Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2025-12-31 @ 5:59 PM
Study NCT ID:
NCT06749600
Status:
RECRUITING
Last Update Posted:
2025-06-18
First Post:
2024-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Management and Outcomes of Primary Ovarian Leiomyosarcoma
Sponsor:
Azienda USL Reggio Emilia - IRCCS
Organization:
Study Overview
Official Title:
Clinical Management and Outcomes of Primary Ovarian Leiomyosarcoma
Status:
RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POLMS
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: