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:
Organization:
Raw JSON
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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': '35354221', 'type': 'BACKGROUND', 'citation': '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': '32497729', 'type': 'BACKGROUND', 'citation': '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': '28751996', 'type': 'BACKGROUND', 'citation': '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': '27073508', 'type': 'BACKGROUND', 'citation': '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': '22873115', 'type': 'BACKGROUND', 'citation': 'Zygouris D, Androutsopoulos G, Grigoriadis C, Arnogiannaki N, Terzakis E. Primary ovarian leiomyosarcoma. Eur J Gynaecol Oncol. 2012;33(3):331-3.'}, {'pmid': '15864383', 'type': 'BACKGROUND', 'citation': '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': '15285319', 'type': 'BACKGROUND', 'citation': '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': '12926085', 'type': 'BACKGROUND', 'citation': 'Mayerhofer K, Lozanov P, Bodner K, Bodner-Adler B, Mayerhofer-Gallenbacher N, Hudelist G, Czerwenka K. Immunohistochemical analysis of a primary ovarian leiomyosarcoma. Case report. Anticancer Res. 2003 Jul-Aug;23(4):3433-6.'}, {'pmid': '12712116', 'type': 'BACKGROUND', 'citation': 'Seracchioli R, Colombo FM, Bagnoli A, Trengia V, Venturoli S. Primary ovarian leiomyosarcoma as a new component in the nevoid basal cell carcinoma syndrome: a case report. Am J Obstet Gynecol. 2003 Apr;188(4):1093-5. doi: 10.1067/mob.2003.86.'}, {'pmid': '3308653', 'type': 'BACKGROUND', 'citation': 'Balaton A, Vaury P, Imbert MC, Mussy MA. Primary leiomyosarcoma of the ovary: a histological and immunocytochemical study. Gynecol Oncol. 1987 Sep;28(1):116-20. doi: 10.1016/s0090-8258(87)80016-1.'}, {'pmid': '1748433', 'type': 'BACKGROUND', 'citation': 'Nogales FF, Ayala A, Ruiz-Avila I, Sirvent JJ. Myxoid leiomyosarcoma of the ovary: analysis of three cases. Hum Pathol. 1991 Dec;22(12):1268-73. doi: 10.1016/0046-8177(91)90110-b.'}, {'pmid': '3643159', 'type': 'BACKGROUND', 'citation': 'Anderson B, Turner DA, Benda J. Ovarian sarcoma. Gynecol Oncol. 1987 Feb;26(2):183-92. doi: 10.1016/0090-8258(87)90272-1.'}, {'pmid': '3299172', 'type': 'BACKGROUND', 'citation': 'Shakfeh SM, Woodruff JD. Primary ovarian sarcomas: report of 46 cases and review of the literature. Obstet Gynecol Surv. 1987 Jun;42(6):331-49. No abstract available.'}, {'pmid': '4378308', 'type': 'BACKGROUND', 'citation': 'Azoury RS, Woodruff JD. Primary ovarian sarcomas. Report of 43 cases from the Emil Novak Ovarian Tumor Registry. Obstet Gynecol. 1971 Jun;37(6):920-41. No abstract available.'}, {'pmid': '5370781', 'type': 'BACKGROUND', 'citation': 'Nieminen U, Numers CV, Purola E. Primary sarcoma of the ovary. Acta Obstet Gynecol Scand. 1969;48(3):423-32. doi: 10.3109/00016346909156657. No abstract available.'}, {'pmid': '13752348', 'type': 'BACKGROUND', 'citation': 'KELLEY RR, SCULLY RE. Cancer developing in dermoid cysts of the ovary. A report of 8 cases, including a carcinoid and a leiomyosarcoma. Cancer. 1961 Sep-Oct;14:989-1000. doi: 10.1002/1097-0142(196109/10)14:53.0.co;2-u. No abstract available.'}, {'pmid': '31398145', 'type': 'BACKGROUND', 'citation': 'Shafiee MN, Kah Teik C, Md Zain RR, Kampan N. Ovarian and uterine leiomyosarcoma: which one is the primary? Horm Mol Biol Clin Investig. 2019 Aug 9;41(2). doi: 10.1515/hmbci-2019-0037.'