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Evaluating the Expression Levels of MicroRNA-10b in Patients With Gliomas

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Dartmouth-Hitchcock Medical Center
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center Identifier:
First received: May 6, 2013
Last updated: October 13, 2014
Last verified: February 2014

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 cerebrospinal fluid samples will be obtained from patients diagnosed with 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.

Anaplastic Astrocytoma
Anaplastic Oligodendroglioma
Anaplastic Oligoastrocytoma
Brain Tumors
Brain Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluating the Expression Levels of microRNA-10b in Patients With Gliomas

Resource links provided by NLM:

Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Patients will be followed for survival every 12 weeks +/- 1 week.

Secondary Outcome Measures:
  • Progression-Free Survival [ Time Frame: 24 Months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood, tumor tissue, cerebrospinal fluid.

Estimated Enrollment: 200
Study Start Date: May 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients seen in the clinic who are going to be treated with surgery, radiation and medical therapy for gliomas will be eligible for the study.


Inclusion/Exclusion Criteria:

  • 18 years of age
  • 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.
  • Adequate decision making ability to review, discuss and sign a consent form to allow their tumor samples to be used for future human brain tumor biology laboratory research. Determination of capacity to consent is made by one of the co-investigators based on clinical assessment.
  • Patients opting for the standard treatment regimen for their disease as well as ongoing clinical trials will be are eligible to participate in this study. Standard care for newly-diagnosed glioblastomas typically consists of surgical resection followed by radiotherapy with concomitant temozolomide, followed by adjuvant temozolomide chemotherapy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01849952

United States, New Hampshire
Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Cancer Research Nurse    800-639-6918   
Principal Investigator: Arti B Gaur, PhD         
Principal Investigator: Camilo E Fadul, MD         
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Principal Investigator: Arti B Gaur, PhD Dartmouth-Hitchcock Medical Center
  More Information

Additional Information:

Responsible Party: Dartmouth-Hitchcock Medical Center Identifier: NCT01849952     History of Changes
Other Study ID Numbers: D12160
Study First Received: May 6, 2013
Last Updated: October 13, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Dartmouth-Hitchcock Medical Center:

Additional relevant MeSH terms:
Brain Neoplasms
Brain Diseases
Central Nervous System Diseases
Central Nervous System Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Nervous System Diseases
Nervous System Neoplasms
Neuroectodermal Tumors processed this record on November 27, 2014