NCT04212858

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 .

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for not_applicable multiple-myeloma

Timeline
Completed

Started Jan 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 30, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

December 30, 2019

Status Verified

December 1, 2019

Enrollment Period

2 years

First QC Date

December 23, 2019

Last Update Submit

December 24, 2019

Conditions

Multiple Myeloma

Keywords

Zinc finger 217 protein gene .Multiple myeloma

Outcome Measures

Primary Outcomes (1)

  • 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

    2 years

Study Arms (2)

case

EXPERIMENTAL

myeloma patients

Genetic: zinc-finger protein 217 gene

control

EXPERIMENTAL

healthy control

Genetic: zinc-finger protein 217 gene

Interventions

zinc-finger protein 217 geneGENETIC

search for zinc-finger protein 217 gene in myeloma patients

casecontrol

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Multiple Myeloma

Interventions

ZNF217 protein, human

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
specialist of clinical pathology

Study Record Dates

First Submitted

December 23, 2019

First Posted

December 30, 2019

Study Start

January 1, 2020

Primary Completion

January 1, 2022

Study Completion

February 1, 2022

Last Updated

December 30, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share