Clinical Trial - NCT01849952

       

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

Recruiting

Sponsor: Dartmouth-Hitchcock Medical Center

Collaborators:

Information provided by (Responsible party): Principal Investigator Dartmouth-Hitchcock Medical Center Arti Gaur PhD

ClinicalTrials.gov Identifier: NCT01849952

Protocol Info

Short Description: Expression Of microRNA-10b In Gliomas
Long Description: Evaluating the expression levels of microRNA-10b in patients with Gliomas
MGH Status: Open
Sponsor: Norris Cotton Cancer Center
Disease Program: Brain/CNS

Next Steps


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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.
Condition Title Intervention Phase
Astrocytoma Oligodendroglioma Oligoastrocytoma Anaplastic Astrocytoma Anaplastic Oligodendroglioma Anaplastic Oligoastrocytoma Glioblastoma Brain Tumors Brain Cancer
Study Type Observational
Official Title Evaluating the Expression Levels of microRNA-10b in Patients With Gliomas

Primary Outcome Measures

Overall Survival [Time Frame: 24 months] [Designated as safety issue: ]


Secondary Outcome Measures

Progression-Free Survival [Time Frame: 24 Months] [Designated as safety issue: ]

Estimated Enrollment: 200
Study Start Date: May 2013
Estimated Study Completion Date: May 2022
Estimated Primary Completion Date: May 2022

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: All

Accepts Healthly Volunteers: No

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01849952

Locations

  • United States, Massachusetts
    • Tufts Medical Center Boston, Massachusetts, United States, 02111
    • Massachusetts General Hospital Boston, Massachusetts, United States, 02114
  • United States, New Hampshire
    • Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire, United States, 03756
  • United States, Vermont
    • University of Vermont Burlington, Vermont, United States, 05405

Sponsors and Collaborators

Dartmouth-Hitchcock Medical Center

More Information

No publications provided

Responsible Party: Principal Investigator Dartmouth-Hitchcock Medical Center Arti Gaur PhD
ClinicalTrials.gov Identifier: NCT01849952
Other Study ID Numbers:
Study First Received:
Last Updated:
Health Authority:

Keywords provided by Dartmouth-Hitchcock Medical Center:

glioblastoma

miRNA

GBM

astrocytoma

Additional relevant MeSH terms:

Glioblastoma

Brain Neoplasms

Astrocytoma

Oligodendroglioma

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on September 03, 2020