Clincosm LogoSign in Get a demo

Study of the Prognostic Role of Gene Polymorphism in the Development of B-cell Leukemias and Lymphomas in Children of Kazakh Nationality

Sponsor
Asfendiyarov Kazakh National Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05095155
Collaborator
(none)
400
Enrollment
1
Location
8.6
Anticipated Duration (Months)
46.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To search for a genetic marker of B-cell leukemias and lymphomas in children of Kazakh nationality, a single nucleotide polymorphism (SNP) analysis of DNA obtained from the peripheral blood of patients with B-cell leukemias and lymphomas in children of Kazakh nationality and normal control will be performed.

Condition or Disease Intervention/Treatment Phase
  • Genetic: SNP analysis of the DNA

Study Design

Study Type:
Observational
Anticipated Enrollment :
400 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Preventive and Personalized Medicine (2021-2023)
Actual Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Dec 20, 2022
Anticipated Study Completion Date :
Dec 20, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental group:

children with B-cell leukemia and lymphoma of Kazakhstani nationality

Genetic: SNP analysis of the DNA
SNP analysis of the DNA obtained from peripheral blood sample
Other Names:
  • SNP analysis of the DNA obtained from peripheral blood sample

    		•
    Control group

    children without B-cell leukemia and lymphoma of Kazakhstani nationality

    Genetic: SNP analysis of the DNA
    SNP analysis of the DNA obtained from peripheral blood sample
    Other Names:
  • SNP analysis of the DNA obtained from peripheral blood sample

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Associated with B-cell lymphoma and B-cell acute lymphoblastic leukemia [1 year]

      Genotype frequency of SNP in the study genes of participants and control participants.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    0 Years to 18 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • ethnicity - Kazakhs in at least three generations

    • active disease or a history of B-line ALL or B-NHL, established on the basis of morphological, cytochemical, immunophenotypic or immunohistochemical research methods with confirmation of the fact of the disease in medical documentation

    • Signed voluntary informed consent of the legal representative to participate in the project

    Exclusion Criteria:

    • Children suffering from other types of malignant neoplasms

    • Children with B-linear leukemia and lymphomas with concomitant specified genetic and chromosomal diseases

    • Children of non-Kazakh nationality

    • Absence of signed informed consent or informed refusal of the legal representative to participate in the study before starting therapy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Scientific Center of Pediatrics and Pediatric Surgery Almaty Kazakhstan

    Sponsors and Collaborators

    • Asfendiyarov Kazakh National Medical University

    Investigators

    • Principal Investigator: Riza Boranbayeva, PhD, JSC "Scientific Center of Pediatrics and Pediatric Surgery"

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ildar Fakhradiyev, Head of the Laboratory of Experimental Medicine, Asfendiyarov Kazakh National Medical University
    ClinicalTrials.gov Identifier:
    NCT05095155
    Other Study ID Numbers:
    • 1190
    First Posted:
    Oct 27, 2021
    Last Update Posted:
    Aug 23, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ildar Fakhradiyev, Head of the Laboratory of Experimental Medicine, Asfendiyarov Kazakh National Medical University
    SNP
    Additional relevant MeSH terms:
    Lymphoma
    Leukemia
    Leukemia, B-Cell
    Leukemia, Lymphocytic, Chronic, B-Cell

    Study Results

    No Results Posted as of Aug 23, 2022