NCT05371392

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 in CLL.

Trial Health

43
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 Jul 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

April 29, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 12, 2022

Completed
2.1 years until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

June 20, 2024

Status Verified

June 1, 2024

Enrollment Period

1 month

First QC Date

April 29, 2022

Last Update Submit

June 17, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • ITGA4 gene expression pattern in chronic lymphocytic leukemia

    Detection of ITGA4 gene expression 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 will be recorded.

    1 year following the startpoint of the study

Study Arms (2)

patient group

control group

Eligibility Criteria

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

newly diagnosed patients with Chronic lymphocytic leukemia

You may qualify if:

  • Patients with newly diagnosed CLL.

You may not qualify if:

  • ▪ Patients previously diagnosed as CLL and received treatment before.
  • Patients with other solid tumors.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag university

Sohag, Egypt

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Amer Ahmed Youssif

    Sohag University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist of clinical and chemical pathology

Study Record Dates

First Submitted

April 29, 2022

First Posted

May 12, 2022

Study Start

July 1, 2024

Primary Completion

August 1, 2024

Study Completion

October 1, 2024

Last Updated

June 20, 2024

Record last verified: 2024-06

Locations