NCT05095155

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 27, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2023

Completed
Last Updated

March 14, 2023

Status Verified

March 1, 2023

Enrollment Period

10 months

First QC Date

October 21, 2021

Last Update Submit

March 13, 2023

Conditions

Keywords

SNP

Outcome Measures

Primary Outcomes (1)

  • Associated with B-cell lymphoma and B-cell acute lymphoblastic leukemia

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

    1 year

Study Arms (2)

Experimental group:

children with B-cell leukemia and lymphoma of Kazakhstani nationality

Genetic: SNP analysis of the DNA

Control group

children without B-cell leukemia and lymphoma of Kazakhstani nationality

Genetic: SNP analysis of the DNA

Interventions

SNP analysis of the DNA obtained from peripheral blood sample

Also known as: SNP analysis of the DNA obtained from peripheral blood sample
Control groupExperimental group:

Eligibility Criteria

Age0 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Children of the Kazakh population

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Scientific Center of Pediatrics and Pediatric Surgery

Almaty, Kazakhstan

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Leukemia, B-CellLymphoma

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Riza Boranbayeva, PhD

    JSC "Scientific Center of Pediatrics and Pediatric Surgery"

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Laboratory of Experimental Medicine

Study Record Dates

First Submitted

October 21, 2021

First Posted

October 27, 2021

Study Start

April 1, 2022

Primary Completion

January 20, 2023

Study Completion

January 20, 2023

Last Updated

March 14, 2023

Record last verified: 2023-03

Locations