MicroRNAs in Patients With Neurofibromatosis Type 1
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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 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 |
|---|
|
Glioma Neurofibromatosis Type 1 |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | MicroRNAs as Disease Markers for Central Nervous System Tumors in Patients With Neurofibromatosis Type 1 |
- Evaluate miRNA expression patterns in tissue of low grade gliomas [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Evaluated miRNA expression patterns between patients with and without imaging findings of gliomas [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | February 2012 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| NF-1 without evidence of glioma |
| NF-1 with evidence of glioma |
Eligibility| Ages Eligible for Study: | 2 Years to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Participation in the study will be offered to patient's ages 2 years to 21 years seen for a routine visit in the Neurofibromatosis Clinic at Children's Memorial Hospital and Lurie Children's Hospital in Chicago.
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| Contact: Carrie Kempler, MPH, CCRP | 773.883.6186 | ckempler@childrensmemorial.org |
| United States, Illinois | |
| Children's Memorial Hospital | Recruiting |
| Chicago, Illinois, United States, 60614 | |
| Contact: Carrie Kempler, MPH 773-883-6186 ckempler@childrensmemorial.org | |
| Contact: Rishi Lulla, MD rlulla@childrensmemorial.org | |
| Principal Investigator: Rishi Lulla, MD | |
| Principal Investigator: | Rishi Lulla, MD | Ann & Robert H Lurie Children's Hospital of Chicago |
More Information
Publications:
| Responsible Party: | Rishi Lulla, Principal Investigator, Children's Memorial Hospital |
| ClinicalTrials.gov Identifier: | NCT01595139 History of Changes |
| Other Study ID Numbers: | 2012-14927 |
| Study First Received: | May 8, 2012 |
| Last Updated: | May 8, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Glioma Nervous System Neoplasms Neurofibromatosis 1 Osteitis Fibrosa Cystica Neurofibromatoses Central Nervous System Neoplasms Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms by Site |
Nervous System Diseases Neurofibroma Nerve Sheath Neoplasms Neoplastic Syndromes, Hereditary Neurocutaneous Syndromes Heredodegenerative Disorders, Nervous System Neurodegenerative Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Genetic Diseases, Inborn Bone Diseases, Endocrine Bone Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on May 23, 2013