Cohort to Augment the Understanding of Sarcoma Survivorship Across the Lifespan
NCT ID: NCT06482957
Last Updated: 2025-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
2100 participants
OBSERVATIONAL
2022-04-01
2029-04-30
Brief Summary
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Detailed Description
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* To evaluate the role of drug metabolism and DNA repair genes via functional polymorphisms, known toxicity associated polymorphisms and genetically predicted gene expression levels, as well as polygenic risk scores, on treatment efficacy, cancer therapy-induced normal tissue toxicity and mortality.
* To identify genomic drivers of sarcoma and to use this information to develop personalized liquid biopsy assays for monitoring treatment response, recurrence, and minimal residual disease (MRD) and mortality.
* Evaluate family functioning, psychosocial wellbeing, and financial toxicity.
OUTLINE: This is an observational study.
Patients monitor physical activity, sedentary behavior, heart rate and sleep wearing a FitBit device, undergo blood urine, stool and/or saliva sample collection, complete surveys and have medical records reviewed throughout study.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Observational
Patients monitor physical activity, sedentary behavior, heart rate and sleep wearing a FitBit device, undergo blood urine, stool and/or saliva sample collection, complete surveys and have medical records reviewed throughout study.
Surveys
Complete surveys
Blood Collection
Undergo blood collection
Saliva Collection
Undergo salvia collection
Urine Collection
Undergo urine collection
Stool Collection
Undergo stool collection
Tissue collection
Undergo tissue collection
Physical Activity Monitoring
FitBit will be worn to track physical activity
Interventions
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Surveys
Complete surveys
Blood Collection
Undergo blood collection
Saliva Collection
Undergo salvia collection
Urine Collection
Undergo urine collection
Stool Collection
Undergo stool collection
Tissue collection
Undergo tissue collection
Physical Activity Monitoring
FitBit will be worn to track physical activity
Eligibility Criteria
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Inclusion Criteria
• For pediatric patients
* Parent/primary caregiver of patient
* Sibling of patient aged 8 years or older
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Vanderbilt-Ingram Cancer Center
OTHER
Responsible Party
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Debra Friedman
Professor of Pediatrics (Pediatric Hematology and Oncology)
Principal Investigators
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Debra Friedman, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University/Ingram Cancer Center
Locations
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Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NCI-2023-00569
Identifier Type: REGISTRY
Identifier Source: secondary_id
VICCPED2222
Identifier Type: -
Identifier Source: org_study_id
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