Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-01-03 @ 4:44 AM
Study NCT ID:
NCT03180567
Status:
UNKNOWN
Last Update Posted:
2017-06-08
First Post:
2017-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacogentic Screening of Coumarine Based Oral Anticoagulant Using Next Generation Seguencer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009154', 'term': 'Mutation'}], 'ancestors': [{'id': 'D014644', 'term': 'Genetic Variation'}, {'id': 'D055614', 'term': 'Genetic Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-06-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-06-06', 'studyFirstSubmitDate': '2017-06-06', 'studyFirstSubmitQcDate': '2017-06-06', 'lastUpdatePostDateStruct': {'date': '2017-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of patients with genetic polymorphism', 'timeFrame': '6 months', 'description': 'patients with abnormal polymorphisms'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thrombosis']}, 'descriptionModule': {'briefSummary': 'As drug response is a complex trait in the majority of cases using an optimal starting dose for an individual may reduce the time taken to reach a stable INR, and reduce the risk of having either a high INR (with a risk of bleeding) or a low INR (with a risk of thrombosis)', 'detailedDescription': 'The results of this project will benefit in (1) Identification of novel features or mutation types in warfarin resistance genomes. (2) To determine whether other polymorphisms in noncoding regions or their unique haplotype combinations contribute to the variability in the maintenance dose of warfarin, and (3)personalization of the drug and deciding the correct dose from the start.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with thrombosis and warfarin resistance\n\nExclusion Criteria:\n\n* less than 18 years'}, 'identificationModule': {'nctId': 'NCT03180567', 'briefTitle': 'Pharmacogentic Screening of Coumarine Based Oral Anticoagulant Using Next Generation Seguencer', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Pharmacogentic Screening of Coumarine Based Oral Anticoagulant Using Next Generation Seguencer', 'orgStudyIdInfo': {'id': 'Prof Amr gawaly'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Warfarin resistant patients', 'description': 'Genetic Mutations', 'interventionNames': ['Diagnostic Test: Genetic Mutations']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Genetic Mutations', 'interventionNames': ['Diagnostic Test: Genetic Mutations']}], 'interventions': [{'name': 'Genetic Mutations', 'type': 'DIAGNOSTIC_TEST', 'description': 'By next generation sequencing', 'armGroupLabels': ['Control', 'Warfarin resistant patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'state': 'Tanta', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Sherief Abd-elsalam, lecturer', 'role': 'CONTACT', 'email': 'Sherif_tropical@yahoo.com', 'phone': '00201000040794'}, {'name': 'Ahmed Elsharkawy, Ass. lect.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Sherief Abd-Elsalam', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Amr Gawaly, Ass Prof', 'role': 'CONTACT', 'email': 'amrgawaly1@yahoo.com', 'phone': '01221793033'}], 'overallOfficials': [{'name': 'Amr Gawaly, Consultant', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hematology Dept. - Tanta University'}, {'name': 'Said Hammad Abdou, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Pathology dept.- Tanta University'}, {'name': 'Enas Abdul-Raouf, Lecturer', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Biology and Genetics- Tanta University'}, {'name': 'Abdelaziz Zidane, Lecturer', 'role': 'STUDY_CHAIR', 'affiliation': 'Genetics-Damanhour University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}