AzTrials
AzTrials

Endometrial Stromal TumorsESTNCT02829437

Observational Study on Endometrial Stromal Tumors

An observational study of Endometrial Stromal Tumors, run by Italian Sarcoma Group at 13 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Observational, retrospective and prospective study on Endometrial Stromal Tumor (EST) Read more about this study

Who is it for?
Ages 18 to 80 years, women only
Conditions the study is for
Endometrial Stromal Tumors
What is being tested?
Treatment for EST
How many people
100 participants
Where
13 sitesItaly
Study dates
Oct 2016to Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • patients with different diagnosis from EST

Trial locations and contacts

13 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Gianluca Ignazzi, PhD contact

+393335359192

gianluca.ignazzi@italiansarcomagroup.org

13 sites in 1 country

Italy13 sites, 13 recruiting

  • Centro di Riferimento Oncologico di Aviano

    Aviano, PD, 33081

    Angela Buonadonna, MD, +390434659190, abuonadonna@cro.it

    Angela Buonadonna, MD

    Not yet recruiting

  • Policlinico S.Orsola Malpighi - Unit of Medical Oncology

    Bologna, 40138

    Maria Abbondanza Pantaleo, MD

    Not yet recruiting

  • Fondazione del Piemonte per l'Oncologia IRCC Candiolo

    Candiolo, Torino, 10060

    Giovanni Grignani, MD, +390119933623, enrico.grignani@ircc.it

    Giovanni Grignani, MD

    Not yet recruiting

  • Azienda Ospedaliera Universitaria Careggi

    Florence, 50100

    Silvia Gasperoni, MD, 39 055 7949648, gasperoni.silvia@gmail.com

    Silvia Gasperoni, MD

    Not yet recruiting

  • Azienda Ospedaliero-Universitaria Careggi

    Florence, 50100

    Daniela Greto, MD, + 39055794 ext. 111, daniela.greto@gmail.com

    Daniela Greto, MD

    Not yet recruiting

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

    Meldola, FC

    Toni Ibrahim, MD

    Not yet recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, MI, 20133

    Paolo G. Casali, MD, paolo.casali@istitutotumori.mi.it

    Paolo G. Casali, MD

    Recruiting

  • Istituto Europeo di Oncologia

    Milan, MI, 20141

    Tommaso M. De Pas, MD

    Not yet recruiting

  • Istituto Oncologico Veneto

    Padova, PD, 35128

    Antonella Brunello, MD

    Not yet recruiting

  • Azienda Ospedaliera Universitaria Paolo Giaccone

    Palermo, PA, 90127

    Antonio Russo, MD, +39 091 6552534, antonio.russo@usa.net

    Antonio Russo, MD

    Not yet recruiting

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

    Prato, 59100

    Giacomo G Baldi, MD

    Not yet recruiting

  • Campus Biomedico

    Roma, 00100

    Bruno Vincenzi, MD

    Bruno Vincenzi, MD

    Not yet recruiting

  • Istituti Fisioterapici Ospitalieri di Roma

    Roma, 00100

    Virginia Ferraresi, MD, virginia.ferraresi@ifo.gov.it

    Virginia Ferraresi, MD

    Not yet recruiting

Other trials in Italy

About this study

Official title: Endometrial Stromal Tumors: an Observational Study

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

Read the 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

Being tested
Treatment for EST
Medical subject headings
Endometrial Stromal Tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Treatment for ESTOther

    Surgery and/or Chemotherapy and or/radiotherapy for EST treatment according to disease guidelines: no specific treatment is imposed by protocol (observational study)

Study groups in NCT02829437
Study groupRoleWhat they receive
Retrospective Observational GroupPatients who received treatment for EST Patients with EST diagnosis prior August 2016
Receives: Other: Treatment for EST
Prospective Observational GroupPatients who will receive treatment for EST Patients with EST diagnosis after August 2016
Receives: Other: Treatment for EST

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease natural history

    Collection of data on the natural history of endometrial stromal tumors

    Measured: Through survival, an average of 5 years

Secondary outcomes (2)

  1. Disease diagnosis and classification

    Highlight some main issues in pathologic diagnosis of these tumors and their classification

    Measured: At the time of diagnosis, an average of 1 month

  2. Chemotherapy received treatment

    Number and type of chemotherapy agents received for EST treatment

    Measured: Through treatment completion, an average of 24 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2016 (estimated)
  2. Study startOct 2016
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02829437
Sponsor's protocol ID
ISG EST
Acronym
EST
Status last verified
Dec 2025
First submitted
8 Jul 2016
Last updated
2 Jan 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: Aggregate anonymized results will be available upon request at the end of the study

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 25125393

  • 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.

    PubMed 20955991

  • 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.

    PubMed 21541824

  • 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.

    PubMed 18978112

  • 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.

    PubMed 21276609

  • 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.

    PubMed 17895898

  • 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.

    PubMed 19959075

  • 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.

    PubMed 23921879

Questions about this trial

What is this clinical trial studying?

An observational study of Endometrial Stromal Tumors, run by Italian Sarcoma Group at 13 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gianluca Ignazzi, PhD (+393335359192, gianluca.ignazzi@italiansarcomagroup.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease natural history (time frame: Through survival, an average of 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02829437, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in