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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.

Status
Suspended
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04669860
Enrollment
90
Registered
2020-12-17
Start date
2021-02-24
Completion date
2029-01-01
Last updated
2026-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Calcium Oxalate Urolithiasis, Renal Cell Carcinoma

Keywords

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

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).

Interventions

None listed

Sponsors

University of Miami
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Microbial community structure in patients with CO urolithiasisDay 1Alpha 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 RCCDay 1Alpha 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 participantsDay 1Alpha and beta diversity, principal coordinate analysis, and phylogenetic trees of the bacterial and fungal microbial community from clean-catch urine specimen.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORHemendra N Shah

University of Miami

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 28, 2026