The Effect of Chemotherapy on Regulatory T Cells
1 other identifier
observational
60
0 countries
N/A
Brief Summary
The investigators aimed to study the effect of chemotherapy on regulatory T cells (Tregs) in children with precursor B (PreB) acute lymphoblastic leukemia (ALL) at 15 and 33 days of malignity directed therapy. The investigators will analyze peripheral and bone marrow blood samples of the participants, obtained at diagnosis, 15 and 33 days of treatment, about Treg / non Treg cells and interleukin (IL)-2, IL-6, IL-10, and transforming growth factor (TGF) beta levels. By this means, investigators will search response to chemotherapy. Also, investigators will analyze correlation between Treg population-Treg related cytokines with demographic, clinical and laboratory findings of the participants with ALL at these certain time points. Additionally, the investigators will compare Treg population and minimal residual disease at 15-33 days of malignity directed therapy. Also investigators will compare these Treg-Treg related cytokines obtained from the participants with ALL and a healthy children control group whom are voluntary donors for bone marrow transplantation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2018
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
December 21, 2017
CompletedStudy Start
First participant enrolled
January 1, 2018
CompletedFirst Posted
Study publicly available on registry
January 29, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2019
CompletedJanuary 29, 2018
January 1, 2018
1 year
December 21, 2017
January 21, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in number of regulatory T-cells at 15 and 33th day during chemotherapy
The number of regulatory T-cells is measured in fresh peripheral and bone marrow blood by flow cytometry.
Baseline, 15 and 33th day
Secondary Outcomes (1)
Change from baseline IL-2, IL-6, IL-10, and TGF-beta levels at 15 and 33th day during chemotherapy
Baseline, 15 and 33th day
Study Arms (2)
ALL
30 children with a recent diagnosis of PreB ALL
Control
30 healthy children
Interventions
We obtained blood from peripheral and bone marrow sampling. Then we analyze Treg population and Treg related cytokines with flow cytometry and ELISA methods.
Eligibility Criteria
The patients diagnosed with PreB ALL in a hematology clinic. Healthy children whom are volunraty bone marrow donors.
You may qualify if:
- Children between 1-18 years
- Recent PreB ALL diagnosis
You may not qualify if:
- Children under 1 or over 18 years
- Underlying disease e.g. immune deficiency, germline mutations or diseases
- Tcell ALL or acute myeloid leukemia (AML) patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 21, 2017
First Posted
January 29, 2018
Study Start
January 1, 2018
Primary Completion
January 1, 2019
Study Completion
May 1, 2019
Last Updated
January 29, 2018
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will share