Gathering data on primary ovarian leiomyosarcoma
Clinical Management and Outcomes of Primary Ovarian Leiomyosarcoma
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 type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | Female |
| Sponsor | Azienda USL Reggio Emilia - IRCCS Government |
| Drugs / interventions | chemotherapy |
| Locations | 10 sites (Modena, Italy and 9 other locations) |
| Trial ID | NCT06749600 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 18 to 99 diagnosed with primary leiomyosarcoma of the ovary.
Not a fit: Patients with other forms of ovarian sarcoma or those diagnosed with leiomyosarcoma of the uterus will not benefit from this study.
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 performed: While this study focuses on a rare cancer, similar observational studies have successfully established treatment guidelines for other rare malignancies.
Eligibility criteria
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 this trial is running
Modena, Italy and 9 other locations
- 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)
- 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
- Study coordinator: Vincenzo Dario Mandato, MD
- Email: vincenzodario.mandato@ausl.re.it
- Phone: +39 0522 295467
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.