MicroRNAs in Patients With Neurofibromatosis Type 1

Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago (Other)
Overall Status
Completed
CT.gov ID
NCT01595139
Collaborator
(none)
9
1
40.9
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Study Details

Study Description

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 in 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 assess the utility of 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 archived tumor tissue and blood of patients with Neurofibromatosis type 1 (NF-1). The investigators propose a feasibility study to evaluate the presence of microRNAs in archived tumor tissue and the blood of patients with NF-1. If the investigators are able to identify circulating microRNAs in this population of pediatric patients, they will build upon this data in proposing a future study.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    9 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    MicroRNAs as Disease Markers for Central Nervous System Tumors in Patients With Neurofibromatosis Type 1
    Study Start Date :
    Feb 1, 2012
    Actual Primary Completion Date :
    Jul 1, 2015
    Actual Study Completion Date :
    Jul 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    NF-1 without evidence of glioma

    NF-1 with evidence of glioma

    Outcome Measures

    Primary Outcome Measures

    1. Evaluate miRNA expression patterns in tissue of low grade gliomas [2 years]

    Secondary Outcome Measures

    1. Evaluated miRNA expression patterns between patients with and without imaging findings of gliomas [2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 21 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients ages 2 years to 21 years.

    • Patients with NF-1 being followed in the Neurofibromatosis Clinic.

    • Patients have had MRI imaging in the 24 months prior to enrollment on the study.

    • Patients may have known concurrent malignancies such as plexiform neurofibroma.

    • Patients and/or parents/legal guardians must have signed an informed consent and assent when applicable.

    Exclusion Criteria:
    • Patients who have had prior tumor-directed therapy (including chemotherapy and/or radiation)

    • Patients with a prior or current diagnosis of a malignant peripheral nerve sheath tumor.

    • Patients who are considered too ill to participate as determined by their treating physician

    • Patients who are pregnant or lactating

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ann & Robert H. Lurie Children's Hospital of Chicago Chicago Illinois United States 60611

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Rishi Lulla, MD, Ann & Robert H Lurie Children's Hospital of Chicago

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Rishi Lulla, Principal Investigator, Ann & Robert H Lurie Children's Hospital of Chicago
    ClinicalTrials.gov Identifier:
    NCT01595139
    Other Study ID Numbers:
    • 2012-14927
    First Posted:
    May 9, 2012
    Last Update Posted:
    Feb 5, 2016
    Last Verified:
    Feb 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 5, 2016