Clinical Management and Outcomes of Primary Ovarian Leiomyosarcoma
ConditionPrimary Ovarian Leiomyosarcoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-99
SponsorAzienda USL Reggio Emilia - IRCCS
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial 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.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
30 Participants
are grouped into 1 trial groupGroup A: Primary leiomyosarcoma of the ovary (POLMS)
Trial outcomes
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).
Time frame
3 years observation periodOther outcomes
1
Correlation between the mitotic index and Ki67
Number of mitotic figures and levels of Ki67 expression in immunohistochemical staining
Time frame
through study completion, an average of 1 year2
Correlation between the mitotic index and progression of disease
Correlation between survival outcomes and mitotic index
Time frame
3 years observation period3
Overall Survival
Time from diagnosis to death from any cause, measured in months.
Time frame
3 years observation period4
Progression free survival in the overall population
Time from diagnosis to disease progression or death, whichever occurs first, measured in months.
Time frame
3 years observation periodSponsors and contacts
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Source ClinicalTrials.gov