Cyclin D1 as a Prognostic Factor in Multiple Myeloma and Its Association With the Immunological Prognostic Factor PDL1 and Clinical and Biochemical Lab Tests
Primary Purpose
Multiple Myeloma
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bone marow biopsy and aspiration
biochemical and heamatological tests
Sponsored by
About this trial
This is an interventional diagnostic trial for Multiple Myeloma
Eligibility Criteria
Inclusion Criteria: Patients older than 18 year with newly diagnosed MM. Approval to sign an informed written consent. Exclusion Criteria: 1. Patient younger than 18 years. 2.Refusal to sign an informed written consent.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
diagnostic group
Arm Description
Outcomes
Primary Outcome Measures
Cycline D1 expression in bone marrow biopsy of multiple myeloma patient
Cycline D1 expression in bone marrow biopsy of multiple myeloma patient
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05995808
Brief Title
Cyclin D1 as a Prognostic Factor in Multiple Myeloma and Its Association With the Immunological Prognostic Factor PDL1 and Clinical and Biochemical Lab Tests
Official Title
Cyclin D1 as a Prognostic Factor in Multiple Myeloma and Its Association With the Immunological Prognostic Factor PDL1 and Clinical and Biochemical Lab Tests
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Multiple myeloma (MM) is the most common bone marrow malignancy of terminally differentiated plasma cells. It accounts for about 1% of all malignant diseases and 10% of haematological malignancies and takes the second place after non-Hodgkin lymphoma .
There are some serological and clinical criteria that help to detect the stage of MM and predict the patients' prognosis. These criteria include the level of M protein, calcium, haemoglobin, albumin, creatinine, β2-microglobulin and glomerular filtration rate (GFR).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
diagnostic group
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Bone marow biopsy and aspiration
Intervention Description
Bone marrow biopsy and biopsy aspiration
Intervention Type
Diagnostic Test
Intervention Name(s)
biochemical and heamatological tests
Other Intervention Name(s)
complete blood count ,urea and creatinine in serum
Intervention Description
complete blood count ,serum urea and creatinine
Primary Outcome Measure Information:
Title
Cycline D1 expression in bone marrow biopsy of multiple myeloma patient
Description
Cycline D1 expression in bone marrow biopsy of multiple myeloma patient
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients older than 18 year with newly diagnosed MM.
Approval to sign an informed written consent.
Exclusion Criteria:
1. Patient younger than 18 years. 2.Refusal to sign an informed written consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fainan K EL Kady, spcialist
Phone
01063017967
Email
fainan_khaled_post@med.sohag.edeu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Douaa M Sayed, professor
12. IPD Sharing Statement
Learn more about this trial
Cyclin D1 as a Prognostic Factor in Multiple Myeloma and Its Association With the Immunological Prognostic Factor PDL1 and Clinical and Biochemical Lab Tests
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