Synovial Sarcoma Registry / Biospecimen Repository

Synovial Sarcoma Registry and Biospecimen Repository

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.

Study Overview

• Status: Recruiting
• Conditions: Synovial Sarcoma

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 Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: James Robinson; Phone Number: 215-590-2053; Email: robinsonj9@chop.edu
• Study Contact Backup: Name: Lauren Gutstein; Phone Number: 267-425-2029; Email: gutsteinl1@chop.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Children's Hospital of Philadelphia
      • Contact: Lauren Gutstein; Phone Number: 267-425-2029; Email: gutsteinl1@chop.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Males and females of any age with a reported diagnoses of synovial sarcoma.

Description

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

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with synovial sarcoma	Number of patients with synovial sarcoma	Up to 10 years

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Investigators: Principal Investigator: Theodore Laetsch, MD, Children's Hospital of Philadelphia

Publications and helpful links

Helpful Links

• Interest Form for Potential Participants

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2023
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2033

Study Registration Dates

• First Submitted: June 1, 2023
• First Submitted That Met QC Criteria: June 9, 2023
• First Posted (Actual): June 18, 2023

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 21, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: cancer; oncology; registry; rare tumor; sarcoma; biorepository
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Connective Tissue; Sarcoma; Sarcoma, Synovial
• Other Study ID Numbers: 23-021012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data and specimens may be provided to other investigators for additional research use. Identifiable data will only be available to the study team.
• IPD Sharing Time Frame: Upon request, data can be made available after review by study team.
• IPD Sharing Access Criteria: The study team will review requests on an individual basis.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No