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

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

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

Study Overview

• Status: Recruiting
• Conditions: Sarcoma
• Intervention / Treatment: Other: Surveys; Other: Blood Collection; Other: Saliva Collection; Other: Urine Collection; Other: Stool Collection; Other: Tissue collection; Other: Physical Activity Monitoring

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 Type: Observational
• Enrollment (Estimated): 2100

Contacts and Locations

• Study Contact: Name: Vanderbilt-Ingram Services for Timely Access; Phone Number: 800-811-8480; Email: cip@vumc.org

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • Vanderbilt University/Ingram Cancer Center
      • Principal Investigator: Debra Friedman, MD
      • Contact: Vanderbilt-Ingram Service for Timely Access; Phone Number: 800-811-8480; Email: cip@vumc.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients at any age with a history of sarcoma, with or without evidence of a persistent disease and parent/caregiver of pediatric patients and siblings of patients 8 years or older

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Vanderbilt-Ingram Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Debra Friedman, MD, Vanderbilt University/Ingram Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2029

Study Registration Dates

• First Submitted: June 12, 2024
• First Submitted That Met QC Criteria: June 25, 2024
• First Posted (Actual): July 1, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2025
• Last Update Submitted That Met QC Criteria: September 15, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Connective and Soft Tissue; Sarcoma; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Health Care Facilities Workforce and Services; Biological Specimen Banks; Health Facilities; Surveys and Questionnaires; Tissue Banks; Blood Specimen Collection; Urine Specimen Collection
• Other Study ID Numbers: VICCPED2222; NCI-2023-00569 (Registry Identifier: NCI, Clinical Trials Reporting Program); 1UG3CA260318-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No