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MicroRNA-10B


Title Evaluating the Expression Levels of MicroRNA-10B in Patients with Primary Gliomas
Therapeutic Area Brain Cancer, Brain Tumors
Principal Investigator Suriya Jeyapalan, MD
Min Age 18 Years
Gender Both
Contact Jessika E Silva
617 636-8897
More Information https://clinicaltrials.gov/ct2/show/NCT01849952

Overview

MicroRNAs (miRNA) are molecular biomarkers that post-transcriptionally control target genes. Deregulated miRNA expression has been observed in diverse cancers. In high grade gliomas, known as glioblastomas, the investigators have identified an oncogenic miRNA, miRNA-10b (mir-10b) that is expressed at higher levels in glioblastomas than in normal brain tissue. This study tests the hypothesis that in primary glioma samples mir-10b expression patterns will serve as a prognostic and diagnostic marker. This study will also characterize the phenotypic and genotypic diversity of glioma subclasses. Furthermore, considering the critical function of anti-mir-10b in blocking established glioblastoma growth, the investigators will test in vitro the sensitivity of individual primary tumors to anti-mir-10b treatment. Tumor, blood and when feasible, cerebrospinal fluid samples will be obtained from patients diagnosed with Grade III and Grade IV gliomas over a period of two years. These samples will be examined for mir-10b expression levels. Patient survival, as well as tumor grade and genotypic variations will be correlated to mir-10b expression levels.

Study Details

Inclusion Criteria

  • Brain tumor(s) to be resected for clinical reasons.
  • Histological pathology confirmation that tumor is of glial origin, WHO Grade II, III or IV.
  • Adequate tissue available for processing as determined by Pathology.

Exclusion Criteria

  • Younger than 18 years old.
  • Inadequate decision making ability to review, discuss and sign consent form to allow their tumor samples to be used for future human brain tumor biology research.

Study Requirements

All patients having resection for primary brain tumors who have consented to participate in this trials will have tissue and cerebrospinal fluid (when feasible) collected at the time of surgical resection. Diagnosis will be provided by pathology, and only WHO grade II, III and IV primary brain tumors will be analyzed per protocol.

The study requires about ½ teaspoon of any extra cerebrospinal fluid that is collected during surgery, when feasible.

If it is determined that the diagnosis is grade III or grade IV glioma, eligibility is still feasible for this study; we will then collect a few more blood samples starting at about 2 weeks after surgery and several times during treatment. In total, we will collect up to 7 blood samples for this study. We will collect about 25 mL (1 ½ tablespoons) of blood at each time point.

All blood samples will be taken during routine blood draws that are part of standard of care treatment. No extra visits to the clinic are required for this study.

If more surgeries are required to remove tissue from a brain tumor, samples from excess tissue and cerebrospinal fluid will be collected from these surgeries for use in this study.

We'll also ask participants to complete quality of life questionnaires; one before surgery, and one at the end of your treatment.

We will also collect information about the patient's health status from the patient's medical record every 12 weeks for the remaining of the patient's life.

There will be no extra doctor's visits, no extra cost and blood will be collected during routine blood draws as part of routine visits to the doctor's office.