- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04019470
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Withdrawn
Conditions
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
-
-
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Beijing, China
- Beijing Shijitan Hospital Cancer Center
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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 )
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The flow cytometric analysis of lymphocyte subtypes populations would be performed
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6 weeks (prior and post the radiation therapy )
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Activation status of T cells
Time Frame: 6 weeks (prior and post the radiation therapy )
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Activation status of peripheral IFN-γ-producing effector CD8+ T cells by Elispot.
|
6 weeks (prior and post the radiation therapy )
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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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRPBT
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.
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