Amplification of Zinc Finger Protein 217 Gene in Multiple Myeloma

Sponsor

Assiut University (Other)

Overall Status

Unknown status

CT.gov ID

NCT04212858

Collaborator

(none)

100

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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 .

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Genetic: zinc-finger protein 217 gene	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

Amplification of Zinc- Finger Protein 217 Gene in Multiple Myeloma Patients as a Prognostic Marker

Anticipated Study Start Date :

Jan 1, 2020

Anticipated Primary Completion Date :

Jan 1, 2022

Anticipated Study Completion Date :

Feb 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: case myeloma patients	Genetic: zinc-finger protein 217 gene search for zinc-finger protein 217 gene in myeloma patients
Experimental: control healthy control	Genetic: zinc-finger protein 217 gene search for zinc-finger protein 217 gene in myeloma patients

Arm

Intervention/Treatment

Experimental: case

myeloma patients

Genetic: zinc-finger protein 217 gene

search for zinc-finger protein 217 gene in myeloma patients

Experimental: control

healthy control

Genetic: zinc-finger protein 217 gene

search for zinc-finger protein 217 gene in myeloma patients

Outcome Measures

Primary Outcome Measures

zinc-finger protein gene 217 in myeloma patients [2 years]
Measurement of amplification of Zinc-finger protein 217 gene in Multiple myeloma patients as a prognostic marker by fluorescence in situ hybridization technique

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Aya Mohammed ebrahim tawfik, specialist of clinical pathology, Assiut University

ClinicalTrials.gov Identifier:

NCT04212858

Other Study ID Numbers:

Zinc finger protein 217 gene

First Posted:

Dec 30, 2019

Last Update Posted:

Dec 30, 2019

Last Verified:

Dec 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Aya Mohammed ebrahim tawfik, specialist of clinical pathology, Assiut University

Zinc finger 217 protein gene .

Multiple myeloma

Additional relevant MeSH terms:

Multiple Myeloma

Neoplasms, Plasma Cell

Study Results

No Results Posted as of Dec 30, 2019