Clinical trial Recruiting at 10 sites Observational Ages 18 to 99 Women only

Gathering data on primary ovarian leiomyosarcoma

Official title: Clinical Management and Outcomes of Primary Ovarian Leiomyosarcoma

Run by Azienda USL Reggio Emilia - IRCCS · NCT06749600 · Data updated 2026-11-12

This study is collecting information on a rare type of ovarian cancer called primary ovarian leiomyosarcoma to help understand how it is diagnosed and treated.

Quick facts

Study typeObservational
Ages18 Years to 99 Years
SexWomen only
Enrollment30 (estimated)
SponsorAzienda USL Reggio Emilia - IRCCS
Government
Drugs / interventionschemotherapy
Locations10 sites (Modena, Italy and 9 other locations)
StatusRecruiting
StartedJune 14, 2024
Main results expectedDecember 31, 2027
Study endsDecember 31, 2027
Registry record updatedMay 5, 2026
Trial IDNCT06749600 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are patients aged 18 to 99 diagnosed with primary leiomyosarcoma of the ovary.

Probably not a fit

Patients with other forms of ovarian sarcoma or those diagnosed with leiomyosarcoma of the uterus will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to collect and analyze comprehensive data on primary ovarian leiomyosarcoma (POLMS), a rare form of ovarian cancer. It will utilize both retrospective and prospective methodologies to gather historical cases diagnosed since 1980, alongside newly identified cases. Data will be standardized and centralized using an electronic Case Report Form (eCRF) on REDCap, focusing on patient demographics, clinical presentation, treatment modalities, and outcomes. The goal is to uncover patterns in diagnosis and treatment to establish evidence-based guidelines for managing this aggressive cancer.

Why it matters

Potential benefit: If successful, this study could lead to improved management and treatment guidelines for patients with primary ovarian leiomyosarcoma.

How similar studies have gone: While this study focuses on a rare cancer, similar observational studies have successfully established treatment guidelines for other rare malignancies.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • AOU Policlinico di Modena
    Modena, Italy, Italy
    Recruiting
  • Azienda Ospedaliero Universitaria di Parma - S.C. Ostetricia e Ginecologia
    Parma, Pr, Italy
    Recruiting
  • Azienda USL IRCCS di Reggio Emilia
    Reggio Emilia, Re, Italy
    Recruiting
  • Malzoni - Avellino
    Avellino, Italy
    Recruiting
  • Azienda Ospedaliero Universitaria Policlinico "G.Rodolico - San Marco" - Catania
    Catania, Italy
    Recruiting
  • IRCCS Ospedale San Raffaele
    Milan, Italy
    Recruiting
Show 4 more locations
  • Fondazione Irccs San Gerardo Dei Tintori
    Monza, Italy
    Recruiting
  • IRCCS Istituto Nazionale Tumori Fondazione Pascale
    Naples, Italy
    Recruiting
  • Università degli Studi di Napoli Federico II
    Naples, Italy
    Recruiting
  • Ospedale "Sacro Cuore"
    Verona, Italy
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.