Studies germs in urine and bladder tissue of men with bladder cancer
Compares urinary germs and bladder tissue in men with bladder cancer and healthy men.
Key facts
- Who runs it
- Theodor Bilharz Research Institute
- Where
- Cairo, EgyptSee the site
- Trial code
- Registry title
- Microbiota in Urine and Urothelium Can be a Factor for Induction of Urinary Bladder Cancer. The Study Will Examine Urine and Bladder Tissues From Egyptian Male Patients and Controls Using Whole Genomic Sequencing Techniques and 16S rRNA. The Aim is to Elucidate Role of Microbiota in Bladder Cancer.
- Status
- Recruiting
- People taking part
- 38 people, planned
- Started
- 20 Sept 2023
- Expected to end
- Jul 2027
- Type of study
- Observational
- Record updated
- 1 March 2024
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adult men with confirmed bladder cancer. Urine and bladder tissue will be studied for microbes (the bacteria living in the urinary tract).
- Age
- 18 years and older
- Sex
- Men only
- Disease stage
- Bladder cancer (carcinoma of the bladder) found on ultrasound and/or CT scan and urine cytology, and confirmed at cystoscopy, in earlier pathology, or in a biopsy sample.
- Earlier treatment
- Must not have had radiotherapy to the bladder or nearby organs, BCG or chemotherapy instilled into the bladder, or chemotherapy before surgery (neoadjuvant chemotherapy).
Main reasons for not taking part
- Previous radiotherapy to the bladder or an adjacent organ
- Previous BCG immunotherapy instilled into the bladder
- Previous chemotherapy instilled into the bladder
- Previous neoadjuvant chemotherapy
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- 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
Who cannot take part
- - 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
Where in Egypt
- Theodor Bilharz Research InstituteCairo, EgyptContact: Mohamed M Wishahi, MDNot yet recruiting
About the trial
What the trial wants to find out
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.
The group in the trial
- 1-muscle invasive bladder cancer., 2-Non-muscle invasive invasive. 3- Control.
Samples: Total number of studied 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). 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 (1 samble). 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 participants is 38 individuals.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Profiling Urinary Microbiota in Male Patients With Bladder Cancer- An Exploratory Study.
- Plain-language title
- Studies germs in urine and bladder tissue of men with bladder cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 1 March 2024