MicroRNAs in Patients With Neurofibromatosis Type 1

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.

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Key information

Conditions

Glioma Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neoplastic Syndromes, Hereditary Nerve Sheath Neoplasms Nervous System Diseases Neurocutaneous Syndromes Neurodegenerative Diseases Neuroectodermal Tumors Neurofibroma Neurofibromatoses Neurofibromatosis 1 Neurofibromatosis Type 1 Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

2 year–21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Evaluate miRNA expression patterns in tissue of low grade gliomas

Time frame: 2 years

Secondary outcomes

Evaluated miRNA expression patterns between patients with and without imaging findings of gliomas

Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Other

Registry information

Official study title

MicroRNAs as Disease Markers for Central Nervous System Tumors in Patients With Neurofibromatosis Type 1

Important dates

Study start: 2012
Primary completion: 2015
Study completion: 2015
First posted: May 9, 2012
Registry last updated: Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed