Ignite Creation Date:
2024-07-17 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06482957
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-06-12
Brief Title:
Cohort to Augment the Understanding of Sarcoma Survivorship Across the Lifespan
Sponsor:
Vanderbilt-Ingram Cancer Center
Organization:
Vanderbilt-Ingram Cancer Center
Study Overview
Official Title:
CAUSAL Cohort to Augment the Understanding of Sarcoma Survivorship Across the Lifespan
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAUSAL
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 andor saliva sample collection complete surveys and have medical records reviewed throughout study
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 andor saliva sample collection complete surveys and have medical records reviewed throughout study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2023-00569 | REGISTRY | None | None |
| 1UG3CA260318-01 | NIH | None | None |