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

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ClinicalTrials.gov Identifier: NCT01849952

Recruitment Status : Recruiting

First Posted : May 9, 2013

Last Update Posted : October 4, 2023

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View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Arti Gaur, Dartmouth-Hitchcock Medical Center

Study Description

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

Study Design

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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

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Glioblastoma Glioma Anaplastic Astrocytoma Oligodendroglioma Anaplastic Oligodendroglioma Oligoastrocytoma Anaplastic Oligoastrocytoma Neuroepithelioma

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

Progression-Free Survival [ Time Frame: 24 Months ]

Biospecimen Retention: Samples With DNA

Blood, tumor tissue, cerebrospinal fluid.

Eligibility Criteria

Information from the National Library of Medicine

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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.

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.

Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01849952

Contacts

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Contact: Charlotte Esancy	6036530619	charlotte.a.esancy@hitchcock.org

Locations

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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 cancer.research.nurse@dartmouth.edu
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

Investigators

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Principal Investigator:	Arti B Gaur, PhD	Dartmouth-Hitchcock Medical Center

More Information

Additional Information:

Norris Cotton Cancer Center Clinical Trial Page This link exits the ClinicalTrials.gov site

Publications:

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.

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.

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.

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.

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.

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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. Erratum In: Acta Neuropathol. 2007 Nov;114(5):547.

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Responsible Party:	Arti Gaur, PhD, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov 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:


glioblastoma miRNA GBM astrocytoma

Additional relevant MeSH terms:

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Glioblastoma Brain Neoplasms Astrocytoma Oligodendroglioma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type	Neoplasms 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

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