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

NCT04669860 | Suspended

• 1 other identifier: 20200100
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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).

Conditions

Calcium Oxalate Urolithiasis; Renal Cell Carcinoma

Keywords

calcium oxalate stones; renal cell carcinoma; microbiome; urinary microbiome

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

the microbiome of voided urine, bladder urine, stone fragments, and tissue from renal papillary biopsies in patients with CO stones. The microbiome of urine from the bladder, tissue from the renal tumor, and tissue from surrounding healthy renal tissue in patients with RCC Voided urine sample from healthy volunteers.

MeSH Terms

Conditions

Nephrolithiasis, Calcium Oxalate; Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Hemendra N Shah

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of clinical Urology

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: December 17, 2020
• Study Start: February 24, 2021
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)