- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05095155
Study of the Prognostic Role of Gene Polymorphism in the Development of B-cell Leukemias and Lymphomas in Children of Kazakh Nationality
March 13, 2023 updated by: Ildar Fakhradiyev, Asfendiyarov Kazakh National Medical University
Preventive and Personalized Medicine (2021-2023)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
400
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Riza Boranbayeva, PhD
- Phone Number: +7 727 299 2121
- Email: riza_brz@mail.ru
Study Contact Backup
- Name: Ljazat Manzhuova, PhD
- Phone Number: +7 727 269 6787
- Email: ljazat.manzhuova@mail.ru
Study Locations
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-
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Almaty, Kazakhstan
- Scientific Center of Pediatrics and Pediatric Surgery
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 second to 18 years (Child, Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Children of the Kazakh population
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Experimental group:
children with B-cell leukemia and lymphoma of Kazakhstani nationality
|
SNP analysis of the DNA obtained from peripheral blood sample
Other Names:
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Control group
children without B-cell leukemia and lymphoma of Kazakhstani nationality
|
SNP analysis of the DNA obtained from peripheral blood sample
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Associated with B-cell lymphoma and B-cell acute lymphoblastic leukemia
Time Frame: 1 year
|
Genotype frequency of SNP in the study genes of participants and control participants.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Riza Boranbayeva, PhD, JSC "Scientific Center of Pediatrics and Pediatric Surgery"
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2022
Primary Completion (Actual)
January 20, 2023
Study Completion (Actual)
January 20, 2023
Study Registration Dates
First Submitted
October 21, 2021
First Submitted That Met QC Criteria
October 26, 2021
First Posted (Actual)
October 27, 2021
Study Record Updates
Last Update Posted (Actual)
March 14, 2023
Last Update Submitted That Met QC Criteria
March 13, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1190
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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