NCT05592470

Brief Summary

  • study the expression pattern of COMMD7 gene in acute lymphoblastic leukemia.
  • investigate correlation between the expression level of COMMD7 gene with other diagnostic parameters and prognosis in ALL .

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
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2022

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

October 20, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 24, 2022

Completed
8 days until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

October 24, 2022

Status Verified

September 1, 2022

Enrollment Period

1.4 years

First QC Date

October 20, 2022

Last Update Submit

October 20, 2022

Conditions

Keywords

COMMD7 , ALL

Outcome Measures

Primary Outcomes (1)

  • The expression pattern of COMMD7 gene in acute lymphoblastic leukemia

    Reverse transcription-quantitative polymerase chain reaction (RT-qPCR) TO DETECT EXPRESSION pattern in ALL

    BASELINE

Secondary Outcomes (1)

  • Correlation between the expression level of COMMD7 GENE with other diagnostic parameters and prognosis in ALL

    baseline

Study Arms (2)

PATEINTS

51 patients newly diagnosed with acute lymphoblastic leukemia

Diagnostic Test: Reverse transcription-quantitative polymerase chain reaction (RT-qPCR).

controls

51 normal persons

Diagnostic Test: Reverse transcription-quantitative polymerase chain reaction (RT-qPCR).

Interventions

Reverse transcription-quantitative polymerase chain reaction on bone marrow aspirates to detect The expression pattern of COMMD7 gene in acute lymphoblastic leukemia

PATEINTScontrols

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The required sample size will be 102 subject (51 newly diagnosed patients with ALL and 51 controls )

You may qualify if:

  • Patients newly diagnosed with acute lymphoblastic leukemia , male or female at any age.

You may not qualify if:

  • history of anti-neoplastic therapy, such as chemotherapy or radiotherapy.
  • Any other types of cancers.
  • Any clinically systemic acute or chronic inflammatory disease/s within one months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • Garza-Veloz I, Martinez-Fierro ML, Jaime-Perez JC, Carrillo-Sanchez K, Ramos-Del Hoyo MG, Lugo-Trampe A, Rojas-Martinez A, Gutierrez-Aguirre CH, Gonzalez-Llano O, Salazar-Riojas R, Hidalgo-Miranda A, Gomez-Almaguer D, Ortiz-Lopez R. Identification of differentially expressed genes associated with prognosis of B acute lymphoblastic leukemia. Dis Markers. 2015;2015:828145. doi: 10.1155/2015/828145. Epub 2015 Feb 24.

    PMID: 25802479BACKGROUND
  • Short NJ, Kantarjian H, Jabbour E. Optimizing the treatment of acute lymphoblastic leukemia in younger and older adults: new drugs and evolving paradigms. Leukemia. 2021 Nov;35(11):3044-3058. doi: 10.1038/s41375-021-01277-3. Epub 2021 Jun 25.

    PMID: 34172894BACKGROUND
  • Bartuzi P, Hofker MH, van de Sluis B. Tuning NF-kappaB activity: a touch of COMMD proteins. Biochim Biophys Acta. 2013 Dec;1832(12):2315-21. doi: 10.1016/j.bbadis.2013.09.014. Epub 2013 Sep 29.

    PMID: 24080195BACKGROUND
  • Burstein E, Hoberg JE, Wilkinson AS, Rumble JM, Csomos RA, Komarck CM, Maine GN, Wilkinson JC, Mayo MW, Duckett CS. COMMD proteins, a novel family of structural and functional homologs of MURR1. J Biol Chem. 2005 Jun 10;280(23):22222-32. doi: 10.1074/jbc.M501928200. Epub 2005 Mar 30.

    PMID: 15799966BACKGROUND
  • You N, Li J, Gong Z, Huang X, Wang W, Wang L, Wu K, Zheng L. COMMD7 functions as molecular target in pancreatic ductal adenocarcinoma. Mol Carcinog. 2017 Feb;56(2):607-624. doi: 10.1002/mc.22520. Epub 2016 Jul 8.

    PMID: 27350032BACKGROUND
  • You N, Li J, Huang X, Wu K, Tang Y, Wang L, Li H, Mi N, Zheng L. COMMD7 promotes hepatocellular carcinoma through regulating CXCL10. Biomed Pharmacother. 2017 Apr;88:653-657. doi: 10.1016/j.biopha.2017.01.046. Epub 2017 Jan 29.

    PMID: 28142122BACKGROUND
  • Li K, Chen L, Zhang H, Wang L, Sha K, Du X, Li D, Zheng Z, Pei R, Lu Y, Tong H. High expression of COMMD7 is an adverse prognostic factor in acute myeloid leukemia. Aging (Albany NY). 2021 Apr 23;13(8):11988-12006. doi: 10.18632/aging.202901. Epub 2021 Apr 23.

    PMID: 33891561BACKGROUND

Central Study Contacts

marwa saad mohamed, master

CONTACT

sohair mohamed ahmed, doctoral

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
AssuitU

Study Record Dates

First Submitted

October 20, 2022

First Posted

October 24, 2022

Study Start

November 1, 2022

Primary Completion

April 1, 2024

Study Completion

November 1, 2024

Last Updated

October 24, 2022

Record last verified: 2022-09