Last updated: 02/06/2024 05:01:50

Real-world burden of illness study among synovial sarcoma participants

GSK study ID
212253
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Real-world burden of illness study among synovial sarcoma patients previously treated in Europe and Asia.
Trial description: The overall aim of this study is to understand the characteristics, treatments and outcomes for metastatic Synovial Sarcoma (SS) participants currently being treated or previously treated in Europe or Asia.
Primary purpose:
Treatment
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Longitudinal treatment patterns in the metastatic setting

Timeframe: Up to 36 months

Time-to-next-treatment at indicated time points

Timeframe: Up to 36 months

Time to death at indicated time points

Timeframe: Up to 36 months

Secondary outcomes:

Healthcare resource utilization

Timeframe: Up to 36 months

Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2020-13-04
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Neoplasms, Sarcoma, Synovial
Product
GSK3377794
Collaborators
Not applicable
Study date(s)
November 2019 to April 2020
Type
Observational
Phase
2

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • Inclusion criteria:
  • Participant Inclusion criteria:
Inclusion and exclusion criteria
Inclusion criteria:
  • Inclusion criteria: Participant Inclusion criteria: Participants will be eligible for inclusion if they satisfy all the following criteria: Actively treated participants:
  • Diagnosed with metastatic SS by case definition
  • Currently receiving cytotoxic and/or targeted therapies, or having received cytotoxic and/or targeted therapies in the 12 months prior to the time of data collection
  • Aged >=18 years at the time of data collection
  • Having been treated in the last 12 months from the time of data collection
  • Participants who have a positive or unknown chromosomal translocation between SYT on the X chromosome and SSX1, SXX2 or SSX4 on chromosome 18. Deceased participants who were previously treated:
  • Diagnosed with metastatic SS by case definition
  • Aged >=18 years at the time of data collection
  • Having received at least two cytotoxic and/or targeted therapies
  • Died of any cause in the 12 months prior to the time of data collection
  • Participants who had a positive or unknown chromosomal translocation between SYT on the X chromosome and SSX1, SSX2 or SSX4 on chromosome 18.

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

No study documents available.

Results overview

No study documents available

Recruitment status
Study complete
Actual primary completion date
2020-13-04
Actual study completion date
2020-13-04

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Not applicable
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