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Immunomodulation Analysis of Radiation Therapy in Pediatric Malignant Brain Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04019470
Recruitment Status : Recruiting
First Posted : July 15, 2019
Last Update Posted : July 15, 2019
Information provided by (Responsible Party):
Jun Ren MD, PhD, Capital Medical University

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

Condition or disease
Brain Tumor, Pediatric

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Immunomodulation Analysis on Peripheral Blood Mononuclear Cells of Radiation Therapy in Pediatric Malignant Brain Tumors
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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.

  2. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04019470

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Contact: Linan Song, MD

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Beijing Shijitan Hospital Cancer Center Recruiting
Beijing, China
Contact: Jun Ren    861063926317   
Sponsors and Collaborators
Capital Medical University

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Responsible Party: Jun Ren MD, PhD, Cancer Center Director, Capital Medical University Identifier: NCT04019470     History of Changes
Other Study ID Numbers: IRPBT
First Posted: July 15, 2019    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases