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The Effect of Chemotherapy on Regulatory T Cells

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ClinicalTrials.gov Identifier: NCT03413046
Recruitment Status : Not yet recruiting
First Posted : January 29, 2018
Last Update Posted : January 29, 2018
Sponsor:
Collaborator:
Turkish Society of Hematology
Information provided by (Responsible Party):
Tekin Aksu, Ankara Children's Health and Diseases Hematology and Oncology Training and Research Hospital

Tracking Information
First Submitted Date December 21, 2017
First Posted Date January 29, 2018
Last Update Posted Date January 29, 2018
Estimated Study Start Date January 2018
Estimated Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 21, 2018)
Change from baseline in number of regulatory T-cells at 15 and 33th day during chemotherapy [ Time Frame: Baseline, 15 and 33th day ]
The number of regulatory T-cells is measured in fresh peripheral and bone marrow blood by flow cytometry.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: January 21, 2018)
Change from baseline IL-2, IL-6, IL-10, and TGF-beta levels at 15 and 33th day during chemotherapy [ Time Frame: Baseline, 15 and 33th day ]
IL-2, IL-6, IL-10, and TGF-beta levels are measured in frozen peripheral and bone marrow blood by ELISA.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Effect of Chemotherapy on Regulatory T Cells
Official Title The Effect of Chemotherapy on Regulatory T Cells in Children With Acute Lymphoblastic Leukemia
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The patients diagnosed with PreB ALL in a hematology clinic. Healthy children whom are volunraty bone marrow donors.
Condition
  • Pre B ALL
  • Regulatory T Cell
Intervention Diagnostic Test: Peripheral and bone marrow sampling
We obtained blood from peripheral and bone marrow sampling. Then we analyze Treg population and Treg related cytokines with flow cytometry and ELISA methods.
Study Groups/Cohorts
  • ALL
    30 children with a recent diagnosis of PreB ALL
    Intervention: Diagnostic Test: Peripheral and bone marrow sampling
  • Control
    30 healthy children
    Intervention: Diagnostic Test: Peripheral and bone marrow sampling
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: January 21, 2018)
60
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 2019
Estimated Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Children between 1-18 years
  • Recent PreB ALL diagnosis

Exclusion Criteria:

  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages 1 Year to 18 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Tekin Aksu, MD 00905459100389 tekinaksu@gmail.com
Contact: Namık Y Özbek, Prof 00903125969870 namikyozbek@gmail.com
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03413046
Other Study ID Numbers 2017-6
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Responsible Party Tekin Aksu, Ankara Children's Health and Diseases Hematology and Oncology Training and Research Hospital
Study Sponsor Ankara Children's Health and Diseases Hematology and Oncology Training and Research Hospital
Collaborators Turkish Society of Hematology
Investigators Not Provided
PRS Account Ankara Children's Health and Diseases Hematology and Oncology Training and Research Hospital
Verification Date January 2018