Swiss Kidney Stone Cohort (SKSC)

NCT ID: NCT01990027

Last Updated: 2017-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Study Completion Date

2024-04-30

Brief Summary

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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

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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.

Conditions

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Kidney Stone

Keywords

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kidney stone

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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


* 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

For SKSC Control Group


* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kantonsspital Aarau

Aarau, Canton of Aargau, Switzerland

Site Status RECRUITING

HUG

Geneva, Canton of Geneva, Switzerland

Site Status RECRUITING

USZ

Zurich, Canton of Zurich, Switzerland

Site Status RECRUITING

Universitätsspital Basel

Basel, , Switzerland

Site Status TERMINATED

Inselspital

Bern, , Switzerland

Site Status RECRUITING

CHUV

Lausanne, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Olivier Bonny, MD-PhD

Role: CONTACT

Email: [email protected]

Carsten Wagner, MD

Role: CONTACT

Facility Contacts

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Florian Buchkremer, MD

Role: primary

Thomas Ernandez, MD

Role: primary

Nilufar Mohebbi

Role: primary

Daniel Fuster, MD

Role: primary

Olivier Bonny, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 28720370 (View on PubMed)

Related Links

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Other Identifiers

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KEK-2013-0330

Identifier Type: -

Identifier Source: org_study_id