Swiss Kidney Stone Cohort (SKSC)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2013 by The Swiss National Centre of Competence in Research Kidney Control of Homeostasis
Sponsor:
Information provided by (Responsible Party):
The Swiss National Centre of Competence in Research Kidney Control of Homeostasis
ClinicalTrials.gov Identifier:
NCT01990027
First received: October 9, 2013
Last updated: November 15, 2013
Last verified: November 2013
  Purpose

The SKSC is a continuous database with the objective of a standardized diagnosis and monitoring of patients with kidney stones as well as the establishment of a Biobank.


Condition
Kidney Stone

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Swiss Kidney Stone Cohort (SKSC)

Resource links provided by NLM:


Further study details as provided by The Swiss National Centre of Competence in Research Kidney Control of Homeostasis:

Primary Outcome Measures:
  • Epidemiological characterization [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    Epidemiological characterization of kidney stone patients


Biospecimen Retention:   Samples With DNA

Whole blood; serum; urine


Estimated Enrollment: 3000
Study Start Date: December 2013
Estimated Primary Completion Date: December 2023 (Final data collection date for primary outcome measure)
Detailed Description:

The objective of this study is multi-site, standardized observation and characterization of kidney stone patients.

Furthermore, an adequate structure should be established for the execution of studies with kidney stone patients, in order to then, if necessary, develop recommendations for useful monitoring or prophylactic measures, as well as new treatment options for kidney stone patients.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with a kidney stone episode

Criteria

Inclusion Criteria:

Only patients that meet all of the following inclusion criteria can be included in this study:

  • Signed Declaration of informed consent
  • Male or female
  • Recurrent kidney stone episodes (more than 1) or an individual kidney stone episode with one or several of the following risk factors:
  • The first manifestation at the a minimum age of 25
  • Positive family history
  • Non-calcium oxalate stones
  • Gastrointestinal disorders (e.g. gastric bypass surgery, inflammatory bowel disease, malabsorption etc.)
  • Osteoporosis
  • Nephrocalcinosis
  • Single kidneyness
  • Currently pregnant
  • Gout
  • Metabolic syndrome ( Diabetes Mellitus type I and II )
  • Residual calculi (at least 3 months after the therapy)
  • Bilateral or multiple stones
  • Chronic urinary tract infection
  • Chronic renal failure (eGFR lower than 60 ml/min.)
  • Kidney transplant

Exclusion Criteria:

Patients with at least one of the following exclusion criteria may not take part in this study.

-No signed Informed Consent form

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01990027

Locations
Switzerland
USZ Not yet recruiting
Zurich, ZH, Switzerland, CH-8091
Contact: Nilufar Mohebbi    +41 44 255 11 11      
Principal Investigator: Nilufar Mohebbi         
Sponsors and Collaborators
The Swiss National Centre of Competence in Research Kidney Control of Homeostasis
  More Information

Additional Information:
No publications provided

Responsible Party: The Swiss National Centre of Competence in Research Kidney Control of Homeostasis
ClinicalTrials.gov Identifier: NCT01990027     History of Changes
Other Study ID Numbers: KEK-2013-0330
Study First Received: October 9, 2013
Last Updated: November 15, 2013
Health Authority: NCCR Kindey.CH: Study coordination

Keywords provided by The Swiss National Centre of Competence in Research Kidney Control of Homeostasis:
kidney stone

Additional relevant MeSH terms:
Calculi
Kidney Calculi
Nephrolithiasis
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi

ClinicalTrials.gov processed this record on September 30, 2014