The Effect of Chemotherapy on Regulatory T Cells

NCT ID: NCT03413046

Last Updated: 2018-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-31

Study Completion Date

2019-05-31

Brief Summary

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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

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Conditions

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Pre B ALL Regulatory T Cell

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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ALL

30 children with a recent diagnosis of PreB ALL

Peripheral and bone marrow sampling

Intervention Type DIAGNOSTIC_TEST

We obtained blood from peripheral and bone marrow sampling. Then we analyze Treg population and Treg related cytokines with flow cytometry and ELISA methods.

Control

30 healthy children

Peripheral and bone marrow sampling

Intervention Type DIAGNOSTIC_TEST

We obtained blood from peripheral and bone marrow sampling. Then we analyze Treg population and Treg related cytokines with flow cytometry and ELISA methods.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Turkish Society of Hematology

OTHER

Sponsor Role collaborator

Ankara Children's Health and Diseases Hematology and Oncology Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Tekin Aksu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Tekin Aksu, MD

Role: CONTACT

00905459100389

Namık Y Özbek, Prof

Role: CONTACT

00903125969870

Other Identifiers

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2017-6

Identifier Type: -

Identifier Source: org_study_id

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