}, {'pmid': '10366481', 'type': 'BACKGROUND', 'citation': 'Rampaul RS, Barrow S, Naraynsingh V. A primary ovarian leiomyosarcoma with micro-invasive features (stage I): is surgical excision enough? Gynecol Oncol. 1999 Jun;73(3):464; author reply 465-7. doi: 10.1006/gyno.1999.5384. No abstract available.'}, {'pmid': '8051647', 'type': 'BACKGROUND', 'citation': 'Dixit S, Singhal S, Baboo HA, Vyas RK, Neema JP, Murthy R, Sooryanaraya U. Leiomyosarcoma of the ovary. J Postgrad Med. 1993 Jul-Sep;39(3):151-3.'}, {'pmid': '11152324', 'type': 'BACKGROUND', 'citation': 'Inoue J, Gomibuchi H, Minoura S. A case of a primary ovarian leiomyosarcoma. J Obstet Gynaecol Res. 2000 Dec;26(6):401-7. doi: 10.1111/j.1447-0756.2000.tb01349.x.'}, {'pmid': '858555', 'type': 'BACKGROUND', 'citation': 'Walts AE, Lichtenstein I. Primary leiomyosarcoma associated with serous cystadenocarcinoma of the ovary. Gynecol Oncol. 1977 Mar;5(1):81-6. doi: 10.1016/0090-8258(77)90010-5. No abstract available.'}, {'pmid': '17572920', 'type': 'BACKGROUND', 'citation': 'Taskin S, Taskin EA, Uzum N, Ataoglu O, Ortac F. Primary ovarian leiomyosarcoma: a review of the clinical and immunohistochemical features of the rare tumor. Obstet Gynecol Surv. 2007 Jul;62(7):480-6. doi: 10.1097/01.ogx.0000268629.16151.71.'}, {'pmid': '2159271', 'type': 'BACKGROUND', 'citation': 'Lastarria D, Sachdev RK, Babury RA, Yu HM, Nuovo GJ. Immunohistochemical analysis for desmin in normal and neoplastic ovarian stromal tissue. Arch Pathol Lab Med. 1990 May;114(5):502-5.'}, {'pmid': '15489647', 'type': 'BACKGROUND', 'citation': 'Lerwill MF, Sung R, Oliva E, Prat J, Young RH. Smooth muscle tumors of the ovary: a clinicopathologic study of 54 cases emphasizing prognostic criteria, histologic variants, and differential diagnosis. Am J Surg Pathol. 2004 Nov;28(11):1436-51. doi: 10.1097/01.pas.0000141393.99300.d0.'}, {'pmid': '15863185', 'type': 'BACKGROUND', 'citation': 'Bouie SM, Cracchiolo B, Heller D. Epithelioid leiomyosarcoma of the ovary. Gynecol Oncol. 2005 May;97(2):697-9. doi: 10.1016/j.ygyno.2005.02.008.'}, {'pmid': '25932048', 'type': 'BACKGROUND', 'citation': 'Vijaya Kumar J, Khurana A, Kaur P, Chuahan AK, Singh S. A rare presentation of primary leiomyosarcoma of ovary in a young woman. Ecancermedicalscience. 2015 Apr 21;9:524. doi: 10.3332/ecancer.2015.524. eCollection 2015.'}, {'pmid': '31149505', 'type': 'BACKGROUND', 'citation': 'Furutake Y, Fukagawa T, Suga Y, Nagasawa T, Sato S, Omi H, Kagabu M, Chiba A, Shoji T, Takeuchi S, Sugai T, Itamochi H, Sugiyama T. Gemcitabine and docetaxel in a patient with primary ovarian leiomyosarcoma: a case report and review of literature. Int Cancer Conf J. 2017 Sep 11;7(1):11-15. doi: 10.1007/s13691-017-0309-7. eCollection 2018 Jan.'}, {'pmid': '9299270', 'type': 'BACKGROUND', 'citation': 'Rasmussen CC, Skilling JS, Sorosky JI, Lager DJ, Buller RE. Stage IIIC ovarian leiomyosarcoma in a premenopausal woman with multiple recurrences: prolonged survival with surgical therapy. Gynecol Oncol. 1997 Sep;66(3):519-25. doi: 10.1006/gyno.1997.4824.'}, {'pmid': '1929791', 'type': 'BACKGROUND', 'citation': 'Friedman HD, Mazur MT. Primary ovarian leiomyosarcoma. An immunohistochemical and ultrastructural study. Arch Pathol Lab Med. 1991 Sep;115(9):941-5.'}, {'pmid': '33732852', 'type': 'BACKGROUND', 'citation': 'Cojocaru E, Palahepitiva Gamage G, Butler J, Barton DP, Thway K, Fisher C, Messiou C, Miah AB, Zaidi S, Gennatas S, Benson C, Huang P, Jones RL. Clinical management and outcomes of primary ovarian leiomyosarcoma - Experience from a sarcoma specialist unit. Gynecol Oncol Rep. 2021 Mar 2;36:100737. doi: 10.1016/j.gore.2021.100737. eCollection 2021 May.'