Brief Title
MicroRNAs in Patients With Neurofibromatosis Type 1
Official Title
MicroRNAs as Disease Markers for Central Nervous System Tumors in Patients With Neurofibromatosis Type 1
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.
Study Type
Observational
Primary Outcome
Evaluate miRNA expression patterns in tissue of low grade gliomas
Secondary Outcome
Evaluated miRNA expression patterns between patients with and without imaging findings of gliomas
Condition
Glioma
Study Arms / Comparison Groups
NF-1 without evidence of glioma
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
9
Start Date
February 2012
Completion Date
July 2015
Primary Completion Date
July 2015
Eligibility Criteria
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
Gender
All
Ages
2 Years - 21 Years
Accepts Healthy Volunteers
No
Contacts
Rishi Lulla, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01595139
Organization ID
2012-14927
Responsible Party
Principal Investigator
Study Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Study Sponsor
Rishi Lulla, MD, Principal Investigator, Ann & Robert H Lurie Children's Hospital of Chicago
Verification Date
February 2016