Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-30 @ 3:10 AM
Study NCT ID:
NCT07337967
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-13
First Post:
2025-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reticulocyte Parameters as Early Indicators of Bone Marrow Erythropoietic Activity in Chronic B Lymphoproliferative Neoplasms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015448', 'term': 'Leukemia, B-Cell'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-07', 'studyFirstSubmitDate': '2025-12-13', 'studyFirstSubmitQcDate': '2026-01-07', 'lastUpdatePostDateStruct': {'date': '2026-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reticulocyte count', 'timeFrame': '1 year', 'description': 'Absolute peripheral blood reticulocyte count measured in patients with chronic B-cell lymphoproliferative disorders (CLPDs).\n\nUnit of Measure: ×10⁹/L'}, {'measure': 'Reticulocyte percentage', 'timeFrame': '1 year', 'description': 'Percentage of reticulocytes among total red blood cells in peripheral blood of patients with CLPDs.\n\nUnit of Measure: %'}, {'measure': 'Immature reticulocyte fraction (IRF)', 'timeFrame': '1 year', 'description': 'Proportion of immature reticulocytes in peripheral blood measured in patients with CLPDs.\n\nUnit of Measure: %'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['B Chronic Lymphocytic Leukemia']}, 'descriptionModule': {'briefSummary': 'Reticulocyte parameters as early indicators of bone marrow erythropoietic activity in chronic B lymphoproliferative neoplasms'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Newly diagnosed adult patients with Chronic B LymphoPoliferative neoplasm according to WHO classification.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Newly diagnosed adult patients with Chronic B LymphoPoliferative neoplasm according to WHO classification.\n\nExclusion Criteria:\n\n1\\) Patients received chemotherapy.\n\n1. Patients with Active bleeding\n2. Patients with recent blood transfusion (less than 2 weeks).\n3. Patients on haematinics or vitamin B 12 therapy'}, 'identificationModule': {'nctId': 'NCT07337967', 'briefTitle': 'Reticulocyte Parameters as Early Indicators of Bone Marrow Erythropoietic Activity in Chronic B Lymphoproliferative Neoplasms', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Reticulocyte Parameters as Early Indicators of Bone Marrow Erythropoietic Activity in Chronic B Lymphoproliferative Neoplasms', 'orgStudyIdInfo': {'id': 'AUN-FOM-CP-CLPD-RETIC-2025'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huda Ahmed Abdelsabour Abdelwahab', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Resident doctor', 'investigatorFullName': 'Huda Ahmed Abdelsabour Abdelwahab', 'investigatorAffiliation': 'Assiut University'}}}}