MicroRNAs in Patients With Neurofibromatosis Type 1
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| ClinicalTrials.gov Identifier: NCT01595139 |
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Recruitment Status :
Completed
First Posted : May 9, 2012
Last Update Posted : February 5, 2016
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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 |
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| Glioma Neurofibromatosis Type 1 |
| 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 : | February 2012 |
| Actual Primary Completion Date : | July 2015 |
| Actual Study Completion Date : | July 2015 |
| Group/Cohort |
|---|
| NF-1 without evidence of glioma |
| NF-1 with evidence of glioma |
- Evaluate miRNA expression patterns in tissue of low grade gliomas [ Time Frame: 2 years ]
- Evaluated miRNA expression patterns between patients with and without imaging findings of gliomas [ Time Frame: 2 years ]
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| Ages Eligible for Study: | 2 Years to 21 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01595139
| United States, Illinois | |
| Ann & Robert H. Lurie Children's Hospital of Chicago | |
| Chicago, Illinois, United States, 60611 | |
| Principal Investigator: | Rishi Lulla, MD | Ann & Robert H Lurie Children's Hospital of Chicago |
| 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 Key Record Dates |
| Last Update Posted: | February 5, 2016 |
| Last Verified: | February 2016 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
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Neurofibromatoses Neurofibromatosis 1 Neurofibroma Nerve Sheath Neoplasms Neoplasms, Nerve Tissue Neoplasms by Histologic Type Neoplasms Neoplastic Syndromes, Hereditary Neurocutaneous Syndromes |
Nervous System Diseases Heredodegenerative Disorders, Nervous System Neurodegenerative Diseases Genetic Diseases, Inborn Peripheral Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Neoplasms Nervous System Neoplasms |