Not Yet RecruitingNot Applicable

Sarcopenia and NMIBC Prognosis Study

150 participantsStarted 2026-03-02

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Progression-Free Survival (PFS)

Timeframe: Up to 36 months

Recurrence-Free Survival (RFS)

Timeframe: Up to 36 months

Trial details

NCT IDNCT07285408

SponsorGeneral Hospital Sveti Duh

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-07-12

Contact for this trial

Adelina Hrkac, MD

+385958146992 adelina.surjan@gmail.com