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NCT04669860 | RECRUITING | Calcium Oxalate Urolithiasis

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

University of Miami

Information provided by (Responsible Party):

Hemendra Shah

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

Calcium Oxalate Urolithiasis

Renal Cell Carcinoma

Study Type : OBSERVATIONAL
Estimated Enrollment : 90 participants
Official Title : Evaluating the Bacterial and Fungal Microbiome in Patients With Calcium Oxalate Urolithiasis and Renal Cell Carcinoma.
Actual Study Start Date : 2021-02-24
Estimated Primary Completion Date : 2026-09-01
Estimated Study Completion Date : 2027-01-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
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.
Evaluating the Bacterial and Fungal Microbiome in Patients With Calcium Oxalate Urolithiasis and Renal Cell Carcinoma

Location Details

NCT04669860

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Locations

RECRUITING

United States, Florida

University of Miami

Miami, Florida, United States, 33136