An observational study in Bladder Cancer, sponsored by University of Kansas Medical Center. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-20.
Sponsored by University of Kansas Medical Center · Observational
This study is being done to learn more about energy needs and muscle function during treatment for bladder cancer. These insights can help improve future patient care. The study team found in a previous study that resting energy can be different than what estimates show. Patients with bladder cancer are known to suffer a decline in physical resilience over time. Monitoring patients to understand these changes better could help design future treatments with these vulnerabilities in mind.
The investigators' long-term goal is to improve cachexia treatment for patients with cancer. The project is significant because identifying cachexia earlier in its onset allows for earlier and more successful treatment. Major barriers to early detection and treatment are: 1) clear specific lab tests to confirm the diagnosis and 2) identifying when resting energy expenditure (REE) increases. It is the investigators' expectation that at the completion of these descriptive studies, key factors will be identified to guide earlier detection and treatment of cachexia. Platinum-based chemotherapy and surgery are a dual-phase treatment regimen to treat bladder cancer that has a high risk of worsening cachexia compared to other cancer types not requiring such an intensive treatment regimen. Inhibition of Growth differentiation factor 15 (GDF-15) is a promising preventive strategy against cachexia in patients with bladder cancer. Understanding GDF-15 and REE changes over the course of treatment could inform proactive rather than reactive strategies to support the health of these patients and translate to patients with other types of cancer. The objective of this application is to assess changes in GDF-15 and REE levels during the treatment course for advanced bladder cancer.
1,798 studies on the registry are indexed under Urinary Bladder Neoplasms; 445 are open to participants now.
This study's planned enrollment of 30 is below the median of 200 across 410 observational studies indexed under Urinary Bladder Neoplasms.
Browse Urinary Bladder Neoplasms studies →University of Kansas Medical Center is the lead sponsor of 492 studies on the registry; 110 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 24 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Potential patients will be scheduled for treatment (chemotherapy and radical cystectomy) for bladder cancer at the University of Kansas Health System.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
To assess Resting Energy Expenditure (REE) changes across key treatment milestones.
Resting Energy Expenditure (REE) will be measured using indirect calorimetry before and after chemotherapy and radical cystectomy and will be associated with clinical outcomes.
Time frame: From enrollment, prior to chemotherapy, to 3 weeks after radical cystectomy.
Blood biomarkers
Blood will be collected at study visits and growth differentiation factor-15 (GDF-15) concentration will be evaluated.
Time frame: From enrollment, prior to chemotherapy, to 3 weeks after radical cystectomy.
Inflammation marker
Blood will be collected at study visits and Interleukin-6 (IL-6) concentration will be evaluated.
Time frame: From enrollment, prior to chemotherapy, to 3 weeks after radical cystectomy.
Immune inflammation marker
Blood will be collected at study visits and tumor necrosis factor alpha (TNFa) concentration will be evaluated.
Time frame: From enrollment, prior to chemotherapy, to 3 weeks after radical cystectomy.
Body composition
Changes in muscle and fat mass will be assessed using dual-energy X-ray (DXA) at study visits.
Time frame: From enrollment, prior to chemotherapy, to 3 weeks after radical cystectomy.
Nutrition assessment
The Patient-Generated Subjective Global Assessment (PG-SGA) and 24-hour dietary recalls will be administered in an interview format by trained study personnel. These will take place at study visits.
Time frame: From enrollment, prior to chemotherapy, to 3 weeks after radical cystectomy.
Grip strength measurement
A hand dynamometer will be used to measure grip strength at study visits.
Time frame: From enrollment, prior to chemotherapy, to 3 weeks after radical cystectomy.
Quality of Life (QOL) and Fatigue assessment
FACIT-Fatigue questionnaires will be administered to evaluate changes in health-related quality of life (HRQOL) at study visits.
Time frame: From enrollment, prior to chemotherapy, to 3 weeks after radical cystectomy.
Quality of Life (QOL) during bladder cancer treatment assessment
FACT-Bl-Cys questionnaires will be administered to evaluate changes in health-related quality of life (HRQOL) at study visits.
Time frame: From enrollment, prior to chemotherapy, to 3 weeks after radical cystectomy.
Started Jan 2025 (actual). Primary completion is estimated for Jan 2027, 24 months after the start.
Of 167 non-industry observational studies under Urinary Bladder Neoplasms, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 30. This study's planned 24 months is below that.
Counting every sponsor, half of 202 studies reached it within 60 months; a quarter within 32.
How these figures are worked out, and which studies are left out of them.
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