Study Stopped
This non-therapeutic study was registered in error. The PRS team doesn't delete studies once registered, so they recommended changing the status to Withdrawn
Biomarkers in Blood Samples From Young Patients With Newly Diagnosed Brain Tumors Undergoing Standard Radiation Therapy and Chemotherapy
Immunologic Profile of Patients With Newly Diagnosed Medulloblastoma at Initial Diagnosis and During Standard Radiation and Chemotherapy
2 other identifiers
interventional
N/A
1 country
11
Brief Summary
RATIONALE: Studying samples of blood in the laboratory from patients receiving radiation therapy and chemotherapy may help doctors learn more about the effects of this treatment on cells. It may also help doctors understand how well patients respond to treatment. PURPOSE: This research study is studying biomarkers in blood samples from young patients with newly diagnosed brain tumors undergoing standard radiation therapy and chemotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2010
Longer than P75 for not_applicable
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 2, 2010
CompletedFirst Posted
Study publicly available on registry
November 3, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 24, 2017
CompletedApril 1, 2019
March 1, 2019
1.2 years
November 2, 2010
March 28, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Peripherally circulating T-regulatory (T-reg) cells in patients with medulloblastoma or Chiari malformation
Longitudinal side effects of standard radiotherapy and chemotherapy regimens on the overall population of lymphocytes as well as the fraction of circulating T-reg cells
Effect of treatment on lymphocytes and T-reg cells
Secondary Outcomes (1)
Baseline fraction of circulating T-reg cells
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- Pediatric Brain Tumor Consortiumlead
- National Cancer Institute (NCI)collaborator
Study Sites (11)
Childrens Hospital Los Angeles
Los Angeles, California, 90027-0700, United States
Lucile Packard Children's Hospital at Stanford University Medical Center
Palo Alto, California, 94304, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2970, United States
Children's Memorial Hospital - Chicago
Chicago, Illinois, 60614, United States
NCI - Pediatric Oncology Branch
Bethesda, Maryland, 20892, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
Duke Cancer Institute
Durham, North Carolina, 27710, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15213, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital
Houston, Texas, 77030-2399, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sri Gururangan, MD
Duke Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Sponsor Type
- NETWORK
Study Record Dates
First Submitted
November 2, 2010
First Posted
November 3, 2010
Study Start
May 1, 2010
Primary Completion
July 1, 2011
Study Completion
August 24, 2017
Last Updated
April 1, 2019
Record last verified: 2019-03