Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 4:37 PM
Study NCT ID:
NCT02718027
Status:
TERMINATED
Last Update Posted:
2023-02-10
First Post:
2015-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarker for Alport Syndrome (BioAlport)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25', 'removedCountries': ['Egypt', 'Germany']}, 'conditionBrowseModule': {'meshes': [{'id': 'D009394', 'term': 'Nephritis, Hereditary'}], 'ancestors': [{'id': 'D014564', 'term': 'Urogenital Abnormalities'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D009393', 'term': 'Nephritis'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003095', 'term': 'Collagen Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood sample applied on the Dry Blood Spot (DBS) Filtercard (Centocard®)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Study no longer pursued.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-08-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-08', 'studyFirstSubmitDate': '2015-11-10', 'studyFirstSubmitQcDate': '2016-03-18', 'lastUpdatePostDateStruct': {'date': '2023-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identification of Alport Syndrome biomarker/s', 'timeFrame': '36 months', 'description': 'All samples will be analyzed for the identification of biomarker/s via Liquid Chromatography Multiple Reaction-monitoring Mass Spectrometry (LC/MRM-MS) and compared to merged control, in order to establish the disease-specific biomarker/s. The LC/MRM-MS is performed on an ABSciex 6500 triple quadrupole mass spectrometer, coupled with a Waters Acquity UPLC.'}], 'secondaryOutcomes': [{'measure': 'Exploring the clinical robustness, specificity, and long-term variability of Alport syndrome biomarker/s', 'timeFrame': '36 months', 'description': 'Samples will be analyzed for the identified biomarker candidates via Liquid Chromatography Multiple Reaction-monitoring Mass Spectrometry (LC/MRM-MS) and compared to merged control, in order to establish the disease-specific biomarker/s. The LC/MRM-MS is performed on an ABSciex 6500 triple quadrupole mass spectrometer, coupled with a Waters Acquity UPLC.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Alport Syndrome', 'Biomarker'], 'conditions': ['Nephritis, Hereditary', 'Hematuria-Nephropathy-Deafness Syndrome']}, 'descriptionModule': {'briefSummary': 'International, multicenter, observational, longitudinal monitoring study to identify biomarker/s for Alport syndrome and to explore the clinical robustness, specificity, and long-term variability of these biomarker/s', 'detailedDescription': "Alport syndrome (AS) is a progressive hereditary glomerular disease with the prevalence 1 in 50,000. AS is caused by pathogenic variants in the COL4A3, COL4A4, and COL4A5 genes encoding type IV collagen α3, α4, and α5 chains, respectively. There are three modes of inheritance: X-linked Alport syndrome (XLAS), autosomal recessive AS (ARAS), and autosomal dominant AS (ADAS).\n\nAlport Syndrome causes progressive kidney damage. The glomeruli and other normal kidney structures such as tubules are gradually replaced by scar tissue, leading to kidney failure. Boys with Alport Syndrome, regardless of the genetic type, eventually develop kidney failure. These boys often need dialysis or transplantation during their teenage or young adult years, but kidney failure can occur as late as 40-50 years of age in some men with Alport Syndrome. Most girls with the X-linked type of Alport Syndrome do not develop kidney failure. However, as women with Alport Syndrome get older the risk of kidney failure increases.\n\nCurrently, diagnosis of Alport Syndrome relies on careful evaluation of the patient's signs and symptoms, along with the family history. Hearing and vision should also be tested. The evaluation can also include a blood test, urine tests, and a kidney biopsy to determine Alport Syndrome. A genetic test is crucial to confirm the diagnosis and determine the genetic type of Alport Syndrome.\n\nThere is no cure for Alport syndrome; however, symptomatic treatment can help relieve symptoms. Kidney transplantation is usually very successful in people with Alport Syndrome and is considered the best treatment when end-stage kidney failure is approaching.\n\nThe aim of this study to identify biomarker/s for Alport Syndrome and to explore their clinical robustness, specificity, and long-term variability, in the attempt to offer access to earlier diagnosis and treatment monitoring."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '2 Months', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with Alport Syndrome', 'healthyVolunteers': False, 'eligibilityCriteria': 'INCLUSION CRITERIA\n\n* Informed consent is obtained from the participant or the parent/ legal guardian.\n* The participant is aged between 2 months and 50 years\n* The diagnosis of Alport Syndrome is genetically confirmed by CENTOGENE\n\nEXCLUSION CRITERIA\n\n* Informed consent is not obtained from the participant or from the parent/ legal guardian\n* The participant is younger than 2 months or older than 50 years\n* The diagnosis of Alport Syndrome is not genetically confirmed by CENTOGENE'}, 'identificationModule': {'nctId': 'NCT02718027', 'acronym': 'BioAlport', 'briefTitle': 'Biomarker for Alport Syndrome (BioAlport)', 'organization': {'class': 'INDUSTRY', 'fullName': 'CENTOGENE GmbH Rostock'}, 'officialTitle': 'Biomarker for Alport Syndrome: An International, Multicenter, Observational, Longitudinal Protocol', 'orgStudyIdInfo': {'id': 'BAP 06-2018'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants with Alport Syndrome', 'description': 'Participants diagnosed with Alport syndrome aged between 2 months and 50 years'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10001', 'city': 'Tirana', 'country': 'Albania', 'facility': 'University Hospital Center Mother Teresa', 'geoPoint': {'lat': 41.32744, 'lon': 19.81866}}, {'zip': '0177', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Department of Molecular and Medical Genetics, Tbilisi State Medical University', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '682041', 'city': 'Kochi', 'state': 'Kerala', 'country': 'India', 'facility': 'Amrita Institute of Medical Sciences & Research Centre', 'geoPoint': {'lat': 9.93988, 'lon': 76.26022}}, {'zip': '08406', 'city': 'Vilnius', 'country': 'Lithuania', 'facility': 'Rare diseases coordinating centre, Vilnius University Hospital Santaros klinikos', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}, {'zip': '54600', 'city': 'Lahore', 'country': 'Pakistan', 'facility': "Department of Pediatric Gastroenterology and Hepatology, The Children's Hospital and Institute of Child Health", 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}, {'zip': '300011', 'city': 'Timișoara', 'country': 'Romania', 'facility': 'Emergency Hospital for Children "Louis Turcanu"', 'geoPoint': {'lat': 45.75372, 'lon': 21.22571}}, {'zip': '00800', 'city': 'Colombo', 'country': 'Sri Lanka', 'facility': 'Lady Ridgeway Hospital for Children', 'geoPoint': {'lat': 6.93548, 'lon': 79.84868}}], 'overallOfficials': [{'name': 'Peter Bauer, Prof. Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Centogene GmbH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CENTOGENE GmbH Rostock', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}