SarcomaCAUSALNCT06482957
Cohort to Augment the Understanding of Sarcoma Survivorship Across the Lifespan
An observational study of Sarcoma, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
Trial summary
This study evaluates the impact that a sarcoma diagnosis and treatment have had on patients over time. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Sarcoma
- What is being tested?
- Surveys, Blood Collection and Saliva Collection
- How many people
- 2,100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2022to Apr 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37203
Vanderbilt-Ingram Service for Timely Access, 800-811-8480, cip@vumc.org
Debra Friedman, MD
About this study
Official title: CAUSAL: 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.
Read the 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.
- Conditions
- Sarcoma
- Being tested
- Surveys, Blood Collection, Saliva Collection, Urine Collection, Stool Collection
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveysOther
Complete surveys
Blood CollectionOther
Undergo blood collection
Saliva CollectionOther
Undergo salvia collection
Urine CollectionOther
Undergo urine collection
Stool CollectionOther
Undergo stool collection
Tissue collectionOther
Undergo tissue collection
Physical Activity MonitoringOther
FitBit will be worn to track physical activity
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Surveys; Other: Blood Collection; Other: Saliva Collection; Other: Urine Collection; Other: Stool Collection; Other: Tissue collection; Other: Physical Activity Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of disease on adverse oncologic outcomes
Medical record review of Common Terminology Criteria for Adverse Events (CTCAEs)
Measured: Approximately six years
Impact of treatment on adverse oncologic outcomes
Medical record review of Common Terminology Criteria for Adverse Events (CTCAEs)
Measured: Approximately six years
Impact of sociodemographic contributors on adverse oncologic outcomes
Patient-Reported Outcomes Measurement Information System (PROMIS) Scores
Measured: Approximately six years
Impact of lifestyle contributors on adverse oncologic outcomes
Patient-reported outcome
Measured: Approximately six years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start1 Apr 2022
- Primary completionApr 2028 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Debra Friedman, Vanderbilt-Ingram Cancer Center
- Investigators
- Debra Friedman, MD, Principal investigator, Vanderbilt University/Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06482957
- Sponsor's protocol ID
- VICCPED2222
- Other IDs
- NCI-2023-00569, 1UG3CA260318-01
- Acronym
- CAUSAL
- Status last verified
- Sep 2025
- First submitted
- 12 Jun 2024
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAUSAL: Cohort to Augment the Understanding of Sarcoma Survivorship Across the Lifespan
- ClinicalTrials.gov ID
- NCT06482957
- Acronym / sponsor ID
- CAUSAL / VICCPED2222
- Conditions
- Sarcoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,100 participants (estimated)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 1 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: Surveys, Other: Blood Collection, Other: Saliva Collection, Other: Urine Collection, Other: Stool Collection, Other: Tissue collection, Other: Physical Activity MonitoringPatients 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 may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveysComplete surveys | Other | Observational |
| Blood CollectionUndergo blood collection | Other | Observational |
| Saliva CollectionUndergo salvia collection | Other | Observational |
| Urine CollectionUndergo urine collection | Other | Observational |
| Stool CollectionUndergo stool collection | Other | Observational |
| Tissue collectionUndergo tissue collection | Other | Observational |
| Physical Activity MonitoringFitBit will be worn to track physical activity | Other | Observational |
Primary outcome
Impact of disease on adverse oncologic outcomes
Time frame: Approximately six years
Medical record review of Common Terminology Criteria for Adverse Events (CTCAEs)
Impact of treatment on adverse oncologic outcomes
Time frame: Approximately six years
Medical record review of Common Terminology Criteria for Adverse Events (CTCAEs)
Impact of sociodemographic contributors on adverse oncologic outcomes
Time frame: Approximately six years
Patient-Reported Outcomes Measurement Information System (PROMIS) Scores
Impact of lifestyle contributors on adverse oncologic outcomes
Time frame: Approximately six years
Patient-reported outcome
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Debra Friedman, MD principal investigator
Vanderbilt University/Ingram Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcoma, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vanderbilt-Ingram Services for Timely Access (800-811-8480, cip@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of disease on adverse oncologic outcomes (time frame: Approximately six years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.