Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-26 @ 12:27 AM
Study NCT ID:
NCT07182760
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-19
First Post:
2025-09-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ultrasound to Detect Splenomegally in Patients With Isolated Thrombocytopenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-13', 'studyFirstSubmitDate': '2025-09-03', 'studyFirstSubmitQcDate': '2025-09-13', 'lastUpdatePostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Investigate prevalence of splenomegally in patients with isolated thrombocytopenia. Asess effect of splenomegally in clinical picture ,Complication, treatment response and disease outcome', 'timeFrame': 'Baseline', 'description': '1. How many patients with isolated thrombocytopenia present with splenomegaly\n2. Do patients with splenomegaly experience different complications compared to those without splenic enlargement\n3. Is there a difference in treatment response between patients presenting with splenomegaly and those without splenic involvement'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Primary Immune Thrombocytopenic Purpura', 'Amegakaryocytic Aplasia', 'Unilineage Myelodysplastic Syndrome ( Megakaryocyte Dysplasia)', 'Lymphoproliferative Disorder With Secondary ITP', 'Autoimmune Diseases With Secondary ITP']}, 'referencesModule': {'references': [{'pmid': '22364760', 'type': 'BACKGROUND', 'citation': 'Achterbergh R, Vermeer HJ, Curtis BR, Porcelijn L, Aster RH, Deenik W, Daemen-Gubbels C. Thrombocytopenia in a nutshell. Lancet. 2012 Feb 25;379(9817):776. doi: 10.1016/S0140-6736(11)61643-7. No abstract available.'}, {'pmid': '9746024', 'type': 'BACKGROUND', 'citation': 'Arnold J, Ouwehand WH, Smith GA, Cohen H. A young woman with petechiae. Lancet. 1998 Aug 22;352(9128):618. doi: 10.1016/s0140-6736(98)05194-0. No abstract available.'}, {'pmid': '14216353', 'type': 'BACKGROUND', 'citation': 'LAVY R. THROMBOCYTOPENIC PURPURA DUE TO LUPINUS TERMIS BEAN. J Allergy. 1964 Sep-Oct;35:386-9. doi: 10.1016/0021-8707(64)90065-6. No abstract available.'}, {'pmid': '25134884', 'type': 'BACKGROUND', 'citation': 'Kam T, Alexander M. Drug-induced immune thrombocytopenia. J Pharm Pract. 2014 Oct;27(5):430-9. doi: 10.1177/0897190014546099. Epub 2014 Aug 17.'}]}, 'descriptionModule': {'briefSummary': 'Investigate prevalence of splenomegally in patients with isolated thrombocytopenia.\n\nAsess effect of splenomegally in clinical picture ,Complication, treatment response and disease outcome To explain possible causes of splenomegally in patients with isolated thrombocytopenia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with isolated thrombocytopenia between 18 years to 65years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients more than 18 years admitted with isolated thrombocytopenia due to primary Immune thrombocytopenic purpura amegakaryocytic aplasia Unilineage myelodysplastic syndrome ( megakaryocyte dysplasia) lymphoproliferative disorder with secondary ITP autoimmune diseases with secondary ITP Willingness to participate in the study Admitted patients or those who follow at hematology outpatients clinic\n\nExclusion Criteria:\n\nEDTA induced pseudothrombocytopenia Platelet satellitism Drug induced thrombocytopenia Heparin induced thrombocytopenia / thrombosis syndrome post transfusion purpura Disseminated intravascular coagulopathy patients less than 18 years old patients with bicytopenia or pancytopenia Pregnancy\n\n\\-'}, 'identificationModule': {'nctId': 'NCT07182760', 'briefTitle': 'Ultrasound to Detect Splenomegally in Patients With Isolated Thrombocytopenia', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Clinicopathologic Significance of Splenomegally in Adult Patients With Isolated Thrombocytopenia', 'orgStudyIdInfo': {'id': 'S.I.TH'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1a patients with isolated thrombocytopenia and splenomegaly', 'description': 'Group 1b patients with isolated thrombocytopenia without splenomegaly.'}, {'label': 'Group 1b patients with isolated thrombocytopenia without splenomegaly.', 'description': 'Group 1b patients with isolated thrombocytopenia without splenomegaly.'}, {'label': 'Group 2 healthy volunteers.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Karim Ashraf, Resident', 'role': 'CONTACT', 'email': 'Karimazqal123@gmail.com', 'phone': '+20', 'phoneExt': '01019954118'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident in Internal Medicine Department in Assiut University Hospitals', 'investigatorFullName': 'Karim Ashraf hussein youssef', 'investigatorAffiliation': 'Assiut University'}}}}