Ignite Creation Date:
2025-12-24 @ 1:29 PM
Ignite Modification Date:
2025-12-30 @ 7:46 AM
Study NCT ID:
NCT07183995
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-25
First Post:
2025-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hematological Disorders in Patients With GI Angiodysplasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006471', 'term': 'Gastrointestinal Hemorrhage'}], 'ancestors': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 55}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-22', 'studyFirstSubmitDate': '2025-09-14', 'studyFirstSubmitQcDate': '2025-09-14', 'lastUpdatePostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between GIT Angiodysplasia and Hematological disorders', 'timeFrame': 'Baseline', 'description': 'All patients eligible to participate will undergo the following:\n\n1. upper endoscopy\n2. Colonoscopy\n3. Complete blood count, CRP\n4. D-Dimer, liver function tests, blood Urea and serum Creatinine\n5. ECG\n6. Coagulation profile (aPTT , von Willebrand factor activity \\&antigen)'}], 'secondaryOutcomes': [{'measure': 'Prevelance of different hematological disorders in angiodysplasia patients', 'timeFrame': 'Baseline'}, {'measure': "Prognostic value of von Willebrand factor on patient's outcomes as risk of rebleeding and hospital mortality", 'timeFrame': 'Baseline'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['GI Bleeding']}, 'descriptionModule': {'briefSummary': "The aim of this study will be to assess the association between GIT angiodysplasia with any hematological disorders as von Willebrand factor and Prognostic value of von Willebrand factor on patient's outcomes as risk of rebleeding and hospital mortality"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients eligible to participate will undergo the following:\n\n1. upper endoscopy\n2. Colonoscopy\n3. Complete blood count, CRP\n4. D-Dimer, liver function tests, blood Urea and serum Creatinine\n5. ECG\n6. Coagulation profile (aPTT , von Willebrand factor activity \\&antigen)', 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdults (above 18 years) and elderly Both genders Admitted to GIT Unit with manifestations of GIT bleeding diagnosed by upper endoscopy and Colonoscopy as angiodyplasia.\n\n\\-\n\nExclusion Criteria:\n\nother causes of GIT bleeding\n\n\\-'}, 'identificationModule': {'nctId': 'NCT07183995', 'briefTitle': 'Hematological Disorders in Patients With GI Angiodysplasia', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Hematological Disorders in Patients With Gastrointestinal Angiodysplasia', 'orgStudyIdInfo': {'id': 'GI angiodysplasia patients'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mennat-allah Alaa Abdelgaber, Resident', 'role': 'CONTACT', 'email': 'Menna.17289695@med.aun.edu.eg', 'phone': '+201021789585'}], 'overallOfficials': [{'name': 'Mennat-allah Alaa Abdelgaber', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut University'}, {'name': 'Mohamed Zein Elabdin Hafez', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}, {'name': 'AbdelHamid Mohamed AbdelHamid', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigatir', 'investigatorFullName': 'Mennat-allah Alaa Abdelgaber Omar', 'investigatorAffiliation': 'Assiut University'}}}}