}, {'pmid': '8462904', 'type': 'BACKGROUND', 'citation': 'Monk BJ, Nieberg R, Berek JS. Primary leiomyosarcoma of the ovary in a perimenarchal female. Gynecol Oncol. 1993 Mar;48(3):389-93. doi: 10.1006/gyno.1993.1067.'}, {'pmid': '21061129', 'type': 'BACKGROUND', 'citation': 'Arslan OS, Sumer C, Cihangiroglu G, Kanat-Pektas M, Gungor T. A rare tumor of the female genital tract: primary ovarian leiomyosarcoma. Arch Gynecol Obstet. 2011 Mar;283 Suppl 1:83-5. doi: 10.1007/s00404-010-1735-3.'}, {'pmid': '29147259', 'type': 'BACKGROUND', 'citation': 'Goodall EJ, Madhuri T, Manuel SB. The Management Dilemma of Leiomyosarcoma of the Ovary. World J Oncol. 2011 Oct;2(5):265-266. doi: 10.4021/wjon362w. Epub 2011 Oct 28.'}, {'type': 'BACKGROUND', 'citation': 'Pankaj, S., Choudhary, V., Singh, R. K., & Harsvardhan, R. (2013). High grade pleomorphic leiomyosarcoma of ovary in a young female: a case report. World Journal of Surgical Research, 2(3).'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nData 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.\n\nThe study will gather extensive data points, including:\n\n* Patient demographics.\n* Clinical presentation and tumor characteristics (symptoms, tumor markers such as CA-125, CEA, and Ki-67).\n* Treatment modalities (surgical details, lymphadenectomy, chemotherapy, radiotherapy, or hormonal therapy).\n* Recurrence patterns and outcomes (disease-free survival, overall survival).\n* 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'genderDescription': 'Only individuals assigned female at birth are eligible to participate in this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of primary leiomyosarcoma of the ovary;\n* Patients diagnosed with POLMS for whom data relating to diagnosis and treatment are available.\n* Aged between 18 and 99 years\n\nExclusion Criteria:\n\n\\- All patients with other forms of ovarian sarcoma (rhabdomyosarcomas, fibrosarcomas, stromal cell sarcomas) and patients diagnosed with leiomyosarcoma of the uterus will be excluded.'}, 'identificationModule': {'nctId': 'NCT06749600', 'acronym': 'POLMS', 'briefTitle': 'Clinical Management and Outcomes of Primary Ovarian Leiomyosarcoma', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Azienda USL Reggio Emilia - IRCCS'}, 'officialTitle': 'Clinical Management and Outcomes of Primary Ovarian Leiomyosarcoma', 'orgStudyIdInfo': {'id': '36/2024/OSS/AUSLRE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Primary leiomyosarcoma of the ovary (POLMS)', 'description': 'The study population includes patients aged between 18 and 99 years diagnosed with primary ovarian leiomyosarcoma (POLMS) afferent to participating centers. This population encompasses both historical cases diagnosed since 1980 and new cases identified during the study period.