NCT04019470

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 15, 2019

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
Last Updated

February 7, 2024

Status Verified

February 1, 2024

Enrollment Period

3.2 years

First QC Date

July 11, 2019

Last Update Submit

February 5, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • The changes of peripheral blood immune cells

    The flow cytometric analysis of lymphocyte subtypes populations would be performed

    6 weeks (prior and post the radiation therapy )

Secondary Outcomes (2)

  • Activation status of T cells

    6 weeks (prior and post the radiation therapy )

  • The changs of inflammatory cytokines and chemokines

    6 weeks (prior and post the radiation therapy )

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Shijitan Hospital Cancer Center

Beijing, China

Location

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cancer Center Director

Study Record Dates

First Submitted

July 11, 2019

First Posted

July 15, 2019

Study Start

February 1, 2019

Primary Completion

May 1, 2022

Study Completion

May 31, 2022

Last Updated

February 7, 2024

Record last verified: 2024-02

Locations