Observational Study on Endometrial Stromal Tumors

Recruiting

• Conditions: Endometrial Stromal Tumors
• Interventions: Other: Treatment for EST

• Registration Number: NCT02829437
• Lead Sponsor: Italian Sarcoma Group

Brief Summary

Observational, retrospective and prospective study on Endometrial Stromal Tumor (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

Study Timeline

• Study First Submitted: 2016-07-08
• Study First Submitted QC: 2016-07-08
• Study First Posted: 2016-07-12
• Study Start: 2016-10
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-19
• Last Update Posted: 2024-12-20
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Disease natural history	Through survival, an average of 5 years	Collection of data on the natural history of endometrial stromal tumors

Secondary Outcome Measures

Name	Time	Method
Disease diagnosis and classification	At the time of diagnosis, an average of 1 month	Highlight some main issues in pathologic diagnosis of these tumors and their classification
Chemotherapy received treatment	Through treatment completion, an average of 24 month	Number and type of chemotherapy agents received for EST treatment

Trial Locations

Locations (13)

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST; 🇮🇹 Meldola, FC, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori; 🇮🇹 Milano, MI, Italy

Istituto Oncologico Veneto; 🇮🇹 Padova, PD, Italy

Fondazione del Piemonte per l'Oncologia IRCC Candiolo; 🇮🇹 Candiolo, Torino, Italy

Azienda Ospedaliero-Universitaria Careggi; 🇮🇹 Firenze, Italy

Policlinico S.Orsola Malpighi - Unit of Medical Oncology; 🇮🇹 Bologna, Italy

Azienda Ospedaliera Universitaria Careggi; 🇮🇹 Firenze, Italy

Azienda Ospedaliera Universitaria Paolo Giaccone; 🇮🇹 Palermo, PA, Italy

Campus Biomedico; 🇮🇹 Roma, Italy

Istituto Europeo di Oncologia; 🇮🇹 Milano, MI, Italy

Centro di Riferimento Oncologico di Aviano; 🇮🇹 Aviano, PD, Italy

Ospedale Misericordia e Dolce Ist. Toscano Tumori, Az. USL4; 🇮🇹 Prato, Italy

Istituti Fisioterapici Ospitalieri di Roma; 🇮🇹 Roma, Italy