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NCT Number: NCT06482957

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.

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Key information

Conditions

Sarcoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37203, United States

Location status: Recruiting

Location contact

Debra Friedman, MD

PRINCIPAL_INVESTIGATOR

Vanderbilt-Ingram Service for Timely Access

CONTACT

[email protected]

800-811-8480

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surveys

Other

Complete surveys

Blood collection

Other

Undergo blood collection

Saliva Collection

Other

Undergo salvia collection

Urine collection

Other

Undergo urine collection

Stool collection

Other

Undergo stool collection

Tissue collection

Other

Undergo tissue collection

Physical activity monitoring

Other

FitBit will be worn to track physical activity

Primary outcomes

  1. Impact of disease on adverse oncologic outcomes

    Time frame: Approximately six years

    Medical record review of Common Terminology Criteria for Adverse Events (CTCAEs)

  2. Impact of treatment on adverse oncologic outcomes

    Time frame: Approximately six years

    Medical record review of Common Terminology Criteria for Adverse Events (CTCAEs)

  3. Impact of sociodemographic contributors on adverse oncologic outcomes

    Time frame: Approximately six years

    Patient-Reported Outcomes Measurement Information System (PROMIS) Scores

  4. Impact of lifestyle contributors on adverse oncologic outcomes

    Time frame: Approximately six years

    Patient-reported outcome

Study contacts

Contact information is provided by the study sponsor or research team.

Vanderbilt-Ingram Services for Timely Access

CONTACT

[email protected]

800-811-8480

Sponsors and collaborators

Lead sponsor

Vanderbilt-Ingram Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Acronym: CAUSAL

Important dates

Study start
2022
Primary completion
2028
Study completion
2029
First posted
Jul 1, 2024
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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