Clinical trial NCT01849952: Evaluating the Expression Levels of MicroRNA-10b in Patients With Gliomas
Official title: Evaluating the Expression Levels of microRNA-10b in Patients With Gliomas
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Astrocytoma
Oligodendroglioma
Oligoastrocytoma
Anaplastic Astrocytoma
Anaplastic Oligodendroglioma
Anaplastic Oligoastrocytoma
Glioblastoma
Brain Tumors
Brain Cancer
Keywords: glioblastoma
miRNA
GBM
astrocytoma
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2013-05-09
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Overall Survival
timeFrame: 24 months
Secondary outcomes:
measure: Progression-Free Survival
timeFrame: 24 Months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Arti B Gaur, PhD
role: PRINCIPAL_INVESTIGATOR
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