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