Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-02-21 @ 9:31 AM
Study NCT ID:
NCT05119205
Status:
UNKNOWN
Last Update Posted:
2021-11-22
First Post:
2021-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Survival Outcomes of Multiple Myeloma Patients Admitted on Assiut Clinical Hematology Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-14', 'studyFirstSubmitDate': '2021-11-02', 'studyFirstSubmitQcDate': '2021-11-02', 'lastUpdatePostDateStruct': {'date': '2021-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine the survival outcomes of multiple myeloma patients admitted on Assiut clinical Hematology unit', 'timeFrame': '2 years', 'description': 'Survival time will be measured as time from index date (that is, diagnosis date for MM patients) to the date of death; patients without a date of death were assumed alive at the end of the study period. Survival estimates will be assessed by types of treatment among MM patients. In addition, the proportion of patients who died or survived at least 2, 3 or 5 years after diagnosis will be also described.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multiple Myeloma Survival Outcome']}, 'descriptionModule': {'briefSummary': 'Our study will discuss survival outcomes of multiple myeloma patients admitted on Assiut clinical Hematology and role of neutrophil to lymphocyte and lymphocyte to monocyte ratios as prognostic factors in multiple myeloma.', 'detailedDescription': "What are survival outcomes and the prognostic value of neutrophil to lymphocyte ratio of multiple myeloma patients admitted on Assiut clinical Hematology unit? Multiple myeloma (MM)is a plasma cell neoplasm associated with its characteristic clinical complications: anemia, infections, renal impairment or bone destruction. MM is the second most commonly diagnosed hematological neoplasm, with an incidence rate of 6.2 per 100 000 individuals .\n\nSurvival outcomes have remained constant over the past few decades; therefore, MM is still considered incurable. However, the increasing use of autologous stem cell transplantation (SCT) and the introduction of novel therapeutic agents, such as thalidomide and bortezomib, have improved the survival of myeloma patients .\n\nRelationship between inflammation and cancer have been established. Some inflammatory factors from accessory cells in tumor milieu, such as interleukin-1 (IL-1), IL-6, and tumor necrosis factor-alpha (TNF-α), facilitated cancer cells' invasiveness .\n\nFurther studies exhibited the reactive oxygen and nitrogen from inflammatory cells induced mutation of some tumor suppressor genes, and inflammatory factors such as IL-6 and prostaglandin E2 (PGE2) caused DNA methylation, which both played an important role in tumorigenesis. Accordingly, neutrophil to lymphocyte ratio (NLR) coinciding with rationales supported by numerous studies, could offer a precise potency in predicting prognosis of cancers. In fact, many studies already demonstrated the prognostic significance of NLR in various cancers Consistently, a number of meta-analyses further confirmed this view in colorectal cancer, lung cancer, ovarian cancer, breast cancer, and lymphoma and others."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with multiple myeloma in our unit will be included in the study and follow-up will be done to determine the outcome.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: clinical and laboratory diagnosis of multiple myeloma\n\n* multiple myeloma patients received chemotherapy in our unit.\n\nExclusion Criteria:\n\n* Waldenstrom macroglobulinemia\n* MGUS\n* Amyloidosis\n* Other plasna cell disorders'}, 'identificationModule': {'nctId': 'NCT05119205', 'briefTitle': 'Survival Outcomes of Multiple Myeloma Patients Admitted on Assiut Clinical Hematology Unit', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Study of Survival Outcomes of Multiple Myeloma Patients Admitted on Assiut Clinical Hematology Unit Observational Study', 'orgStudyIdInfo': {'id': 'assiut5000'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Bone marrow biopsy and compete blood count', 'type': 'DIAGNOSTIC_TEST', 'description': 'Bone marrow biopsy and compete blood count will be done for follow up in patients with multiple myeloma'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assiut University', 'investigatorFullName': 'Reham Badr', 'investigatorAffiliation': 'Assiut University'}}}}