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WithdrawnNCT04019470Updated Feb 7, 2024

Immunomodulation Analysis of Radiation Therapy in Pediatric Malignant Brain Tumors

An observational study in Brain Tumor, Pediatric, sponsored by Capital Medical University. Withdrawn at 1 site in China. Open to participants aged 3 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-02-07.

Sponsored by Capital Medical University · Observational

Why this study was withdrawn
No participants enrolled
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
3 Years to 18 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Brain Tumor, Pediatric

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03

In context

Brain Neoplasms

1,960 studies on the registry are indexed under Brain Neoplasms; 515 are open to participants now.

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Lead sponsor

Capital Medical University is the lead sponsor of 283 studies on the registry; 92 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
3 Years to 18 Years
Sexes eligible
All
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

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. The changes of peripheral blood immune cells

    The flow cytometric analysis of lymphocyte subtypes populations would be performed

    Time frame: 6 weeks (prior and post the radiation therapy )

Secondary outcomes

  1. Activation status of T cells

    Activation status of peripheral IFN-γ-producing effector CD8+ T cells by Elispot.

    Time frame: 6 weeks (prior and post the radiation therapy )

  2. The changs of inflammatory cytokines and chemokines

    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

    Time frame: 6 weeks (prior and post the radiation therapy )

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Study locations

1 site
  • Beijing Shijitan Hospital Cancer Center
    Beijing, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04019470
Lead sponsor
Capital Medical University
Responsible party
Jun Ren MD, PhD (Cancer Center Director, Capital Medical University) — Principal investigator
First posted
Jul 15, 2019
Start date
Feb 1, 2019
Primary completion
May 1, 2022
Completion
May 31, 2022
Last update
Feb 7, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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