Menu
Recruiting NCT06482957

Cohort to Augment the Understanding of Sarcoma Survivorship Across the Lifespan

— Observational Sarcoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Surveys, Blood Collection, Saliva Collection, Urine Collection.
Who it may be relevant to
Registry conditions: Sarcoma. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Impact of disease on adverse oncologic outcomes [Time frame: Approximately six years]
  • Impact of treatment on adverse oncologic outcomes [Time frame: Approximately six years]
  • Impact of sociodemographic contributors on adverse oncologic outcomes [Time frame: Approximately six years]
  • Impact of lifestyle contributors on adverse oncologic outcomes [Time frame: Approximately six years]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Vanderbilt University/Ingram Cancer Center — Nashville

Identifiers

NCT: NCT06482957 · VICCPED2222 · NCI-2023-00569 · 1UG3CA260318-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