Clinical Management and Outcomes of Primary Ovarian Leiomyosarcoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Primary Ovarian Leiomyosarcoma. Basic parameters: 18 years — 99 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Correlation between the primary ovarian leiomyosarcoma treatment and prognosis [Time frame: 3 years observation period]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 10 centers
- AOU Policlinico di Modena — Modena
- Azienda Ospedaliero Universitaria di Parma - S.C. Ostetricia e Ginecologia — Parma
- Azienda USL IRCCS di Reggio Emilia — Reggio Emilia
- Malzoni - Avellino — Avellino
- Azienda Ospedaliero Universitaria Policlinico "G.Rodolico - San Marco" - Catania — Catania
- IRCCS Ospedale San Raffaele — Milan
- Fondazione Irccs San Gerardo Dei Tintori — Monza
- IRCCS Istituto Nazionale Tumori Fondazione Pascale — Naples
- … and 2 more centers
Publications
- Mandato VD, Torricelli F, Mastrofilippo V, Palicelli A, Costagliola L, Aguzzoli L. Primary Ovarian Leiomyosarcoma Is a Very Rare Entity: A Narrative Review of the Literature. Cancers (Basel). 2023 May 28;15(11):2953. doi: 10.3390/cancers15112953. PMID 37296915
- Pu T, Fan L, Wang L, Li L, Zeng H. Recurrent primary ovarian leiomyosarcoma preconception, pregnancy, delivery, and puerperal management: A case report and literature review. J Obstet Gynaecol Res. 2022 Jun;48(6):1489-1494. doi: 10.1111/jog.15244. Epub 2022 Mar 30. PMID 35354221
- Yuksel D, Cakir C, Kilic C, Karalok A, Kimyon G, Coteli S, Boyraz G, Tekin OM, Turan T. Primary leiomyosarcoma of the ovary: a report of three cases and a systematic review of literature. J Gynecol Obstet Hum Reprod. 2021 Jun;50(6):101825. doi: 10.1016/j.jogoh.2020.101825. Epub 2020 Jun 1. PMID 32497729
- Pongsuvareeyakul T, Sukpan K, Chaicharoen S, Khunamornpong S. Leiomyosarcoma and Squamous Cell Carcinoma Arising in Mature Cystic Teratoma of the Ovary. Case Rep Pathol. 2017;2017:7907359. doi: 10.1155/2017/7907359. Epub 2017 Jul 2. PMID 28751996
- He M, Deng YJ, Zhao DY, Zhang Y, Wu T. Synchronous leiomyosarcoma and fibroma in a single ovary: A case report and review of the literature. Oncol Lett. 2016 Apr;11(4):2510-2514. doi: 10.3892/ol.2016.4241. Epub 2016 Feb 17. PMID 27073508
- Zygouris D, Androutsopoulos G, Grigoriadis C, Arnogiannaki N, Terzakis E. Primary ovarian leiomyosarcoma. Eur J Gynaecol Oncol. 2012;33(3):331-3. PMID 22873115
- Chang A, Schuetze SM, Conrad EU 3rd, Swisshelm KL, Norwood TH, Rubin BP. So-called "inflammatory leiomyosarcoma'': a series of 3 cases providing additional insights into a rare entity. Int J Surg Pathol. 2005 Apr;13(2):185-95. doi: 10.1177/106689690501300210. PMID 15864383
- Nicotina PA, Antico F, Caruso C, Triolo O. Primary ovarian leiomyosarcoma. Proliferation rate and survival. Eur J Gynaecol Oncol. 2004;25(4):515-6. PMID 15285319
Identifiers
NCT: NCT06749600 · 36/2024/OSS/AUSLRE