Expression of Programmed Death-1 (PD-1) & Programmed Death Ligand-1 (PDL-1) in Acute Lymphoblastic Leukemia in Pediatric
Primary Purpose
Acute Lymphoblastic Leukemia in Pediatric
Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
flow cytometric immunophynotyping
Sponsored by
About this trial
This is an interventional diagnostic trial for Acute Lymphoblastic Leukemia in Pediatric
Eligibility Criteria
Inclusion Criteria:
- Age range from 1 day to 18 years old
- Patients who are newly diagnosed and under treatment of acute lymphoblastic leukemia
Exclusion Criteria:
- Other types of acute leukemia rather than acute lymphoblastic leukemia
Sites / Locations
- Sohag University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
control
case
Arm Description
healthy control individuals
Newly diagnosed and under treatment cases of acute lymphoblastic leukemic
Outcomes
Primary Outcome Measures
programmed death-1 (PD-1) by flow cytometry immunophynotyping
Assess programmed death-1 by flow cytometry immunophynotyping
Programmed death ligand -1 (PDL-1) by flow cytometry immunophynotyping
Assess programmed death ligand -1 by flow cytometry immunophynotyping
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05428111
Brief Title
Expression of Programmed Death-1 (PD-1) & Programmed Death Ligand-1 (PDL-1) in Acute Lymphoblastic Leukemia in Pediatric
Official Title
Expression of Programmed Death-1 (PD-1) & Programmed Death Ligand-1 (PDL-1) in Acute Lymphoblastic Leukemia in Pediatric
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2022 (Anticipated)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Acute lymphoblastic leukemia (ALL) is the most common childhood malignancy in the world.
It is a malignant clonal proliferation of lymphoid progenitor cells, but most commonly of the B cell lineage (B ALL). .
Acute Lymphoblastic Leukemia (ALL) is a heterogeneous disease that causes malignant hematological disorders at any age. It mainly affects children aged 2 to 5; in fact, 60% of pediatric leukemia cases are ALL, with an incidence of 3-4 cases per 100,000 per year. It is divided into two subtypes B-ALL and T-ALL depending on whether transformation occurs in B- or T-cell precursors, respectively .
Leukemic cells apply multiple immune evasion mechanisms resulting in tumor progression. One of the most important immune escape mechanisms is over expression of immune checkpoint receptors and their ligands such as PD-1 and PD-L1 .
The PD-1 receptor plays a crucial role in a broad spectrum of immune regulatory mechanisms .
It is a negative co-receptor that down regulates T-cell activity .
PDL 1, which is known as B7 H1 , is a cell surface protein of B7 family member .
PD L1 is expressed on all types of lympho hematopoietic cells at variable levels and is constitutively expressed on T cells, B cells, macrophages, and dendritic cells .
Tumors exploit the PD-1/PD-L1 pathway to evade host immune surveillance .
PD-1/PD-L1 pathway controls the induction and maintenance of immune tolerance within the tumor microenvironment. The activity of PD-1 and its ligands PD-L1 or PD-L2 are responsible for T cell activation, proliferation, and cytotoxic secretion in cancer to produce anti-tumor immune responses .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoblastic Leukemia in Pediatric
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
Active Comparator
Arm Description
healthy control individuals
Arm Title
case
Arm Type
Active Comparator
Arm Description
Newly diagnosed and under treatment cases of acute lymphoblastic leukemic
Intervention Type
Diagnostic Test
Intervention Name(s)
flow cytometric immunophynotyping
Intervention Description
Expression of programmed death-1 (PD-1) & programmed death ligand-1 (PDL-1) in flow cytometric immunophynotyping
Primary Outcome Measure Information:
Title
programmed death-1 (PD-1) by flow cytometry immunophynotyping
Description
Assess programmed death-1 by flow cytometry immunophynotyping
Time Frame
6 months
Title
Programmed death ligand -1 (PDL-1) by flow cytometry immunophynotyping
Description
Assess programmed death ligand -1 by flow cytometry immunophynotyping
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age range from 1 day to 18 years old
Patients who are newly diagnosed and under treatment of acute lymphoblastic leukemia
Exclusion Criteria:
Other types of acute leukemia rather than acute lymphoblastic leukemia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nada M Rafat, resident
Phone
01001857100
Email
nada011207@med.sohag.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed A Allam, assisstant professor
Phone
01001636593
Facility Information:
Facility Name
Sohag University Hospital
City
Sohag
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Osama R Elshrif, professor
12. IPD Sharing Statement
Citations:
PubMed Identifier
33271388
Citation
Taghiloo S, Asgarian-Omran H. Immune evasion mechanisms in acute myeloid leukemia: A focus on immune checkpoint pathways. Crit Rev Oncol Hematol. 2021 Jan;157:103164. doi: 10.1016/j.critrevonc.2020.103164. Epub 2020 Nov 18.
Results Reference
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PubMed Identifier
31345517
Citation
Bergman PJ, Clifford CA. Recent Advancements in Veterinary Oncology. Vet Clin North Am Small Anim Pract. 2019 Sep;49(5):xiii-xiv. doi: 10.1016/j.cvsm.2019.06.001. No abstract available.
Results Reference
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PubMed Identifier
24949228
Citation
Woo JS, Alberti MO, Tirado CA. Childhood B-acute lymphoblastic leukemia: a genetic update. Exp Hematol Oncol. 2014 Jun 13;3:16. doi: 10.1186/2162-3619-3-16. eCollection 2014.
Results Reference
background
PubMed Identifier
23716539
Citation
Chiaretti S, Vitale A, Cazzaniga G, Orlando SM, Silvestri D, Fazi P, Valsecchi MG, Elia L, Testi AM, Mancini F, Conter V, te Kronnie G, Ferrara F, Di Raimondo F, Tedeschi A, Fioritoni G, Fabbiano F, Meloni G, Specchia G, Pizzolo G, Mandelli F, Guarini A, Basso G, Biondi A, Foa R. Clinico-biological features of 5202 patients with acute lymphoblastic leukemia enrolled in the Italian AIEOP and GIMEMA protocols and stratified in age cohorts. Haematologica. 2013 Nov;98(11):1702-10. doi: 10.3324/haematol.2012.080432. Epub 2013 May 28.
Results Reference
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Expression of Programmed Death-1 (PD-1) & Programmed Death Ligand-1 (PDL-1) in Acute Lymphoblastic Leukemia in Pediatric
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