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Trial record 20 of 287 for:    Cerebral Hypoxia

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
Sponsor:
Collaborator:
Azienda Ospedaliero, Universitaria Pisana
Information provided by (Responsible Party):
Guido Bocci, University of Pisa

Brief Summary:

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
Glioblastoma

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 65 participants
Observational Model: Case-Only
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
GBM patients
patients with diagnosis of glioblastoma treated with concomitant radio-chemotherapy with temozolomide as Stupp protocol will be evaluated for pharmacogenetic evaluation



Primary Outcome Measures :
  1. progression-free survival [ Time Frame: 12 months ]
    progression-free survival in GBM patients with different MC4R genotypes and treated with combined radiotherapy and temozolomide


Secondary Outcome Measures :
  1. 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
Blood samples (3 ml) will be collected in EDTA tubes and stored at -80°C from glioblastoma patients


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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 with diagnosis of glioblastoma treated with concomitant radio-chemotherapy with temozolomide as Stupp protocol will be evaluated for pharmacogenetic evaluation.
Criteria

Inclusion Criteria:

  • Patients with proven diagnosis of GBM
  • Patients suitable for Radio-chemotherapy with temozolomide
  • Eastern Cooperative Oncology Group Performance Status 0-2
  • Age ≥ 18 years
  • Willingness to provide a blood sample for genetic analysis

Exclusion Criteria:

  • Patients previously treated with radio or chemotherapy for central nervous system cancer

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): NCT02458508


Locations
Italy
Division of Radiotherapy, Department Of Oncology, University Hospital of Pisa
Pisa, Italy, 56126
Sponsors and Collaborators
University of Pisa
Azienda Ospedaliero, Universitaria Pisana
Investigators
Principal Investigator: Guido Bocci, MD, PhD University of Pisa

Publications of Results:
Responsible Party: Guido Bocci, Asssistant Professor; MD, PhD, University of Pisa
ClinicalTrials.gov Identifier: NCT02458508     History of Changes
Other Study ID Numbers: University of Pisa
First Posted: June 1, 2015    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: October 2017

Keywords provided by Guido Bocci, University of Pisa:
MC4R
chemotherapy
radiotherapy

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue