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Health-related Quality of Life in Rare Kidney Stone

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ClinicalTrials.gov Identifier: NCT02124395
Recruitment Status : Recruiting
First Posted : April 28, 2014
Last Update Posted : November 22, 2017
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
New York University School of Medicine

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 Type : Observational [Patient Registry]
Estimated Enrollment : 320 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
Study Start Date : August 2013
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018


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



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



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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


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


Contacts
Contact: Frank Modersitzki, MPH 212-686-7500 ext 6379 Frank.Modersitzki@nyumc.org

Locations
United States, Minnesota
Primary Hyperoxaluria and Dent Disease Registry - Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Barb M Seide, Study Coord    800-270-4637    hyperoxaluriacenter@mayo.edu   
Principal Investigator: Dawn S Milliner, MD         
United States, New York
New York University School of Medicine - Cystinuria Registry Recruiting
New York, New York, United States, 1001+
Contact: Frank Modersitzki, MPH    212-686-7500 ext 6379    Frank.Modersitzki@nyumc.org   
Principal Investigator: David S Goldfarb, MD         
Iceland
APRT Registry - Landspitali Universtiy Hospital Not yet recruiting
Reykjavik, Iceland
Contact: Vidar Edvardsson, MD    354-824-5227    vidare@landspitali.is   
Principal Investigator: Vidar Edvardsson, MD         
Sponsors and Collaborators
New York University School of Medicine
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: David Goldfarb, MD New York University School of Medicine

Additional Information:
Publications:
Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT02124395     History of Changes
Other Study ID Numbers: 13-00968
1U54DK083908-01 ( U.S. NIH Grant/Contract )
First Posted: April 28, 2014    Key Record Dates
Last Update Posted: November 22, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Kidney Calculi
Nephrolithiasis
Hyperoxaluria, Primary
Cystinuria
Dent Disease
Metabolism, Inborn Errors
Urolithiasis
Kidney Diseases
Urologic Diseases
Urinary Calculi
Calculi
Pathological Conditions, Anatomical
Hyperoxaluria
Carbohydrate Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Renal Aminoacidurias
Renal Tubular Transport, Inborn Errors
Genetic Diseases, X-Linked