Immunomodulation Analysis of Radiation Therapy in Pediatric Malignant Brain Tumors

Brain Tumor, Pediatric Clinical Trial

Official title:

Immunomodulation Analysis on Peripheral Blood Mononuclear Cells of Radiation Therapy in Pediatric Malignant Brain Tumors

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04019470
• Other study ID #: IRPBT
• Status: Withdrawn
• Start date: February 1, 2019
• Est. completion date: May 31, 2022

Study information

• Verified date: February 2024
• Source: Capital Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 31, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor, Pediatric

Locations

Country	Name	City	State
China	Beijing Shijitan Hospital Cancer Center	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Activation status of T cells	Activation status of peripheral IFN-?-producing effector CD8+ T cells by Elispot.	6 weeks (prior and post the radiation therapy )
Secondary	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-?, TNF-a	6 weeks (prior and post the radiation therapy )