Clinical trial NCT02829437: Observational Study on Endometrial Stromal Tumors
Official title: Endometrial Stromal Tumors: an Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endometrial Stromal Tumors
Lead sponsor: Italian Sarcoma Group
Sponsor class: NETWORK
First posted: 2016-07-12
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: All the patients with a diagnosis of Endometrial Stromal Tumor (EST)

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

Eligibility 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

Primary outcomes:
measure: Disease natural history
timeFrame: Through survival, an average of 5 years
Secondary outcomes:
measure: Disease diagnosis and classification
timeFrame: At the time of diagnosis, an average of 1 month
measure: Chemotherapy received treatment
timeFrame: Through treatment completion, an average of 24 month
Other outcomes:
Locations:
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST
state: FC
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
state: MI
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia
state: MI
city: Palermo
country: Italy
facility: Azienda Ospedaliera Universitaria Paolo Giaccone
state: PA
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico di Aviano
state: PD
city: Padova
country: Italy
facility: Istituto Oncologico Veneto
state: PD
city: Candiolo
country: Italy
facility: Fondazione del Piemonte per l'Oncologia IRCC Candiolo
state: Torino
city: Bologna
country: Italy
facility: Policlinico S.Orsola Malpighi - Unit of Medical Oncology
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
city: Firenze
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi
city: Prato
country: Italy
facility: Ospedale Misericordia e Dolce Ist. Toscano Tumori, Az. USL4
city: Roma
country: Italy
facility: Campus Biomedico
city: Roma
country: Italy
facility: Istituti Fisioterapici Ospitalieri di Roma
Study officials:
affiliation: Italian Sarcoma Group
name: Paolo G Casali, MD
role: STUDY_CHAIR
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