Swiss Kidney Stone Cohort (SKSC) (SKSC)

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: NCT01990027
Recruitment Status : Recruiting
First Posted : November 21, 2013
Last Update Posted : November 29, 2017
Information provided by (Responsible Party):
The Swiss National Centre of Competence in Research Kidney Control of Homeostasis

Brief Summary:
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 or disease
Kidney Stone

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.

A control group of 250 stone-free volunteers matching patients cohort participants for sex and age started recruitment in October 2017 and will serve the purpose of comparison in future studies.

Study Type : Observational [Patient Registry]
Estimated Enrollment : 1250 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Swiss Kidney Stone Cohort (SKSC)
Study Start Date : April 2014
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : April 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Stones

SKSC Patients group

A group a 1000 subjects affected by kidney stone as described in the eligibility criteria will be recruited in the period 2014-2024 and the same exams will be repeated for each participants for a period of 3 years.

No intervention will be undertaken.

SKSC Control group

A group of 250 stone-free participants will be recruited and analysed with the same protocol as the patients but in a single visit. This group will be used for comparison with the patients group in future studies.

No intervention will be undertaken.

Primary Outcome Measures :
  1. Epidemiological characterization [ Time Frame: 10 years ]
    Epidemiological characterization of kidney stone patients

Biospecimen Retention:   Samples With DNA
Whole blood; plasma; serum; urine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with a kidney stone episode + Kidney stone-free control group

For SKSC Patients Group:

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.

  • Not signed Informed Consent form
  • Age below 18 years old

For SKSC Control Group

Inclusion criteria:

  • Signed Declaration of informed consent
  • Male or female
  • Kidney-stone free (screening verification by low-dose CT-scan)

Exclusion criteria:

  • Not signed Informed Consent form
  • Age below 18 years old
  • Pregnancy
  • History of kidney stones
  • Low-dose CT-scan positive for kidney stones during screening phase

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): NCT01990027

Contact: Olivier Bonny, MD-PhD
Contact: Carsten Wagner, MD

HUG Recruiting
Geneva, GE, Switzerland
Contact: Thomas Ernandez, MD    +41 79 55 33284   
Sub-Investigator: Catherine Stoermann, MD         
Principal Investigator: Thomas Ernandez, MD         
Kantonsspital Aarau Recruiting
Aarau, Kanton Aargau, Switzerland, 5001
Contact: Florian Buchkremer, MD    +41 62 838 43 06   
Principal Investigator: Florian Buchkremer, MD         
USZ Recruiting
Zurich, ZH, Switzerland, CH-8091
Contact: Nilufar Mohebbi    +41 44 255 11 11      
Principal Investigator: Nilufar Mohebbi         
Universitätsspital Basel Terminated
Basel, Switzerland
Inselspital Recruiting
Bern, Switzerland
Contact: Daniel Fuster, MD    +41 31 632 97 72   
Principal Investigator: Daniel Fuster, MD         
Sub-Investigator: Nasser Dhayat, MD         
CHUV Recruiting
Lausanne, Switzerland
Contact: Olivier Bonny, MD    +41795564612   
Principal Investigator: Olivier Bonny, MD         
Sponsors and Collaborators
The Swiss National Centre of Competence in Research Kidney Control of Homeostasis

Additional Information:
Responsible Party: The Swiss National Centre of Competence in Research Kidney Control of Homeostasis Identifier: NCT01990027     History of Changes
Other Study ID Numbers: KEK-2013-0330
First Posted: November 21, 2013    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: November 2017

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

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