Status:
SUSPENDED
Evaluating the Bacterial and Fungal Microbiome in Patients With Calcium Oxalate Urolithiasis and Renal Cell Carcinoma
Lead Sponsor:
University of Miami
Conditions:
Calcium Oxalate Urolithiasis
Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
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).
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 24 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04669860
Start Date
February 24 2021
End Date
January 1 2028
Last Update
September 8 2025
Active Locations (1)
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1
University of Miami
Miami, Florida, United States, 33136