Evaluating the Bacterial and Fungal Microbiome in Patients With Calcium Oxalate Urolithiasis and Renal Cell Carcinoma

Study Overview
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Brief Summary
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The purpose of the study is to identify bacterial and fungal microbiome associated with calcium oxalate (CO) urolithiasis and renal cell carcinoma (RCC).

Official Title
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Evaluating the Bacterial and Fungal Microbiome in Patients With Calcium Oxalate Urolithiasis and Renal Cell Carcinoma.

Conditions
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Calcium Oxalate Urolithiasis, Renal Cell Carcinoma

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| calcium oxalate urolithiasis group<br>Participants with CO urolithiasis scheduled for definitive endoscopic stone removal will be evaluated to identify bacterial and fungal microbiome in mid-stream voided urine sample, urine sample collected from the bladder, kidney stone fragment, and a renal papillae biopsy specimen. | |
| renal cell carcinoma group<br>Participants with RCC scheduled for definitive kidney removal surgery will be evaluated to identify bacterial and fungal microbiome in a catheterized urine specimen from the bladder, a biopsy of the tumor, and a biopsy of normal-appearing renal papillae specimen. | |
| healthy control group<br>The participants will provide a clean-catch voided midstream urine sample to identify bacterial and fungal microbiome. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbial community structure in patients with CO urolithiasis | Alpha and beta diversity, principal coordinate analysis, and phylogenetic trees of the bacterial and fungal microbial community from mid-stream voided urine sample, urine sample collected from the bladder, kidney stone fragment, and a renal papillae biopsy specimen. | Day 1 | 
| Microbial community structure in patients with RCC | Alpha and beta diversity, principal coordinate analysis, and phylogenetic trees of the bacterial and fungal microbial community from catheterized urine specimen from the bladder, a biopsy of the tumor, and a biopsy of normal-appearing renal papillae specimen. | Day 1 | 
| Microbial community structure in healthy participants | Alpha and beta diversity, principal coordinate analysis, and phylogenetic trees of the bacterial and fungal microbial community from clean-catch urine specimen. | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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calcium oxalate stones, renal cell carcinoma, microbiome, urinary microbiome