Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2026-01-01 @ 1:56 PM
Study NCT ID:
NCT05950750
Status:
RECRUITING
Last Update Posted:
2023-07-18
First Post:
2023-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Turkey Thrombotic Thrombocytopenic Purpura Disease Registry: National Multicenter Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011697', 'term': 'Purpura, Thrombotic Thrombocytopenic'}], 'ancestors': [{'id': 'D011696', 'term': 'Purpura, Thrombocytopenic'}, {'id': 'D011693', 'term': 'Purpura'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D057049', 'term': 'Thrombotic Microangiopathies'}, {'id': 'D013921', 'term': 'Thrombocytopenia'}, {'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D019851', 'term': 'Thrombophilia'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 960}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2026-12-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-15', 'studyFirstSubmitDate': '2023-01-31', 'studyFirstSubmitQcDate': '2023-07-15', 'lastUpdatePostDateStruct': {'date': '2023-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of episodes', 'timeFrame': 'Through study completion, an average of 4 years', 'description': 'Median number of episodes will be given'}, {'measure': 'To describe treatment patterns among TTP patients', 'timeFrame': 'Through study completion, an average of 4 years', 'description': 'All treatments received by patients will be expressed as percentages'}], 'secondaryOutcomes': [{'measure': 'To describe demographic characteristics of TTP patients', 'timeFrame': '24 months', 'description': 'Age, sex, family history, comorbidities will be expressed as percentages'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TTP', 'THD'], 'conditions': ['TTP - Thrombotic Thrombocytopenic Purpura']}, 'referencesModule': {'references': [{'pmid': '40699136', 'type': 'DERIVED', 'citation': 'Karakus S, Bakanay SM, Kalayoglu Besisik S, Eskazan AE, Ayyildiz O, Gurkan E, Salim O, Karakus V, Guler N, Keklik M, Ozcebe OI, Ozkalemkas F, Ozkocaman V, Yilmaz U, Dadin S, Ucar MA, Sonmez M, Karakus A, Atas U, Koc LZ, Gunduz E, Kabukcu Hacioglu S, Unver Koluman B, Ozet G, Guney T, Fidan K, Karaagac Akyol T, Kikili CI, Demirkan F, Yavasoglu I, Dagtas S, Kestane M, Uskudar Teke H, Kocak Toprak S, Karatas A, Yagci M, Ozatli D, Ozkurt ZN, Ilhan O, Ar MC. Clinical Manifestations, Treatment Characteristics, and Clinical Outcomes in Patients with Immune Thrombotic Thrombocytopenic Purpura (iTTP) in a Real-World Setting: An Interim Analysis of the Turkish iTTP Registry. Turk J Haematol. 2025 Aug 29;42(3):203-212. doi: 10.4274/tjh.galenos.2025.2025.0134. Epub 2025 Jul 23.'}]}, 'descriptionModule': {'briefSummary': "21 hematology centers in Turkey will participate in this noninterventional observational study. The recruitment target is 960 cases. Patients will be followed-up at least 1 year or to the end of the study according to the physicians' discretion, or withdrawal of consent. Recruitment period will be 36 months. Data will be collected via electronic case report form. Since the study cohort does not include only newly diagnosed patients, all aTTP patients will be included to the study, previous treatments and diagnosis information data could also be collected from hospital records. Patients recruitment duration: 3 years (36 months) Patients follow-up duration: 1 year (12 months)", 'detailedDescription': "Because of the non-interventional nature of the study, there is no predefined treatment protocol. The patients will be treated according to the routine practices of the centers. In observational drug studies, the drug to be administered in treatment should be prescribed and patient's treatment should be started prior to study inclusion decision is made as a principle. The participating physician will continue to treat the patients according to their routine practices. Not only newly diagnosed patients, all aTTP patients within participated centers will be recruited and 12 months follow-up data will be collected. 21 hematology centers in Turkey will participate in this noninterventional observational study. The recruitment target is 960 cases. Patients will be followed-up at least 1 year or to the end of the study according to the physicians' discretion, or withdrawal of consent. Recruitment period will be 36 months. Data will be collected via electronic case report form. Since the study cohort does not include only newly diagnosed patients, all aTTP patients will be included to the study, previous treatments and diagnosis information data could also be collected from hospital records. Patients recruitment duration: 3 years (36 months) Patients follow-up duration: 1 year (12 months)"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Patients diagnosed with TTP and signed an informed written consent will be included into the study. Because of the non-interventional nature of the study, there is no predefined treatment protocol. The patients will be treated according to the routine practices of the centers. In observational drug studies, the drug to be administered in treatment should be prescribed and patient's treatment should be started prior to study inclusion decision is made as a principle. The participating physician will continue to treat the patients according to their routine practices. Not only newly diagnosed patients, all aTTP patients within participated centers will be recruited and 12 months follow-up data will be collected.", 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed as aTTP after 01.01.2015\n* Patients with ADAMS13\\<10%\n* Thrombocytopenia (\\<100.000)\n* Coombs (-)\n* Microangiopathic hemolytic amenia\n* 18 years and older\n\nExclusion Criteria:\n\n\\- Patient who does not sign informed consent form'}, 'identificationModule': {'nctId': 'NCT05950750', 'briefTitle': 'Turkey Thrombotic Thrombocytopenic Purpura Disease Registry: National Multicenter Study', 'organization': {'class': 'OTHER', 'fullName': 'Turkish Hematology Association'}, 'officialTitle': 'Turkey Thrombotic Thrombocytopenic Purpura Disease Registry: National Multicenter Study', 'orgStudyIdInfo': {'id': 'eTTP-THD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'All Patients', 'description': 'Non interventional observational'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Sema Karakus, Prof', 'role': 'CONTACT', 'email': 'sema_karakus@hotmail.com', 'phone': '+905335476318'}], 'facility': 'Baskent Universtiy Faculty of Medicine', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'ilker kurkcu', 'role': 'CONTACT', 'email': 'ilker.kurkcu@sentez-cro.com', 'phone': '+905326354515'}], 'overallOfficials': [{'name': 'ilker kurkcu', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sentez-CRO'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Turkish Hematology Association', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sanofi', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}