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

University of Miami

Status: Suspended

Conditions: Calcium Oxalate Urolithiasis; Renal Cell Carcinoma

Study type: Observational

Funder types: Other

Identifiers

NCT04669860

20200100

Details and patient eligibility

About

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

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

90 participants in 3 patient groups

calcium oxalate urolithiasis group

Description:

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

Description:

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

Description:

The participants will provide a clean-catch voided midstream urine sample to identify bacterial and fungal microbiome.