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OpenTrials
Completed

NCT Number: NCT01595126

Longitudinal Study of Biomarkers

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).

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Key information

Age range

1 day–21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2021
Study completion
2021
First posted
May 9, 2012
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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