Sarcoma, Soft Tissue Clinical Trial
Official title:
Trabectedin in Soft Tissue Sarcomas. A Retrospective Observational Analysis (TrObs)
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.
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.
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