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
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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 |
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Synovial Sarcoma |
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 [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 |
- Number of patients with synovial sarcoma [ Time Frame: Up to 10 years ]Number of patients with synovial sarcoma
Biospecimen Retention: Samples With DNA
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Males or females of any age
- Reported diagnosis of synovial sarcoma
- Informed consent from subject (aged ≥18 years) or parent/guardian
Exclusion Criteria:
- Individuals with sarcomas that do not fit the definition of those considered for this registry
- Individuals who are unwilling to participate
- Individuals who are unwilling or unable to provide written consent
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
Contact: Lauren Gutstein | 267-425-2029 | gutsteinl1@chop.edu | |
Contact: James Robinson | 215-590-2053 | robinsonj9@chop.edu |
United States, Pennsylvania | |
Children's Hospital of Philadelphia | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Lauren Gutstein 267-425-2029 gutsteinl1@chop.edu |
Principal Investigator: | Theodore Laetsch, MD | Children's Hospital of Philadelphia |
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. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
registry biorepository sarcoma |
oncology cancer rare tumor |
Sarcoma Sarcoma, Synovial Neoplasms, Connective and Soft Tissue |
Neoplasms by Histologic Type Neoplasms Neoplasms, Connective Tissue |