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

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

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

Study Overview

• Status: Suspended
• Conditions: Renal Cell Carcinoma; Calcium Oxalate Urolithiasis

• Study Type: Observational
• Enrollment (Estimated): 90

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

1. Healthy participants
2. Participants with CO urolithiasis scheduled for endoscopic kidney stone removal surgery.
3. Participants with RCC who are scheduled for kidney removal surgery.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
calcium oxalate urolithiasis group; 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; 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; The participants will provide a clean-catch voided midstream urine sample to identify bacterial and fungal microbiome.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Hemendra N Shah, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2021
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: December 10, 2020
• First Submitted That Met QC Criteria: December 10, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Actual): August 27, 2026
• Last Update Submitted That Met QC Criteria: August 25, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: microbiome; renal cell carcinoma; calcium oxalate stones; urinary microbiome
• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Urologic Neoplasms; Carcinoma; Kidney Neoplasms; Carcinoma, Renal Cell; Nephrolithiasis, Calcium Oxalate
• Other Study ID Numbers: 20200100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No