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Clinical Management and Outcomes of Primary Ovarian Leiomyosarcoma

Study acronym: POLMS
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Minor Re-verified, no change to tracked fieldsv5
  2. Minor Study sites: 4 to 10v4
  3. Minor Study sites: 3 to 4v3
  4. Notable Primary endpoint revised
    • Study description revised
    v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06749600
Lead Sponsor Azienda USL Reggio Emilia - IRCCS
Conditions
(from sponsor)
Primary Ovarian Leiomyosarcoma
Related terms Neoplasms, Neoplasms by Histologic Type, Neoplasms, Connective and Soft Tissue, Neoplasms, Muscle Tissue, Sarcoma
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov