NCT06482957

Cohort to Augment the Understanding of Sarcoma Survivorship Across the Lifespan

CAUSAL: Cohort to Augment the Understanding of Sarcoma Survivorship Across the Lifespan

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,100 (estimated)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

This study evaluates the impact that a sarcoma diagnosis and treatment have had on patients over time.

Detailed description

* To evaluate the incidence and prevalence and the impact of disease, treatment, sociodemographic and lifestyle contributors on adverse oncologic outcomes (lack of response, recurrence) and non- oncologic outcomes (physical and psychosocial function, financial toxicity, short and long-term organ toxicity) and mortality in the cohort. * 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

• Sarcoma

Interventions

Type	Name	Description
OTHER	Surveys	Complete surveys
OTHER	Blood Collection	Undergo blood collection
OTHER	Saliva Collection	Undergo salvia collection
OTHER	Urine Collection	Undergo urine collection
OTHER	Stool Collection	Undergo stool collection
OTHER	Tissue collection	Undergo tissue collection
OTHER	Physical Activity Monitoring	FitBit will be worn to track physical activity

Timeline

• Start date: 2022-04-01
• Primary completion: 2028-04-01
• Completion: 2029-04-01
• First posted: 2024-07-01
• Last updated: 2025-09-19

Locations

1 site across 1 country: United States