Calcium Oxalate UrolithiasisNCT04669860
Evaluating the Bacterial and Fungal Microbiome in Patients With Calcium Oxalate Urolithiasis and Renal Cell Carcinoma
An observational study of Calcium Oxalate Urolithiasis and Renal Cell Carcinoma, run by University of Miami at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Calcium Oxalate Urolithiasis, Renal Cell Carcinoma
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2021to 1 Jan 2029
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. Healthy participants 2. Participants with CO urolithiasis scheduled for endoscopic kidney stone removal surgery. 3. Participants with RCC who are scheduled for kidney removal surgery.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Calcium Oxalate Urolithiasis, Renal Cell Carcinoma
- Keywords
- calcium oxalate stones, renal cell carcinoma, microbiome, urinary microbiome
- Medical subject headings
- Nephrolithiasis, Calcium Oxalate, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start24 Feb 2021
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Jan 2029 (estimated)
Why it stopped: lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Calcium Oxalate UrolithiasisStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hemendra Shah, University of Miami
- Investigators
- Hemendra N Shah, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04669860
- Sponsor's protocol ID
- 20200100
- Status last verified
- Aug 2026
- First submitted
- 10 Dec 2020
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Bacterial and Fungal Microbiome in Patients With Calcium Oxalate Urolithiasis and Renal Cell Carcinoma.
- ClinicalTrials.gov ID
- NCT04669860
- Acronym / sponsor ID
- 20200100
- Conditions
- Calcium Oxalate Urolithiasis, Renal Cell Carcinoma
- Keywords
- calcium oxalate stones, renal cell carcinoma, microbiome, urinary microbiome
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: lack of funding
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 24 Feb 2021 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to identify bacterial and fungal microbiome associated with calcium oxalate (CO) urolithiasis and renal cell carcinoma (RCC).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Healthy participants 2. Participants with CO urolithiasis scheduled for endoscopic kidney stone removal surgery. 3. Participants with RCC who are scheduled for kidney removal surgery.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hemendra N Shah principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Calcium Oxalate Urolithiasis and Renal Cell Carcinoma, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbial community structure in patients with CO urolithiasis (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.