NCT04215822

Brief Summary

The study aims to detect pattern of expression of PHF19 gene and EZH2 gene deletion in acute myeloid leukemia patients and detect their prognostic role on patients outcome.

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
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

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 30, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 2, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

January 3, 2020

Status Verified

December 1, 2019

Enrollment Period

2.1 years

First QC Date

December 30, 2019

Last Update Submit

January 1, 2020

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

  • detection of pattern of expression of PHF19 gene and EZH2 gene deletion in newly diagnosed AML patients.

    Cytogenetic analysis (FISH) for EZH2 gene deletion. -Real time PCR for PHF 19 gene expression.

    2 years

Study Arms (1)

acute myeloid leukemia patients - control group

acute myeloid leukemia

Diagnostic Test: Cytogenetic analysis (FISH) for EZH2 gene deletion. -Real time PCR for PHF 19 gene expression.

Interventions

Cytogenetic analysis (FISH) for EZH2 gene deletion. -Real time PCR for PHF 19 gene expression.DIAGNOSTIC_TEST

Cytogenetic analysis (FISH) for EZH2 gene deletion. -Real time PCR for PHF 19 gene expression.

acute myeloid leukemia patients - control group

Eligibility Criteria

Age16 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

newly diagnosed AML patients and healthy subjects as control group.

You may qualify if:

  • Adult newly diagnosed Patients with acute myeloid leukemia (AML), who fullfill the WHO criteria.

You may not qualify if:

  • Patients with any other type of malignant tumors.
  • Therapy related AML patients.
  • AML on top of myeloproliferative neoplasms or MDS.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Skoda RC, Schwaller J. Dual roles of EZH2 in acute myeloid leukemia. J Exp Med. 2019 Apr 1;216(4):725-727. doi: 10.1084/jem.20190250. Epub 2019 Mar 19.

    PMID: 30890555BACKGROUND

  • Chu MQ, Zhang TJ, Xu ZJ, Gu Y, Ma JC, Zhang W, Wen XM, Lin J, Qian J, Zhou JD. EZH2 dysregulation: Potential biomarkers predicting prognosis and guiding treatment choice in acute myeloid leukaemia. J Cell Mol Med. 2020 Jan;24(2):1640-1649. doi: 10.1111/jcmm.14855. Epub 2019 Dec 3.

    PMID: 31794134BACKGROUND

  • Ren Z, Ahn JH, Liu H, Tsai YH, Bhanu NV, Koss B, Allison DF, Ma A, Storey AJ, Wang P, Mackintosh SG, Edmondson RD, Groen RWJ, Martens AC, Garcia BA, Tackett AJ, Jin J, Cai L, Zheng D, Wang GG. PHF19 promotes multiple myeloma tumorigenicity through PRC2 activation and broad H3K27me3 domain formation. Blood. 2019 Oct 3;134(14):1176-1189. doi: 10.1182/blood.2019000578. Epub 2019 Aug 5.

    PMID: 31383640BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

peripheral blood and bone marrrow aspirate samples

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Cytogenetic AnalysisIn Situ Hybridization, Fluorescence

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Cytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesGenetic TechniquesIn Situ HybridizationStaining and LabelingHistocytological Preparation TechniquesHistological TechniquesNucleic Acid Hybridization

Study Officials

  • Somaia Abd El Rahman

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

safia abd el hakeem hussien

CONTACT

01064438345dr_safia@yahoo.com

alaa soliman

CONTACT

01061329093dr_alaa57@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

December 30, 2019

First Posted

January 2, 2020

Study Start

January 1, 2020

Primary Completion

January 30, 2022

Study Completion

April 1, 2022

Last Updated

January 3, 2020

Record last verified: 2019-12