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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. Identifier: NCT00169806
Recruitment Status : Recruiting
First Posted : September 15, 2005
Last Update Posted : January 20, 2022
Indiana University School of Medicine
University of Chicago
Information provided by (Responsible Party):
James Lingeman, Indiana Kidney Stone Institute

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.

Condition or disease Intervention/treatment Phase
Nephrocalcinosis Renal Calculi Hypercalciuria Hyperparathyroidism Cystinuria Other: videotape for mapping of renal anatomy and papillary biopsy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randall's Plaques: Pathogenesis and Relationship to Nephrolithiasis
Study Start Date : November 1998
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Subjects who are scheduled to undergo a percutaneous kidney stone removal who do not have complicated comorbidities
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.

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00169806

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Contact: Kim Smoot 317-962-0869

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United States, Indiana
IU Health Methodist Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Kim Smoot    317-962-0869   
Principal Investigator: James Lingeman, MD         
Sponsors and Collaborators
Indiana Kidney Stone Institute
Indiana University School of Medicine
University of Chicago
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Principal Investigator: James Lingeman, MD IU Health Physicians Urology
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Responsible Party: James Lingeman, James Lingeman, MD, Indiana Kidney Stone Institute Identifier: NCT00169806    
Other Study ID Numbers: 98-073
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: January 20, 2022
Last Verified: January 2022
Keywords provided by James Lingeman, Indiana Kidney Stone Institute:
Randall's Plaque
Kidney stones
Additional relevant MeSH terms:
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Kidney Calculi
Parathyroid Diseases
Endocrine System Diseases
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Urinary Calculi
Urological Manifestations
Renal Aminoacidurias
Renal Tubular Transport, Inborn Errors
Genetic Diseases, Inborn
Calcium Metabolism Disorders
Metabolic Diseases