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

NCT ID: NCT01849952

Last Updated: 2025-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

94 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-09

Study Completion Date

2025-08-25

Brief Summary

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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.

Detailed Description

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Conditions

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Astrocytoma Oligodendroglioma Oligoastrocytoma Anaplastic Astrocytoma Anaplastic Oligodendroglioma Anaplastic Oligoastrocytoma Glioblastoma Brain Tumors Brain Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Arti B Gaur, PhD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Locations

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Tufts Medical Center

Boston, Massachusetts, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

University of Vermont

Burlington, Vermont, United States

Site Status

Countries

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United States

References

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Gaur A, Jewell DA, Liang Y, Ridzon D, Moore JH, Chen C, Ambros VR, Israel MA. Characterization of microRNA expression levels and their biological correlates in human cancer cell lines. Cancer Res. 2007 Mar 15;67(6):2456-68. doi: 10.1158/0008-5472.CAN-06-2698.

Reference Type BACKGROUND
PMID: 17363563 (View on PubMed)

Gaur AB, Holbeck SL, Colburn NH, Israel MA. Downregulation of Pdcd4 by mir-21 facilitates glioblastoma proliferation in vivo. Neuro Oncol. 2011 Jun;13(6):580-90. doi: 10.1093/neuonc/nor033.

Reference Type BACKGROUND
PMID: 21636706 (View on PubMed)

Sathornsumetee S, Rich JN. Designer therapies for glioblastoma multiforme. Ann N Y Acad Sci. 2008 Oct;1142:108-32. doi: 10.1196/annals.1444.009.

Reference Type BACKGROUND
PMID: 18990124 (View on PubMed)

Lo HW. EGFR-targeted therapy in malignant glioma: novel aspects and mechanisms of drug resistance. Curr Mol Pharmacol. 2010 Jan;3(1):37-52. doi: 10.2174/1874467211003010037.

Reference Type BACKGROUND
PMID: 20030624 (View on PubMed)

Nagarajan RP, Costello JF. Epigenetic mechanisms in glioblastoma multiforme. Semin Cancer Biol. 2009 Jun;19(3):188-97. doi: 10.1016/j.semcancer.2009.02.005. Epub 2009 Feb 20.

Reference Type BACKGROUND
PMID: 19429483 (View on PubMed)

Quick A, Patel D, Hadziahmetovic M, Chakravarti A, Mehta M. Current therapeutic paradigms in glioblastoma. Rev Recent Clin Trials. 2010 Jan;5(1):14-27. doi: 10.2174/157488710790820544.

Reference Type BACKGROUND
PMID: 20205684 (View on PubMed)

Stupp R, Mason WP, van den Bent MJ, Weller M, Fisher B, Taphoorn MJ, Belanger K, Brandes AA, Marosi C, Bogdahn U, Curschmann J, Janzer RC, Ludwin SK, Gorlia T, Allgeier A, Lacombe D, Cairncross JG, Eisenhauer E, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumor and Radiotherapy Groups; National Cancer Institute of Canada Clinical Trials Group. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005 Mar 10;352(10):987-96. doi: 10.1056/NEJMoa043330.

Reference Type BACKGROUND
PMID: 15758009 (View on PubMed)

Salcman M. Survival in glioblastoma: historical perspective. Neurosurgery. 1980 Nov;7(5):435-9. doi: 10.1227/00006123-198011000-00001.

Reference Type BACKGROUND
PMID: 6255368 (View on PubMed)

Stewart LA. Chemotherapy in adult high-grade glioma: a systematic review and meta-analysis of individual patient data from 12 randomised trials. Lancet. 2002 Mar 23;359(9311):1011-8. doi: 10.1016/s0140-6736(02)08091-1.

Reference Type BACKGROUND
PMID: 11937180 (View on PubMed)

Brada M, Hoang-Xuan K, Rampling R, Dietrich PY, Dirix LY, Macdonald D, Heimans JJ, Zonnenberg BA, Bravo-Marques JM, Henriksson R, Stupp R, Yue N, Bruner J, Dugan M, Rao S, Zaknoen S. Multicenter phase II trial of temozolomide in patients with glioblastoma multiforme at first relapse. Ann Oncol. 2001 Feb;12(2):259-66. doi: 10.1023/a:1008382516636.

