Using Genomic Analysis to Guide Individual Treatment in Glioblastoma
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02725684 |
Recruitment Status :
Completed
First Posted : April 1, 2016
Last Update Posted : October 25, 2017
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Glioblastoma | Other: Observational study, no intervention |
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.
Study Type : | Observational |
Actual Enrollment : | 36 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Using Genomic Analysis to Guide Individual Treatment in Glioblastoma |
Actual Study Start Date : | March 12, 2015 |
Actual Primary Completion Date : | July 7, 2017 |
Actual Study Completion Date : | July 7, 2017 |

Group/Cohort | Intervention/treatment |
---|---|
Glioblastoma
Observational study, no intervention
|
Other: Observational study, no intervention
Observational study, no intervention |
- Identification of targetable variants in the tumor [ Time Frame: 6 months ]Identification of variants in each tumor that are potential drug targets
Biospecimen Retention: Samples With DNA

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 3 Years to 100 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Histologically confirmed glioblastoma multiforme
- Enough tumor tissue available from initial surgery to obtain at least 5 ug DNA and 5 ug RNA
- Sufficient blood sample to obtain 5 ug DNA and 5 ug RNA
- Karnofsky score at least 60
- Life expectancy at least 6 months
Exclusion Criteria:
- Subjects not interested in further treatment of their brain tumor

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): NCT02725684
United States, New York | |
New York University Langone Medical Center | |
New York, New York, United States, 10016 | |
Memorial Sloan Kettering Cancer Center | |
New York, New York, United States, 10017 | |
Rockefeller University | |
New York, New York, United States, 10065 | |
Weill Cornell Medical College | |
New York, New York, United States, 10065 | |
Lenox Hill Hospital | |
New York, New York, United States, 10075 | |
North Shore University Hospital | |
New York, New York, United States, 11030 | |
Montefiore Medical Center | |
The Bronx, New York, United States, 10467 |
Principal Investigator: | Robert Darnell, MD, PhD | Rockefeller University |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Rockefeller University |
ClinicalTrials.gov Identifier: | NCT02725684 |
Other Study ID Numbers: |
RDA-0837 |
First Posted: | April 1, 2016 Key Record Dates |
Last Update Posted: | October 25, 2017 |
Last Verified: | October 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | The data will be coded and shared with members of the collaboration. |
Glioblastoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |