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Amplification of Zinc Finger Protein 217 Gene in Multiple Myeloma

Primary Purpose

Multiple Myeloma

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
zinc-finger protein 217 gene
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Multiple Myeloma focused on measuring Zinc finger 217 protein gene ., Multiple myeloma

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Newly diagnosed multiple myeloma patients, who fulfill the WHO criteria of myeloma diagnosis.

Exclusion Criteria:

  • Patients with any other type of malignant or benign tumors should be excluded from our study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    case

    control

    Arm Description

    myeloma patients

    healthy control

    Outcomes

    Primary Outcome Measures

    zinc-finger protein gene 217 in myeloma patients
    Measurement of amplification of Zinc-finger protein 217 gene in Multiple myeloma patients as a prognostic marker by fluorescence in situ hybridization technique

    Secondary Outcome Measures

    Full Information

    First Posted
    December 23, 2019
    Last Updated
    December 24, 2019
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04212858
    Brief Title
    Amplification of Zinc Finger Protein 217 Gene in Multiple Myeloma
    Official Title
    Amplification of Zinc- Finger Protein 217 Gene in Multiple Myeloma Patients as a Prognostic Marker
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 1, 2020 (Anticipated)
    Primary Completion Date
    January 1, 2022 (Anticipated)
    Study Completion Date
    February 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut 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 blood disorder characterized by the detection of a monoclonal paraprotein in serum or urine, which is often associated with the presence of clonal plasma cells (PCs) mainly in the bone marrow (BM) .The zinc-finger protein 217 (ZNF217) is an oncogenic protein that plays deleterious functions in various human cancers. The ZNF217 gene is located at the 20q13 chromosomal region, which is frequently amplified in human tumors .
    Detailed Description
    Multiple myeloma (MM) is blood disorder characterized by the detection of a monoclonal paraprotein in serum or urine, which is often associated with the presence of clonal plasma cells (PCs) mainly in the bone marrow (BM) . MM is the second most common hematologic malignancy and is expected to cause ∼13 000 new cases and 30 000 deaths in 2018. Myeloma is a genetically complex disorder characterized by multiple genetic changes, affecting different pathways, that have the ability to deregulate plasma cell biology leading to a broadly similar phenotypic manifestation of disease. From a genetic perspective, myeloma can be divided into those with and without a hyperdiploid karyotype .The zinc-finger protein 217 (ZNF217) is an oncogenic protein that plays deleterious functions in various human cancers. The ZNF217 gene is located at the 20q13 chromosomal region, which is frequently amplified in human tumors . This region also contains several oncogenes thought to confer selective advantages to cancer cells. Increased copy numbers of ZNF217 have been reported in various tumors and linked to poor outcome in some studies . ZNF217 can attenuate apoptotic signals resulting from telomere dysfunction and may promote neoplastic transformation and later stages of malignancy. ZNF217 was shown to be a prognostic biomarker and therapeutic target during breast cancer progression. In our best knowledge, No studies were done to detect ZNF217 in multiple myeloma.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Multiple Myeloma
    Keywords
    Zinc finger 217 protein gene ., Multiple myeloma

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    case
    Arm Type
    Experimental
    Arm Description
    myeloma patients
    Arm Title
    control
    Arm Type
    Experimental
    Arm Description
    healthy control
    Intervention Type
    Genetic
    Intervention Name(s)
    zinc-finger protein 217 gene
    Intervention Description
    search for zinc-finger protein 217 gene in myeloma patients
    Primary Outcome Measure Information:
    Title
    zinc-finger protein gene 217 in myeloma patients
    Description
    Measurement of amplification of Zinc-finger protein 217 gene in Multiple myeloma patients as a prognostic marker by fluorescence in situ hybridization technique
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Newly diagnosed multiple myeloma patients, who fulfill the WHO criteria of myeloma diagnosis. Exclusion Criteria: Patients with any other type of malignant or benign tumors should be excluded from our study.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Amplification of Zinc Finger Protein 217 Gene in Multiple Myeloma

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