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Observational Study on Endometrial Stromal Tumors (EST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02829437
Recruitment Status : Recruiting
First Posted : July 12, 2016
Last Update Posted : September 19, 2022
Sponsor:
Information provided by (Responsible Party):
Italian Sarcoma Group

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

Condition or disease Intervention/treatment
Endometrial Stromal Tumors Other: Treatment for 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

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Endometrial Stromal Tumors: an Observational Study
Study Start Date : October 2016
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. Disease natural history [ Time Frame: Through survival, an average of 5 years ]
    Collection of data on the natural history of endometrial stromal tumors


Secondary Outcome Measures :
  1. 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

  2. Chemotherapy received treatment [ Time Frame: Through treatment completion, an average of 24 month ]
    Number and type of chemotherapy agents received for EST treatment


Biospecimen Retention:   Samples With DNA
Paraffin-embedded pathologic tissue used for diagnostic confirmation purposes only


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All the patients with a diagnosis of Endometrial Stromal Tumor (EST)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02829437


Contacts
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Contact: Gianluca Ignazzi, PhD +393335359192 gianluca.ignazzi@italiansarcomagroup.org

Locations
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Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST Not yet recruiting
Meldola, FC, Italy
Principal Investigator: Toni Ibrahim, MD         
Fondazione IRCCS Istituto Nazionale dei Tumori Recruiting
Milano, MI, Italy, 20133
Contact: Paolo G. Casali, MD       paolo.casali@istitutotumori.mi.it   
Principal Investigator: Paolo G. Casali, MD         
Istituto Europeo di Oncologia Not yet recruiting
Milano, MI, Italy, 20141
Principal Investigator: Tommaso M. De Pas, MD         
Azienda Ospedaliera Universitaria Paolo Giaccone Not yet recruiting
Palermo, PA, Italy, 90127
Contact: Antonio Russo, MD    +39 091 6552534    antonio.russo@usa.net   
Principal Investigator: Antonio Russo, MD         
Centro di Riferimento Oncologico di Aviano Not yet recruiting
Aviano, PD, Italy, 33081
Contact: Angela Buonadonna, MD    +390434659190    abuonadonna@cro.it   
Principal Investigator: Angela Buonadonna, MD         
Istituto Oncologico Veneto Not yet recruiting
Padova, PD, Italy, 35128
Principal Investigator: Antonella Brunello, MD         
Fondazione del Piemonte per l'Oncologia IRCC Candiolo Not yet recruiting
Candiolo, Torino, Italy, 10060
Contact: Giovanni Grignani, MD    +390119933623    enrico.grignani@ircc.it   
Principal Investigator: Giovanni Grignani, MD         
Policlinico S.Orsola Malpighi - Unit of Medical Oncology Not yet recruiting
Bologna, Italy, 40138
Principal Investigator: Maria Abbondanza Pantaleo, MD         
Azienda Ospedaliera Universitaria Careggi Not yet recruiting
Firenze, Italy, 50100
Contact: Silvia Gasperoni, MD    39 055 7949648    gasperoni.silvia@gmail.com   
Principal Investigator: Silvia Gasperoni, MD         
Azienda Ospedaliero-Universitaria Careggi Not yet recruiting
Firenze, Italy, 50100
Contact: Daniela Greto, MD    + 39055794 ext 111    daniela.greto@gmail.com   
Principal Investigator: Daniela Greto, MD         
Ospedale Misericordia e Dolce Ist. Toscano Tumori, Az. USL4 Not yet recruiting
Prato, Italy, 59100
Principal Investigator: Giacomo G Baldi, MD         
Campus Biomedico Not yet recruiting
Roma, Italy, 00100
Contact: Bruno Vincenzi, MD         
Principal Investigator: Bruno Vincenzi, MD         
Istituti Fisioterapici Ospitalieri di Roma Not yet recruiting
Roma, Italy, 00100
Contact: Virginia Ferraresi, MD       virginia.ferraresi@ifo.gov.it   
Principal Investigator: Virginia Ferraresi, MD         
Sponsors and Collaborators
Italian Sarcoma Group
Investigators
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Study Chair: Paolo G Casali, MD Italian Sarcoma Group
Publications:

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Responsible Party: Italian Sarcoma Group
ClinicalTrials.gov Identifier: NCT02829437    
Other Study ID Numbers: ISG EST
First Posted: July 12, 2016    Key Record Dates
Last Update Posted: September 19, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Aggregate anonymized results will be available upon request at the end of the study
Additional relevant MeSH terms:
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Endometrial Stromal Tumors
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma
Endometrial Neoplasms
Uterine Neoplasms
Uterine Diseases
Genital Neoplasms, Female
Urogenital Neoplasms