Brain Tumor, PediatricNCT04019470
Immunomodulation Analysis of Radiation Therapy in Pediatric Malignant Brain Tumors
An observational study of Brain Tumor, Pediatric, run by Capital Medical University at 1 site in China.
Trial summary
To investigate the effect of radiotherapy on peripheral blood immune cell composition and function in pediatric malignant brain tumor patients. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Brain Tumor, Pediatric
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2019to 31 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Who may be able to join
- 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
Who cannot join
- Patients had received radiotherapy previously.
- Patients who had no histological diagnosis
- Patients who do not wish to participate
- Patients with infections
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Brain Tumor, Pediatric
- Medical subject headings
- Brain Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes of peripheral blood immune cells
The flow cytometric analysis of lymphocyte subtypes populations would be performed
Measured: 6 weeks (prior and post the radiation therapy )
Secondary outcomes (2)
Activation status of T cells
Activation status of peripheral IFN-γ-producing effector CD8+ T cells by Elispot.
Measured: 6 weeks (prior and post the radiation therapy )
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
Measured: 6 weeks (prior and post the radiation therapy )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2019
- Study start1 Feb 2019
- Primary completion1 May 2022
- Study completion31 May 2022
Why it stopped: No participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Tumor, PediatricStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Ren MD, PhD, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04019470
- Sponsor's protocol ID
- IRPBT
- Status last verified
- Feb 2024
- First submitted
- 11 Jul 2019
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunomodulation Analysis on Peripheral Blood Mononuclear Cells of Radiation Therapy in Pediatric Malignant Brain Tumors
- ClinicalTrials.gov ID
- NCT04019470
- Acronym / sponsor ID
- IRPBT
- Conditions
- Brain Tumor, Pediatric
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 15 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the effect of radiotherapy on peripheral blood immune cell composition and function in pediatric malignant brain tumor patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Patients had received radiotherapy previously.
- Patients who had no histological diagnosis
- Patients who do not wish to participate
- Patients with infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Activation status of T cells
Time frame: 6 weeks (prior and post the radiation therapy )
The changs of inflammatory cytokines and chemokines
Time frame: 6 weeks (prior and post the radiation therapy )
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Tumor, Pediatric, run by Capital Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes of peripheral blood immune cells (time frame: 6 weeks (prior and post the radiation therapy )). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.