SUSPENDED

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

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Conditions

Calcium Oxalate UrolithiasisRenal Cell Carcinomacalcium oxalate stonesmicrobiomeurinary microbiome

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2021-02-24
Study Completion:2028-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:SUSPENDED

Study ID

NCT04669860

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults that are able to consent (≥ 18 years of age)
  2. * No history of asymptomatic bacteriuria or Urinary Tract Infection within the past 1 month
  3. * No history of coagulopathy and not on anticoagulant or antiplatelet medication at the time of surgery.
  4. * For patients with urolithiasis, must not have a history of RCC
  5. * For patients with RCC, must not have a history of urolithiasis
  6. * Controls must have no history of stones, RCC, or urinary tract infection (within 1 month).
  7. * For all participants, no antimicrobial treatment within the past month
  1. * Adults unable to consent
  2. * For patients with urolithiasis, technical difficulty in taking renal papillae biopsy.
  3. * History of urinary tract infection within the past 1 month
  4. * History of coagulopathy and on anticoagulants or antiplatelets that could not be stopped perioperatively.
  5. * Patients with nephrolithiasis and renal tumors with positive preoperative urine cultures- suggesting asymptomatic bacteriuria.
  6. * For patients with urolithiasis, a history of RCC
  7. * For patients with RCC, a history of urolithiasis
  8. * Controls who have a history of stones, RCC, or urinary tract infection.
  9. * For all participants, antimicrobial treatment within the past month.

Contacts and Locations

Principal Investigator

Hemendra N Shah
PRINCIPAL_INVESTIGATOR
University of Miami

Study Locations (Sites)

University of Miami
Miami, Florida, 33136
United States

Collaborators and Investigators

Sponsor: University of Miami

  • Hemendra N Shah, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2021-02-24
Study Completion Date2028-01-01

Study Record Updates

Study Start Date2021-02-24
Study Completion Date2028-01-01

Terms related to this study

Keywords Provided by Researchers

  • calcium oxalate stones
  • renal cell carcinoma
  • microbiome
  • urinary microbiome

Additional Relevant MeSH Terms

  • Calcium Oxalate Urolithiasis
  • Renal Cell Carcinoma