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

Renal Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04669860
• Other study ID #: 20200100
• Status: Recruiting
• Start date: February 24, 2021
• Est. completion date: January 1, 2026

Study information

• Verified date: September 2023
• Source: University of Miami
• Contact: Hemendra N Shah
• Phone: 3052433246
• Email: hns35[@]miami.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: January 1, 2026
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Calcium Oxalate Urolithiasis
• Carcinoma
• Carcinoma, Renal Cell
• Nephrolithiasis
• Renal Cell Carcinoma
• Urinary Calculi
• Urolithiasis

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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