B Cell LeukemiaNCT05095155
Study of the Prognostic Role of Gene Polymorphism in the Development of B-cell Leukemias and Lymphomas in Children of Kazakh Nationality
An observational study of B Cell Leukemia and Lymphoma, run by Asfendiyarov Kazakh National Medical University at 1 site in Kazakhstan.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- B Cell Leukemia, Lymphoma
- What is being tested?
- SNP analysis of the DNA
- How many people
- 400 participants
- Where
- 1 siteKazakhstan
- Study dates
- 1 Apr 2022to 20 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 18 years
- All sexes
- Child, Adult
Study population: Children of the Kazakh population
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Kazakhstan1 site
Scientific Center of Pediatrics and Pediatric Surgery
Almaty
About this study
Official title: 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.
- Conditions
- B Cell Leukemia, Lymphoma
- Being tested
- SNP analysis of the DNA
- Keywords
- SNP
- Medical subject headings
- Leukemia, B-Cell, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNP analysis of the DNAGenetic
Also called SNP analysis of the DNA obtained from peripheral blood sample
SNP analysis of the DNA obtained from peripheral blood sample
| Study group | Role | What they receive |
|---|---|---|
| Experimental group: | children with B-cell leukemia and lymphoma of Kazakhstani nationality Receives: Genetic: SNP analysis of the DNA | |
| Control group | children without B-cell leukemia and lymphoma of Kazakhstani nationality Receives: Genetic: SNP analysis of the DNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Associated with B-cell lymphoma and B-cell acute lymphoblastic leukemia
Genotype frequency of SNP in the study genes of participants and control participants.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start1 Apr 2022
- Primary completion20 Jan 2023
- Study completion20 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B Cell LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asfendiyarov Kazakh National Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ildar Fakhradiyev, Asfendiyarov Kazakh National Medical University
- Investigators
- Riza Boranbayeva, PhD, Principal investigator, JSC "Scientific Center of Pediatrics and Pediatric Surgery"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05095155
- Sponsor's protocol ID
- 1190
- Status last verified
- Mar 2023
- First submitted
- 21 Oct 2021
- Last updated
- 14 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventive and Personalized Medicine (2021-2023)
- ClinicalTrials.gov ID
- NCT05095155
- Acronym / sponsor ID
- 1190
- Conditions
- B Cell Leukemia, Lymphoma
- Keywords
- SNP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Asfendiyarov Kazakh National Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 20 Jan 2023 (actual)
- Study completion
- 20 Jan 2023 (actual)
- First posted
- 27 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group: | – | Genetic: SNP analysis of the DNAchildren with B-cell leukemia and lymphoma of Kazakhstani nationality |
| Control group | – | Genetic: SNP analysis of the DNAchildren without B-cell leukemia and lymphoma of Kazakhstani nationality |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Children of the Kazakh population
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SNP analysis of the DNAAlso: SNP analysis of the DNA obtained from peripheral blood sampleSNP analysis of the DNA obtained from peripheral blood sample | Genetic | Control group, Experimental group: |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Individual participant dataSharing planned: Undecided
Related trials for B Cell Leukemia
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Recruiting
A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymph...
B-All, Acute Lymphoblastic Leukemia
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
Not yet recruitingPhase 2
Nemtabrutinib for Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Leukemia (SLL) Refractory to Covalent Bruton Tyrosine Kinase Inhibitor or Pirtobrutinib and Previously Treated With a BCL2 Inhibitor
Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia
RecruitingPhase 1
A Phase I Dose Finding Study of MB-CART2219.1
Lymphoma, CLL
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Riza Boranbayeva, PhD principal investigator
JSC "Scientific Center of Pediatrics and Pediatric Surgery"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of B Cell Leukemia and Lymphoma, run by Asfendiyarov Kazakh National Medical University at 1 site in Kazakhstan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Associated with B-cell lymphoma and B-cell acute lymphoblastic leukemia (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.