Cohort to Augment the Understanding of Sarcoma Survivorship Across the Lifespan

Recruiting

• Conditions: Sarcoma
• Interventions: Other: Surveys; Other: Blood Collection; Other: Saliva Collection; Other: Urine Collection; Other: Stool Collection; Other: Tissue collection; Other: Physical Activity Monitoring

• Registration Number: NCT06482957
• Lead Sponsor: Vanderbilt-Ingram Cancer Center

Brief 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.

Study Timeline

• Study Start: 2022-04-01
• Status Verified: 2024-06
• Study First Submitted: 2024-06-12
• Study First Submitted QC: 2024-06-25
• Last Update Submitted: 2024-06-25
• Study First Posted: 2024-07-01
• Last Update Posted: 2024-07-01
• Primary Completion: 2028-04
• Study Completion: 2029-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational	Saliva Collection	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.
Observational	Surveys	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.
Observational	Blood Collection	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.
Observational	Urine Collection	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.
Observational	Stool Collection	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.
Observational	Physical Activity Monitoring	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.
Observational	Tissue collection	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.

Primary Outcome Measures

Name	Time	Method
Impact of treatment on adverse oncologic outcomes	Approximately six years	Medical record review of Common Terminology Criteria for Adverse Events (CTCAEs)
Impact of lifestyle contributors on adverse oncologic outcomes	Approximately six years	Patient-reported outcome
Impact of disease on adverse oncologic outcomes	Approximately six years	Medical record review of Common Terminology Criteria for Adverse Events (CTCAEs)
Impact of sociodemographic contributors on adverse oncologic outcomes	Approximately six years	Patient-Reported Outcomes Measurement Information System (PROMIS) Scores

Trial Locations

Locations (1)

Vanderbilt University/Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States