Swiss Kidney Stone Cohort (SKSC)

• Conditions: Kidney Stone

• Registration Number: NCT01990027
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2013-10-09
• Study First Submitted QC: 2013-11-15
• Study First Posted: 2013-11-21
• Study Start: 2014-04
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-28
• Last Update Posted: 2017-11-29
• Primary Completion: 2024-04
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1250

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Epidemiological characterization	10 years	Epidemiological characterization of kidney stone patients

Trial Locations

Locations (6)

CHUV; 🇨🇭 Lausanne, Switzerland

HUG; 🇨🇭 Geneva, GE, Switzerland

USZ; 🇨🇭 Zurich, ZH, Switzerland

Kantonsspital Aarau; 🇨🇭 Aarau, Kanton Aargau, Switzerland

Inselspital; 🇨🇭 Bern, Switzerland

Universitätsspital Basel; 🇨🇭 Basel, Switzerland