SuspendedNot Applicable

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

Stopped: lack of funding

United States90 participantsStarted 2021-02-24

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Microbial community structure in patients with CO urolithiasis

Timeframe: Day 1

Microbial community structure in patients with RCC

Timeframe: Day 1

Microbial community structure in healthy participants

Timeframe: Day 1

Trial details

NCT IDNCT04669860

SponsorUniversity of Miami

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-09-01

View on ClinicalTrials.gov More Calcium Oxalate Urolithiasis trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.