Sarcopenia and NMIBC Prognosis Study (NCT07285408) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.