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '41125', 'city': 'Modena', 'state': 'Italy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Cinzia Baldessari, MD', 'role': 'CONTACT', 'email': 'Baldessari.cinzia@aou.mo.it'}, {'name': 'Cinzia Baldessari, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AOU Policlinico di Modena', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}, {'zip': '43126', 'city': 'Parma', 'state': 'PR', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Roberto Berretta, MD', 'role': 'CONTACT', 'email': 'roberto.berrettamd@gmail.com', 'phone': '+390521704068'}, {'name': 'Roberto Berretta, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Azienda Ospedaliero Universitaria di Parma - S.C. Ostetricia e Ginecologia', 'geoPoint': {'lat': 44.79935, 'lon': 10.32618}}, {'zip': '42123', 'city': 'Reggio Emilia', 'state': 'RE', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Jasmine Lonetti, Clinical Research Coordinator', 'role': 'CONTACT', 'email': 'jasmine.lonetti@ausl.re.it', 'phone': '+39 0522295467'}, {'name': 'Vincenzo Mandato', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Azienda USL IRCCS di Reggio Emilia', 'geoPoint': {'lat': 44.69825, 'lon': 10.63125}}, {'zip': '83100', 'city': 'Avellino', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Francesca Falcone, MD', 'role': 'CONTACT', 'email': 'francesca.falcone3@icloud.com', 'phone': '+39 0825 25596'}, {'name': 'Francesca Falcone, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Malzoni - Avellino', 'geoPoint': {'lat': 40.91494, 'lon': 14.79103}}, {'zip': '95123', 'city': 'Catania', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Liliana Mereu, MD', 'role': 'CONTACT', 'email': 'liliana.mereu@unict.it', 'phone': '+39 095 479 4111'}, {'name': 'Liliana Mereu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Azienda Ospedaliero Universitaria Policlinico "G.Rodolico - San Marco" - Catania', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'zip': '20132', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Raffaella Cioffi, MD PhD', 'role': 'CONTACT', 'email': 'raffaella.cioffi@hsr.it', 'phone': '02 2643 4880'}, {'name': 'Raffaella Cioffi, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'IRCCS Ospedale San Raffaele', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Monza', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Tommaso Grassi, MD', 'role': 'CONTACT', 'email': 'tommaso.grassi@irccs-sangerardo.it', 'phone': '039 2331'}, {'name': 'Tommaso Grassi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fondazione Irccs San Gerardo Dei Tintori', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}, {'zip': '80131', 'city': 'Napoli', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Jole Ventriglia, MD', 'role': 'CONTACT', 'email': 'j.ventriglia@istitutotumori.na.it', 'phone': '+39 081 17770468'}, {'name': 'Jole Ventriglia, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'IRCCS Istituto Nazionale Tumori Fondazione Pascale', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Napoli', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Roberto Bianco, MD PhD', 'role': 'CONTACT', 'email': 'roberto.bianco@unina.it', 'phone': '081-7462061'}, {'name': 'Roberto Bianco, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Università degli Studi di Napoli Federico II', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Verona', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giovanni Roviglione, MD', 'role': 'CONTACT', 'email': 'giovanni.roviglione@sacrocuore.it', 'phone': '0456014581'}, {'name': 'Giovanni Roviglione, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale "Sacro Cuore"', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}], 'centralContacts': [{'name': 'Vincenzo Dario Mandato, MD', 'role': 'CONTACT', 'email': 'vincenzodario.mandato@ausl.re.it', 'phone': '+39 0522 295467'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda USL Reggio Emilia - IRCCS', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}