Clinical trial · Observational
Microbiota in Urine and Urothelium Can be a Factor for Induction of Urinary Bladder Cancer. The Study Will Examine Urine and Bladder Cancer Tissues From Male Patients and Urine of Controls Using Whole Genomic Sequencing Techniques and 16S rRNA. The Aim is to Elucidate Role of Microbiota in Bladder
Profiling Urinary Microbiota In Male Patients With Bladder Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Microbes inhabiting the urinary tract that are playing an important role in maintenance of health and the development of diseases and bladder cancer. There is correlation between initiation of bladder cancer and microbes. Urine and bladder tissues from healthy individuals and patients with bladder cancer were analyzed using 16S rRNA sequencing, results show abundant phylum. Next-generation sequencing technologies will be applied with whole genomic and 16S ribosomal RNA gene sequencing for microbiota profiling in urine and bladder tissue of male healthy individuals and patients with bladder cancer. Results will lead to prevention, diagnosis and new treatment strategies for bladder cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Microtia | — | UNRESOLVED | — |
| Urinary Bladder Neoplasms | Bladder Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Urine samples and tissue samples: Samples will be collected in clean leak-proof containers without disinfectant or detergent residue and with tight-fitting leak-proof lids and preserved in a refrigera | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Bladder carcinoma of non muscle invasive bladder cancer and muscle invasive bladder cancer.
- description
- Group I: Non-muscle invasive bladder cancer,16 patients, 16 for bladder tissue, and 16 for urine samples. Total 32 samples. (The study will explore the microbiota in urine and in tissue samples, so every patient with bladder cancer will give (2 samples). The control group will give urine sample ( one samble). Recent research showed that microbiota is detecred in the urothelium of normal undividuals and patients with bladder cancer, this microbiota would differ from urine( liquid) microbiota.(References: ) Group II: Muscle invasive bladder cancer, 11 patients. 22 samples 11 for bladder tissue and 11 for urine samples obtained from the same patients. Group III: 11 Normal adults: urine samples from serves as control group of the study. Total number of participant is 38 individual
- interventionNames
- Other: Urine samples and tissue samples: Samples will be collected in clean leak-proof containers without disinfectant or detergent residue and with tight-fitting leak-proof lids and preserved in a refrigera
Primary outcomes (1)
- measure
- To characterize the microbiota in health and bladder cancer, and may lead to new prevention, diagnosis and treatment strategies for bladder cancer
- timeFrame
- Sample sollection 12 months, next generation sequencing ind bioinformatics 6 months, interpretation of data 6 months.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult men above 18 years, * Diagnosed of carcinoma of the bladder with imaging ultrasonography and/ or computerized tomography, and urine cytology. * Confirmed bladder cancer either during diagnostic cystoscopy, previous pathology, or pathological examination of the biopsy specimens. Exclusion criteria: * Previous radiotherapy to the bladder or to adjacent organ. * Previous intravesical instillation immunotherapy with bacillus Calmette-Guérin (BCG), or intravesical instillation of chemotherapeutics. * Previous neoadjuvant chemotherapy.
References
Publications (1)
- BACKGROUNDWhiteside SA, Razvi H, Dave S, Reid G, Burton JP. The microbiome of the urinary tract--a role beyond infection. Nat Rev Urol. 2015 Feb;12(2):81-90. doi: 10.1038/nrurol.2014.361. Epub 2015 Jan 20. PMID 25600098