NCT02187432

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,100

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2013

Typical duration for all trials

Geographic Reach
10 countries

14 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

Study Start

First participant enrolled

August 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2014

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 11, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

May 27, 2015

Status Verified

May 1, 2015

Enrollment Period

2.3 years

First QC Date

February 24, 2014

Last Update Submit

May 26, 2015

Conditions

Autosomal Dominant Polycystic Kidney Disease

Outcome Measures

Primary Outcomes (1)

  • disease progression

    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 Outcomes (1)

  • QOL (Quality of Life)

    participants will be followed annually for at least 3 years

Study Arms (1)

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).

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

NOT YET RECRUITING

Charles University Prague

Prague, 128 08, Czechia

NOT YET RECRUITING

Centre hospitalier universitaire de Brest

Brest, 29609, France

NOT YET RECRUITING

Hôpital de Rangueil

Toulouse, 31059, France

NOT YET RECRUITING

Charité Universitätsmedizin Berlin

Berlin, 10117, Germany

NOT YET RECRUITING

University Hospital Erlangen

Erlangen, 91054, Germany

NOT YET RECRUITING

University Hospital Freiburg

Freiburg im Breisgau, 79095, Germany

NOT YET RECRUITING

Istituto di Ricerche Farmacologiche "Mario Negri"

Bergamo, 24126, Italy

NOT YET RECRUITING

University Medical Center Groningen

Groningen, 9713, Netherlands

RECRUITING

Fundació Puigvert

Barcelona, 08025, Spain

NOT YET RECRUITING

University Hospital Zurich

Zurich, 8091, Switzerland

NOT YET RECRUITING

Istanbul School of Medicine

Istanbul, 34390, Turkey (Türkiye)

NOT YET RECRUITING

University of Cambridge, Cambridge Cancer Center

Cambridge, CB2 0XY, United Kingdom

NOT YET RECRUITING

University of Sheffield Medical School Academic Unit of Nephrology Department of Infection and Immunity

Sheffield, S10 2RX, United Kingdom

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The following samples will be collected: blood, spot urine and 24h urine

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant

Condition Hierarchy (Ancestors)

Polycystic Kidney DiseasesKidney Diseases, CysticKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCiliopathiesGenetic Diseases, Inborn

Study Officials

  • Andreas L Serra, MD

    University of Zurich

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andreas L Serra, MD

CONTACT

a.serra@gmx.ch

Andreas Serra, MD, MPH

CONTACT

a.serra@gmx.ch

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 24, 2014

First Posted

July 11, 2014

Study Start

August 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2016

Last Updated

May 27, 2015

Record last verified: 2015-05

Locations

CH(1)BE(1)NL(1)CZ(1)ES(1)TU(1)GB(2)FR(2)IT(1)DE(3)