Observational Study on Endometrial Stromal Tumors (EST)

October 3, 2023 updated by: Italian Sarcoma Group

Endometrial Stromal Tumors: an Observational Study

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Bologna, Italy, 40138
        • Not yet recruiting
        • Policlinico S.Orsola Malpighi - Unit of Medical Oncology
        • Principal Investigator:
          • Maria Abbondanza Pantaleo, MD
      • Firenze, Italy, 50100
        • Not yet recruiting
        • Azienda Ospedaliera Universitaria Careggi
        • Contact:
        • Principal Investigator:
          • Silvia Gasperoni, MD
      • Firenze, Italy, 50100
        • Not yet recruiting
        • Azienda Ospedaliero-Universitaria Careggi
        • Contact:
        • Principal Investigator:
          • Daniela Greto, MD
      • Prato, Italy, 59100
        • Not yet recruiting
        • Ospedale Misericordia e Dolce Ist. Toscano Tumori, Az. USL4
        • Principal Investigator:
          • Giacomo G Baldi, MD
      • Roma, Italy, 00100
        • Not yet recruiting
        • Campus Biomedico
        • Contact:
          • Bruno Vincenzi, MD
        • Principal Investigator:
          • Bruno Vincenzi, MD
      • Roma, Italy, 00100
        • Not yet recruiting
        • Istituti Fisioterapici Ospitalieri di Roma
        • Contact:
        • Principal Investigator:
          • Virginia Ferraresi, MD
    • FC
      • Meldola, FC, Italy
        • Not yet recruiting
        • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST
        • Principal Investigator:
          • Toni Ibrahim, MD
    • MI
      • Milano, MI, Italy, 20133
        • Recruiting
        • Fondazione Irccs Istituto Nazionale Dei Tumori
        • Contact:
        • Principal Investigator:
          • Paolo G. Casali, MD
      • Milano, MI, Italy, 20141
        • Not yet recruiting
        • Istituto Europeo Di Oncologia
        • Principal Investigator:
          • Tommaso M. De Pas, MD
    • PA
      • Palermo, PA, Italy, 90127
        • Not yet recruiting
        • Azienda ospedaliera universitaria paolo giaccone
        • Principal Investigator:
          • Antonio Russo, MD
        • Contact:
    • PD
      • Aviano, PD, Italy, 33081
        • Not yet recruiting
        • Centro di Riferimento Oncologico di Aviano
        • Contact:
        • Principal Investigator:
          • Angela Buonadonna, MD
      • Padova, PD, Italy, 35128
        • Not yet recruiting
        • Istituto Oncologico Veneto
        • Principal Investigator:
          • Antonella Brunello, MD
    • Torino
      • Candiolo, Torino, Italy, 10060
        • Not yet recruiting
        • Fondazione Del Piemonte Per L'Oncologia Ircc Candiolo
        • Contact:
        • Principal Investigator:
          • Giovanni Grignani, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Retrospective Observational Group
Patients who received treatment for EST Patients with EST diagnosis prior August 2016
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)
Prospective Observational Group
Patients who will receive treatment for EST Patients with EST diagnosis after August 2016
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease natural history
Time Frame: Through survival, an average of 5 years
Collection of data on the natural history of endometrial stromal tumors
Through survival, an average of 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease diagnosis and classification
Time Frame: At the time of diagnosis, an average of 1 month
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
Time Frame: Through treatment completion, an average of 24 month
Number and type of chemotherapy agents received for EST treatment
Through treatment completion, an average of 24 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Italian Sarcoma Group

Investigators

  • Study Chair: Paolo G Casali, MD, Italian Sarcoma Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

July 8, 2016

First Submitted That Met QC Criteria

July 8, 2016

First Posted (Estimated)

July 12, 2016

Study Record Updates

Last Update Posted (Actual)

October 4, 2023

Last Update Submitted That Met QC Criteria

October 3, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISG EST

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Aggregate anonymized results will be available upon request at the end of the study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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