NCT01990027

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2014

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 21, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

November 29, 2017

Status Verified

November 1, 2017

Enrollment Period

10 years

First QC Date

October 9, 2013

Last Update Submit

November 28, 2017

Conditions

Kidney Stone

Keywords

kidney stone

Outcome Measures

Primary Outcomes (1)

  • Epidemiological characterization

    Epidemiological characterization of kidney stone patients

    10 years

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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
  • +3 more criteria

You may not qualify if:

  • Not signed Informed Consent form
  • Age below 18 years old
  • For SKSC Control Group
  • Signed Declaration of informed consent
  • Male or female
  • Kidney-stone free (screening verification by low-dose CT-scan)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Kantonsspital Aarau

Aarau, Canton of Aargau, 5001, Switzerland

RECRUITING

HUG

Geneva, Canton of Geneva, Switzerland

RECRUITING

USZ

Zurich, Canton of Zurich, CH-8091, Switzerland

RECRUITING

Universitätsspital Basel

Basel, Switzerland

TERMINATED

Inselspital

Bern, Switzerland

RECRUITING

CHUV

Lausanne, Switzerland

RECRUITING

Related Publications (1)

  • 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.

    PMID: 28720370DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood; plasma; serum; urine

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Olivier Bonny, MD-PhD

CONTACT

Olivier.Bonny@unil.ch

Carsten Wagner, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2013

First Posted

November 21, 2013

Study Start

April 1, 2014

Primary Completion

April 1, 2024

Study Completion

April 1, 2024

Last Updated

November 29, 2017

Record last verified: 2017-11

Locations

CH(6)