Immunomodulation Analysis of Radiation Therapy in Pediatric Malignant Brain Tumors

February 5, 2024 updated by: Jun Ren MD, PhD, Capital Medical University

Immunomodulation Analysis on Peripheral Blood Mononuclear Cells of Radiation Therapy in Pediatric Malignant Brain Tumors

To investigate the effect of radiotherapy on peripheral blood immune cell composition and function in pediatric malignant brain tumor patients.

Study Overview

Status

Withdrawn

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Beijing, China
        • Beijing Shijitan Hospital Cancer Center

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

3 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The brain tumors patients between the ages of 3 year and 18 years who will be received radiation therapy evaluated and determined by their physician

Description

Inclusion Criteria:

  • Age from 3 to 18
  • To be diagnosed with malignant brain tumors
  • To eligible for radiation therapy
  • Karnofsky performance status ≥ 70
  • No prior radiation exposure
  • Informed consent signed for blood sample collection and used for research purpose

Exclusion Criteria:

  • Patients had received radiotherapy previously.
  • Patients who had no histological diagnosis
  • Patients who do not wish to participate
  • Patients with infections

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The changes of peripheral blood immune cells
Time Frame: 6 weeks (prior and post the radiation therapy )
The flow cytometric analysis of lymphocyte subtypes populations would be performed
6 weeks (prior and post the radiation therapy )

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Activation status of T cells
Time Frame: 6 weeks (prior and post the radiation therapy )
Activation status of peripheral IFN-γ-producing effector CD8+ T cells by Elispot.
6 weeks (prior and post the radiation therapy )
The changs of inflammatory cytokines and chemokines
Time Frame: 6 weeks (prior and post the radiation therapy )
Human inflammatory cytokines and chemokines will be analyzed by ELISA during radiation therapy. The cytokines and chemokines are IL-2, IL-10, IFN-γ, TNF-α
6 weeks (prior and post the radiation therapy )

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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)

February 1, 2019

Primary Completion (Actual)

May 1, 2022

Study Completion (Actual)

May 31, 2022

Study Registration Dates

First Submitted

July 11, 2019

First Submitted That Met QC Criteria

July 11, 2019

First Posted (Actual)

July 15, 2019

Study Record Updates

Last Update Posted (Actual)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

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.

Clinical Trials on Brain Tumor, Pediatric

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