Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:37 PM
Study NCT ID:
NCT06691451
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-15
First Post:
2024-11-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Inherited Thromophilia and Thrombotic Risks in Inflammatory Bowel Disease During Activity and Remission
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 93}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-14', 'studyFirstSubmitDate': '2024-11-14', 'studyFirstSubmitQcDate': '2024-11-14', 'lastUpdatePostDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison between the number of IBD patients with tendency to thrombosis in cases of activity-', 'timeFrame': 'Baseline', 'description': '-investigate the presence of multiple mutations associated with IBD patients with or without vascular complications.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inflammatory Bowel Diseases']}, 'referencesModule': {'references': [{'pmid': '27942288', 'type': 'RESULT', 'citation': 'Yazici A, Senturk O, Aygun C, Celebi A, Caglayan C, Hulagu S. Thrombophilic Risk Factors in Patients With Inflammatory Bowel Disease. Gastroenterology Res. 2010 Jun;3(3):112-119. doi: 10.4021/gr2010.06.209w. Epub 2010 May 20.'}]}, 'descriptionModule': {'briefSummary': 'Inherited thombopllia and thrombotic risks in inflammatory bowel Disease during activity and remission', 'detailedDescription': "Inflammatory bowel diseases (IBD) are systemic conditions characterized by multiple intestinal and extra-intestinal manifestations related to the associated chronic inflammatory state. Among their diverse extra-intestinal complications, venous thromboembolism (VTE) remains one of the most under recognized causes of morbidity and mortality in these patients, highlighting the need for a better understanding of the underlying mechanism of hypercoagulability, in addition to the role of acquired and inherited risk factors that further increase the risk of thrombosis with its impact on patients' outcomes.\\[1, 2\\]"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study will be conducted at internal medicine department Assiut universty', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age (18yrs - 65yrs) both sex\n\nExclusion Criteria:\n\n* Presence of acquired cause (pregnancy, recent surgery, history of drug, History of malignant Disease, History of blood or blood product transfusion in last 4 weeks)'}, 'identificationModule': {'nctId': 'NCT06691451', 'briefTitle': 'Inherited Thromophilia and Thrombotic Risks in Inflammatory Bowel Disease During Activity and Remission', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Inherited Thrombophilia and Thrombotic Risks in Inflammatory Bowel Disease During Activity and Remission', 'orgStudyIdInfo': {'id': 'Thrombophilia in ibd patients'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Asmaa Mohammed Abdelaal, Master', 'role': 'CONTACT', 'email': 'Asmaamohammedabdelaal0098@gmail.com', 'phone': '01066239562', 'phoneExt': '01066239562'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asmaa mohammed abdelaal abdelaal', 'class': 'OTHER'}, 'collaborators': [{'name': 'Assiut University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dr Asmaa Abdelaal', 'investigatorFullName': 'Asmaa mohammed abdelaal abdelaal', 'investigatorAffiliation': 'Assiut University'}}}}