Cohort to Augment the Understanding of Sarcoma Survivorship Across the Lifespan

NCT ID: NCT06482957

Last Updated: 2025-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-01

Study Completion Date

2029-04-30

Brief Summary

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

Detailed Description

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* 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.

Conditions

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Sarcoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Surveys

Intervention Type OTHER

Complete surveys

Blood Collection

Intervention Type OTHER

Undergo blood collection

Saliva Collection

Intervention Type OTHER

Undergo salvia collection

Urine Collection

Intervention Type OTHER

Undergo urine collection

Stool Collection

Intervention Type OTHER

Undergo stool collection

Tissue collection

Intervention Type OTHER

Undergo tissue collection

Physical Activity Monitoring

Intervention Type OTHER

FitBit will be worn to track physical activity

Interventions

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Surveys

Complete surveys

Intervention Type OTHER

Blood Collection

Undergo blood collection

Intervention Type OTHER

Saliva Collection

Undergo salvia collection

Intervention Type OTHER

Urine Collection

Undergo urine collection

Intervention Type OTHER

Stool Collection

Undergo stool collection

Intervention Type OTHER

Tissue collection

Undergo tissue collection

Intervention Type OTHER

Physical Activity Monitoring

FitBit will be worn to track physical activity

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Vanderbilt-Ingram Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Debra Friedman

Professor of Pediatrics (Pediatric Hematology and Oncology)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Debra Friedman, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University/Ingram Cancer Center

Locations

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Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Vanderbilt-Ingram Services for Timely Access

Role: CONTACT

800-811-8480

Facility Contacts

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Vanderbilt-Ingram Service for Timely Access

Role: primary

800-811-8480

Other Identifiers

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NCI-2023-00569

Identifier Type: REGISTRY

Identifier Source: secondary_id

1UG3CA260318-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

VICCPED2222

Identifier Type: -

Identifier Source: org_study_id

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