Retrospective Evaluation of Melanocortin Receptor 4 Polymorphisms in Patients With GBM Treated With Radiochemotherapy (GLIOMELA)
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|ClinicalTrials.gov Identifier: NCT02458508|
Recruitment Status : Completed
First Posted : June 1, 2015
Last Update Posted : October 25, 2017
Glioblastoma (GBM) accounts for approximately 50% of all glioma and among these tumors, are the most malignant. The cells of origin of glioma are still undefined, but the most putative target cells include astrocytes, neural stem cells, and oligodendrocyte precursor cells. The current standard of care for patients with newly diagnosed GBM includes temozolomide and radiotherapy . Melanocortins are peptides with well-recognized anti-inflammatory and neuroprotective activity. Of the five known melanocortin receptors (MCRs), only subtype 4 is present in astrocytes and it is expressed predominantly in the brain. No data are currently available on MC4R gene polymorphisms and gliomas or their relationship with radiotherapy or chemotherapy.
Aim. Given the association of MC4R with antiinflammatory activity, neuroprotection, induction of neural stem/progenitor cell proliferation in brain hypoxia, and prevention of astrocyte apoptosis, the aim of this study is to retrospectively evaluate the possible prognostic/predictive role of the MC4R SNPs on GBM therapy.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||65 participants|
|Official Title:||Retrospective Evaluation of Prognostic and/or Predictive Profile of Melanocortin Receptor-4 Gene Polymorphisms in Patient With a Diagnosis of Glioblastoma Treated With Upfront Concomitant Radio-chemotherapy or Chemotherapy|
|Study Start Date :||March 2015|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||March 2017|
patients with diagnosis of glioblastoma treated with concomitant radio-chemotherapy with temozolomide as Stupp protocol will be evaluated for pharmacogenetic evaluation
- progression-free survival [ Time Frame: 12 months ]progression-free survival in GBM patients with different MC4R genotypes and treated with combined radiotherapy and temozolomide
- overall survival [ Time Frame: 24 months ]overall survival in GBM patients with different MC4R genotypes and treated with combined radiotherapy and temozolomide
Biospecimen Retention: Samples With DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02458508
|Division of Radiotherapy, Department Of Oncology, University Hospital of Pisa|
|Pisa, Italy, 56126|
|Principal Investigator:||Guido Bocci, MD, PhD||University of Pisa|