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

Sponsor

University of Miami (Other)

Overall Status

Recruiting

CT.gov ID

NCT04669860

Collaborator

(none)

Enrollment

Location

34.2

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Calcium Oxalate Urolithiasis Renal Cell Carcinoma

Study Design

Study Type:

Observational

Anticipated Enrollment :

90 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 24, 2021

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.