Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-29 @ 8:03 PM
Study NCT ID:
NCT04648059
Status:
UNKNOWN
Last Update Posted:
2022-03-14
First Post:
2020-11-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epigenetics in Lupus Nephritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}, {'id': 'D008181', 'term': 'Lupus Nephritis'}, {'id': 'D005355', 'term': 'Fibrosis'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D005921', 'term': 'Glomerulonephritis'}, {'id': 'D009393', 'term': 'Nephritis'}, {'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': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Circulating CpG-rich DNA fragments'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-24', 'studyFirstSubmitDate': '2020-11-23', 'studyFirstSubmitQcDate': '2020-11-23', 'lastUpdatePostDateStruct': {'date': '2022-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Methylated CpG-rich DNA fragments', 'timeFrame': '12 months', 'description': "it will be analyzed whether circulating CpG-rich DNA fragments are present in patients' blood"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Epigenetics', 'Methylation', 'Toll-like receptors', 'Fibrosis'], 'conditions': ['Systemic Lupus Erythematosus', 'Lupus Nephritis']}, 'descriptionModule': {'briefSummary': 'This is a translational study for the identification of epigenetic changes detectable in sera of patients suffering from Systemic Lupus erythematosus. The aim of the study is to analyze whether circulating DNA fragments are 1) different in patients with or without Lupus nephritis and 2) present and detectable in the circulation before the development of Lupus nephritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of a sample of patients with systemic lupus nephritis (SLE). There will be analyses for the presence of epigenetic markers (methylated CpG-rich DNA fragments) between two groups: 1) patients with SLE with Lupus nephritis (LN) and 2) patients with SLE without LN. In the first phase of the study, a cross-sectional sample of patients will be analyzed. In the second phase of the study, patient samples will be prospectively analyzed for the presence of these markers.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of systemic lupus erythematosus according to the current classification criteria\n* a subgroup requires the presence of Lupus nephritis (no restriction to specific LN histologic subtypes)\n\nExclusion Criteria:\n\n* patients not able or unwilling to provide written informed consent'}, 'identificationModule': {'nctId': 'NCT04648059', 'acronym': 'Epi_LN', 'briefTitle': 'Epigenetics in Lupus Nephritis', 'organization': {'class': 'OTHER', 'fullName': 'University of Göttingen'}, 'officialTitle': 'Unmethylated CpG-rich DNA Fragments in TLR-mediated Renal Fibrogenesis of Lupus Nephritis', 'orgStudyIdInfo': {'id': '28/9/17'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Lupus nephritis +ve', 'description': 'This group consists of patients with Lupus nephritis', 'interventionNames': ['Diagnostic Test: Blood sampling']}, {'label': 'Lupus nephritis -ve', 'description': 'This group consist of patients with SLE without Lupus nephritis', 'interventionNames': ['Diagnostic Test: Blood sampling']}], 'interventions': [{'name': 'Blood sampling', 'type': 'DIAGNOSTIC_TEST', 'description': 'Blood sampling will be performed to allow analyses of epigenetic markers', 'armGroupLabels': ['Lupus nephritis +ve', 'Lupus nephritis -ve']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37075', 'city': 'Göttingen', 'state': 'Lower Saxony', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'PETER KORSTEN', 'role': 'CONTACT', 'email': 'peter.korsten@med.uni-goettingen.de', 'phone': '0551398904'}], 'facility': 'University Medical Center Göttingen', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}], 'centralContacts': [{'name': 'PETER KORSTEN, MD', 'role': 'CONTACT', 'email': 'peter.korsten@med.uni-goettingen.de', 'phone': '055139', 'phoneExt': '8904'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Göttingen', 'class': 'OTHER'}, 'collaborators': [{'name': "King's College London", 'class': 'OTHER'}, {'name': 'Università degli Studi di Brescia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Peter Korsten', 'investigatorAffiliation': 'University of Göttingen'}}}}