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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01849952
Recruitment Status : Recruiting
First Posted : May 9, 2013
Last Update Posted : October 4, 2023
Information provided by (Responsible Party):
Arti Gaur, 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.

Condition or disease
Astrocytoma Oligodendroglioma Oligoastrocytoma Anaplastic Astrocytoma Anaplastic Oligodendroglioma Anaplastic Oligoastrocytoma Glioblastoma Brain Tumors Brain Cancer

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluating the Expression Levels of microRNA-10b in Patients With Gliomas
Actual Study Start Date : February 28, 2020
Estimated Primary Completion Date : May 2024
Estimated Study Completion Date : May 2024

Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 24 months ]
    Patients will be followed for survival every 12 weeks +/- 1 week.

Secondary Outcome Measures :
  1. Progression-Free Survival [ Time Frame: 24 Months ]

Biospecimen Retention:   Samples With DNA
Blood, tumor tissue, cerebrospinal fluid.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01849952

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Contact: Charlotte Esancy 6036530619

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United States, Massachusetts
Tufts Medical Center Active, not recruiting
Boston, Massachusetts, United States, 02111
Massachusetts General Hospital Active, not recruiting
Boston, Massachusetts, United States, 02114
United States, New Hampshire
Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Cancer Research Nurse    800-639-6918   
Principal Investigator: Arti B Gaur, PhD         
Principal Investigator: Linton T Evans, MD         
United States, Vermont
University of Vermont Active, not recruiting
Burlington, Vermont, United States, 05405
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
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Principal Investigator: Arti B Gaur, PhD Dartmouth-Hitchcock Medical Center
Additional Information:

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Responsible Party: Arti Gaur, PhD, Dartmouth-Hitchcock Medical Center Identifier: NCT01849952    
Other Study ID Numbers: D12160
First Posted: May 9, 2013    Key Record Dates
Last Update Posted: October 4, 2023
Last Verified: October 2023
Keywords provided by Arti Gaur, Dartmouth-Hitchcock Medical Center:
Additional relevant MeSH terms:
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Brain Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
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