Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2026-01-01 @ 1:49 AM
Study NCT ID:
NCT02187432
Status:
UNKNOWN
Last Update Posted:
2015-05-27
First Post:
2014-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Eurocyst Initiative: Building a Network of ADPKD Reference Centers Across Europe
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016891', 'term': 'Polycystic Kidney, Autosomal Dominant'}], 'ancestors': [{'id': 'D007690', 'term': 'Polycystic Kidney Diseases'}, {'id': 'D052177', 'term': 'Kidney Diseases, Cystic'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D000072661', 'term': 'Ciliopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'The following samples will be collected: blood, spot urine and 24h urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-05-26', 'studyFirstSubmitDate': '2014-02-24', 'studyFirstSubmitQcDate': '2014-07-07', 'lastUpdatePostDateStruct': {'date': '2015-05-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'disease progression', 'timeFrame': 'participants will be followed annually for at least 3 years', 'description': 'Investigate disease progression and association of disease biomarkers with the onset and severity of ADPKD-related outcomes.'}], 'secondaryOutcomes': [{'measure': 'QOL (Quality of Life)', 'timeFrame': 'participants will be followed annually for at least 3 years', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Autosomal Dominant Polycystic Kidney Disease']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants ≥ 18 years;\n* Clinical diagnosis of ADPKD based on kidney imaging and family history;\n* Estimated Glomerular Filtration Rate (eGFR) ≥ 30 ml/min/1.73m2 (Chronic Kidney Disease Epidemiology Collaboration(CKD-EPI)- formula);\n* Provided written informed consent.\n\nExclusion Criteria:\n\n* Receiving chronic renal replacement therapy before enrollment (dialysis, allograft) or anticipated in the following 12 months after enrollment;\n* Participation in a clinical trial aiming to modify disease outcome one year or less before enrollment in the EuroCYST study;\n* New York Heart Association (NYHA) stadium IV.'}, 'identificationModule': {'nctId': 'NCT02187432', 'briefTitle': 'The Eurocyst Initiative: Building a Network of ADPKD Reference Centers Across Europe', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'Eurocyst'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ADPKD', 'description': '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).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1200', 'city': 'Brussels', 'status': 'NOT_YET_RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Yves Pirson, Prof', 'role': 'CONTACT', 'email': 'yves.pirson@uclouvain.be'}, {'name': 'Yves Pirson, Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cliniques universitaires Saint-Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '128 08', 'city': 'Prague', 'status': 'NOT_YET_RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Vladimir Tesar, Prof', 'role': 'CONTACT', 'email': 'vladimir.tesar@lf1.cuni.cz'}, {'name': 'Vladimir Tesar, Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Charles University Prague', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '29609', 'city': 'Brest', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Yannick Le Meur, Prof', 'role': 'CONTACT', 'email': 'yannick.lemeur@chu-brest.fr'}, {'name': 'Yannick Le Meur, Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre hospitalier universitaire de Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '31059', 'city': 'Toulouse', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Dominique Chaveau, Prof', 'role': 'CONTACT', 'email': 'chauveau.d@chu-toulouse.fr'}, {'name': 'Dominique Chaveau, Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital de Rangueil', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '10117', 'city': 'Berlin', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Klemens Budde, Prof', 'role': 'CONTACT', 'email': 'klemens.budde@charite.de'}, {'name': 'Klemens Budde, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Charité Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '91054', 'city': 'Erlangen', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Kai-Uwe Eckardt, Prof', 'role': 'CONTACT', 'email': 'Kai-Uwe.Eckardt@uk-erlangen.de'}, {'name': 'Kai-Uwe Eckardt, Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital Erlangen', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'zip': '79095', 'city': 'Freiburg im Breisgau', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Anna Koettgen, MD', 'role': 'CONTACT', 'email': 'anna.koettgen@uniklinik-freiburg.de'}, {'name': 'Anna Koettgen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital Freiburg', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '24126', 'city': 'Bergamo', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giuseppe Remuzzi, Prof', 'role': 'CONTACT', 'email': 'giuseppe.remuzzi@marionegri.it'}, {'name': 'Giuseppe Remuzzi, Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Istituto di Ricerche Farmacologiche "Mario Negri"', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}, {'zip': '9713', 'city': 'Groningen', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Ron Gansevoort, MD', 'role': 'CONTACT', 'email': 'R.T.Gansevoort@int.umcg.nl'}, {'name': 'Ron Gansevoort, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Medical Center Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'zip': '08025', 'city': 'Barcelona', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Roser Torra, MD', 'role': 'CONTACT', 'email': 'rtorra@fundacio-puigvert.es'}, {'name': 'Roser Torra, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fundació Puigvert', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '8091', 'city': 'Zurich', 'status': 'NOT_YET_RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Andreas L Serra, MD', 'role': 'CONTACT', 'email': 'a.serra@gmx.ch', 'phone': '+41 44 635 51 07'}, {'name': 'Andreas L Serra, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'zip': '34390', 'city': 'Istanbul', 'status': 'NOT_YET_RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Tefvik Ecder, Prof', 'role': 'CONTACT', 'email': 'ecder@istanbul.edu.tr'}, {'name': 'Tefvik Ecder, Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Istanbul School of Medicine', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': 'CB2 0XY', 'city': 'Cambridge', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Richard Sandford, Prof', 'role': 'CONTACT', 'email': 'rns13@medschl.cam.ac.uk'}, {'name': 'Richard Sandford, Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Cambridge, Cambridge Cancer Center', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'S10 2RX', 'city': 'Sheffield', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Albert CM Ong, Prof', 'role': 'CONTACT', 'email': 'a.ong@sheffield.ac.uk'}, {'name': 'Albert CM Ong, Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Sheffield Medical School Academic Unit of Nephrology Department of Infection and Immunity', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}], 'centralContacts': [{'name': 'Andreas L Serra, MD', 'role': 'CONTACT', 'email': 'a.serra@gmx.ch'}, {'name': 'Andreas Serra, MD, MPH', 'role': 'CONTACT', 'email': 'a.serra@gmx.ch'}], 'overallOfficials': [{'name': 'Andreas L Serra, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Zurich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Andreas L. Serra', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Andreas L. Serra', 'investigatorAffiliation': 'University of Zurich'}}}}