- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04669860
Evaluating the Bacterial and Fungal Microbiome in Patients With Calcium Oxalate Urolithiasis and Renal Cell Carcinoma
September 11, 2023 updated by: Hemendra Shah, University of Miami
Evaluating the Bacterial and Fungal Microbiome in Patients With Calcium Oxalate Urolithiasis and Renal Cell Carcinoma.
The purpose of the study is to identify bacterial and fungal microbiome associated with calcium oxalate (CO) urolithiasis and renal cell carcinoma (RCC).
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
90
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hemendra N Shah
- Phone Number: 3052433246
- Email: hns35@miami.edu
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33136
- Recruiting
- University of Miami
-
Contact:
- Hemendra N Shah
- Phone Number: 305-243-3246
- Email: hns35@miami.edu
-
Principal Investigator:
- Hemendra N Shah
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
- Healthy participants
- Participants with CO urolithiasis scheduled for endoscopic kidney stone removal surgery.
- Participants with RCC who are scheduled for kidney removal surgery.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Microbial community structure in patients with CO urolithiasis
Time Frame: 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.
|
Day 1
|
Microbial community structure in patients with RCC
Time Frame: 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.
|
Day 1
|
Microbial community structure in healthy participants
Time Frame: Day 1
|
Alpha and beta diversity, principal coordinate analysis, and phylogenetic trees of the bacterial and fungal microbial community from clean-catch urine specimen.
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hemendra N Shah, University of Miami
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 24, 2021
Primary Completion (Estimated)
September 1, 2025
Study Completion (Estimated)
January 1, 2026
Study Registration Dates
First Submitted
December 10, 2020
First Submitted That Met QC Criteria
December 10, 2020
First Posted (Actual)
December 17, 2020
Study Record Updates
Last Update Posted (Actual)
September 13, 2023
Last Update Submitted That Met QC Criteria
September 11, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Kidney Neoplasms
- Pathological Conditions, Anatomical
- Calculi
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Carcinoma, Renal Cell
- Carcinoma
- Urinary Calculi
- Urolithiasis
- Nephrolithiasis
Other Study ID Numbers
- 20200100
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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