Observational Study on Endometrial Stromal Tumors

NCT02829437 | Recruiting

• 1 other identifier: ISG EST
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 13

Brief Summary

Observational, retrospective and prospective study on Endometrial Stromal Tumor (EST)

Conditions

Endometrial Stromal Tumors

Outcome Measures

Primary Outcomes (1)

• Disease natural history

  Collection of data on the natural history of endometrial stromal tumors

  Through survival, an average of 5 years

Secondary Outcomes (2)

• Disease diagnosis and classification

  At the time of diagnosis, an average of 1 month

• Chemotherapy received treatment

  Through treatment completion, an average of 24 month

Study Arms (2)

Retrospective Observational Group

Patients who received treatment for EST Patients with EST diagnosis prior August 2016

Other: Treatment for EST

Prospective Observational Group

Patients who will receive treatment for EST Patients with EST diagnosis after August 2016

Other: Treatment for EST

Interventions

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)

Prospective Observational Group; Retrospective Observational Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All the patients with a diagnosis of Endometrial Stromal Tumor (EST)

You may qualify if:

• patients with a diagnosis of Endometrial Stromal Tumor (EST) according to the World Health Organization (WHO) classification 2003 or 2014
• Informed consent signature

You may not qualify if:

• patients with different diagnosis from EST

Sponsors & Collaborators

• Italian Sarcoma Group: lead

Study Sites (13)

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST

Meldola, FC, Italy

NOT YET RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, MI, 20133, Italy

RECRUITING

Istituto Europeo di Oncologia

Milan, MI, 20141, Italy

NOT YET RECRUITING

Azienda Ospedaliera Universitaria Paolo Giaccone

Palermo, PA, 90127, Italy

NOT YET RECRUITING

Centro di Riferimento Oncologico di Aviano

Aviano, PD, 33081, Italy

NOT YET RECRUITING

Istituto Oncologico Veneto

Padua, PD, 35128, Italy

NOT YET RECRUITING

Fondazione del Piemonte per l'Oncologia IRCC Candiolo

Candiolo, Torino, 10060, Italy

NOT YET RECRUITING

Policlinico S.Orsola Malpighi - Unit of Medical Oncology

Bologna, 40138, Italy

NOT YET RECRUITING

Azienda Ospedaliera Universitaria Careggi

Florence, 50100, Italy

NOT YET RECRUITING

Azienda Ospedaliero-Universitaria Careggi

Florence, 50100, Italy

NOT YET RECRUITING

Ospedale Misericordia e Dolce Ist. Toscano Tumori, Az. USL4

Prato, 59100, Italy

NOT YET RECRUITING

Campus Biomedico

Roma, 00100, Italy

NOT YET RECRUITING

Istituti Fisioterapici Ospitalieri di Roma

Roma, 00100, Italy

NOT YET RECRUITING

Related Publications (26)

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• 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.

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• 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.

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• 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.

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• 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 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.

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• 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.

  PMID: 20955991 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.

  PMID: 21541824 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.

  PMID: 18978112 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.

  PMID: 21276609 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

  PMID: 16319256 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.

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  PMID: 8677079 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Paraffin-embedded pathologic tissue used for diagnostic confirmation purposes only

MeSH Terms

Conditions

Endometrial Stromal Tumors

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma; Endometrial Neoplasms; Uterine Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases

Study Officials

• Paolo G Casali, MD

  Italian Sarcoma Group

  STUDY CHAIR

Central Study Contacts

Gianluca Ignazzi, PhD

CONTACT

+393335359192; gianluca.ignazzi@italiansarcomagroup.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2016
• First Posted: July 12, 2016
• Study Start: October 1, 2016
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

IT (13)