Ignite Creation Date:
2025-12-25 @ 12:55 AM
Ignite Modification Date:
2026-04-23 @ 1:18 PM
Study NCT ID:
NCT02373267
Status:
UNKNOWN
Last Update Posted:
2015-02-26
First Post:
2015-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Screening of TMA Patients für ADAMTS13 Activity (Adamscreen)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057049', 'term': 'Thrombotic Microangiopathies'}], 'ancestors': [{'id': 'D013921', 'term': 'Thrombocytopenia'}, {'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000095542', 'term': 'Cytopenia'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': '* 2x 5 ml citrate blood\n* 2x 3 ml EDTA blood\n* 1x 5 ml lithium heparin blood\n* 1x 5 ml serum blood\n* 1x 3 ml stool\n* 1x 9 ml urine\n* 1x blood smear'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2019-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-02-20', 'studyFirstSubmitDate': '2015-01-24', 'studyFirstSubmitQcDate': '2015-02-20', 'lastUpdatePostDateStruct': {'date': '2015-02-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'clinical presentation, clinical course and outcome of different TMA forms particularly with regard to treatment procedures. Monitoring of how ADAMTS13 activity and antigen changes in the course of the disease and in response to treatme', 'timeFrame': 'at baseline and in course'}], 'primaryOutcomes': [{'measure': 'relative incidences of different entities of TMA', 'timeFrame': 'at baseline'}], 'secondaryOutcomes': [{'measure': 'Mean value of ADAMTS13 activity and antigen measured at date of first diagnosis.', 'timeFrame': 'at baseline'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Thrombotic Microangiopathies']}, 'descriptionModule': {'briefSummary': 'Screening of TMA patients for ADAMTS13 activity and the description of systemic organ damage and/or organ failure in different entities of thrombotic microangiopathies (TMA)', 'detailedDescription': 'This is a prospective diagnostic analysis enrolling 100 patients with clinically suspected thrombotic microangiopathy (TMA) on the basis of laboratory findings such as thrombocytopenia, Coombs negative haemolytic anemia with increased LDH and increased schistozytes. As a first step of differential diagnosis, patients are classified by determining ADAMTS13 activity and antigen concentration and also analyzing for Shigatoxin and Shigatoxin producing bacteria respectively. Primary objective is to determine the relative incidences of the three major entities i.e. aHUS, STEC-HUS and TTP considering distribution of age and gender as well. Mean value of ADAMTS13 activity and antigen measured at date of first diagnosis is considered to line out a threshold value for ADAMTS13 activity pronouncing clinical apparent TMA. Furthermore the present study intends to characterize clinical presentation, clinical course and outcome of different TMA forms particularly with regard to treatment procedures. Monitoring of how ADAMTS13 activity and antigen changes in the course of the disease and in response to treatment is of particular concern for this study. Family history and special clinical conditions should be noted identifying potential genetic predisposition and definite clinical triggers leading to disease manifestation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with a constellation of thrombocytopenia, Coombs negative hemolytic anaemia and clinical signs of ischaemic end organ damage or abdominal symptoms.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Patients with first history of TMA as patients with recurrent TMA or TMA in complete or partial remission are eligible for analysis\n\nExclusion Criteria:\n\n-Patients who received plasma intervention more than 3 weeks prior to screening must be excluded from the observational study'}, 'identificationModule': {'nctId': 'NCT02373267', 'acronym': 'Adamscreen', 'briefTitle': 'Screening of TMA Patients für ADAMTS13 Activity (Adamscreen)', 'organization': {'class': 'OTHER', 'fullName': 'University of Cologne'}, 'officialTitle': 'Screening of TMA Patients for ADAMTS13 Activity and the Description of Systematic Organ Damage and/or Organ Failure in Different Entities of Thrombotic Microangiopathies (TMA)', 'orgStudyIdInfo': {'id': '41-14'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Technozyme', 'type': 'BIOLOGICAL', 'description': 'determination of ADAMTS13 activity'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cologne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'physician', 'investigatorFullName': 'Dr. med. Brigitte Schneider', 'investigatorAffiliation': 'University of Cologne'}}}}