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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2026-00124 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| R03AG095803 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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This study evaluates how the treatment for gastroesophageal cancer affects physical function in patients who receive chemotherapy as part of their treatment for gastroesophageal cancer.
PRIMARY OBJECTIVE:
I. To determine the change in physical function from baseline to 6 months of treatment, as measured by the short physical performance battery (SPPB).
OUTLINE: This is an observational study.
Patients undergo blood sample collection as well as complete surveys, physical function tests and may complete an interview on study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational | Patients undergo blood sample collection as well as complete surveys, physical function tests and may complete an interview on study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Interventional Study | Other | Non-interventional study |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in SPPB | Will characterize the levels of function at each time point and longitudinal changes in function using descriptive statistics (means, SDs, change scores) in the overall patient sample and by pre-treatment/treatment variables. To assess the associations between pre-treatment/treatment variables and change in function, we will use linear regression models with SPPB change score from baseline to 6 months as the dependent variable and pre-treatment demographic, clinical, and geriatric assessment characteristics as the predictor variables, controlling for the patient's pre-treatment level of function. Potential predictors will be examined individually and in a parsimonious multivariable model. We will also fit linear mixed models for each outcome variable using measurements at all time points and examine differences in change over time by pre-treatment/treatment variables using interaction terms. Time will be treated as a categorical variable, using indicator variables of time. | Through the end of cancer treatment, an average of 6 months |
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Inclusion Criteria:
* Adults ≥ 18 years old at the start of study treatment.
Exclusion Criteria:
* Patients with stage I disease with plans to undergo endoscopic resection or surgery alone without perioperative systemic therapy.
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Patients with early stage esophageal, gastroesophageal junction, or gastric cancer who plan to start systemic therapy.
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| Name | Affiliation | Role |
|---|---|---|
| Jingran Ji | UCLA / Jonsson Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA / Jonsson Comprehensive Cancer Center | Los Angeles | California | 90095 | United States |
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