Using Genomic Analysis to Guide Individual Treatment in Glioblastoma
Condition: Glioblastoma
MeSH terms: Glioblastoma
Study type: Observational

Summary: 
      The purpose of this study is to assess whether the use of genomics can help identify patient
      specific treatment choices in cancer. In order to test this, the investigators plan to use
      genomic sequencing technology to identify patient specific mutations in glioblastoma
      multiforme (GBM) as compared to normal cells to identify mutations. Further analysis will
      identify potential treatment targets and whether there are any drugs that could be used for
      these particular mutations. Follow up clinical data will be assessed to see if this
      individualized method of choosing treatment options can improve clinical outcomes in patients
      with GBM.
    

Detailed description: 
      The purpose of the study is to assess whether the use of genomics can identify patient
      specific treatment choices in glioblastoma (GBM) that improves clinical outcomes over
      standard of care. GBM is a devastating disease, the most common primary brain tumor and the
      most aggressive. With current standard therapy, which includes surgery, radiation therapy,
      and chemotherapy with temozolomide, the median survival is only 14.6 months. Once patients
      fail temozolomide, there are no other proven therapies, although other chemotherapies,
      bevacizumab, and tyrosine kinase inhibitors are often tried. Because tumors are different
      between patients, outcomes vary among patients. For example, temozolomide, though recommended
      to all patients with GBM as the only chemotherapy to improve survival, is also known not to
      be effective in patients with o6-methylguanine-DNA-methyltransferase (MGMT) unmethylated
      tumors. This example underscores the idea that if each tumor is different, and that perhaps
      there would be better outcomes if each tumor was treated uniquely.

      Genomic sequencing is a technology that can be employed to identify specific characteristics
      of each tumor as compared to healthy cells. Since 2008, genomic sequencing technology has
      advanced significantly, having entered the era of next generation sequencing, and
      simultaneously, the cost of using this technology has dramatically decreased, nearing the
      cost of some currently used diagnostic tests such as MRI. In this study, the investigators
      plan to assess the usefulness of this technology and its analysis as a method of guiding
      treatment choices for the individual patient with GBM.

      The investigators plan to sequence tumor/normal from GBM patients to identify mutations. The
      mutations will be analyzed for potential drug targets for treatment and recommendations for
      treatment will be suggested if any are identified. If the clinician implements the
      recommendations, clinical follow up data will be collected. The investigators will compare
      clinical outcomes, such as survival to historical controls undergoing standard of care
      treatment to assess whether this genomic guided, individualized therapy determination
      improves these measures.

      In addition, the investigators plan to use next generation sequencing methods to determine
      whether the presence of brain messenger ribonucleic acid (mRNA) and miRNA can be detected in
      the peripheral blood and whether there is biological relevance to their presence if detected.
    

Intervention name(s): Observational study, no intervention
Intervention type(s): Other
Intervention description(s): Observational study, no intervention
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with glioblastoma
      
Biospecimen description: 
      Unused samples retained