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Ovarian CancerGEN_EXP_CO2021NCT07169396

Identifying Genetic Targets in Gynecological Tumors

An observational study of Ovarian Cancer, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
RNA extraction and gene expression
How many people
180 participants
Where
1 siteItaly
Study dates
17 Nov 2021to Nov 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study 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).

Who may be able to join

  • 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)

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Beatrice Melli, MD contact

0522-29577

beatrice.melli@ausl.re.it

Italy1 site, 1 recruiting

  • Azienda USL IRCCS di Reggio Emilia

    Reggio Emilia

    Jasmine Lonetti, jasmine.lonetti@ausl.re.it

    Recruiting

Other trials in Italy

About this study

Official title: Identification of Genetic Targets in Gynecological Tumors Via a Triple in Silico Ex-vivo / in Vivo Approach

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.

Read the detailed description

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:

  • In silico: differentially expressed genes were identified from public datasets (GSE18521 and GSE26712) via transcriptomic analysis and pathway analysis;
  • Ex vivo: mRNA and protein expression will be assessed in fresh-frozen and FFPE tissue samples from patients with HGSOC and other rare epithelial ovarian tumor subtypes (e.g., mesonephric-like, mucinous, endometrioid, clear cell);
  • In vitro: functional experiments using ovarian cancer cell lines (e.g., A2780, KGN, HGL5) will evaluate the effects of gene overexpression or silencing on cell viability, apoptosis and proliferation.

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.

Conditions
Ovarian Cancer
Being tested
RNA extraction and gene expression
Keywords
gene expression, high-grade serous carcinoma, molecular oncology, tumor biomarkers
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RNA extraction and gene expressionOther

    RNA extraction and gene expression

Study groups in NCT07169396
Study groupRoleWhat they receive
Ovarian CancerParticipants 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.
Receives: Other: RNA extraction and gene expression
Control groupPatients 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.
Receives: Other: RNA extraction and gene expression

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 18 months

Secondary outcomes (3)

  1. Protein expression analysis by immunohistochemistry

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

    Measured: 24 months

  2. Functional in vitro validation

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

    Measured: 30 months

  3. Transcriptome-wide analysis in recurrent cases

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

    Measured: 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2025
  2. Study start17 Nov 2021
  3. Primary completion17 Nov 2021
  4. Study completionNov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Other
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07169396
Sponsor's protocol ID
676/2021/TESS/AUSLRE
Acronym
GEN_EXP_CO2021
Status last verified
Jul 2026
First submitted
29 Aug 2025
Last updated
24 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zheng W, Lu JJ, Luo F, Zheng Y, Feng Yj, Felix JC, Lauchlan SC, Pike MC. Ovarian epithelial tumor growth promotion by follicle-stimulating hormone and inhibition of the effect by luteinizing hormone. Gynecol Oncol. 2000 Jan;76(1):80-8. doi: 10.1006/gyno.1999.5628.

    PubMed 10620446

  • Zhang Z, Jia L, Feng Y, Zheng W. Overexpression of follicle-stimulating hormone receptor facilitates the development of ovarian epithelial cancer. Cancer Lett. 2009 Jun 8;278(1):56-64. doi: 10.1016/j.canlet.2008.12.024. Epub 2009 Jan 31.

    PubMed 19181441

  • Czogalla B, Partenheimer A, Jeschke U, von Schonfeldt V, Mayr D, Mahner S, Burges A, Simoni M, Melli B, Benevelli R, Bertini S, Casarini L, Trillsch F. beta-arrestin 2 Is a Prognostic Factor for Survival of Ovarian Cancer Patients Upregulating Cell Proliferation. Front Endocrinol (Lausanne). 2020 Sep 18;11:554733. doi: 10.3389/fendo.2020.554733. eCollection 2020.

    PubMed 33042017

  • Casarini L, Lazzaretti C, Paradiso E, Limoncella S, Riccetti L, Sperduti S, Melli B, Marcozzi S, Anzivino C, Sayers NS, Czapinski J, Brigante G, Poti F, La Marca A, De Pascali F, Reiter E, Falbo A, Daolio J, Villani MT, Lispi M, Orlando G, Klinger FG, Fanelli F, Rivero-Muller A, Hanyaloglu AC, Simoni M. Membrane Estrogen Receptor (GPER) and Follicle-Stimulating Hormone Receptor (FSHR) Heteromeric Complexes Promote Human Ovarian Follicle Survival. iScience. 2020 Nov 18;23(12):101812. doi: 10.1016/j.isci.2020.101812. eCollection 2020 Dec 18.

    PubMed 33299978

Questions about this trial

What is this clinical trial studying?

An observational study of Ovarian Cancer, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Beatrice Melli, MD (0522-29577, beatrice.melli@ausl.re.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gene expression profiling of selected target genes (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07169396, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.

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