ITGA4 Gene Methylation Status in Chronic Lymphocytic Leukemia

May 7, 2022 updated by: Amer Ahmed Youssef Abdalkareem, Sohag University

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

80

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

newly diagnosed patients with Chronic lymphocytic leukemia

Description

Inclusion Criteria:

  • Patients with newly diagnosed CLL.

Exclusion Criteria:

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

    • Patients with other solid tumors.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
control group
patient group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year following the startpoint of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2022

Primary Completion (Anticipated)

August 1, 2023

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

April 29, 2022

First Submitted That Met QC Criteria

May 7, 2022

First Posted (Actual)

May 12, 2022

Study Record Updates

Last Update Posted (Actual)

May 12, 2022

Last Update Submitted That Met QC Criteria

May 7, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • soh-med-22-04-21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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