The Eurocyst Initiative: Building a Network of ADPKD Reference Centers Across Europe

May 26, 2015 updated by: Andreas L. Serra

The Eurocyst Initiative: Building a Reference Center Network Across EUROpe to Establish a Large-scale Longitudinal Observational Cohort of Autosomal Dominant polyCYSTic Kidney Disease (ADPKD) Patients

EuroCYST initiative aims to build a large, well-characterized cohort of Autosomal Dominant polyCYSTic Kidney Disease (ADPKD) subjects who are followed in a longitudinal observational cohort study has the potential to identify progression factors and biomarkers, and to assess disease stage specific mortality, morbidity and health care costs.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

The EuroCYST Initiative aims to build a network of ADPKD reference centers across Europe and to establish a large-scale observational cohort of ADPKD patients for the purpose of studying the pathogenesis, rate of disease progression, progression rate modifiers, disease stage specific morbidity, mortality, health economic issues and the predictive value of biomarkers in ADPKD. Overall 1,100 patients will be enrolled in 14 study sites across Europe and will be followed up for at least three years. The ADPKD reference center network across Europe and the observational cohort study will enable European ADPKD researchers to gain insight into the natural history, heterogeneity and associated complications of the disease as well as how it affects the lives of patients across Europe.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1100

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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Belgium
      • Brussel, Belgium, 1200
        • Not yet recruiting
        • Cliniques universitaires Saint-Luc
        • Contact:
        • Principal Investigator:
          • Yves Pirson, Prof
  • Czech Republic
      • Prague, Czech Republic, 128 08
        • Not yet recruiting
        • Charles University Prague
        • Contact:
        • Principal Investigator:
          • Vladimir Tesar, Prof
  • France
      • Brest, France, 29609
        • Not yet recruiting
        • Centre Hospitalier Universitaire de Brest
        • Contact:
        • Principal Investigator:
          • Yannick Le Meur, Prof
      • Toulouse, France, 31059
        • Not yet recruiting
        • Hôpital de Rangueil
        • Contact:
        • Principal Investigator:
          • Dominique Chaveau, Prof
  • Germany
      • Berlin, Germany, 10117
        • Not yet recruiting
        • Charité Universitätsmedizin Berlin
        • Principal Investigator:
          • Klemens Budde, MD
        • Contact:
      • Erlangen, Germany, 91054
        • Not yet recruiting
        • University Hospital Erlangen
        • Contact:
        • Principal Investigator:
          • Kai-Uwe Eckardt, Prof
      • Freiburg, Germany, 79095
  • Italy
      • Bergamo, Italy, 24126
        • Not yet recruiting
        • Istituto di Ricerche Farmacologiche "Mario Negri"
        • Contact:
        • Principal Investigator:
          • Giuseppe Remuzzi, Prof
  • Netherlands
      • Groningen, Netherlands, 9713
        • Recruiting
        • University Medical Center Groningen
        • Contact:
        • Principal Investigator:
          • Ron Gansevoort, MD
  • Spain
      • Barcelona, Spain, 08025
        • Not yet recruiting
        • Fundacio Puigvert
        • Principal Investigator:
          • Roser Torra, MD
        • Contact:
  • Switzerland
      • Zurich, Switzerland, 8091
        • Not yet recruiting
        • University Hospital Zurich
        • Contact:
          • Andreas L Serra, MD
          • Phone Number: +41 44 635 51 07
          • Email: a.serra@gmx.ch
        • Principal Investigator:
          • Andreas L Serra, MD
  • Turkey
      • Istanbul, Turkey, 34390
        • Not yet recruiting
        • Istanbul School of Medicine
        • Contact:
        • Principal Investigator:
          • Tefvik Ecder, Prof
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0XY
        • Not yet recruiting
        • University of Cambridge, Cambridge Cancer Center
        • Contact:
        • Principal Investigator:
          • Richard Sandford, Prof
      • Sheffield, United Kingdom, S10 2RX
        • Not yet recruiting
        • University of Sheffield Medical School Academic Unit of Nephrology Department of Infection and Immunity
        • Contact:
        • Principal Investigator:
          • Albert CM Ong, Prof

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

The study will include 1,100 participants aged 18 and above with a diagnosis of ADPKD, diagnosed via imaging and family history. The assessment of participants is based on defined inclusion and exclusion criteria.

Description

Inclusion Criteria:

  • Participants ≥ 18 years;
  • Clinical diagnosis of ADPKD based on kidney imaging and family history;
  • Estimated Glomerular Filtration Rate (eGFR) ≥ 30 ml/min/1.73m2 (Chronic Kidney Disease Epidemiology Collaboration(CKD-EPI)- formula);
  • Provided written informed consent.

Exclusion Criteria:

  • Receiving chronic renal replacement therapy before enrollment (dialysis, allograft) or anticipated in the following 12 months after enrollment;
  • Participation in a clinical trial aiming to modify disease outcome one year or less before enrollment in the EuroCYST study;
  • New York Heart Association (NYHA) stadium IV.

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
ADPKD
EuroCYST is and observational trail aiming to investigate disease progression across the different stages of disease and stage specific morbidity and mortality factors in a longitudinal observational multi center study and to evaluate the levels of and associations between the impacts of patients reported disease outcome (quality of life (QoL), pain, self-estimated health status, health burden).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
disease progression
Time Frame: participants will be followed annually for at least 3 years
Investigate disease progression and association of disease biomarkers with the onset and severity of ADPKD-related outcomes.
participants will be followed annually for at least 3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
QOL (Quality of Life)
Time Frame: participants will be followed annually for at least 3 years
Evaluate and establish the level of disease impact on self-estimated health status, pain, QoL, socioeconomic status (SES), ADPKD-related health burden, health care resource use.
participants will be followed annually for at least 3 years

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Andreas L. Serra

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andreas L Serra, MD, University of Zurich

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2013

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 24, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 11, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 27, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Eurocyst

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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