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Immunomodulation Analysis of Radiation Therapy in Pediatric Malignant Brain Tumors

Sponsor
Capital Medical University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04019470
Collaborator
(none)
30
Enrollment
1
Location
23
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Immunomodulation Analysis on Peripheral Blood Mononuclear Cells of Radiation Therapy in Pediatric Malignant Brain Tumors
    Actual Study Start Date :
    Feb 1, 2019
    Anticipated Primary Completion Date :
    Oct 1, 2020
    Anticipated Study Completion Date :
    Dec 31, 2020

    Outcome Measures

    Primary Outcome Measures

    1. The changes of peripheral blood immune cells [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 [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 [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beijing Shijitan Hospital Cancer Center Beijing China

    Sponsors and Collaborators

    • Capital Medical University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jun Ren MD, PhD, Cancer Center Director, Capital Medical University
    ClinicalTrials.gov Identifier:
    NCT04019470
    Other Study ID Numbers:
    • IRPBT
    First Posted:
    Jul 15, 2019
    Last Update Posted:
    Sep 21, 2020
    Last Verified:
    Sep 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Brain Neoplasms

    Study Results

    No Results Posted as of Sep 21, 2020