Clinical Management and Outcomes of Primary Ovarian Leiomyosarcoma
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Primary Ovarian Leiomyosarcoma. Базовые параметры: 18 лет — 99 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Италия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Обзор
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.
Подробное описание
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.
Первичные конечные точки
- Correlation between the primary ovarian leiomyosarcoma treatment and prognosis [Срок оценки: 3 years observation period]
Критерии участия
Критерии включения
- 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
Критерии исключения
\- All patients with other forms of ovarian sarcoma (rhabdomyosarcomas, fibrosarcomas, stromal cell sarcomas) and patients diagnosed with leiomyosarcoma of the uterus will be excluded.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Италия · 10 центров
- AOU Policlinico di Modena — Modena
- Azienda Ospedaliero Universitaria di Parma - S.C. Ostetricia e Ginecologia — Parma
- Azienda USL IRCCS di Reggio Emilia — Reggio Emilia
- Malzoni - Avellino — Avellino
- Azienda Ospedaliero Universitaria Policlinico "G.Rodolico - San Marco" - Catania — Catania
- IRCCS Ospedale San Raffaele — Milan
- Fondazione Irccs San Gerardo Dei Tintori — Monza
- IRCCS Istituto Nazionale Tumori Fondazione Pascale — Naples
- … и ещё 2 центра
Публикации
- Mandato VD, Torricelli F, Mastrofilippo V, Palicelli A, Costagliola L, Aguzzoli L. Primary Ovarian Leiomyosarcoma Is a Very Rare Entity: A Narrative Review of the Literature. Cancers (Basel). 2023 May 28;15(11):2953. doi: 10.3390/cancers15112953. PMID 37296915
- Pu T, Fan L, Wang L, Li L, Zeng H. Recurrent primary ovarian leiomyosarcoma preconception, pregnancy, delivery, and puerperal management: A case report and literature review. J Obstet Gynaecol Res. 2022 Jun;48(6):1489-1494. doi: 10.1111/jog.15244. Epub 2022 Mar 30. PMID 35354221
- Yuksel D, Cakir C, Kilic C, Karalok A, Kimyon G, Coteli S, Boyraz G, Tekin OM, Turan T. Primary leiomyosarcoma of the ovary: a report of three cases and a systematic review of literature. J Gynecol Obstet Hum Reprod. 2021 Jun;50(6):101825. doi: 10.1016/j.jogoh.2020.101825. Epub 2020 Jun 1. PMID 32497729
- Pongsuvareeyakul T, Sukpan K, Chaicharoen S, Khunamornpong S. Leiomyosarcoma and Squamous Cell Carcinoma Arising in Mature Cystic Teratoma of the Ovary. Case Rep Pathol. 2017;2017:7907359. doi: 10.1155/2017/7907359. Epub 2017 Jul 2. PMID 28751996
- He M, Deng YJ, Zhao DY, Zhang Y, Wu T. Synchronous leiomyosarcoma and fibroma in a single ovary: A case report and review of the literature. Oncol Lett. 2016 Apr;11(4):2510-2514. doi: 10.3892/ol.2016.4241. Epub 2016 Feb 17. PMID 27073508
- Zygouris D, Androutsopoulos G, Grigoriadis C, Arnogiannaki N, Terzakis E. Primary ovarian leiomyosarcoma. Eur J Gynaecol Oncol. 2012;33(3):331-3. PMID 22873115
- Chang A, Schuetze SM, Conrad EU 3rd, Swisshelm KL, Norwood TH, Rubin BP. So-called "inflammatory leiomyosarcoma'': a series of 3 cases providing additional insights into a rare entity. Int J Surg Pathol. 2005 Apr;13(2):185-95. doi: 10.1177/106689690501300210. PMID 15864383
- Nicotina PA, Antico F, Caruso C, Triolo O. Primary ovarian leiomyosarcoma. Proliferation rate and survival. Eur J Gynaecol Oncol. 2004;25(4):515-6. PMID 15285319
Идентификаторы
NCT: NCT06749600 · 36/2024/OSS/AUSLRE