Cohort to Augment the Understanding of Sarcoma Survivorship Across the Lifespan (CAUSAL)

Vanderbilt University Medical Center

Status: Enrolling

Conditions: Sarcoma

Treatments: Other: Tissue collection; Other: Urine Collection; Other: Physical Activity Monitoring; Other: Saliva Collection; Other: Blood Collection; Other: Surveys; Other: Stool Collection

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT06482957

VICCPED2222

1UG3CA260318-01 (U.S. NIH Grant/Contract)

NCI-2023-00569 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 2,100 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Patients at any age with a history of sarcoma, with or without evidence of a persistent disease

• For pediatric patients

• Parent/primary caregiver of patient
• Sibling of patient aged 8 years or older

Trial design

2,100 participants in 1 patient group

Observational

Description:

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.

Treatment:

Other: Stool Collection

Other: Blood Collection

Other: Surveys

Other: Saliva Collection

Other: Physical Activity Monitoring

Other: Urine Collection

Other: Tissue collection