Synovial Sarcoma Registry / Biospecimen Repository

Recruiting

• Conditions: Synovial Sarcoma

• Registration Number: NCT05910307
• Lead Sponsor: Children's Hospital of Philadelphia

Brief Summary

The purpose of this study is to collect and store data and samples for future research to attempt to improve outcomes for patients with synovial sarcoma. The future research will involve various types of genetic testing.

Participants will be asked to allow access to medical records and leftover tumor tissue and may be asked to give a blood or saliva sample. Participants will also be asked to completed questionnaires about their medical history and may be contacted every 6 to 12 months for updates for up to 10 years.

Detailed Description

This study will enroll patients with a diagnosis of Synovial Sarcoma.

Following consent, demographic, clinical, treatment and outcome data will be collected from an interview and/or online survey. This will include a request for contact information for the subject's treating hospitals/physicians and a release of records request to obtain medical records.

At approximately 6-12 month intervals for up to 10 years after initial diagnosis and/or relapse, subjects and/or their treating hospitals may be contacted to provide updates on treatment and outcomes.

Tumor samples may be collected from residual material obtained during clinically indicated procedures occurring before or after consent to this study. No additional material will be collected or procedures performed solely for the purpose of this study.

Blood may be collected at the participant's local institution at the time of a clinically indicated blood draw and/or saliva or a buccal swab may be collected as a germline sample and for analysis of circulating free DNA (cfDNA) and/or circulating tumor cells (CTCs).

Genetic testing may be performed on tumor and germline samples submitted by subjects. Results will only be returned if deemed clinically significant.

Study Timeline

• Study First Submitted: 2023-06-01
• Study First Submitted QC: 2023-06-09
• Study Start: 2023-06-12
• Study First Posted: 2023-06-18
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-03
• Last Update Posted: 2024-06-04
• Primary Completion: 2028-06
• Study Completion: 2033-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

1. Males or females of any age
2. Reported diagnosis of synovial sarcoma
3. Informed consent from subject (aged ≥18 years) or parent/guardian

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Exclusion Criteria

1. Individuals with sarcomas that do not fit the definition of those considered for this registry
2. Individuals who are unwilling to participate
3. Individuals who are unwilling or unable to provide written consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients with synovial sarcoma	Up to 10 years	Number of patients with synovial sarcoma

Trial Locations

Locations (1)

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States