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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT01849952
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Dartmouth-Hitchcock Medical Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Arti B Gaur, PhD
Principal Investigator Affiliation Dartmouth-Hitchcock Medical Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Astrocytoma, Oligodendroglioma, Oligoastrocytoma, Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, Anaplastic Oligoastrocytoma, Glioblastoma, Brain Tumors, Brain Cancer
Study Website: View Trial Website

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Tufts Medical Center, Boston, Massachusetts

Status

Active, not recruiting

Address

Tufts Medical Center

Boston, Massachusetts, 02111

Massachusetts General Hospital, Boston, Massachusetts

Status

Active, not recruiting

Address

Massachusetts General Hospital

Boston, Massachusetts, 02114

Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire

Status

Recruiting

Address

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756

Site Contact

Cancer Research Nurse

[email protected]

800-639-6918

University of Vermont, Burlington, Vermont

Status

Active, not recruiting

Address

University of Vermont

Burlington, Vermont, 05405