Clinical trial NCT01990027: Swiss Kidney Stone Cohort (SKSC)
Official title: Swiss Kidney Stone Cohort (SKSC)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Kidney Stone
Keywords: kidney stone
Lead sponsor: The Swiss National Centre of Competence in Research Kidney Control of Homeostasis
Sponsor class: OTHER
First posted: 2013-11-21
Enrollment: 1250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a kidney stone episode + Kidney stone-free control group

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Epidemiological characterization
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: HUG
state: GE
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau
state: Kanton Aargau
city: Zurich
country: Switzerland
facility: USZ
state: ZH
city: Basel
country: Switzerland
facility: Universitätsspital Basel
city: Bern
country: Switzerland
facility: Inselspital
city: Lausanne
country: Switzerland
facility: CHUV
Study officials:
References:
citation: Roth B, Bonny O; Swiss Kidney Stone Cohort Investigators. The Swiss Kidney Stone Cohort: An Observational Study to Unravel the Cause of Renal Stone Formation. Eur Urol Focus. 2017 Feb;3(1):7-9. doi: 10.1016/j.euf.2017.03.003. Epub 2017 Mar 21.