免费获得国外相关药品，最快 1 个工作日回馈药物信息

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
Layout table for study information
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 :
  1. 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 :
  1. 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.

  2. 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
Layout table for eligibility information
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
Layout table for location information
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
 (submitted: July 11, 2019) 		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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 11, 2019)
  • 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
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.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: July 11, 2019) 		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:

  • 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
Sex/Gender
Sexes Eligible for Study: All
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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

治疗医院

新药特效药

前沿医讯