Cohort to Augment the Understanding of Sarcoma Survivorship Across the Lifespan

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06482957

Acronym

CAUSAL

Enrollment

2100

Registered

2024-07-01

Start date

2022-04-01

Completion date

2029-04-30

Last updated

2025-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcoma

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.

Interventions

OTHERSurveys

Complete surveys

OTHERBlood Collection

Undergo blood collection

OTHERSaliva Collection

Undergo salvia collection

OTHERUrine Collection

Undergo urine collection

OTHERStool Collection

Undergo stool collection

OTHERTissue collection

Undergo tissue collection

OTHERPhysical Activity Monitoring

FitBit will be worn to track physical activity

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
Impact of lifestyle contributors on adverse oncologic outcomes	Approximately six years	Patient-reported outcome
Impact of treatment 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
Impact of disease on adverse oncologic outcomes	Approximately six years	Medical record review of Common Terminology Criteria for Adverse Events (CTCAEs)

Countries

United States

Contacts

Primary ContactVanderbilt-Ingram Services for Timely Access

cip@vumc.org800-811-8480

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026