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.

NCT06289270 | Recruiting

• 1 other identifier: Microbiota and bladder cancer
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 2

Brief Summary

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

Microbiota in Patients With Urinary Bladder Carcinoma in Urine and Cancer Tissues

Outcome Measures

Primary Outcomes (1)

• To characterize the microbiota in male patients with bladder cancer.

  Urine and tissue samples from patients will bladder cancer will be examined with next generation sequencing for whole genomic and with 16S rRNA to define the microbiota distribution in cancer patients and in healthy control(Urine sample)-

  2 years

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Bladder cancer: 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.

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Theodor Bilharz Research Institute: lead

Study Sites (2)

Theodor Bilharz Research Institute

Cairo, Giza Governorate, 12411, Egypt

NOT YET RECRUITING

Theodor Bilharz Research Institute

Cairo, 12411, Egypt

RECRUITING

Study Officials

• Mohamed M Wishahi, MD

  Theodor Bilharz Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed M Wishahi, MD

CONTACT

+201222247437; wishahi@gmx.net

Mohamed Wishahi, MD

CONTACT

+491744120184; wishahi@gmx.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Dr

Study Record Dates

• First Submitted: February 25, 2024
• First Posted: March 1, 2024
• Study Start: September 20, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 1, 2024

Record last verified: 2024-02

Locations

EG (2)