Clinical trial · Observational
Evaluating the Bacterial and Fungal Microbiome in Patients With Calcium Oxalate Urolithiasis and Renal Cell Carcinoma
Evaluating the Bacterial and Fungal Microbiome in Patients With Calcium Oxalate Urolithiasis and Renal Cell Carcinoma.
NCT04669860CI-TRIAL-00124138suspendedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): lack of funding
Summary
Brief summary (as posted)
The purpose of the study is to identify bacterial and fungal microbiome associated with calcium oxalate (CO) urolithiasis and renal cell carcinoma (RCC).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Calcium Oxalate Urolithiasis | — | UNRESOLVED | — |
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (3)
- label
- calcium oxalate urolithiasis group
- description
- 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.
- label
- renal cell carcinoma group
- description
- 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.
- label
- healthy control group
- description
- The participants will provide a clean-catch voided midstream urine sample to identify bacterial and fungal microbiome.
Primary outcomes (3)
- measure
- Microbial community structure in patients with CO urolithiasis
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.