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

NCT01849952 | Terminated DMC

• 1 other identifier: D12160
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Astrocytoma; Oligodendroglioma; Oligoastrocytoma; Anaplastic Astrocytoma; Anaplastic Oligodendroglioma; Anaplastic Oligoastrocytoma; Glioblastoma; Brain Tumors; Brain Cancer

Keywords

glioblastoma; miRNA; GBM; astrocytoma

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Patients will be followed for survival every 12 weeks +/- 1 week.

  24 months

Secondary Outcomes (1)

• Progression-Free Survival

  24 Months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (4)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

University of Vermont

Burlington, Vermont, 05405, United States

Location

Related Publications (21)

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Related Links

• Norris Cotton Cancer Center Clinical Trial Page

Biospecimen

Retention: SAMPLES WITH DNA

Blood, tumor tissue, cerebrospinal fluid.

MeSH Terms

Conditions

Astrocytoma; Oligodendroglioma; Glioblastoma; Brain Neoplasms

Condition Hierarchy (Ancestors)

Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Arti B Gaur, PhD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2013
• First Posted: May 9, 2013
• Study Start: October 9, 2013
• Primary Completion: April 12, 2024
• Study Completion: August 25, 2025
• Last Updated: September 15, 2025

Record last verified: 2025-09

Locations

US (4)