraction and gene expression

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: Ovarian Cancer1 intervention
Group B: Control group1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

Protein expression analysis by immunohistochemistry

evaluation of protein levels of selected genes in ovarian tumor and control tissues.

Time frame
24 months
2

Functional in vitro validation

assessment of cellular response to gene modulation (overexpression / silencing) in ovarian tumor cell lines.

Time frame
30 months
3

Transcriptome-wide analysis in recurrent cases

extended differential gene expression and pathway analysis in samples from patients with tumor recurrence.

Time frame
30 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.