Retrospective Study of Trabectedin in Soft Tissue Sarcomas

NCT ID: NCT02793050

Last Updated: 2019-05-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 510 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-06-15
• Study Completion Date: 2018-10-02

Brief Summary

This is an independent, observational, retrospective post marketing study on the use of trabectedin in a clinical setting.

A data collection on the clinical use of the drug will help to improve knowledge and might contribute to optimize the clinical use of the drug.

Detailed Description

This is a national, multi-centre observational retrospective and prospective chart review study of treatment patterns and clinical outcomes in a subset of patients with Soft Tissue Sarcoma who received trabectedin as per licensed indication.

In the absence of availability of existing databases, a retrospective chart review design was selected.

It is anticipated that the medical charts will contain the information required to answer study objectives. This chart review study will be conducted in 25 sites in Italy An estimated total of 900 charts will be abstracted. This study requires no intervention or interference with standard medical care, and thus it will not affect patient treatment.

The study is sponsored by Italian Sarcoma Group Charts of patients who initiated trabectedin as part of the approved treatment for a Soft Tissue Sarcoma , will be identified by site staff. Each identified chart will be assigned a unique study identification number. Site staff will review the medical charts for all identified patients to determine patient eligibility. Those patients who meet eligibility criteria will be enrolled into the final study cohort as subject.

Data from subject medical charts will be abstracted by local site study staff and entered at the site into an electronic data capture (EDC) system. The system will also facilitate the monitoring of the completeness and quality of study data as the study data accrue.

Conditions

Sarcoma, Soft Tissue

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Trabectedin

Trabectedin give according the market authorization for advanced soft tissue sarcoma

Trabectedin

Intervention Type: DRUG

Collection of data on the clinical use of Trabectedin

Interventions

Trabectedin

Collection of data on the clinical use of Trabectedin

Intervention Type: DRUG

Other Intervention Names

yondelis

Eligibility Criteria

Inclusion Criteria

• Patients who received trabectedin according to the approved indication in the period January 2010 December 2015

Exclusion Criteria

• Trabectedin started before January 2010 and after December 2015
• Participation into clinical trials with trabectedin
• Clinical chart missing, empty, or not retrievable.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Italian Sarcoma Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stefano Ferrari, MD

Role: PRINCIPAL_INVESTIGATOR

Italian Sarcoma Group

Locations

A.O. SS Antonio e Biagio e Cesare Arrigo

Alessandria, AL, Italy

Istituto Tumori Giovanni Paolo II

Bari, BA, Italy

Ospedali Riuniti di Bergamo

Bergamo, BG, Italy

Ospedale Oncologico A. Businco

Cagliari, CA, Italy

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

Meldola, FC, Italy

Istituto Europeo di Oncologia

Milan, MI, Italy

Istituto Clinico Humanitas

Rozzano, MI, Italy

Azienda Ospedaliera Universitaria Paolo Giaccone

Palermo, PA, Italy

Centro di Riferimento Oncologico di Aviano

Aviano, PD, Italy

Istituto Oncologico Veneto

Padua, PD, Italy

Azienda Ospedaliera Universitaria Santa Chiara

Pisa, PI, Italy

Policlinico Universitario Campus Biomedico

Roma, RM, Italy

Fondazione del Piemonte per l'Oncologia IRCC Candiolo

Candiolo, Torino, Italy

Istituto Ortopedico Rizzoli

Bologna, , Italy

Policlinico S.Orsola Malpighi - Unit of Medical Oncology

Bologna, , Italy

Pres.Ospedal.Spedali Civili Brescia -

Brescia (BS), , Italy

Azienda Ospedaliero-Universitaria Careggi

Florence, , Italy

Irccs Istituto Nazionale Dei Tumori (Int)

Milano (MI), , Italy

Azienda Ospedaliero-Universitaria di Modena - Policlinico

Modena, , Italy

Irccs Istituto Nazionale Tumori Fondazione Pascale -

Napoli (NA), , Italy

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

Prato, , Italy

Arcispedale S. Maria Nuova Azienda Ospedaliera Di Reggio Emilia

Reggio Emilia, , Italy

Fondazione Policlinico Universitario "Agostino Gemelli"

Roma, , Italy

Istituto Regina Elena - IFO

Rome, , Italy

Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino

Torino, , Italy

Presidio Sanitario Gradenigo Di Torino

Torino (TO), , Italy

Countries

Italy

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Other Identifiers

ISG TrObs

Identifier Type: -

Identifier Source: org_study_id