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Predictive Role and HuR Mechanisms of Regulation in the Brain Tumours (HUR)

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ClinicalTrials.gov Identifier: NCT03615391
Recruitment Status : Unknown
Verified August 2018 by Central Hospital, Nancy, France.
Recruitment status was:  Recruiting
First Posted : August 3, 2018
Last Update Posted : August 3, 2018
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

Study Description
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Brief Summary:

The HuR protein binds to AU-rich elements in the untranslated 3' region of messenger RNA, thus allowing their stabilization. Its targets include multiple cell cycle regulating proteins, cytokines and growth factors. In some cancers, its overall expression level but especially its cytoplasmic expression are correlated to a higher grade and constitute a poor prognostic factor. To date, HuR's deregulation mechanisms remain poorly understood. A few experimental studies have shown the role of certain microARNS, or of post-translational modifications. In brain tumours, HuR expression, its prognostic value and its deregulation mechanisms have been little studied to date.

The first part of the project will be a monocentric retrospective study of human brain tumour samples collected during biopsies or surgical removal. We will first evaluate HuR expression in 140 brain tumors, including 40 meningiomas and 100 gliomas of increasing grade, and look for a correlation with histological grade and survival. We will then apprehend the consequences of its deregulation by analyzing different factors involved in the cell cycle and stress response markers. Finally, we will study the mechanisms of HuR deregulation by analyzing the expression level of several microRNAs (miR16, miR519) and the methylation state of HuR.

The second part of the project will focus on cell lines from human brain tumours. We will first attempt to confirm the interactions between HuR and markers involved in the cell cycle and stress response, then the regulation of HuR by its methylation and by microRNAs (miR16 and miR519). We would also like to study the consequences of HuR inhibition and overexpression on cell proliferation, under various conditions of induced stress (pharmacological agents, physical stress). Finally, we will study the consequences of an experimental vitamin B12 deficiency on HuR expression and tumor cell adaptation to stress.


Condition or disease
Brain Tumours

Study Design
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Study Type : Observational
Estimated Enrollment : 140 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Predictive Role and HuR Mechanisms of Regulation in the Brain Tumours
Actual Study Start Date : October 1, 2012
Actual Primary Completion Date : October 1, 2015
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. level HuR's immunohistochemical expression [ Time Frame: at diagnosis ]
  2. time progression-free [ Time Frame: through study completion, an average 3 years ]
  3. time overall survival [ Time Frame: through study completion, an average 3 years ]

Secondary Outcome Measures :
  1. methyl-HuR level [ Time Frame: 1 day at diagnosis ]
  2. PHH3 level [ Time Frame: 1 day at diagnosis ]
  3. MCM6 level [ Time Frame: 1 day at diagnosis ]
  4. Ki-67 level [ Time Frame: 1 day at diagnosis ]
  5. cyclin D1 level [ Time Frame: 1 day at diagnosis ]
  6. Bcl-2 [ Time Frame: 1 day at diagnosis ]
  7. pPERK level [ Time Frame: 1 day at diagnosis ]
  8. ATF6 level [ Time Frame: 1 day at diagnosis ]
  9. SIRT1 level [ Time Frame: 1 day at diagnosis ]
  10. IRE-1α level [ Time Frame: 1 day at diagnosis ]
  11. HIF-1α level [ Time Frame: 1 day at diagnosis ]
  12. caspase 3 activated level [ Time Frame: 1 day at diagnosis ]
  13. VEGF level [ Time Frame: 1 day at diagnosis ]
  14. CARM1 level [ Time Frame: 1 day at diagnosis ]
    Vitamin B12 metabolism

  15. miR16 expression level by qRT-PCR [ Time Frame: 1 day at diagnosis ]
  16. miR519 expression level by qRT-PCR [ Time Frame: 1 day at diagnosis ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patient with braim tumor (meningioma, glioma, glioblastoma)
Criteria

Inclusion Criteria

  • Grade I and II meningiomas (WHO)
  • Diffuse grade II glioma (astrocytoma, oligodendroglioma)
  • Grade III anaplastic gliomas (astrocytomas and anaplastic oligodendrogliomas)
  • Grade IV glioblastoma
Contacts and Locations
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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): NCT03615391


Contacts
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Contact: Guillaume GAUCHOTTE, PU-PH g.gauchotte@chru-nancy.fr

Locations
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France
Guillaume GAUCHOTTE Recruiting
Vandoeuvre Les Nancy, France, 54511
Contact: Guillaume GAUCHOTTE, PU-PH         
Sponsors and Collaborators
Central Hospital, Nancy, France
More Information
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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT03615391    
Other Study ID Numbers: 2011/APJC/HUR/GAUCHOTTE/MS
First Posted: August 3, 2018    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018
Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
 Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases