Clinical trial NCT01595126: Longitudinal Study of Biomarkers
Official title: A Longitudinal Study of Biomarkers in Pediatric Patients With Central Nervous System Tumors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Central Nervous System Tumor
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
First posted: 2012-05-09
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newly diagnosed patients with central nervous system tumors

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).


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

Primary outcomes:
measure: 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
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
Study officials:
affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
name: Rishi Lulla, MD
role: PRINCIPAL_INVESTIGATOR
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