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NCT05910307 Clinical Trial

Synovial Sarcoma Registry / Biospecimen Repository

Synovial Sarcoma Clinical Trial

Official title:
Synovial Sarcoma Registry and Biospecimen Repository

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05910307
Other study ID # 23-021012
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 12, 2023
Est. completion date June 2033

Study information
Verified date June 2023
Source Children's Hospital of Philadelphia
Contact Lauren Gutstein
Phone 267-425-2029
Email gutsteinl1@chop.edu
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1000
Est. completion date June 2033
Est. primary completion date June 2028
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Children's Hospital of Philadelphia Philadelphia Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of patients with synovial sarcoma Number of patients with synovial sarcoma Up to 10 years
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