NCT02793050

Retrospective Study of Trabectedin in Soft Tissue Sarcomas

Trabectedin in Soft Tissue Sarcomas. A Retrospective Observational Analysis (TrObs)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 510 (actual)
• Sponsor: Italian Sarcoma Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Trabectedin	Collection of data on the clinical use of Trabectedin

Timeline

• Start date: 2016-06-15
• Primary completion: 2018-10-02
• Completion: 2018-10-02
• First posted: 2016-06-08
• Last updated: 2019-05-10

Locations

26 sites across 1 country: Italy