NCT06482957

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,100

participants targeted

Target at P75+ for all trials

Timeline
35mo left

Started Apr 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
Apr 2022Apr 2029

Study Start

First participant enrolled

April 1, 2022

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 1, 2024

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2029

Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

6 years

First QC Date

June 12, 2024

Last Update Submit

September 15, 2025

Conditions

Sarcoma

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (1)

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: SurveysOther: Blood CollectionOther: Saliva CollectionOther: Urine CollectionOther: Stool CollectionOther: Tissue collectionOther: Physical Activity Monitoring

Interventions

SurveysOTHER

Complete surveys

Observational
Blood CollectionOTHER

Undergo blood collection

Observational
Saliva CollectionOTHER

Undergo salvia collection

Observational
Urine CollectionOTHER

Undergo urine collection

Observational
Stool CollectionOTHER

Undergo stool collection

Observational
Tissue collectionOTHER

Undergo tissue collection

Observational
Physical Activity MonitoringOTHER

FitBit will be worn to track physical activity

Observational

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37203, United States

RECRUITING

MeSH Terms

Conditions

Sarcoma

Interventions

Surveys and QuestionnairesBlood Specimen CollectionUrine Specimen CollectionTissue Banks

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeBiological Specimen BanksHealth FacilitiesHealth Care Facilities Workforce and Services

Study Officials

  • Debra Friedman, MD

    Vanderbilt University/Ingram Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vanderbilt-Ingram Services for Timely Access

CONTACT

800-811-8480cip@vumc.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics (Pediatric Hematology and Oncology)

Study Record Dates

First Submitted

June 12, 2024

First Posted

July 1, 2024

Study Start

April 1, 2022

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2029

Last Updated

September 19, 2025

Record last verified: 2025-09

Locations

US(1)