Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

MicroRNAs in Patients With Neurofibromatosis Type 1

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01595139
Recruitment Status : Completed
First Posted : May 9, 2012
Last Update Posted : February 5, 2016
Sponsor:
Information provided by (Responsible Party):
Rishi Lulla, Ann & Robert H Lurie Children's Hospital of Chicago

Tracking Information
First Submitted Date May 8, 2012
First Posted Date May 9, 2012
Last Update Posted Date February 5, 2016
Study Start Date February 2012
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 8, 2012)
Evaluate miRNA expression patterns in tissue of low grade gliomas [ Time Frame: 2 years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 8, 2012)
Evaluated miRNA expression patterns between patients with and without imaging findings of gliomas [ Time Frame: 2 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 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.
Condition
  • Glioma
  • Neurofibromatosis Type 1
Intervention Not Provided
Study Groups/Cohorts
  • NF-1 without evidence of glioma
  • NF-1 with evidence of glioma
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 3, 2016)
9
Original Estimated Enrollment
 (submitted: May 8, 2012)
40
Actual Study Completion Date July 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 2 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01595139
Other Study ID Numbers 2012-14927
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Rishi Lulla, Ann & Robert H Lurie Children's Hospital of Chicago
Study Sponsor Ann & Robert H Lurie Children's Hospital of Chicago
Collaborators Not Provided
Investigators
Principal Investigator: Rishi Lulla, MD Ann & Robert H Lurie Children's Hospital of Chicago
PRS Account Ann & Robert H Lurie Children's Hospital of Chicago
Verification Date February 2016