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出境医 / 临床实验 / Immunomodulation Analysis of Radiation Therapy in Pediatric Malignant Brain Tumors
Immunomodulation Analysis of Radiation Therapy in Pediatric Malignant Brain Tumors
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 |
|---|
| Brain Tumor, Pediatric |
Study Design
| Study Type : | Observational |
| Estimated 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 : | February 1, 2019 |
| Estimated Primary Completion Date : | October 1, 2020 |
| Estimated Study Completion Date : | December 31, 2020 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- 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
Secondary Outcome Measures :
- Activation status of T cells [ Time Frame: 6 weeks (prior and post the radiation therapy ) ]Activation status of peripheral IFN-γ-producing effector CD8+ T cells by Elispot.
- 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
Eligibility Criteria
| Ages Eligible for Study: | 3 Years to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | 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
Criteria
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
| China | |
| Beijing Shijitan Hospital Cancer Center | |
| Beijing, China | |
Sponsors and Collaborators
Capital Medical University
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | July 11, 2019 | ||||
| First Posted Date | July 15, 2019 | ||||
| Last Update Posted Date | September 21, 2020 | ||||
| Actual Study Start Date | February 1, 2019 | ||||
| Estimated Primary Completion Date | October 1, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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
|
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures |
|
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| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Immunomodulation Analysis of Radiation Therapy in Pediatric Malignant Brain Tumors | ||||
| Official Title | Immunomodulation Analysis on Peripheral Blood Mononuclear Cells of Radiation Therapy in Pediatric Malignant Brain Tumors | ||||
| Brief Summary | To investigate the effect of radiotherapy on peripheral blood immune cell composition and function in pediatric malignant brain tumor patients. | ||||
| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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 | ||||
| Condition | Brain Tumor, Pediatric | ||||
| Intervention | Not Provided | ||||
| Study Groups/Cohorts | Not Provided | ||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Active, not recruiting | ||||
| Estimated Enrollment |
30 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | December 31, 2020 | ||||
| Estimated Primary Completion Date | October 1, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
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| Ages | 3 Years to 18 Years (Child, Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | China | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT04019470 | ||||
| Other Study ID Numbers | IRPBT | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||
| Responsible Party | Jun Ren MD, PhD, Capital Medical University | ||||
| Study Sponsor | Capital Medical University | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | Capital Medical University | ||||
| Verification Date | September 2020 | ||||