Reference Type BACKGROUND
PMID: 11300335 (View on PubMed)

Westphal M, Hilt DC, Bortey E, Delavault P, Olivares R, Warnke PC, Whittle IR, Jaaskelainen J, Ram Z. A phase 3 trial of local chemotherapy with biodegradable carmustine (BCNU) wafers (Gliadel wafers) in patients with primary malignant glioma. Neuro Oncol. 2003 Apr;5(2):79-88. doi: 10.1093/neuonc/5.2.79.

Reference Type BACKGROUND
PMID: 12672279 (View on PubMed)

Holland EC, Celestino J, Dai C, Schaefer L, Sawaya RE, Fuller GN. Combined activation of Ras and Akt in neural progenitors induces glioblastoma formation in mice. Nat Genet. 2000 May;25(1):55-7. doi: 10.1038/75596.

Reference Type BACKGROUND
PMID: 10802656 (View on PubMed)

Sonoda Y, Ozawa T, Hirose Y, Aldape KD, McMahon M, Berger MS, Pieper RO. Formation of intracranial tumors by genetically modified human astrocytes defines four pathways critical in the development of human anaplastic astrocytoma. Cancer Res. 2001 Jul 1;61(13):4956-60.

Reference Type BACKGROUND
PMID: 11431323 (View on PubMed)

Furnari FB, Fenton T, Bachoo RM, Mukasa A, Stommel JM, Stegh A, Hahn WC, Ligon KL, Louis DN, Brennan C, Chin L, DePinho RA, Cavenee WK. Malignant astrocytic glioma: genetics, biology, and paths to treatment. Genes Dev. 2007 Nov 1;21(21):2683-710. doi: 10.1101/gad.1596707.

Reference Type BACKGROUND
PMID: 17974913 (View on PubMed)

Dell'Albani P. Stem cell markers in gliomas. Neurochem Res. 2008 Dec;33(12):2407-15. doi: 10.1007/s11064-008-9723-8. Epub 2008 May 21.

Reference Type BACKGROUND
PMID: 18493853 (View on PubMed)

Standart N, Jackson RJ. MicroRNAs repress translation of m7Gppp-capped target mRNAs in vitro by inhibiting initiation and promoting deadenylation. Genes Dev. 2007 Aug 15;21(16):1975-82. doi: 10.1101/gad.1591507. No abstract available.

Reference Type BACKGROUND
PMID: 17699746 (View on PubMed)

de Moor CH, Meijer H, Lissenden S. Mechanisms of translational control by the 3' UTR in development and differentiation. Semin Cell Dev Biol. 2005 Feb;16(1):49-58. doi: 10.1016/j.semcdb.2004.11.007. Epub 2005 Jan 12.

Reference Type BACKGROUND
PMID: 15659339 (View on PubMed)

Zhang B, Wang Q, Pan X. MicroRNAs and their regulatory roles in animals and plants. J Cell Physiol. 2007 Feb;210(2):279-89. doi: 10.1002/jcp.20869.

Reference Type BACKGROUND
PMID: 17096367 (View on PubMed)

Miska EA. How microRNAs control cell division, differentiation and death. Curr Opin Genet Dev. 2005 Oct;15(5):563-8. doi: 10.1016/j.gde.2005.08.005.

Reference Type BACKGROUND
PMID: 16099643 (View on PubMed)

Sevignani C, Calin GA, Siracusa LD, Croce CM. Mammalian microRNAs: a small world for fine-tuning gene expression. Mamm Genome. 2006 Mar;17(3):189-202. doi: 10.1007/s00335-005-0066-3. Epub 2006 Mar 3.

Reference Type BACKGROUND
PMID: 16518686 (View on PubMed)

Louis DN, Ohgaki H, Wiestler OD, Cavenee WK, Burger PC, Jouvet A, Scheithauer BW, Kleihues P. The 2007 WHO classification of tumours of the central nervous system. Acta Neuropathol. 2007 Aug;114(2):97-109. doi: 10.1007/s00401-007-0243-4. Epub 2007 Jul 6.

Reference Type BACKGROUND
PMID: 17618441 (View on PubMed)

Related Links

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Other Identifiers

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D12160

Identifier Type: -

Identifier Source: org_study_id

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