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

Sponsor

Dartmouth-Hitchcock Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT01849952

Collaborator

(none)

200

Enrollment

Locations

108

Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Astrocytoma Oligodendroglioma Oligoastrocytoma Anaplastic Astrocytoma Anaplastic Oligodendroglioma Anaplastic Oligoastrocytoma Glioblastoma Brain Tumors Brain Cancer

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

May 1, 2013

Anticipated Primary Completion Date :

May 1, 2022

Anticipated Study Completion Date :

May 1, 2022

Outcome Measures

Primary Outcome Measures

Overall Survival [24 months]
Patients will be followed for survival every 12 weeks +/- 1 week.

Secondary Outcome Measures

Progression-Free Survival [24 Months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Tufts Medical Center	Boston	Massachusetts	United States	02111
2	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
3	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756
4	University of Vermont	Burlington	Vermont	United States	05405