Last updated: 12/08/2020 23:00:05

Synovial Sarcoma Burden of Illness Study

GSK study ID
208280
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: Burden of Illness Study in Synovial Sarcoma Patients in the US
Trial description: Synovial sarcoma (SS) is a rare and aggressive subtype of soft tissue sarcoma (STS). The aim of this retrospective
chart review study is to examine the natural history of SS participants and treatment patterns of participants diagnosed with metastatic SS.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Cohort A: Time to disease progression

Timeframe: Up to 45 days

Cohort B: Number of participants receiving systemic therapy by line of treatment

Timeframe: Up to 45 days

Cohort B: Treatment patterns

Timeframe: Up to 45 days

Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2020-19-11
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Neoplasms
Product
GSK3377794
Collaborators
Not applicable
Study date(s)
June 2020 to November 2020
Type
Observational
Phase
2

Participation criteria

Sex
Female & Male
Age
18 Years - NA
Accepts healthy volunteers
No
  • Inclusion Criteria:
  • For cohort A:
Inclusion and exclusion criteria
Inclusion criteria:
  • Inclusion Criteria: For cohort A:
  • Participants with a diagnosis of SS in the United States Oncology Network (USON).
  • Participants >=18 years of age at first diagnosis of SS.
  • Participants with >= 2 visits during the study observation period. For cohort B:
  • Participants who met the eligibility criteria for cohort A.
  • Participants with evidence of metastatic disease.
  • Participants who initiated systemic treatment during the study identification period.
  • Participants whose systemic anticancer treatments from the point of initial metastatic diagnosis are documented in the chart. Exclusion Criteria For cohort A:
  • Participants diagnosed with a different primary tumor other than SS. For cohort B:
  • Not applicable.

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
2020-19-11
Actual study completion date
2020-19-11

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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