Clinical Management and Outcomes of Primary Ovarian Leiomyosarcoma

NCT ID: NCT06749600

Last Updated: 2025-06-18

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-14
• Study Completion Date: 2027-12-31

Brief Summary

This observational study aims to gather comprehensive data on primary ovarian leiomyosarcoma (POLMS). This extremely rare malignancy accounts for less than 3% of primary ovarian malignancies and has an incidence of only 1% among ovarian cancers. This national, retrospective and prospective multicenter study will collect and analyze historical cases of POLMS with remote diagnoses accessed through clinical case reviews and newly identified cases. The study aims to expand a previously identified series of 113 cases described in the literature, uncovering patterns in diagnosis, treatment, and outcomes and ultimately establishing evidence-based guidelines for the optimal management of this rare and aggressive cancer.

Detailed Description

This study adopts a national, multicenter, observational design, incorporating both retrospective and prospective methodologies to collect and analyze primary ovarian leiomyosarcoma (POLMS) cases. The retrospective component will include cases diagnosed since 1980, leveraging institutional archives and clinical case reviews.

Data collection will be standardized using an electronic Case Report Form (eCRF) implemented on REDCap. All data will be centralized for uniformity and undergo rigorous validation to ensure consistency across centers. Findings will be reported in aggregated form to preserve patient confidentiality.

The study will gather extensive data points, including:

• Patient demographics.
• Clinical presentation and tumor characteristics (symptoms, tumor markers such as CA-125, CEA, and Ki-67).
• Treatment modalities (surgical details, lymphadenectomy, chemotherapy, radiotherapy, or hormonal therapy).
• Recurrence patterns and outcomes (disease-free survival, overall survival).
• Immunohistochemical findings (positivity for desmin, SMA, and vimentin). The statistical analysis primarily involves descriptive and exploratory techniques to identify patterns and correlations within the dataset.

Conditions

Primary Ovarian Leiomyosarcoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

Primary leiomyosarcoma of the ovary (POLMS)

The study population includes patients aged between 18 and 99 years diagnosed with primary ovarian leiomyosarcoma (POLMS) afferent to participating centers. This population encompasses both historical cases diagnosed since 1980 and new cases identified during the study period.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Diagnosis of primary leiomyosarcoma of the ovary;
• Patients diagnosed with POLMS for whom data relating to diagnosis and treatment are available.
• Aged between 18 and 99 years

Exclusion Criteria

• All patients with other forms of ovarian sarcoma (rhabdomyosarcomas, fibrosarcomas, stromal cell sarcomas) and patients diagnosed with leiomyosarcoma of the uterus will be excluded.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Azienda USL Reggio Emilia - IRCCS

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

AOU Policlinico di Modena

Modena, Italy, Italy

Site Status: RECRUITING

Azienda Ospedaliero Universitaria di Parma - S.C. Ostetricia e Ginecologia

Parma, PR, Italy

Site Status: RECRUITING

Azienda USL IRCCS di Reggio Emilia

Reggio Emilia, RE, Italy

Site Status: RECRUITING

Malzoni - Avellino

Avellino, , Italy

Site Status: RECRUITING

Azienda Ospedaliero Universitaria Policlinico "G.Rodolico - San Marco" - Catania

Catania, , Italy

Site Status: RECRUITING

IRCCS Ospedale San Raffaele

Milan, , Italy

Site Status: RECRUITING

Fondazione Irccs San Gerardo Dei Tintori

Monza, , Italy

Site Status: RECRUITING

IRCCS Istituto Nazionale Tumori Fondazione Pascale

Napoli, , Italy

Site Status: RECRUITING

Università degli Studi di Napoli Federico II

Napoli, , Italy

Site Status: RECRUITING

Ospedale "Sacro Cuore"

Verona, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Vincenzo Dario Mandato, MD

Role: CONTACT

vincenzodario.mandato@ausl.re.it

+39 0522 295467

Facility Contacts

Cinzia Baldessari, MD

Role: primary

Baldessari.cinzia@aou.mo.it

Roberto Berretta, MD

Role: primary

roberto.berrettamd@gmail.com

+390521704068

Jasmine Lonetti, Clinical Research Coordinator

Role: primary

jasmine.lonetti@ausl.re.it

+39 0522295467

Francesca Falcone, MD

Role: primary

francesca.falcone3@icloud.com

+39 0825 25596

Liliana Mereu, MD

Role: primary

liliana.mereu@unict.it

+39 095 479 4111

Raffaella Cioffi, MD PhD

Role: primary

raffaella.cioffi@hsr.it

02 2643 4880

Tommaso Grassi, MD

Role: primary

tommaso.grassi@irccs-sangerardo.it

039 2331

Jole Ventriglia, MD

Role: primary

j.ventriglia@istitutotumori.na.it

+39 081 17770468

Roberto Bianco, MD PhD

Role: primary

roberto.bianco@unina.it

081-7462061

Giovanni Roviglione, MD

Role: primary

giovanni.roviglione@sacrocuore.it

0456014581

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Other Identifiers

36/2024/OSS/AUSLRE

Identifier Type: -

Identifier Source: org_study_id