Circulating microRNAs as Disease Markers in Pediatric Cancers
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Purpose
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.
| Condition |
|---|
|
Leukemia Lymphoma Central Nervous System |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | A Feasibility Study of Circulating microRNAs as Disease Markers in Pediatric Cancers |
- 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 ]
Biospecimen Retention: Samples Without DNA
whole blood and cerebral spinal fluid
| Estimated Enrollment: | 20 |
| Study Start Date: | March 2010 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Patients
All children who are in treatment for leukemia, lymphoblastic lymphoma and central nervous system tumors between 3 years and 21 years of age
|
Eligibility| Ages Eligible for Study: | 3 Years to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
All children who are in treatment for leukemia, lymphoblastic lymphoma and central nervous system tumors
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.
Contacts and Locations| United States, Illinois | |
| Children's Memorial Hospital | |
| Chicago, Illinois, United States, 60614 | |
| Principal Investigator: | Rishi Lulla, MD | Ann & Robert H Lurie Children's Hospital of Chicago |
More Information
Publications:
| Responsible Party: | Rishi Lulla, Attending, Children's Memorial Hospital |
| ClinicalTrials.gov Identifier: | NCT01541800 History of Changes |
| Other Study ID Numbers: | 2010-14205 |
| Study First Received: | February 24, 2012 |
| Last Updated: | March 13, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Leukemia Lymphoma Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013