The Role of NK Cells to Detect Blood Infection in ALL.

NCT ID: NCT06160115

Last Updated: 2023-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

56 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-01

Study Completion Date

2025-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Acute lymphoblastic leukemia (ALL) is the most common malignancy affecting children accounting for approximately 30% of childhood cancers (Zeng XL et al, 2023 ALL is characterized by chromosomal abnormalities and genetic alterations involved in the differentiation and proliferation of lymphoid precursor cells (Fujita, Sousa-Pereira et al. 2021).

ALL is categorized in B-Lymphoblastic Leukemia (B-ALL) And T-Lymphoblastic Leukemia (T-ALL), originated from B- and T-Lineage lymphoid precursor cells, respectively (Chiaretti S et al, 2014).

Recent progress in treatment of ALL has increased the survival rate significantly. The 5-year survival rate in children with ALL is approximately 90% (Paul 2016).

Bloodstream infection is a major cause of treatment-related morbidity and mortality in pediatric patients treated for acute lymphoblastic leukemia (Wolf, Tang et al. 2017).

This is caused by severe and prolonged immunosuppression due to neutropenia, and other chemotherapy-induced alterations of host defense mechanisms The rise of multidrug-resistant bacteria has generated a great challenge to treat infections caused by bacteria with the available antibiotics One of the crucial first line of defense against bloodstream infections in the immune system are Natural Killer cells Natural killer (NK) cells are lymphocytes of the innate immune system that are critical in host defense and immune regulation They can mediate spontaneous cytotoxicity towards malignant cells and microbes, and rapidly secrete numerous cytokines and chemokines to promote subsequent adaptive immune responses

NK cells can be subdivided into different populations based on the relative expression of the surface markers CD16 and CD56

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Lymphoblastic Leukemia Bloodstream Infection

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Natural Killed cells

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Flow cytometry

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.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Microbial identification instrument

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

1. Patients over 17 years of age.
2. Presence of other hematological malignancies or history of other malignancies.
Minimum Eligible Age

0 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mostafa Sayed Mohamed Ahmed

MSMohamedAhmed

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Shaimaa G Mansour, Professor

Role: STUDY_CHAIR

South Egypt Cancer Institure, Assiut, Egypt

Eman M Abdel Rahman, Lecturer

Role: STUDY_CHAIR

Assiut University

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mostafa S Mohamed Ahmed, Resident

Role: CONTACT

Phone: 1015277059

Email: [email protected]

Rania M Bakry, Professor

Role: CONTACT

Phone: 1013341395

Email: [email protected]

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 25804192 (View on PubMed)

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.

Reference Type RESULT
PMID: 36460881 (View on PubMed)

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

Reference Type RESULT
PMID: 28702032 (View on PubMed)

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.

Reference Type RESULT
PMID: 23906377 (View on PubMed)

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.

Reference Type RESULT
PMID: 33438082 (View on PubMed)

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.

Reference Type RESULT
PMID: 34617433 (View on PubMed)

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.

Reference Type RESULT
PMID: 32586045 (View on PubMed)

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.

Reference Type RESULT
PMID: 34352002 (View on PubMed)

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.

Reference Type RESULT
PMID: 16765573 (View on PubMed)

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.

Reference Type RESULT
PMID: 32817330 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NK cells for infection in ALL

Identifier Type: -

Identifier Source: org_study_id