Circulating microRNAs as Disease Markers in Pediatric Cancers

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Rishi Lulla, Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier:
NCT01541800
First received: February 24, 2012
Last updated: January 27, 2014
Last verified: January 2014

February 24, 2012
January 27, 2014
March 2010
July 2015   (final data collection date for primary outcome measure)
  • Determine if miRNAs are present in the blood of patients with pediatric cancers [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Determine if miRNAs are detectable in the CSF of patients with pediatric cancers. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01541800 on ClinicalTrials.gov Archive Site
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Circulating microRNAs as Disease Markers in Pediatric Cancers
A Feasibility Study of 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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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Retention:   Samples Without DNA
Description:

whole blood and cerebral spinal fluid

Non-Probability Sample

All children who are in treatment for leukemia, lymphoblastic lymphoma and central nervous system tumors

  • Leukemia
  • Lymphoma
  • Central Nervous System
Not Provided
Patients
All children who are in treatment for leukemia, lymphoblastic lymphoma and central nervous system tumors between 3 years and 21 years of age

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
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July 2015   (final data collection date for primary outcome measure)

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.
Both
3 Years to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01541800
2010-14205
No
Rishi Lulla, Ann & Robert H Lurie Children's Hospital of Chicago
Ann & Robert H Lurie Children's Hospital of Chicago
Not Provided
Principal Investigator: Rishi Lulla, MD Ann & Robert H Lurie Children's Hospital of Chicago
Ann & Robert H Lurie Children's Hospital of Chicago
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP