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Health-related Quality of Life in Rare Kidney Stone

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02124395
Recruitment Status : Completed
First Posted : April 28, 2014
Last Update Posted : September 2, 2022
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
NYU Langone Health

Study Description
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Brief Summary:
Assessment of Health-related Quality of Life in Rare Kidney Stone Formers in the Rare Kidney Stone Consortium

Condition or disease Intervention/treatment
Primary Hyperoxaluria Cystinuria Adenine Phosphoribosyl Transferase Deficiency Dent Disease Other: Health-related Quality of Life in Rare Kidney Stone Questionnaire

Detailed Description:
The purpose of this study is to learn about Health-related Quality Of Life (HRQoL) in patients enrolled in the Rare Kidney Stone Consortium (RKSC) registries. Quality of life studies look at different aspects of both physical and mental components of people's lives. HRQoL data for people affected by kidney stones are not currently available for people followed over time.
Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 365 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Assessment of Health-related Quality of Life in Rare Kidney Stone Formers in the Rare Kidney Stone Consortium
Actual Study Start Date : August 2013
Actual Primary Completion Date : July 2022
Actual Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Stones

Groups and Cohorts
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Group/Cohort Intervention/treatment
Primary Hyperoxaluria
All rare kidney stone patients enrolled in RKSC registries that are able to communicate using the English language, are able to consent to participation in the study, have internet access with an email account and/or a valid address and are at minimum 5 years of age (for SF-10)
 Other: Health-related Quality of Life in Rare Kidney Stone Questionnaire
Cystinuria
All rare kidney stone patients enrolled in RKSC registries that are able to communicate using the English language, are able to consent to participation in the study, have internet access with an email account and/or a valid address and are at minimum 5 years of age (for SF-10)
 Other: Health-related Quality of Life in Rare Kidney Stone Questionnaire
Dent Disease
All rare kidney stone patients enrolled in RKSC registries that are able to communicate using the English language, are able to consent to participation in the study, have internet access with an email account and/or a valid address and are at minimum 5 years of age (for SF-10)
 Other: Health-related Quality of Life in Rare Kidney Stone Questionnaire
APRT deficiency
All rare kidney stone patients enrolled in RKSC registries that are able to communicate using the English language, are able to consent to participation in the study, have internet access with an email account and/or a valid address and are at minimum 5 years of age (for SF-10)
 Other: Health-related Quality of Life in Rare Kidney Stone Questionnaire


Outcome Measures
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Primary Outcome Measures :
  1. Assessment of HRQoL in patients with rare kidney stones [ Time Frame: Once a year for up to 5 years after signed consent ]
    Assessment of HRQoL in patients with rare kidney stones. Comparison of HRQoL results between rare kidney stone formers, general population and other populations with relevant chronic diseases


Eligibility Criteria
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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:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Sample will be selected from the Rare Kidney Stone Consortium registries
Criteria

Inclusion Criteria:

  • Qualify to participate in one of the Rare Kidney Stone Registries.
  • Be at least 5 years old (for SF-10)
  • Are able to communicate using the English language
  • Consent to participate in the study (or "assent" if under 18 years old)
  • Have internet access with an email account or a valid home address

Exclusion Criteria:

None, if inclusion criteria are met

Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT02124395


Locations
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United States, Minnesota
Primary Hyperoxaluria and Dent Disease Registry - Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
New York University School of Medicine - Cystinuria Registry
New York, New York, United States, 1001+
Iceland
APRT Registry - Landspitali Universtiy Hospital
Reykjavik, Iceland
Sponsors and Collaborators
NYU Langone Health
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: David Goldfarb, MD NYU Langone Health
More Information
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Additional Information:

Publications:

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02124395    
Other Study ID Numbers: 13-00968
1U54DK083908-01 ( U.S. NIH Grant/Contract )
First Posted: April 28, 2014    Key Record Dates
Last Update Posted: September 2, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cystinuria
Kidney Calculi
Nephrolithiasis
Hyperoxaluria, Primary
Dent Disease
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Calculi
 Pathological Conditions, Anatomical
Hyperoxaluria
Carbohydrate Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Renal Aminoacidurias
Renal Tubular Transport, Inborn Errors
Genetic Diseases, X-Linked