Circulating microRNAs as Disease Markers in Pediatric Cancers

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Rishi Lulla, Children's Memorial Hospital

ClinicalTrials.gov Identifier:

NCT01541800

First received: February 24, 2012

Last updated: March 13, 2012

Last verified: March 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

February 24, 2012

Last Updated Date

March 13, 2012

Start Date ^ICMJE

March 2010

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01541800 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Circulating microRNAs as Disease Markers in Pediatric Cancers

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples Without DNA

Description:

whole blood and cerebral spinal fluid

Sampling Method

Non-Probability Sample

Study Population

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

Condition ^ICMJE

Leukemia
Lymphoma
Central Nervous System

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Patients

All children who are in treatment for leukemia, lymphoblastic lymphoma and central nervous system tumors between 3 years and 21 years of age

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

3 Years to 21 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01541800

Other Study ID Numbers ^ICMJE

2010-14205

Has Data Monitoring Committee

Responsible Party

Rishi Lulla, Children's Memorial Hospital

Study Sponsor ^ICMJE

Ann & Robert H Lurie Children's Hospital of Chicago

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Rishi Lulla, MD

Ann & Robert H Lurie Children's Hospital of Chicago

Information Provided By

Ann & Robert H Lurie Children's Hospital of Chicago

Verification Date

March 2012

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

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