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Observational, retrospective and prospective study on Endometrial Stromal Tumor (EST)
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retrospective Observational Group | Patients who received treatment for EST Patients with EST diagnosis prior August 2016 |
| |
| Prospective Observational Group | Patients who will receive treatment for EST Patients with EST diagnosis after August 2016 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment for EST | Other | Surgery and/or Chemotherapy and or/radiotherapy for EST treatment according to disease guidelines: no specific treatment is imposed by protocol (observational study) |
| Measure | Description | Time Frame |
|---|---|---|
| Disease natural history | Collection of data on the natural history of endometrial stromal tumors | Through survival, an average of 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Disease diagnosis and classification | Highlight some main issues in pathologic diagnosis of these tumors and their classification | At the time of diagnosis, an average of 1 month |
| Chemotherapy received treatment |
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Inclusion Criteria:
Exclusion Criteria:
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All the patients with a diagnosis of Endometrial Stromal Tumor (EST)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gianluca Ignazzi, PhD | Contact | +393335359192 | gianluca.ignazzi@italiansarcomagroup.org |
| Name | Affiliation | Role |
|---|---|---|
| Paolo G Casali, MD | Italian Sarcoma Group | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST | Not yet recruiting | Meldola | FC | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15047237 | Background | 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. | |
| 17013893 | Background | 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. |
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Aggregate anonymized results will be available upon request at the end of the study
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| ID | Term |
|---|---|
| D036821 | Endometrial Stromal Tumors |
| ID | Term |
|---|---|
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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Paraffin-embedded pathologic tissue used for diagnostic confirmation purposes only
Number and type of chemotherapy agents received for EST treatment
| Through treatment completion, an average of 24 month |
| Fondazione IRCCS Istituto Nazionale dei Tumori | Recruiting | Milan | MI | 20133 | Italy |
|
| Istituto Europeo di Oncologia | Not yet recruiting | Milan | MI | 20141 | Italy |
|
| Azienda Ospedaliera Universitaria Paolo Giaccone | Not yet recruiting | Palermo | PA | 90127 | Italy |
|
| Centro di Riferimento Oncologico di Aviano | Not yet recruiting | Aviano | PD | 33081 | Italy |
|
| Istituto Oncologico Veneto | Not yet recruiting | Padova | PD | 35128 | Italy |
|
| Fondazione del Piemonte per l'Oncologia IRCC Candiolo | Not yet recruiting | Candiolo | Torino | 10060 | Italy |
|
| Policlinico S.Orsola Malpighi - Unit of Medical Oncology | Not yet recruiting | Bologna | 40138 | Italy |
|
| Azienda Ospedaliera Universitaria Careggi | Not yet recruiting | Florence | 50100 | Italy |
|
| Azienda Ospedaliero-Universitaria Careggi | Not yet recruiting | Florence | 50100 | Italy |
|
| Ospedale Misericordia e Dolce Ist. Toscano Tumori, Az. USL4 | Not yet recruiting | Prato | 59100 | Italy |
|
| Campus Biomedico | Not yet recruiting | Roma | 00100 | Italy |
|
| Istituti Fisioterapici Ospitalieri di Roma | Not yet recruiting | Roma | 00100 | Italy |
|
| 25595274 | Background | 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. |
| 7216172 | Background | 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. |
| 11979087 | Background | 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. |
| 24155223 | Background | 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. |
| 24944665 | Background | 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. |
| 25125393 | Background | 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. |
| 20955991 | Background | Della Badia C, Karini H. Endometrial stromal sarcoma diagnosed after uterine morcellation in laparoscopic supracervical hysterectomy. J Minim Invasive Gynecol. 2010 Nov-Dec;17(6):791-3. doi: 10.1016/j.jmig.2010.07.001. |
| 21541824 | Background | Park JY, Kim DY, Kim JH, Kim YM, Kim YT, Nam JH. The impact of tumor morcellation during surgery on the outcomes of patients with apparently early low-grade endometrial stromal sarcoma of the uterus. Ann Surg Oncol. 2011 Nov;18(12):3453-61. doi: 10.1245/s10434-011-1751-y. Epub 2011 May 4. |
| 18978112 | Background | Shah JP, Bryant CS, Kumar S, Ali-Fehmi R, Malone JM Jr, Morris RT. Lymphadenectomy and ovarian preservation in low-grade endometrial stromal sarcoma. Obstet Gynecol. 2008 Nov;112(5):1102-8. doi: 10.1097/AOG.0b013e31818aa89a. |
| 21276609 | Background | Dos Santos LA, Garg K, Diaz JP, Soslow RA, Hensley ML, Alektiar KM, Barakat RR, Leitao MM Jr. Incidence of lymph node and adnexal metastasis in endometrial stromal sarcoma. Gynecol Oncol. 2011 May 1;121(2):319-22. doi: 10.1016/j.ygyno.2010.12.363. Epub 2011 Jan 26. |
| 17895898 | Background | Amant F, De Knijf A, Van Calster B, Leunen K, Neven P, Berteloot P, Vergote I, Van Huffel S, Moerman P. Clinical study investigating the role of lymphadenectomy, surgical castration and adjuvant hormonal treatment in endometrial stromal sarcoma. Br J Cancer. 2007 Nov 5;97(9):1194-9. doi: 10.1038/sj.bjc.6603986. Epub 2007 Sep 25. |
| 19959075 | Background | Amant F, Coosemans A, Debiec-Rychter M, Timmerman D, Vergote I. Clinical management of uterine sarcomas. Lancet Oncol. 2009 Dec;10(12):1188-98. doi: 10.1016/S1470-2045(09)70226-8. |
| 23921879 | Background | Rauh-Hain JA, del Carmen MG. Endometrial stromal sarcoma: a systematic review. Obstet Gynecol. 2013 Sep;122(3):676-83. doi: 10.1097/AOG.0b013e3182a189ac. |
| 8910635 | Background | Gadducci A, Sartori E, Landoni F, Zola P, Maggino T, Urgesi A, Lissoni A, Losa G, Fanucchi A. Endometrial stromal sarcoma: analysis of treatment failures and survival. Gynecol Oncol. 1996 Nov;63(2):247-53. doi: 10.1006/gyno.1996.0314. |
| 12821359 | Background | Chu MC, Mor G, Lim C, Zheng W, Parkash V, Schwartz PE. Low-grade endometrial stromal sarcoma: hormonal aspects. Gynecol Oncol. 2003 Jul;90(1):170-6. doi: 10.1016/s0090-8258(03)00258-0. |
| 16319256 | Background | Li AJ, Giuntoli RL 2nd, Drake R, Byun SY, Rojas F, Barbuto D, Klipfel N, Edmonds P, Miller DS, Karlan BY. Ovarian preservation in stage I low-grade endometrial stromal sarcomas. Obstet Gynecol. 2005 Dec;106(6):1304-8. doi: 10.1097/01.AOG.0000185511.91694.1e. |
| 18179547 | Background | Kim WY, Lee JW, Choi CH, Kang H, Kim TJ, Kim BG, Lee JH, Bae DS. Low-grade endometrial stromal sarcoma: a single center's experience with 22 cases. Int J Gynecol Cancer. 2008 Sep-Oct;18(5):1084-9. doi: 10.1111/j.1525-1438.2007.01159.x. Epub 2007 Dec 27. |
| 22740004 | Background | Altman AD, Nelson GS, Chu P, Nation J, Ghatage P. Uterine sarcoma and aromatase inhibitors: Tom Baker Cancer Centre experience and review of the literature. Int J Gynecol Cancer. 2012 Jul;22(6):1006-12. doi: 10.1097/IGC.0b013e31825b7de8. |
| 17320937 | Background | Leath CA 3rd, Huh WK, Hyde J Jr, Cohn DE, Resnick KE, Taylor NP, Powell MA, Mutch DG, Bradley WH, Geller MA, Argenta PA, Gold MA. A multi-institutional review of outcomes of endometrial stromal sarcoma. Gynecol Oncol. 2007 Jun;105(3):630-4. doi: 10.1016/j.ygyno.2007.01.031. Epub 2007 Feb 23. |
| 19396004 | Background | Thomas MB, Keeney GL, Podratz KC, Dowdy SC. Endometrial stromal sarcoma: treatment and patterns of recurrence. Int J Gynecol Cancer. 2009 Feb;19(2):253-6. doi: 10.1111/IGC.0b013e3181999c5f. |
| 6344983 | Background | Omura GA, Major FJ, Blessing JA, Sedlacek TV, Thigpen JT, Creasman WT, Zaino RJ. A randomized study of adriamycin with and without dimethyl triazenoimidazole carboxamide in advanced uterine sarcomas. Cancer. 1983 Aug 15;52(4):626-32. doi: 10.1002/1097-0142(19830815)52:43.0.co;2-e. |
| 21277011 | Background | Cheng X, Yang G, Schmeler KM, Coleman RL, Tu X, Liu J, Kavanagh JJ. Recurrence patterns and prognosis of endometrial stromal sarcoma and the potential of tyrosine kinase-inhibiting therapy. Gynecol Oncol. 2011 May 1;121(2):323-7. doi: 10.1016/j.ygyno.2010.12.360. Epub 2011 Jan 28. |
| 6738952 | Background | Piver MS, Rutledge FN, Copeland L, Webster K, Blumenson L, Suh O. Uterine endolymphatic stromal myosis: a collaborative study. Obstet Gynecol. 1984 Aug;64(2):173-8. |
| 8677079 | Background | Sutton G, Blessing JA, Park R, DiSaia PJ, Rosenshein N. Ifosfamide treatment of recurrent or metastatic endometrial stromal sarcomas previously unexposed to chemotherapy: a study of the Gynecologic Oncology Group. Obstet Gynecol. 1996 May;87(5 Pt 1):747-50. doi: 10.1016/0029-7844(96)00003-8. |
| D012509 | Sarcoma |
| D016889 | Endometrial Neoplasms |
| D014594 | Uterine Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |