Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2025-12-26 @ 12:58 AM
Study NCT ID:
NCT05371392
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-20
First Post:
2022-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Polymorphism of ITGA4 Gene in Chronic Lymphocytic Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}], 'ancestors': [{'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-17', 'studyFirstSubmitDate': '2022-04-29', 'studyFirstSubmitQcDate': '2022-05-07', 'lastUpdatePostDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ITGA4 gene expression pattern in chronic lymphocytic leukemia', 'timeFrame': '1 year following the startpoint of the study', 'description': 'Detection of ITGA4 gene expression in blood samples in patients with chronic lymphocytic leukemia, Briefly, total RNA and genomic DNA extraction from fresh peripheral blood samples by Real-time -RT-polymerase chain reaction system (RT-PCR) will be carried out. Rate of ITGA4 gene expression will be recorded.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Lymphocytic Leukemia']}, 'descriptionModule': {'briefSummary': 'Chronic lymphocytic leukemia (CLL) is a clonal lymphoproliferative disorder that is characterized by heterogeneous presentation at the clinical and molecular levels. ITGA4 protein has been found to be deregulated in CLL with adverse clinical outcome. ITGA4 gene (CD49d) encodes a member of the integrin alpha chain family of proteins and is considered a negative prognosticator in CLL with aggressive course and short time to treatment.\n\nThe aim of the study:\n\nis to investigate ITGA4 gene expression pattern in CLL.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'newly diagnosed patients with Chronic lymphocytic leukemia', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with newly diagnosed CLL.\n\nExclusion Criteria:\n\n* ▪ Patients previously diagnosed as CLL and received treatment before.\n\n * Patients with other solid tumors.'}, 'identificationModule': {'nctId': 'NCT05371392', 'briefTitle': 'Polymorphism of ITGA4 Gene in Chronic Lymphocytic Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Polymorphism of the ITGA4 Gene (Integrin Subunit Alpha 4) in Chronic Lymphocytic Leukemia', 'orgStudyIdInfo': {'id': 'soh-med-22-04-21'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patient group'}, {'label': 'control group'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'country': 'Egypt', 'contacts': [{'name': 'Amer Ahmed Youssef', 'role': 'CONTACT', 'email': 'Amer_ahmed_post@med.sohag.edu.eg', 'phone': '01033000406'}], 'facility': 'Sohag university', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Amer Ahmed Youssif', 'role': 'CONTACT', 'email': 'Amer_ahmed_post@med.sohag.edu.eg', 'phone': '01033000406', 'phoneExt': 'Sohag'}], 'overallOfficials': [{'name': 'Amer Ahmed Youssif', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sohag University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Specialist of clinical and chemical pathology', 'investigatorFullName': 'Amer Ahmed Youssef Abdalkareem', 'investigatorAffiliation': 'Sohag University'}}}}