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ITGA4 Gene Methylation Status in Chronic Lymphocytic Leukemia

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ClinicalTrials.gov Identifier: NCT05371392
Recruitment Status : Unknown
Verified May 2022 by Amer Ahmed Youssef Abdalkareem, Sohag University.
Recruitment status was:  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

Tracking Information
First Submitted Date April 29, 2022
First Posted Date May 12, 2022
Last Update Posted Date May 12, 2022
Estimated Study Start Date July 1, 2022
Estimated Primary Completion Date August 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 7, 2022)		 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title ITGA4 Gene Methylation Status in Chronic Lymphocytic Leukemia
Official Title ITGA4 Gene Methylation Status in Chronic Lymphocytic Leukemia
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population newly diagnosed patients with Chronic lymphocytic leukemia
Condition Chronic Lymphocytic Leukemia
Intervention Not Provided
Study Groups/Cohorts
  • patient group
  • control group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: May 7, 2022)		 80
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 1, 2023
Estimated Primary Completion Date August 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients with newly diagnosed CLL.

Exclusion Criteria:

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

    • Patients with other solid tumors.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT05371392
Other Study ID Numbers soh-med-22-04-21
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Current Responsible Party Amer Ahmed Youssef Abdalkareem, Sohag University
Original Responsible Party Same as current
Current Study Sponsor Sohag University
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Sohag University
Verification Date May 2022