Clinical Management and Outcomes of Primary Ovarian Leiomyosarcoma

NCT06749600 | Recruiting

• 1 other identifier: 36/2024/OSS/AUSLRE
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 10

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.

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

Outcome Measures

Primary Outcomes (1)

• Correlation between the primary ovarian leiomyosarcoma treatment and prognosis

  Correlation between survival outcomes and treatments (type of surgery ,type of chemotherapy, hormone therapy, radiotherapy).

  3 years observation period

Other Outcomes (4)

• Correlation between the mitotic index and Ki67

  through study completion, an average of 1 year

• Correlation between the mitotic index and progression of disease

  3 years observation period

• Overall Survival

  3 years observation period

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: Only individuals assigned female at birth are eligible to participate in this study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• \- All patients with other forms of ovarian sarcoma (rhabdomyosarcomas, fibrosarcomas, stromal cell sarcomas) and patients diagnosed with leiomyosarcoma of the uterus will be excluded.

Sponsors & Collaborators

• Azienda USL Reggio Emilia - IRCCS: lead

Study Sites (10)

AOU Policlinico di Modena

Modena, Italy, 41125, Italy

RECRUITING

Azienda Ospedaliero Universitaria di Parma - S.C. Ostetricia e Ginecologia

Parma, PR, 43126, Italy

RECRUITING

Azienda USL IRCCS di Reggio Emilia

Reggio Emilia, RE, 42123, Italy

RECRUITING

Malzoni - Avellino

Avellino, 83100, Italy

RECRUITING

Azienda Ospedaliero Universitaria Policlinico "G.Rodolico - San Marco" - Catania

Catania, 95123, Italy

RECRUITING

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

RECRUITING

Fondazione Irccs San Gerardo Dei Tintori

Monza, Italy

RECRUITING

IRCCS Istituto Nazionale Tumori Fondazione Pascale

Naples, 80131, Italy

RECRUITING

Università degli Studi di Napoli Federico II

Naples, Italy

RECRUITING

Ospedale "Sacro Cuore"

Verona, Italy

RECRUITING

Related Publications (35)

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  BACKGROUND

MeSH Terms

Conditions

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Sarcoma; Neoplasms

Central Study Contacts

Vincenzo Dario Mandato, MD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 27, 2024
• Study Start: June 14, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (10)