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OpenTrials
Completed

NCT Number: NCT01541800

Circulating microRNAs as Disease Markers in Pediatric Cancers

MicroRNAs 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 in normal tissues as well as a wide variety of cancers.

Recently, microRNAs from tumor cells have been detected circulating in the blood of patients with cancer. This presents a novel opportunity to use microRNAs in the blood as an early predictor of cancer as well as a marker of response to therapy. No previous studies have been performed evaluating microRNAs in the blood or cerebrospinal fluid of patients with childhood cancers. We propose a feasibility study to evaluate the presence of microRNAs in the blood and cerebrospinal fluid of patients with central nervous system tumors, leukemia and lymphoma who are currently on chemotherapy and undergoing blood draws, lumbar punctures and/or reservoir taps for routine clinical care. If we're able to identify circulating microRNAs in this population of pediatric patients, we will build upon this data in proposing a future study.

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Key information

Age range

3 year–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

  • All children who are in treatment for leukemia, lymphoblastic lymphoma and central nervous system tumors
  • age: greater than 3 years and less than or equal to 21 years of age
  • Patients must be in a phase of their treatment during which routine blood draws, lumbar punctures or CSF sampling from Ommaya reservoirs are required for treatment of their cancers.

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 with a known genetic condition that predisposed them to the development of cancer.

Treatment and study plan

Primary outcomes

  1. Determine if miRNAs are present in the blood of patients with pediatric cancers

    Time frame: 1 year

  2. Determine if miRNAs are detectable in the CSF of patients with pediatric cancers.

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Other

Registry information

Official study title

A Feasibility Study of Circulating microRNAs as Disease Markers in Pediatric Cancers

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Mar 1, 2012
Registry last updated
Jan 24, 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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