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

Recruiting

• Conditions: Renal Cell Carcinoma; Calcium Oxalate Urolithiasis

• Registration Number: NCT04669860
• Lead Sponsor: University of Miami

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-10
• Study First Submitted QC: 2020-12-10
• Study First Posted: 2020-12-17
• Study Start: 2021-02-24
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-11
• Last Update Posted: 2023-09-13
• Primary Completion: 2025-09-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Microbial community structure in healthy participants	Day 1	Alpha and beta diversity, principal coordinate analysis, and phylogenetic trees of the bacterial and fungal microbial community from clean-catch urine specimen.
Microbial community structure in patients with CO urolithiasis	Day 1	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.
Microbial community structure in patients with RCC	Day 1	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.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States