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Cyclin D1 as a Prognostic Factor in Multiple Myeloma and Its Association With the Immunological Prognostic Factor PDL1 and Clinical and Biochemical Lab Tests

Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05995808
Collaborator
(none)
30
Enrollment
1
Arm
23
Anticipated Duration (Months)

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Procedure: Bone marow biopsy and aspiration
  • Diagnostic Test: biochemical and heamatological tests
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
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
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Aug 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: diagnostic group

Procedure: Bone marow biopsy and aspiration
Bone marrow biopsy and biopsy aspiration

Diagnostic Test: biochemical and heamatological tests
complete blood count ,serum urea and creatinine
Other Names:
  • complete blood count ,urea and creatinine in serum

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Cycline D1 expression in bone marrow biopsy of multiple myeloma patient [1 year]

      Cycline D1 expression in bone marrow biopsy of multiple myeloma patient

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Patients older than 18 year with newly diagnosed MM.

    2. Approval to sign an informed written consent.

    Exclusion Criteria:
      1. Patient younger than 18 years. 2.Refusal to sign an informed written consent.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Sohag University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fainan Khaled Ahmed, clinical pathology specialist, Sohag University
    ClinicalTrials.gov Identifier:
    NCT05995808
    Other Study ID Numbers:
    • Soh-Med-23-07-02MD
    First Posted:
    Aug 16, 2023
    Last Update Posted:
    Aug 16, 2023
    Last Verified:
    Aug 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Multiple Myeloma
    Neoplasms, Plasma Cell

    Study Results

    No Results Posted as of Aug 16, 2023