"Regina Elena" National Cancer Institute
Rome, 00144, Italy
Location status: Recruiting
Location contact
Giuseppe Simone, Doctor
CONTACT
06-5266.5005 ext. +39
Riccardo Mastroianni, Doctor
CONTACT
06-5266.5005 ext. +39
NCT Number: NCT06992986
The study aims to investigate alterations in the bladder microbiome in adult men with bladder cancer, healthy men, and men with benign urinary disease
Interested in participating?
Request Info50 year–70 year
Male
Observational
Rome, 00144, Italy
Location status: Recruiting
Giuseppe Simone, Doctor
CONTACT
06-5266.5005 ext. +39
Riccardo Mastroianni, Doctor
CONTACT
06-5266.5005 ext. +39
The presence of diverse bacterial representations characterizes a healthy microbiome in both men and women. Differences in bacterial diversity and richness have been observed in subjects with bladder cancer. Investigating the complex relationship between the urinary microbiome and bladder cancer is imperative and requires extensive exploration. The urinary microbiome in patients with bladder cancer has shown high variability in results between studies.
These differences may suggest an interaction with bladder tissue and a potential association; however, it is still unclear whether this association precedes or follows bladder cancer. Regarding phylum-level representations, an abundance of Proteobacteria and Corynebacterium, and a decreased abundance of the genera Ruminococcus and Bifidobacterium have been identified in patients with bladder cancer. The latter two are considered anti-inflammatory bacteria important for mucosal homeostasis. Furthermore, with regard to tumor grade, an increase in Veillonella has been reported in pTa/T1Hg, CIS and T2 tumors; Corynebacterium and Staphylococcus are increased in high-grade NMIBC and low-grade pTa tumors, respectively.
The study aims to investigate possible differences in bacterial representations in patients with bladder cancer, patients with benign urinary diseases and healthy subjects.
Furthermore, possible variations in bacterial profiles in patients with bladder cancer based on tumor stage will be investigated.
differences in bacterial representations in patients with bladder cancer, patients with benign urinary diseases and healthy subjects. In addition to possible variations in bacterial profiles in patients with bladder cancer based on tumor stage.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(Bladder Cancer Patients):
Exclusion criteria
Inclusion criteria
Controls No-Pathologic/Healthy):
Exclusion criteria
Inclusion criteria
(Benign Urinary Disease)
-To ensure that alterations in the microbiome observed in bladder cancer patients are unique to this condition, an additional group with benign urinary diseases will be included in the analysis. This group will encompass individuals with renal cysts, benign prostatic obstruction, ureteropelvic or ureteral obstruction undergoing surgical therapy.
Exclusion criteria
Urine samples and tissue from radical cystectomy specimens will be analyzed for the assessment of the urinary microbiome.
The 16s rRNA gene will be amplified and the resulting amplicons analyzed by Illumina sequencing. To distinguish contaminants, DNA from the sample will be quantified by qPCR and compared to a known urine sample of E. coli. DNA will be extracted using the Quiagen kit and stored at -20 °C until PCR amplification. Bacterial DNA will be amplified with specific primers covering the V1-V3 hypervariable region of the 16S rRNA gene. Libraries will be prepared using the Illumina 16S microbiome sequencing protocol, and their quality will be verified by Bioanalyzer and quantity by qPCR. Sequencing will be performed in "paired-end" mode on Illumina sequencers. Alpha, beta diversity and species richness will be measured.
Time frame: 36 months
To investigate differences in the bladder microbiome in men with bladder cancer, healthy men, and men with benign urinary disease. The study involves collecting urine using a mid-stream clean-catch technique.
Subsequent DNA extraction, sequencing, and identification will allow the study of the bacteria within the samples. In this way, variations in bacterial profiles between patients will be measured.
Contact information is provided by the study sponsor or research team.
Regina Elena Cancer Institute
Other
Urinary Microbiome Differences in Bladder Cancer, Benign Urinary Diseases and Healthy Counterpars Adult Male Population: a Pilot Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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