Sarcopenia and NMIBC Prognosis Study

NCT07285408 | Not Yet Recruiting

• 2 other identifiers: KBSD-2025-03-3556KBSD-URO--2025
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Bladder Cancer Cell Transitional

Outcome Measures

Primary Outcomes (2)

• Progression-Free Survival (PFS)

  Time from TURBT to progression to muscle-invasive bladder cancer (≥ T2) or other defined progression endpoints (CIS emergence, variant histology progression).

  Up to 36 months

• Recurrence-Free Survival (RFS)

  Time from transurethral resection of bladder tumor (TURBT) to the first documented recurrence of non-muscle-invasive bladder cancer, confirmed by cystoscopy, urine cytology, or pathology.

  Up to 36 months

Secondary Outcomes (10)

• Impact of Preoperative Skeletal Muscle Index (SMI) on Recurrence Free Survival (RFS)

  baseline to 36 months

• Impact of Preoperative Skeletal Muscle Density (SMD) on Recurrence Free Survival (RFS)

  baseline to 36 months

• Impact of Preoperative Body Mass Index (BMI) on Recurrence Free Survival (RFS)

  baseline to 36 months

• Impact of Preoperative Nutritional Risk Score (NRS 2002) on Recurrence Free Survival (RFS)

  baseline to 36 months

• Overall Survival (OS)

  Up to 36 months

Study Arms (2)

Altered Body Composition / Nutritional Risk

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.

Normal Body Composition / No Nutritional Risk

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients diagnosed with non-muscle-invasive bladder cancer (NMIBC) undergoing transurethral resection of bladder tumor (TURBT) and guideline-based surveillance at a tertiary urology center. The study population includes individuals with and without body composition and nutritional abnormalities (sarcopenia, myosteatosis, obesity, or malnutrition) who meet eligibility criteria and consent to participate.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• General Hospital Sveti Duh: lead

Study Officials

• Adelina Hrkac, MD

  Klinička bolnica "Sveti Duh", Zavod za urologiju

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adelina Hrkac, MD

CONTACT

+385958146992; adelina.surjan@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, FEBU

Study Record Dates

• First Submitted: November 30, 2025
• First Posted: December 16, 2025
• Study Start: March 2, 2026
• Primary Completion (Estimated): July 12, 2027
• Study Completion (Estimated): July 9, 2029
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share