Primary Ovarian LeiomyosarcomaPOLMSNCT06749600
Clinical Management and Outcomes of Primary Ovarian Leiomyosarcoma
An observational study of Primary Ovarian Leiomyosarcoma, run by Azienda USL Reggio Emilia - IRCCS at 10 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Primary Ovarian Leiomyosarcoma
- How many people
- 30 participants
- Where
- 10 sitesItaly
- Study dates
- 14 Jun 2024to 31 Dec 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Consent for study participation will be obtained from living patients during follow-up visits. Historical cases with remote diagnoses since 1980 will be accessed through clinical case reviews in the databases of each participating center. For patients lost to follow-up or deceased, a waiver of informed consent has been obtained from the Ethics Committee by applicable regulations.
Who may be able to join
- 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
Who cannot join
- All patients with other forms of ovarian sarcoma (rhabdomyosarcomas, fibrosarcomas, stromal cell sarcomas) and patients diagnosed with leiomyosarcoma of the uterus will be excluded.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
Italy10 sites, 10 recruiting
- Recruiting
Malzoni - Avellino
Avellino, 83100
Francesca Falcone, MD, +39 0825 25596, francesca.falcone3@icloud.com
Francesca Falcone, MD
- Recruiting
Azienda Ospedaliero Universitaria Policlinico "G.Rodolico - San Marco" - Catania
Catania, 95123
Liliana Mereu, MD, +39 095 479 4111, liliana.mereu@unict.it
Liliana Mereu, MD
- Recruiting
IRCCS Ospedale San Raffaele
Milan, 20132
Raffaella Cioffi, MD PhD, 02 2643 4880, raffaella.cioffi@hsr.it
Raffaella Cioffi, MD PhD
- Recruiting
AOU Policlinico di Modena
Modena, Italy, 41125
Cinzia Baldessari, MD, Baldessari.cinzia@aou.mo.it
Cinzia Baldessari, MD
- Recruiting
Fondazione Irccs San Gerardo Dei Tintori
Monza
Tommaso Grassi, MD, 039 2331, tommaso.grassi@irccs-sangerardo.it
Tommaso Grassi
- Recruiting
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Naples, 80131
Jole Ventriglia, MD, +39 081 17770468, j.ventriglia@istitutotumori.na.it
Jole Ventriglia, MD
- Recruiting
Università degli Studi di Napoli Federico II
Naples
Roberto Bianco, MD PhD, 081-7462061, roberto.bianco@unina.it
Roberto Bianco, MD PhD
- Recruiting
Azienda Ospedaliero Universitaria di Parma - S.C. Ostetricia e Ginecologia
Parma, PR, 43126
Roberto Berretta, MD, +390521704068, roberto.berrettamd@gmail.com
Roberto Berretta, MD
- Recruiting
Azienda USL IRCCS di Reggio Emilia
Reggio Emilia, RE, 42123
Jasmine Lonetti, Clinical Research Coordinator, +39 0522295467, jasmine.lonetti@ausl.re.it
Vincenzo Mandato
- Recruiting
Ospedale "Sacro Cuore"
Verona
Giovanni Roviglione, MD, 0456014581, giovanni.roviglione@sacrocuore.it
Giovanni Roviglione, MD
About this study
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.
Read the 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.
- 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
- Medical subject headings
- Neoplasms, Muscle Tissue, Neoplasms, Connective and Soft Tissue, Neoplasms by Histologic Type, Sarcoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Primary leiomyosarcoma of the ovary (POLMS) | The study population includes patients aged between 18 and 99 years diagnosed with primary ovarian leiomyosarcoma (POLMS) afferent to participating centers. This population encompasses both historical cases diagnosed since 1980 and new cases identified during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the primary ovarian leiomyosarcoma treatment and prognosis
Correlation between survival outcomes and treatments (type of surgery ,type of chemotherapy, hormone therapy, radiotherapy).
Measured: 3 years observation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start14 Jun 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for Primary Ovarian LeiomyosarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06749600
- Sponsor's protocol ID
- 36/2024/OSS/AUSLRE
- Acronym
- POLMS
- Status last verified
- May 2026
- First submitted
- 17 Dec 2024
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 37296915Pu 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.
PubMed 35354221Yuksel 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.
PubMed 32497729Pongsuvareeyakul 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.
PubMed 28751996He 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.
PubMed 27073508Zygouris D, Androutsopoulos G, Grigoriadis C, Arnogiannaki N, Terzakis E. Primary ovarian leiomyosarcoma. Eur J Gynaecol Oncol. 2012;33(3):331-3.
PubMed 22873115Chang 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.
PubMed 15864383Nicotina PA, Antico F, Caruso C, Triolo O. Primary ovarian leiomyosarcoma. Proliferation rate and survival. Eur J Gynaecol Oncol. 2004;25(4):515-6.
PubMed 15285319Mayerhofer K, Lozanov P, Bodner K, Bodner-Adler B, Mayerhofer-Gallenbacher N, Hudelist G, Czerwenka K. Immunohistochemical analysis of a primary ovarian leiomyosarcoma. Case report. Anticancer Res. 2003 Jul-Aug;23(4):3433-6.
PubMed 12926085Seracchioli R, Colombo FM, Bagnoli A, Trengia V, Venturoli S. Primary ovarian leiomyosarcoma as a new component in the nevoid basal cell carcinoma syndrome: a case report. Am J Obstet Gynecol. 2003 Apr;188(4):1093-5. doi: 10.1067/mob.2003.86.
PubMed 12712116Balaton A, Vaury P, Imbert MC, Mussy MA. Primary leiomyosarcoma of the ovary: a histological and immunocytochemical study. Gynecol Oncol. 1987 Sep;28(1):116-20. doi: 10.1016/s0090-8258(87)80016-1.
PubMed 3308653Nogales FF, Ayala A, Ruiz-Avila I, Sirvent JJ. Myxoid leiomyosarcoma of the ovary: analysis of three cases. Hum Pathol. 1991 Dec;22(12):1268-73. doi: 10.1016/0046-8177(91)90110-b.
PubMed 1748433Anderson B, Turner DA, Benda J. Ovarian sarcoma. Gynecol Oncol. 1987 Feb;26(2):183-92. doi: 10.1016/0090-8258(87)90272-1.
PubMed 3643159Shakfeh SM, Woodruff JD. Primary ovarian sarcomas: report of 46 cases and review of the literature. Obstet Gynecol Surv. 1987 Jun;42(6):331-49. No abstract available.
PubMed 3299172Azoury RS, Woodruff JD. Primary ovarian sarcomas. Report of 43 cases from the Emil Novak Ovarian Tumor Registry. Obstet Gynecol. 1971 Jun;37(6):920-41. No abstract available.
PubMed 4378308