Recruiting NCT02829437
Observational Study on Endometrial Stromal Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Treatment for EST.
- Who it may be relevant to
- Registry conditions: Endometrial Stromal Tumors. Basic parameters: 18 years — 80 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Endometrial Stromal Tumors: an Observational Study
Overview
Observational, retrospective and prospective study on Endometrial Stromal Tumor (EST)
Detailed description
Observational, retrospective and prospective study on EST aimed to understand more about its biology, natural history and antitumor activity of different treatment options.
This study will collect data in prospective and retrospective way of patients affected by EST and treated according disease guidelines and local practices.
The study will also review the diagnosis by a central expert pathologist in order to its confirmation
Interventions
- Other Treatment for EST
Surgery and/or Chemotherapy and or/radiotherapy for EST treatment according to disease guidelines: no specific treatment is imposed by protocol (observational study)
Primary outcome measures
- Disease natural history [Time frame: Through survival, an average of 5 years]
Secondary outcome measures (2)
- Disease diagnosis and classification [Time frame: At the time of diagnosis, an average of 1 month]
- Chemotherapy received treatment [Time frame: Through treatment completion, an average of 24 month]
Eligibility criteria
Inclusion criteria
- patients with a diagnosis of Endometrial Stromal Tumor (EST) according to the World Health Organization (WHO) classification 2003 or 2014
- Informed consent signature
Exclusion criteria
- patients with different diagnosis from EST
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 13 centers
- Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST — Meldola
- Fondazione IRCCS Istituto Nazionale dei Tumori — Milan
- Istituto Europeo di Oncologia — Milan
- Azienda Ospedaliera Universitaria Paolo Giaccone — Palermo
- Centro di Riferimento Oncologico di Aviano — Aviano
- Istituto Oncologico Veneto — Padova
- Fondazione del Piemonte per l'Oncologia IRCC Candiolo — Candiolo
- Policlinico S.Orsola Malpighi - Unit of Medical Oncology — Bologna
- … and 5 more centers
Publications
- Brooks SE, Zhan M, Cote T, Baquet CR. Surveillance, epidemiology, and end results analysis of 2677 cases of uterine sarcoma 1989-1999. Gynecol Oncol. 2004 Apr;93(1):204-8. doi: 10.1016/j.ygyno.2003.12.029. PMID 15047237
- Toro JR, Travis LB, Wu HJ, Zhu K, Fletcher CD, Devesa SS. Incidence patterns of soft tissue sarcomas, regardless of primary site, in the surveillance, epidemiology and end results program, 1978-2001: An analysis of 26,758 cases. Int J Cancer. 2006 Dec 15;119(12):2922-30. doi: 10.1002/ijc.22239. PMID 17013893
- Ali RH, Rouzbahman M. Endometrial stromal tumours revisited: an update based on the 2014 WHO classification. J Clin Pathol. 2015 May;68(5):325-32. doi: 10.1136/jclinpath-2014-202829. Epub 2015 Jan 16. PMID 25595274
- Tavassoli FA, Norris HJ. Mesenchymal tumours of the uterus. VII. A clinicopathological study of 60 endometrial stromal nodules. Histopathology. 1981 Jan;5(1):1-10. doi: 10.1111/j.1365-2559.1981.tb01761.x. PMID 7216172
- Dionigi A, Oliva E, Clement PB, Young RH. Endometrial stromal nodules and endometrial stromal tumors with limited infiltration: a clinicopathologic study of 50 cases. Am J Surg Pathol. 2002 May;26(5):567-81. doi: 10.1097/00000478-200205000-00003. PMID 11979087
- Su TF, Chao TK, Lee HS, Perng CL, Nieh S. Malignant potential of endometrial stromal tumor with limited infiltration: a case report. Int J Surg Pathol. 2014 Sep;22(6):559-63. doi: 10.1177/1066896913506934. Epub 2013 Oct 23. PMID 24155223
- Dong R, Pang Y, Mao H, Yang N, Liu P. Successful pregnancy following conservative management of low-grade endometrial stromal sarcoma: A case report. Oncol Lett. 2014 Apr;7(4):1039-1042. doi: 10.3892/ol.2014.1858. Epub 2014 Feb 7. PMID 24944665
- Choi MC, Kim G, Hwang YY. Fertility-sparing management combined with photodynamic therapy for endometrial stromal sarcoma: a case report. Photodiagnosis Photodyn Ther. 2014 Dec;11(4):533-6. doi: 10.1016/j.pdpdt.2014.07.007. Epub 2014 Aug 11. PMID 25125393
Identifiers
NCT: NCT02829437 · ISG EST