Clinical trial · Observational
Sarcopenia and NMIBC Prognosis Study
Impact of Body Composition, Sarcopenia, Myosteatosis, and Nutritional Status on Recurrence and Progression in Patients With Non-Muscle-Invasive Bladder Cancer: A Prospective Observational Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this observational study is to evaluate whether body composition abnormalities (sarcopenia, myosteatosis, and obesity) and nutritional status influence the risk of recurrence and progression in adult patients with non-muscle-invasive bladder cancer (NMIBC). The main questions it aims to answer are: Do sarcopenia, myosteatosis, obesity, or malnutrition increase the likelihood of NMIBC recurrence and progression? Can clinical, laboratory, and CT-derived body composition parameters serve as predictive biomarkers that improve individualized risk stratification? Participants will undergo routine clinical and radiologic assessments, including: * completion of the SARC-F and NRS nutritional screening questionnaires * anthropometric measurements (BMI, waist circumference) * laboratory evaluation including serum albumin and testosterone * CT-based assessment of skeletal muscle index (SMI) and muscle density (SMD) * standard TURBT and structured follow-up with cystoscopy, cytology, imaging, and clinical evaluations to document recurrence and progression.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer Cell Transitional | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Altered Body Composition / Nutritional Risk
- description
- Participants with one or more body composition or nutritional abnormalities, including sarcopenia (low skeletal muscle index), myosteatosis (low skeletal muscle density), obesity (elevated BMI or waist circumference), or malnutrition (NRS ≥ 3 or low serum albumin). These participants will undergo standard TURBT and prospective follow-up to evaluate recurrence and progression of NMIBC.
- label
- Normal Body Composition / No Nutritional Risk
- description
- Participants without sarcopenia, myosteatosis, obesity, or malnutrition according to predefined clinical and radiologic criteria. These individuals will also undergo standard TURBT and prospective NMIBC surveillance to allow comparison of recurrence and progression outcomes with the altered body composition group.
Primary outcomes (2)
- measure
- Progression-Free Survival (PFS)
- timeFrame
- Up to 36 months
- description
- Time from TURBT to progression to muscle-invasive bladder cancer (≥ T2) or other defined progression endpoints (CIS emergence, variant histology progression).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adults aged 18 years or older * Histologically confirmed non-muscle-invasive bladder cancer (NMIBC) (Ta, T1, or CIS) * Scheduled for transurethral resection of bladder tumor (TURBT) as part of standard care * Able to undergo CT imaging required for assessment of skeletal muscle index (SMI) and skeletal muscle density (SMD) * Completed preoperative clinical evaluation including: SARC-F, NRS, anthropometric measurements (BMI, waist circumference), serum albumin, and routine laboratory tests * Able and willing to provide written informed consent Exclusion Criteria: * Low-risk NMIBC, as defined by clinical guidelines * Muscle-invasive bladder cancer (≥ T2) at diagnosis * Expected survival less than 3 months * Contraindications to CT imaging (e.g., severe renal dysfunction, contrast allergy if contrast required) * Age under 18 years * Inability or unwillingness to adhere to scheduled follow-up * Any condition that, in the investigator's judgment, would interfere with participation or data integrity
References
Publications (0)
Data not yet available