Clinical trial NCT06749600: Clinical Management and Outcomes of Primary Ovarian Leiomyosarcoma
Official title: Clinical Management and Outcomes of Primary Ovarian Leiomyosarcoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Azienda USL Reggio Emilia - IRCCS
Sponsor class: OTHER_GOV
First posted: 2024-12-27
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.

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.

Primary outcomes:
measure: Correlation between the primary ovarian leiomyosarcoma treatment and prognosis
timeFrame: 3 years observation period
Secondary outcomes:
Other outcomes:
measure: Correlation between the mitotic index and Ki67
timeFrame: through study completion, an average of 1 year
measure: Correlation between the mitotic index and progression of disease
timeFrame: 3 years observation period
measure: Overall Survival
timeFrame: 3 years observation period
measure: Progression free survival in the overall population
timeFrame: 3 years observation period
Locations:
city: Parma
country: Italy
facility: Azienda Ospedaliero Universitaria di Parma - S.C. Ostetricia e Ginecologia
state: PR
city: Reggio Emilia
country: Italy
facility: Azienda USL IRCCS di Reggio Emilia
state: RE
city: Avellino
country: Italy
facility: Malzoni - Avellino
city: Catania
country: Italy
facility: Azienda Ospedaliero Universitaria Policlinico "G.Rodolico - San Marco" - Catania
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele
city: Modena
country: Italy
facility: AOU Policlinico di Modena
city: Monza
country: Italy
facility: Fondazione Irccs San Gerardo Dei Tintori
city: Napoli
country: Italy
facility: IRCCS Istituto Nazionale Tumori Fondazione Pascale
city: Napoli
country: Italy
facility: Università degli Studi di Napoli Federico II
city: Verona
country: Italy
facility: Ospedale "Sacro Cuore"
Study officials:
References:
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