Examining the role of urinary microbiota in bladder cancer among Egyptian men
Profiling Urinary Microbiota in Male Patients With Bladder Cancer- An Exploratory Study.
This study is testing how the bacteria in urine might be linked to bladder cancer in men to help find better ways to prevent and treat the disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 38 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Theodor Bilharz Research Institute Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 2 sites (Cairo, Giza Governorate and 1 other locations) |
| Trial ID | NCT06289270 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the relationship between urinary microbiota and bladder cancer in adult male patients. It will analyze urine and bladder tissue samples from both patients diagnosed with bladder cancer and healthy controls using advanced genomic sequencing techniques, including whole genomic sequencing and 16S rRNA sequencing. The goal is to identify specific microbial profiles that may contribute to the development of bladder cancer, which could lead to improved prevention, diagnosis, and treatment strategies.
Who should consider this trial
Good fit: Ideal candidates for this study are adult men over 18 years old who have been diagnosed with bladder cancer.
Not a fit: Patients who have undergone previous treatments such as radiotherapy or intravesical chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the role of microbiota in bladder cancer, potentially leading to new diagnostic and therapeutic approaches.
How similar studies have performed: While the role of microbiota in various cancers has been explored, this specific approach focusing on bladder cancer in Egyptian men is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Cairo, Giza Governorate and 1 other locations
- Theodor Bilharz Research Institute — Cairo, Giza Governorate, Egypt (Not_yet_recruiting)
- Theodor Bilharz Research Institute — Cairo, Egypt (Recruiting)
Study contacts
- Principal investigator: Mohamed M Wishahi, MD — Theodor Bilharz Research Institute
- Study coordinator: Mohamed M Wishahi, MD
- Email: wishahi@gmx.net
- Phone: +201222247437
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.