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Synovial Sarcoma Registry / Biospecimen Repository

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ClinicalTrials.gov Identifier: NCT05910307
Recruitment Status : Recruiting
First Posted : June 18, 2023
Last Update Posted : June 22, 2023
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Study Description
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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.


Condition or disease
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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration: 10 Years
Official Title: Synovial Sarcoma Registry and Biospecimen Repository
Actual Study Start Date : June 12, 2023
Estimated Primary Completion Date : June 2028
Estimated Study Completion Date : June 2033

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Number of patients with synovial sarcoma [ Time Frame: Up to 10 years ]
    Number of patients with synovial sarcoma


Biospecimen Retention:   Samples With DNA
Samples may include tumor tissue and its excipients (DNA, RNA, protein), blood, saliva, and/or buccal swabs.

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Males and females of any age with a reported diagnoses of synovial sarcoma.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05910307


Contacts
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Contact: Lauren Gutstein 267-425-2029 gutsteinl1@chop.edu
Contact: James Robinson 215-590-2053 robinsonj9@chop.edu

Locations
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United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Lauren Gutstein    267-425-2029    gutsteinl1@chop.edu   
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
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Principal Investigator: Theodore Laetsch, MD Children's Hospital of Philadelphia
More Information
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Additional Information:

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Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT05910307    
Other Study ID Numbers: 23-021012
First Posted: June 18, 2023    Key Record Dates
Last Update Posted: June 22, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: Upon request, data can be made available after review by study team.
Access Criteria: The study team will review requests on an individual basis.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Children's Hospital of Philadelphia:
registry
biorepository
sarcoma
 oncology
cancer
rare tumor
Additional relevant MeSH terms:
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Sarcoma
Sarcoma, Synovial
Neoplasms, Connective and Soft Tissue
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue