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

Recruiting

• Conditions: Oligodendroglioma; Anaplastic Astrocytoma; Brain Tumors; Anaplastic Oligodendroglioma; Anaplastic Oligoastrocytoma; Oligoastrocytoma; Glioblastoma; Astrocytoma; Brain Cancer

• Registration Number: NCT01849952
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-06
• Study First Submitted QC: 2013-05-08
• Study First Posted: 2013-05-09
• Study Start: 2013-10-09
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-27
• Primary Completion: 2025-05-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Survival	24 months	Patients will be followed for survival every 12 weeks +/- 1 week.

Secondary Outcome Measures

Name	Time	Method
Progression-Free Survival	24 Months

Trial Locations

Locations (4)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States

University of Vermont; 🇺🇸 Burlington, Vermont, United States