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Clinical Trials/NCT01595126
NCT01595126
Completed
Not Applicable

A Longitudinal Study of Biomarkers in Pediatric Patients With Central Nervous System Tumors

Ann & Robert H Lurie Children's Hospital of Chicago1 site in 1 country100 target enrollmentDecember 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Central Nervous System Tumor
Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Enrollment
100
Locations
1
Primary Endpoint
Presence of microRNAs and proteins in the blood, cerebrospinal fluid and urine of patients with central nervous system tumors from diagnosis through the course of their treatment
Status
Completed
Last Updated
last year

Overview

Brief Summary

Biomarkers are small molecules that can be detected in the body fluids of patients; they often correlate with the presence of a cancer. MicroRNAs and proteins are small molecules which have recently been discovered in cells. They are known to be responsible for the normal development of cells and when they are disrupted can contribute to the development of cancer. Many previous studies have been done evaluating the expression of microRNAs and proteins in normal tissues as well as a wide variety of cancers.

Recently, microRNAs and proteins from tumor cells have been detected circulating in the blood of patients with cancer. This presents a novel opportunity to use microRNAs and proteins in the blood as an early predictor of cancer as well as a marker of response to therapy. Previous work in our labs have identified miRNAs and proteins in the blood and cerebrospinal fluid (CSF) of pediatric patients with brain tumors.

To determine a longitudinal evaluation of the presence of microRNAs and proteins in the blood, cerebrospinal fluid and urine of patients with central nervous system tumors from diagnosis through the course of their treatment. Though the duration of active treatment varies significantly based upon the diagnosis, patients will be followed for up to 24 months after enrollment onto the study).

Registry
clinicaltrials.gov
Start Date
December 2011
End Date
May 14, 2021
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Patients ages 1 day to 21 years
  • Patients with radiographically and/or histologically confirmed CNS tumors treated at Children's Memorial Hospital and Lurie Children's Hospital in Chicago
  • Patients must be newly diagnosed and have had no prior anticancer therapy (except surgery) for their current diagnosis. The use of steroids is permissible.
  • Patients and/or parents/legal guardians must have signed an informed consent and assent when applicable.

Exclusion Criteria

  • Patients who have completed treatment and do not require routine blood draws and/or lumbar punctures
  • Patients who are considered too ill to participate as determined by their treating physician
  • Patients who are pregnant or lactating

Outcomes

Primary Outcomes

Presence of microRNAs and proteins in the blood, cerebrospinal fluid and urine of patients with central nervous system tumors from diagnosis through the course of their treatment

Time Frame: 24 months

Study Sites (1)

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