NCT06160115

Brief Summary

  1. 1.Assess possibility of prediction of blood stream infections in ALL patients by profiling of NK cells using flow cytometry.
  2. 2.Assess the role of NK cells in development of drug resistance post chemotherapy.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2024

Status
unknown

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

November 29, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 7, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

December 7, 2023

Status Verified

November 1, 2023

Enrollment Period

1 year

First QC Date

November 29, 2023

Last Update Submit

November 29, 2023

Conditions

Keywords

Natural Killed cells

Outcome Measures

Primary Outcomes (1)

  • Number of participants who test positive for bloodstream infection and NK cells profile

    Assess the number of participants who are positive for bloodstream infection in microbial identification instrument, then comparison of Flow cytometry results for CD16 and CD56 to identify role of NK cells.

    Baseline

Interventions

1. Profiling of NK cells using flow cytometry on peripheral blood and bone marrow aspirate samples. 2. Isolation and identification of pathogens causing BSI and bacterial drug susceptibility testing using VITEK compact fully automatic microbial identification instrument.

Also known as: Microbial identification instrument

Eligibility Criteria

Age0 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Primary care clinic.

You may qualify if:

  • Patients aged less than 17 years diagnosed as Acute Lymphoblastic Leukemia and on chemotherapy, who are positive for blood stream infection.

You may not qualify if:

  • Patients over 17 years of age.
  • Presence of other hematological malignancies or history of other malignancies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • Ammann RA, Laws HJ, Schrey D, Ehlert K, Moser O, Dilloo D, Bode U, Wawer A, Schrauder A, Cario G, Laengler A, Graf N, Furtwangler R, Simon A. Bloodstream infection in paediatric cancer centres--leukaemia and relapsed malignancies are independent risk factors. Eur J Pediatr. 2015 May;174(5):675-86. doi: 10.1007/s00431-015-2525-5. Epub 2015 Mar 26.

  • Bayatipoor H, Mehdizadeh S, Jafarpour R, Shojaei Z, Pashangzadeh S, Motallebnezhad M. Role of NKT cells in cancer immunotherapy-from bench to bed. Med Oncol. 2022 Dec 2;40(1):29. doi: 10.1007/s12032-022-01888-5.

  • Bi J, Tian Z. NK Cell Exhaustion. Front Immunol. 2017 Jun 28;8:760. doi: 10.3389/fimmu.2017.00760. eCollection 2017.

  • Campbell KS, Hasegawa J. Natural killer cell biology: an update and future directions. J Allergy Clin Immunol. 2013 Sep;132(3):536-544. doi: 10.1016/j.jaci.2013.07.006. Epub 2013 Jul 30.

  • Fujita TC, Sousa-Pereira N, Amarante MK, Watanabe MAE. Acute lymphoid leukemia etiopathogenesis. Mol Biol Rep. 2021 Jan;48(1):817-822. doi: 10.1007/s11033-020-06073-3. Epub 2021 Jan 13.

  • Gupta DG, Varma N, Naseem S, Sachdeva MUS, Bose P, Binota J, Kumar A, Gupta M, Rana P, Sonam P, Malhotra P, Trehan A, Khadwal A, Varma S. Characterization of Immunophenotypic Aberrancies with Respect to Common Fusion Transcripts in B-Cell Precursor Acute Lymphoblastic Leukemia: A Report of 986 Indian Patients. Turk J Haematol. 2022 Feb 23;39(1):1-12. doi: 10.4274/tjh.galenos.2021.2021.0326. Epub 2021 Oct 7.

  • Karaman R, Jubeh B, Breijyeh Z. Resistance of Gram-Positive Bacteria to Current Antibacterial Agents and Overcoming Approaches. Molecules. 2020 Jun 23;25(12):2888. doi: 10.3390/molecules25122888.

  • Littera R, Chessa L, Deidda S, Angioni G, Campagna M, Lai S, Melis M, Cipri S, Firinu D, Santus S, Lai A, Porcella R, Rassu S, Meloni F, Schirru D, Cordeddu W, Kowalik MA, Ragatzu P, Vacca M, Cannas F, Alba F, Carta MG, Del Giacco S, Restivo A, Deidda S, Palimodde A, Congera P, Perra R, Orru G, Pes F, Loi M, Murru C, Urru E, Onali S, Coghe F, Giglio S, Perra A. Natural killer-cell immunoglobulin-like receptors trigger differences in immune response to SARS-CoV-2 infection. PLoS One. 2021 Aug 5;16(8):e0255608. doi: 10.1371/journal.pone.0255608. eCollection 2021.

  • Lodoen MB, Lanier LL. Natural killer cells as an initial defense against pathogens. Curr Opin Immunol. 2006 Aug;18(4):391-8. doi: 10.1016/j.coi.2006.05.002. Epub 2006 Jun 12.

  • Matthiesen S, Zaeck L, Franzke K, Jahnke R, Fricke C, Mauermeir M, Finke S, Luhrmann A, Knittler MR. Coxiella burnetii-Infected NK Cells Release Infectious Bacteria by Degranulation. Infect Immun. 2020 Oct 19;88(11):e00172-20. doi: 10.1128/IAI.00172-20. Print 2020 Oct 19.

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-LymphomaSepsis

Interventions

Flow Cytometry

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cell SeparationCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisCytophotometryFluorometryLuminescent MeasurementsPhotometryChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Shaimaa G Mansour, Professor

    South Egypt Cancer Institure, Assiut, Egypt

    STUDY CHAIR
  • Eman M Abdel Rahman, Lecturer

    Assiut University

    STUDY CHAIR

Central Study Contacts

Mostafa S Mohamed Ahmed, Resident

CONTACT

Rania M Bakry, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSMohamedAhmed

Study Record Dates

First Submitted

November 29, 2023

First Posted

December 7, 2023

Study Start

February 1, 2024

Primary Completion

February 1, 2025

Study Completion

April 1, 2025

Last Updated

December 7, 2023

Record last verified: 2023-11