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Trial Title:
Synovial Sarcoma Registry / Biospecimen Repository
NCT ID:
NCT05910307
Condition:
Synovial Sarcoma
Conditions: Official terms:
Sarcoma
Sarcoma, Synovial
Conditions: Keywords:
registry
biorepository
sarcoma
oncology
cancer
rare tumor
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Other
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.
Criteria for eligibility:
Study pop:
Males and females of any age with a reported diagnoses of synovial sarcoma.
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Children's Hospital of Philadelphia
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lauren Gutstein
Phone:
267-425-2029
Email:
gutsteinl1@chop.edu
Start date:
June 12, 2023
Completion date:
June 2033
Lead sponsor:
Agency:
Children's Hospital of Philadelphia
Agency class:
Other
Source:
Children's Hospital of Philadelphia
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05910307
https://redcap.link/synovialsarcomaregistry
https://redcap.link/synovialregistryconsent
