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Randall's Plaque Study: Pathogenesis and Relationship to Nephrolithiasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00169806
Recruitment Status : Recruiting
First Posted : September 15, 2005
Last Update Posted : January 20, 2022
Sponsor:
Collaborators:
Indiana University School of Medicine
University of Chicago
Information provided by (Responsible Party):
James Lingeman, Indiana Kidney Stone Institute

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 15, 2005
Last Update Posted Date January 20, 2022
Study Start Date  ICMJE November 1998
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 16, 2007)
To find out why people form stones by comparing 24 urine collections, biopsy and anatomy to other patients who do not form stones and other patients who do form stones to see if the differences are significant [ Time Frame: One year from study completion ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
To find out why people form stones by comparing 24 urine collections, biopsy and anatomy to other patients that do not form stones and other patients that do form stones to see if the differences are significant.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randall's Plaque Study: Pathogenesis and Relationship to Nephrolithiasis
Official Title  ICMJE Randall's Plaques: Pathogenesis and Relationship to Nephrolithiasis
Brief Summary

Kidney stones are very common. They affect 3-5% of the population in the United States. Many people are hospitalized for the treatment of kidney stones and some may die. Better understanding of what causes kidney stones is useful in both the treatment and prevention of kidney stones. However, exactly what causes kidney stones is unknown.

The most common type of kidney stones contains calcium, which sometimes is attached to a part of the kidney important in producing the final urine, called the papilla. The investigators have noticed that persons who form kidney stones seem to have more papilla with stones attached. They propose to study these areas of the papilla, called Randall's plaques (named after their discoverer), in patients undergoing surgery for kidney stones.

Detailed Description In order to attempt to explain the pathogenesis of renal calculi, the investigators videotape and document the location and characteristics of each stone, papillae and calyces. One or more small papillary biopsies are taken for analysis to help determine the point of origin of the kidney stone and histological studies are undertaken to determine tissue differences amongst different types of stone formers. Approximately one month after surgery, metabolic studies are undertaken to further review potential causes of stone formation.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Nephrocalcinosis
  • Renal Calculi
  • Hypercalciuria
  • Hyperparathyroidism
  • Cystinuria
Intervention  ICMJE Other: videotape for mapping of renal anatomy and papillary biopsy
Subjects who enroll in this study will have their renal anatomy videotaped for mapping purposes. Stone location and characteristics will be documented as will papilla and calyces. One or more papillary biopsies will be taken for analysis.
Study Arms  ICMJE cohort
Subjects who are scheduled to undergo a percutaneous kidney stone removal who do not have complicated comorbidities
Intervention: Other: videotape for mapping of renal anatomy and papillary biopsy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 27, 2018)
600
Original Enrollment  ICMJE
 (submitted: September 12, 2005)
155
Estimated Study Completion Date  ICMJE December 2025
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients of Methodist Urology in Indianapolis, IN who are undergoing endoscopic procedures for nephrolithiasis or other urologic disease.
  • Upper urinary tract endoscopic or PERC procedure for kidney stones removal
  • General medical health allowing surgical procedure
  • Ability to complete all the necessary components of the study
  • Able to sign an informed consent

Exclusion Criteria:

  • Poor general medical health
  • Bleeding diathesis
  • Inability or unwillingness to comply with post-surgical follow-up
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kim Smoot 317-962-0869 ksmoot@iuhealth.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00169806
Other Study ID Numbers  ICMJE 98-073
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party James Lingeman, Indiana Kidney Stone Institute
Study Sponsor  ICMJE Indiana Kidney Stone Institute
Collaborators  ICMJE
  • Indiana University School of Medicine
  • University of Chicago
Investigators  ICMJE
Principal Investigator: James Lingeman, MD IU Health Physicians Urology
PRS Account Indiana Kidney Stone Institute
Verification Date January 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP