Swiss Kidney Stone Cohort (SKSC) (SKSC)

November 28, 2017 updated by: The Swiss National Centre of Competence in Research Kidney Control of Homeostasis
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.

Study Overview

Status

Recruiting

Conditions

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

Enrollment (Anticipated)

1250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Carsten Wagner, MD

Study Locations

  • Switzerland
      • Basel, Switzerland
        • Terminated
        • Universitatsspital Basel
      • Bern, Switzerland
        • Recruiting
        • Inselspital
        • Contact:
        • Principal Investigator:
          • Daniel Fuster, MD
        • Sub-Investigator:
          • Nasser Dhayat, MD
      • Lausanne, Switzerland
        • Recruiting
        • CHUV
        • Contact:
        • Principal Investigator:
          • Olivier Bonny, MD
    • GE
      • Geneva, GE, Switzerland
        • Recruiting
        • HUG
        • Contact:
        • Sub-Investigator:
          • Catherine Stoermann, MD
        • Principal Investigator:
          • Thomas Ernandez, MD
    • Kanton Aargau
      • Aarau, Kanton Aargau, Switzerland, 5001
        • Recruiting
        • Kantonsspital Aarau
        • Contact:
        • Principal Investigator:
          • Florian Buchkremer, MD
    • ZH
      • Zurich, ZH, Switzerland, CH-8091
        • Recruiting
        • USZ
        • Contact:
          • Nilufar Mohebbi
          • Phone Number: +41 44 255 11 11
        • Principal Investigator:
          • Nilufar Mohebbi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with a kidney stone episode + Kidney stone-free control group

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epidemiological characterization
Time Frame: 10 years
Epidemiological characterization of kidney stone patients
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Swiss National Centre of Competence in Research Kidney Control of Homeostasis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Anticipated)

April 1, 2024

Study Completion (Anticipated)

April 1, 2024

Study Registration Dates

First Submitted

October 9, 2013

First Submitted That Met QC Criteria

November 15, 2013

First Posted (Estimate)

November 21, 2013

Study Record Updates

Last Update Posted (Actual)

November 29, 2017

Last Update Submitted That Met QC Criteria

November 28, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KEK-2013-0330

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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