Identifying Genetic Targets in Gynecological Tumors

NCT07169396 | Recruiting

• 1 other identifier: 676/2021/TESS/AUSLRE
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Ovarian Cancer

Keywords

gene expression; high-grade serous carcinoma; molecular oncology; tumor biomarkers

Outcome Measures

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.

  18 months

Secondary Outcomes (3)

• Protein expression analysis by immunohistochemistry

  24 months

• Functional in vitro validation

  30 months

• Transcriptome-wide analysis in recurrent cases

  30 months

Study Arms (2)

Ovarian Cancer

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

Control group

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

Interventions

RNA extraction and gene expression OTHER

RNA extraction and gene expression

Control group; Ovarian Cancer

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only individuals assigned female at birth are eligible to participate in this study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

• 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)

You may not qualify if:

• Refusal to sign informed consent
• Diagnosis of low-grade or non-epithelial ovarian tumors

Sponsors & Collaborators

• Azienda USL Reggio Emilia - IRCCS: lead

Study Sites (1)

Azienda USL IRCCS di Reggio Emilia

Reggio Emilia, Italy

RECRUITING

Related Publications (4)

• 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.

  PMID: 10620446 BACKGROUND

• 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.

  PMID: 19181441 BACKGROUND

• 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.

  PMID: 33042017 BACKGROUND

• 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.

  PMID: 33299978 BACKGROUND

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Gene Expression

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Genetic Phenomena

Central Study Contacts

Beatrice Melli, MD

CONTACT

0522-29577; beatrice.melli@ausl.re.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: September 11, 2025
• Study Start: November 17, 2021
• Primary Completion: November 17, 2021
• Study Completion (Estimated): November 1, 2027
• Last Updated: September 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)