Clinical Management and Outcomes of Primary Ovarian Leiomyosarcoma

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.

NCT Number	NCT06749600
Lead Sponsor	Azienda USL Reggio Emilia - IRCCS
Conditions	Primary Ovarian Leiomyosarcoma
Enrollment	30 participants
Start Date	2024-06-14
Primary Completion	2027-12-31 (estimated)
Study Completion	2027-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-05-05