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).

Why the study stopped: lack of funding

Suspended

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Key information

Conditions

Calcium Oxalate Urolithiasis Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Nephrolithiasis, Calcium Oxalate Renal Cell Carcinoma Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Microbial community structure in patients with CO urolithiasis

Time frame: 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

Time frame: 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.
Microbial community structure in healthy participants

Time frame: Day 1

Alpha and beta diversity, principal coordinate analysis, and phylogenetic trees of the bacterial and fungal microbial community from clean-catch urine specimen.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2028
Study completion: 2029
First posted: Dec 17, 2020
Registry last updated: Aug 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed