Examining the microbiome in patients with kidney stones and kidney cancer
Evaluating the Bacterial and Fungal Microbiome in Patients With Calcium Oxalate Urolithiasis and Renal Cell Carcinoma.
This study is testing whether the bacteria and fungi in the gut of people with kidney stones or kidney cancer are different from those in healthy individuals to see if there's a connection.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Miami Academic / other |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT04669860 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify the bacterial and fungal microbiome associated with calcium oxalate urolithiasis and renal cell carcinoma. It will involve adult participants who meet specific eligibility criteria, including those with a history of either condition and healthy controls. The study will analyze microbiome samples to explore potential links between these conditions and microbial presence. The findings could provide insights into the role of the microbiome in these diseases.
Who should consider this trial
Good fit: Ideal candidates include adults with calcium oxalate urolithiasis or renal cell carcinoma, as well as healthy controls without a history of these conditions.
Not a fit: Patients with recent urinary tract infections or those unable to consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of the microbiome's role in kidney stones and cancer, potentially leading to new prevention or treatment strategies.
How similar studies have performed: While the specific approach of examining the microbiome in relation to these conditions is relatively novel, similar studies have shown promising results in other areas of research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults that are able to consent (≥ 18 years of age) * No history of asymptomatic bacteriuria or Urinary Tract Infection within the past 1 month * No history of coagulopathy and not on anticoagulant or antiplatelet medication at the time of surgery. * For patients with urolithiasis, must not have a history of RCC * For patients with RCC, must not have a history of urolithiasis * Controls must have no history of stones, RCC, or urinary tract infection (within 1 month). * For all participants, no antimicrobial treatment within the past month Exclusion Criteria: * Adults unable to consent * For patients with urolithiasis, technical difficulty in taking renal papillae biopsy. * History of urinary tract infection within the past 1 month * History of coagulopathy and on anticoagulants or antiplatelets that could not be stopped perioperatively. * Patients with nephrolithiasis and renal tumors with positive preoperative urine cultures- suggesting asymptomatic bacteriuria. * For patients with urolithiasis, a history of RCC * For patients with RCC, a history of urolithiasis * Controls who have a history of stones, RCC, or urinary tract infection. * For all participants, antimicrobial treatment within the past month.
Where this trial is running
Miami, Florida
- University of Miami — Miami, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Hemendra N Shah — University of Miami
- Study coordinator: Hemendra N Shah
- Email: hns35@miami.edu
- Phone: 3052433246
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.