search
Back to results

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
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Multiple Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    August 9, 2023
    Last Updated
    August 9, 2023
    Sponsor
    Sohag University
    search

    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

    We'll reach out to this number within 24 hrs