Health TrialsbyHealthPanel

Sarcopenia and NMIBC Prognosis Study

ConditionBladder Cancer Cell Transitional
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGeneral Hospital Sveti Duh

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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)

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

150 Participants
are grouped into 2 trial groups
Group A: Altered Body Composition / Nutritional Risk
Group B: Normal Body Composition / No Nutritional Risk

Trial outcomes

Primary outcomes

1

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).

Time frame
Up to 36 months
2

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.

Time frame
Up to 36 months

Secondary outcomes

1

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

Recurrence-free survival according to skeletal muscle index (SMI) measured on baseline computed tomography (CT) images at L3 level (cm²/m²).

Time frame
baseline to 36 months
2

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

Recurrence-free survival according to skeletal muscle density (SMD) measured in Hounsfield units (HU) on baseline computed tomography (CT) images at L3 level

Time frame
baseline to 36 months
3

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

Recurrence-free survival according to body mass index (BMI) measured at the baseline evaluation (kg/m²)

Time frame
baseline to 36 months
4

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

Recurrence-free survival according to Nutritional Risk Score (NRS 2002) assesed at the baseline evaluation (expressed in points using the standardized NRS-2002 questionnaire)

Time frame
baseline to 36 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

General Hospital Sveti Duh

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: