Bladder Cancer Cell TransitionalSARC-NMIBCNCT07285408
Sarcopenia and NMIBC Prognosis Study
An observational study of Bladder Cancer Cell Transitional, run by General Hospital Sveti Duh.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer Cell Transitional
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 2 Mar 2026to 9 Jul 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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?
Read more
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.
Read the detailed description
Non-muscle-invasive bladder cancer (NMIBC) accounts for approximately 75% of bladder cancer cases and is characterized by a high rate of recurrence and a variable risk of progression. Existing prognostic models, such as EAU and EORTC calculators, incorporate tumor-specific features but do not consider patient-related factors such as body composition or nutritional status. Emerging evidence suggests that sarcopenia, myosteatosis, obesity, and malnutrition may adversely influence oncologic outcomes through mechanisms involving systemic inflammation, impaired immune response, metabolic dysfunction, and reduced physiological reserve. These host-related factors may therefore represent important, yet under-recognized, prognostic biomarkers in NMIBC.
This prospective observational cohort study aims to determine whether clinical and radiologic measures of body composition and nutritional status are associated with the risk of recurrence and progression in patients with NMIBC. Preoperative assessment will include SARC-F screening for sarcopenia, NRS screening for nutritional risk, anthropometric measurements (BMI and waist circumference), serum albumin and testosterone measurement, and CT-based quantification of skeletal muscle index (SMI) and skeletal muscle density (SMD). Tumor-related variables including stage, grade, presence of carcinoma in situ, variant histology, lymphovascular invasion, and tumor size and multiplicity will be abstracted from pathology and clinical records. All participants will undergo standard transurethral resection of bladder tumor (TURBT), and postoperative management will follow guideline-recommended NMIBC surveillance schedules based on individual EAU/EORTC risk stratification.
During follow-up, patients will undergo regular cystoscopic evaluations, urine cytology, serial SARC-F and NRS assessments, anthropometric measurements, albumin monitoring, and periodic CT imaging to reassess SMI and SMD. Recurrence and progression events will be documented according to standard clinical criteria.
By identifying clinically meaningful host-related predictors of recurrence and progression, this study may improve individualized risk stratification, inform tailored surveillance strategies, and highlight the need for early identification and correction of adverse body composition and nutritional states in patients with NMIBC.
- Conditions
- Bladder Cancer Cell Transitional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Up to 36 months
Secondary outcomes (10)
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).
Measured: baseline to 36 months
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
Measured: baseline to 36 months
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)
Measured: baseline to 36 months
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)
Measured: baseline to 36 months
Overall Survival (OS)
Time from TURBT to death from any cause.
Measured: Up to 36 months
Cancer-Specific Survival (CSS)
Time from TURBT to death specifically attributed to bladder cancer.
Measured: Up to 36 months
Impact of Preoperative Skeletal Muscle Index (SMI) on Progression Free Survival (PFS)
Progression-free survival according to skeletal muscle index (SMI) measured on baseline computed tomography (CT) images at L3 level (cm²/m²).
Measured: baseline to 36 months
Impact of Preoperative Skeletal Muscle Density (SMD) on Progression Free Survival (PFS)
Progression-free survival according to skeletal muscle density (SMD) measured in Hounsfield units (HU) on baseline computed tomography (CT) images at L3 level
Measured: baseline to 36 months
Impact of Preoperative Body Mass Index (BMI) on Progression Free Survival (PFS)
Progression-free survival according to body mass index (BMI) measured at the baseline evaluation (kg/m²)
Measured: baseline to 36 months
Impact of Preoperative Nutritional Risk Score (NRS 2002) on Progression Free Survival (PFS)
Progression-free survival according to Nutritional Risk Score (NRS 2002) assesed at the baseline evaluation (expressed in points using the standardized NRS-2002 questionnaire)
Measured: baseline to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start2 Mar 2026 (estimated)
- Primary completion12 Jul 2027 (estimated)
- Study completion9 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder Cancer Cell TransitionalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital Sveti Duh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adelina Hrkac, General Hospital Sveti Duh
- Investigators
- Adelina Hrkac, MD, Principal investigator, Klinička bolnica "Sveti Duh", Zavod za urologiju
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07285408
- Sponsor's protocol ID
- KBSD-2025-03-3556
- Other IDs
- KBSD-URO--2025
- Acronym
- SARC-NMIBC
- Status last verified
- Dec 2025
- First submitted
- 30 Nov 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07285408
- Acronym / sponsor ID
- SARC-NMIBC / KBSD-2025-03-3556
- Conditions
- Bladder Cancer Cell Transitional
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- General Hospital Sveti DuhUniversity, hospital or other
- Study start
- 2 Mar 2026 (estimated)
- Primary completion
- 12 Jul 2027 (estimated)
- Study completion
- 9 Jul 2029 (estimated)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Non-muscle-invasive bladder cancer (NMIBC) accounts for approximately 75% of bladder cancer cases and is characterized by a high rate of recurrence and a variable risk of progression. Existing prognostic models, such as EAU and EORTC calculators, incorporate tumor-specific features but do not consider patient-related factors such as body composition or nutritional status. Emerging evidence suggests that sarcopenia, myosteatosis, obesity, and malnutrition may adversely influence oncologic outcomes through mechanisms involving systemic inflammation, impaired immune response, metabolic dysfunction, and reduced physiological reserve. These host-related factors may therefore represent important, yet under-recognized, prognostic biomarkers in NMIBC.
