We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

ITGA4 Gene Methylation Status in Chronic Lymphocytic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05371392
Recruitment Status : Not yet recruiting
First Posted : May 12, 2022
Last Update Posted : May 12, 2022
Sponsor:
Information provided by (Responsible Party):
Amer Ahmed Youssef Abdalkareem, Sohag University

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

Chronic lymphocytic leukemia (CLL) is a clonal lymphoproliferative disorder that is characterized by heterogeneous presentation at the clinical and molecular levels. ITGA4 protein has been found to be deregulated in CLL with adverse clinical outcome. ITGA4 gene (CD49d) encodes a member of the integrin alpha chain family of proteins and is considered a negative prognosticator in CLL with aggressive course and short time to treatment.

The aim of the study:

is to investigate ITGA4 gene expression pattern and to explore its methylation heterogeneity in CLL.


Condition or disease
Chronic Lymphocytic Leukemia

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: ITGA4 Gene Methylation Status in Chronic Lymphocytic Leukemia
Estimated Study Start Date : July 1, 2022
Estimated Primary Completion Date : August 1, 2023
Estimated Study Completion Date : October 1, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
patient group
control group


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. ITGA4 gene expression pattern and its methylation heterogeneity in chronic lymphocytic leukemia [ Time Frame: 1 year following the startpoint of the study ]
    Detection of ITGA4 gene expression and ITGA4 gene methylation in blood samples in patients with chronic lymphocytic leukemia, Briefly, total RNA and genomic DNA extraction from fresh peripheral blood samples by Real-time -RT-polymerase chain reaction system (RT-PCR) will be carried out. Rate of ITGA4 gene expression and its methylation will be recorded.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
newly diagnosed patients with Chronic lymphocytic leukemia
Criteria

Inclusion Criteria:

  • Patients with newly diagnosed CLL.

Exclusion Criteria:

  • ▪ Patients previously diagnosed as CLL and received treatment before.

    • Patients with other solid tumors.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Amer Ahmed Youssef Abdalkareem, Specialist of clinical and chemical pathology, Sohag University
ClinicalTrials.gov Identifier: NCT05371392    
Other Study ID Numbers: soh-med-22-04-21
First Posted: May 12, 2022    Key Record Dates
Last Update Posted: May 12, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell