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Trial record 15 of 19 for:    "Cystinuria"

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 : October 9, 2020
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
NYU Langone Health

Tracking Information
First Submitted Date April 23, 2014
First Posted Date April 28, 2014
Last Update Posted Date October 9, 2020
Study Start Date August 2013
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 24, 2014)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Health-related Quality of Life in Rare Kidney Stone
Official Title Assessment of Health-related Quality of Life in Rare Kidney Stone Formers in the Rare Kidney Stone Consortium
Brief Summary Assessment of Health-related Quality of Life in Rare Kidney Stone Formers in the Rare Kidney Stone Consortium
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]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Sample will be selected from the Rare Kidney Stone Consortium registries
Condition
  • Primary Hyperoxaluria
  • Cystinuria
  • Adenine Phosphoribosyl Transferase Deficiency
  • Dent Disease
Intervention Other: Health-related Quality of Life in Rare Kidney Stone Questionnaire
Study Groups/Cohorts
  • 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)
    Intervention: 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)
    Intervention: 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)
    Intervention: 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)
    Intervention: Other: Health-related Quality of Life in Rare Kidney Stone Questionnaire
Publications * Modersitzki F, Pizzi L, Grasso M, Goldfarb DS. Health-related quality of life (HRQoL) in cystine compared with non-cystine stone formers. Urolithiasis. 2014 Feb;42(1):53-60. doi: 10.1007/s00240-013-0621-4. Epub 2013 Nov 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 24, 2014)
320
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2022
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Eligibility 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

Sex/Gender
Sexes Eligible for Study: All
Ages 5 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Frank Modersitzki, MPH 212-686-7500 ext 6379 Frank.Modersitzki@nyumc.org
Listed Location Countries Iceland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02124395
Other Study ID Numbers 13-00968
1U54DK083908-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party NYU Langone Health
Study Sponsor NYU Langone Health
Collaborators National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: David Goldfarb, MD NYU Langone Health
PRS Account NYU Langone Health
Verification Date October 2020