This prospective observational cohort study aims to determine whether clinical and radiologic measures of body composition and nutritional status are associated with the risk of recurrence and progression in patients with NMIBC. Preoperative assessment will include SARC-F screening for sarcopenia, NRS screening for nutritional risk, anthropometric measurements (BMI and waist circumference), serum albumin and testosterone measurement, and CT-based quantification of skeletal muscle index (SMI) and skeletal muscle density (SMD). Tumor-related variables including stage, grade, presence of carcinoma in situ, variant histology, lymphovascular invasion, and tumor size and multiplicity will be abstracted from pathology and clinical records. All participants will undergo standard transurethral resection of bladder tumor (TURBT), and postoperative management will follow guideline-recommended NMIBC surveillance schedules based on individual EAU/EORTC risk stratification.
During follow-up, patients will undergo regular cystoscopic evaluations, urine cytology, serial SARC-F and NRS assessments, anthropometric measurements, albumin monitoring, and periodic CT imaging to reassess SMI and SMD. Recurrence and progression events will be documented according to standard clinical criteria.
By identifying clinically meaningful host-related predictors of recurrence and progression, this study may improve individualized risk stratification, inform tailored surveillance strategies, and highlight the need for early identification and correction of adverse body composition and nutritional states in patients with NMIBC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression-Free Survival (PFS)
Time frame: Up to 36 months
Time from TURBT to progression to muscle-invasive bladder cancer (≥ T2) or other defined progression endpoints (CIS emergence, variant histology progression).
Recurrence-Free Survival (RFS)
Time frame: Up to 36 months
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.
10 secondary outcomes
Impact of Preoperative Skeletal Muscle Index (SMI) on Recurrence Free Survival (RFS)
Time frame: baseline to 36 months
Impact of Preoperative Skeletal Muscle Density (SMD) on Recurrence Free Survival (RFS)
Time frame: baseline to 36 months
Impact of Preoperative Body Mass Index (BMI) on Recurrence Free Survival (RFS)
Time frame: baseline to 36 months
Impact of Preoperative Nutritional Risk Score (NRS 2002) on Recurrence Free Survival (RFS)
Time frame: baseline to 36 months
Overall Survival (OS)
Time frame: Up to 36 months
Cancer-Specific Survival (CSS)
Time frame: Up to 36 months
Impact of Preoperative Skeletal Muscle Index (SMI) on Progression Free Survival (PFS)
Time frame: baseline to 36 months
Impact of Preoperative Skeletal Muscle Density (SMD) on Progression Free Survival (PFS)
Time frame: baseline to 36 months
Impact of Preoperative Body Mass Index (BMI) on Progression Free Survival (PFS)
Time frame: baseline to 36 months
Impact of Preoperative Nutritional Risk Score (NRS 2002) on Progression Free Survival (PFS)
Time frame: baseline to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adelina Hrkac, MD principal investigator
Klinička bolnica "Sveti Duh", Zavod za urologiju
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer Cell Transitional, run by General Hospital Sveti Duh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adelina Hrkac, MD (+385958146992, adelina.surjan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: Up to 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.