Clinical Management and Outcomes of Primary Ovarian Leiomyosarcoma

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06749600

Acronym

POLMS

Enrollment

Registered

2024-12-27

Start date

2024-06-14

Completion date

2027-12-31

Last updated

2026-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Ovarian Leiomyosarcoma

Keywords

Primary ovarian leiomyosarcoma, Gynecologic oncology, Neoplasms, Muscle Tissue, Neoplasms, Connective and Soft Tissue, Neoplasms by Histologic Type, Sarcoma, Neoplasms, Histopathology, Prognostic factors, Tumor markers

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 99 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Correlation between the primary ovarian leiomyosarcoma treatment and prognosis	3 years observation period	Correlation between survival outcomes and treatments (type of surgery ,type of chemotherapy, hormone therapy, radiotherapy).

Countries

Italy

Contacts

CONTACTVincenzo Dario Mandato, MD

vincenzodario.mandato@ausl.re.it+39 0522 295467

Outcome results