Ignite Creation Date:
2025-12-24 @ 5:04 PM
Ignite Modification Date:
2025-12-25 @ 9:00 PM
Study NCT ID:
NCT02793050
Status:
COMPLETED
Last Update Posted:
2019-05-10
First Post:
2016-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrospective Study of Trabectedin in Soft Tissue Sarcomas
Sponsor:
Italian Sarcoma Group
Organization:
Study Overview
Official Title:
Trabectedin in Soft Tissue Sarcomas. A Retrospective Observational Analysis (TrObs)
Status:
COMPLETED
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TrObs
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: